Generic Name: eflornithine topical (ee FLOOR nih theen)
Brand Names: Vaniqa
Eflornithine interferes with a chemical in the hair follicles of the skin. This results in slower hair growth where eflornithine topical is applied.
Eflornithine topical is used to reduce unwanted facial hair in women. Eflornithine topical does not permanently remove hair or "cure" unwanted facial hair. Eflornithine topical will help you manage your condition and improve your appearance.
Eflornithine topical may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about eflornithine topical? Eflornithine topical is for external use only.Continue to use eflornithine topical even if you do not see immediate results. Reduction in facial hair occurs gradually. Improvement may be seen as early as 4 to 8 weeks of treatment, however it may take longer in some individuals. If no improvement is seen after 6 months of use, treatment with eflornithine topical should be discontinued. Hair growth may return to pretreatment levels approximately 8 weeks after discontinuation of treatment with eflornithine topical.
Who should not use eflornithine topical? Do not use eflornithine topical if you have had an allergic reaction to it in the past. Eflornithine topical is in the FDA pregnancy category C. This means that it is not known whether eflornithine topical will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is also not known whether eflornithine passes into breast milk. Do not use eflornithine topical without first talking to your doctor if you are breast-feeding a baby. Eflornithine topical has not been approved for use by children younger than 12 years of age. How should I use eflornithine topical? Apply eflornithine topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.Eflornithine topical does not permanently remove hair or "cure" unwanted facial hair. It is not a hair remover (depilatory). You will need to continue using your current hair removal techniques. Eflornithine topical will help you manage your condition and improve your appearance.
Eflornithine topical is for external use only.Eflornithine topical is usually applied twice daily, at least eight hours apart, or as directed by your doctor.
Wash your hands before and after each application of eflornithine topical.
Remove any facial hair that is present using your current hair removal techniques. Wait at least 5 minutes after hair removal before applying eflornithine topical. Apply a thin layer of eflornithine topical to the affected areas of the face and nearby affected areas under the chin and rub it in thoroughly.
Cosmetics or sunscreen may be used after applying eflornithine topical, but you should wait a few minutes to allow the treatment to be absorbed before applying them.
Do not wash the treatment areas for at least 4 hours after application of eflornithine topical. Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wash the area with water. If eflornithine topical gets in your eyes, rinse them thoroughly with water and contact your doctor.Eflornithine topical may cause temporary redness, rash, burning, stinging, or tingling, especially if it is applied to broken or irritated skin. If irritation develops, reduce the application of eflornithine topical to once a day. If irritation continues, stop using eflornithine topical and contact your doctor.
Continue to use eflornithine topical even if you do not see immediate results. Reduction in facial hair occurs gradually. Improvement may be seen as early as 4 to 8 weeks of treatment, however it may take longer in some individuals. If no improvement is seen after 6 months of use, treatment with eflornithine topical should be discontinued. Hair growth may return to pretreatment levels approximately 8 weeks after discontinuation of treatment with eflornithine topical.
Store eflornithine topical at room temperature away from moisture and heat. Do not allow the medication to freeze. What happens if I miss a dose?If you miss a dose of eflornithine topical, skip the dose you missed and apply your next regularly scheduled dose as directed. Do not apply a double dose of this medication or try to "make up" a missed dose.
What happens if I overdose?An overdose of eflornithine topical is not likely to occur. If the cream has been ingested, or if you suspect an overdose has occurred, contact your doctor, hospital emergency room, or poison control center for advice.
What should I avoid while using eflornithine topical? Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wash the area with water. If eflornithine topical gets in your eyes, rinse thoroughly with water and contact your doctor. Eflornithine topical side effectsEflornithine topical may cause temporary redness, rash, burning, stinging, or tingling, especially if it is applied to broken or irritated skin. If irritation develops, reduce the application of eflornithine topical to once a day. If irritation continues, stop using eflornithine topical and contact your doctor.
Hair bumps (folliculitis) may also occur. If these continue, contact your doctor.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Eflornithine topical Dosing InformationUsual Adult Dose for Hirsutism:
Apply a thin layer of eflornithine topical cream to affected areas of the face and adjacent involved areas under the chin and rub in thoroughly. Do not wash treated area for at least 4 hours. Use twice a day, allowing at least 8 hours between applications or as directed by a physician.
Continue to use hair removal techniques as needed in conjunction with eflornithine. Apply eflornithine at least 5 minutes after hair removal. Cosmetics or sunscreens may be applied over treated areas after cream has dried.
Before using eflornithine topical, talk to your doctor if you are taking any other prescription or over-the-counter medications, especially if you are using any other topical preparations. You may not be able to use eflornithine topical, or you may require a dosage adjustment or special monitoring during treatment.
Drugs other than those listed here may also interact with eflornithine topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines.
More eflornithine topical resources Eflornithine topical Side Effects (in more detail) Eflornithine topical Dosage Eflornithine topical Use in Pregnancy & Breastfeeding Eflornithine topical Support Group 8 Reviews for Eflornithine - Add your own review/rating Vaniqa Monograph (AHFS DI) Vaniqa Topical Advanced Consumer (Micromedex) - Includes Dosage Information Vaniqa Cream MedFacts Consumer Leaflet (Wolters Kluwer) Vaniqa Consumer Overview Compare eflornithine topical with other medications Hirsutism Where can I get more information? Your pharmacist has additional information about eflornithine topical written for health professionals that you may read.See also: eflornithine side effects (in more detail)
Kemicetine Succinate Injection
1. Name Of The Medicinal Product
Kemicetine Succinate Injection or Chloramphenicol Sodium Succinate 1.377g Injection
2. Qualitative And Quantitative CompositionChloramphenicol sodium succinate (BP) 1.377 g
– equivalent to laevorotatory chloramphenicol 1.0 g
3. Pharmaceutical FormFreeze dried powder for injection.
4. Clinical Particulars 4.1 Therapeutic IndicationsKemicetine (chloramphenicol) is a broad-spectrum antibiotic and is active against many gram-negative organisms, Spirillae and Rickettsia. Kemicetine should not be used for trivial infections due to the possibility of severe blood dyscrasias, which may prove fatal.
Kemicetine succinate is indicated for typhoid, meningitis caused by H. influenzae and other serious infections caused by bacteria susceptible to chloramphenicol. It is also indicated wherever chloramphenicol is deemed the antibiotic of choice and oral administration is not possible, or where higher than usual blood concentrations are required.
4.2 Posology And Method Of AdministrationTo be given by i.v. or i.m. injection.
In order to ensure rapid attainment of high blood levels, Kemicetine succinate is best administered by i.v. injection. Where this is not possible, however, intramuscular administration may be used, although it should be borne in mind that absorption may be slow and unpredictable.
The injection should be reconstituted with Water for Injections, Sodium ChlorideInjection, or Dextrose Injection 5 %. The following dilution table may be useful for the administration of a proportion of the contents of a vial:
Concentration
Solution strength
Volume of diluent to be added
Total volume after dilution
40%
400 mg/ml
1.7 ml
2.5 ml
25%
250 mg/ml
3.2 ml
4.0 ml
20%
200 mg/ml
4.2 ml
5.0 ml
The dose administered and the concentration used is dependent on the severity of the infection. The recommended standard dosage is as follows:
Adults : The equivalent of 1 g of chloramphenicol every 6-8 hours.
Elderly : The usual adult dosage should be given subject to normal hepatic and renal function.
Children : The equivalent of 50 mg/kg chloramphenicol according to body weight, daily in divided doses every 6 hours (this dose should not be exceeded). The patient should be carefully observed for signs of toxicity.
Neonates and Premature Infants : 25 mg/kg in divided doses.
Only 10% or lower concentrations to be used. The 10% solution can be prepared by extracting 5ml of the 20% solution and adding 5ml of diluent (Water for Injections, Sodium Chloride Injection or Dextrose Injection 5%) under aseptic conditions.
The 10 % solution should be given by intravenous injection over a period of about a minute, or in a larger volume of fluid, by slow intravenous infusion. The concurrent administration of i.v. Kemicetine succinate with topical treatment has been found to be very effective in the treatment of osteomyelitic foci, abscesses, empyema and skin and urinary infections.
In exceptional cases, such as patients with septicaemia or meningitis, dosage schedule up to 100 mg/kg/day may be prescribed. However, these high doses should be decreased as soon as clinically indicated. To prevent relapses treatment should be continued after the temperature has returned to normal for 4 days in rickettsial diseases and for 8 – 10 days in typhoid fever.
4.3 ContraindicationsKemicetine succinate is contra-indicated in patients with a previous history of sensitivity and/or toxic reaction to chloramphenicol.
4.4 Special Warnings And Precautions For Use Kemicetine is to be administered only under the direction of a medical practitioner.Chloramphenicol may cause severe bone marrow depression which may lead to agranulocytosis, thrombocytopenic purpura or aplastic anaemia. These effects of the haemopoietic system are usually associated with a high dose, prolonged administration, or repeated courses, but they may occur at relatively low doses.
Chloramphenicol should not be used in the treatment of any infection for which a less toxic antibiotic is available. It is also advisable to perform blood tests in the case of prolonged or repeated administration. Evidence of any detrimental effect on blood elements is an indication to discontinue therapy immediately.
The dosage of chloramphenicol should be reduced in patients with impairment of hepatic or renal function.
Because of its toxic nature it is important to monitor serum levels of this antibiotic particularly in new-born and premature infants, in the elderly, in patients with renal or hepatic disease and in those receiving other drugs with which chloramphenicol may interact.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction Chloramphenicol has been shown to interact with, and enhance the effects of coumarin anticoagulants, some hypoglycaemic agents (e.g. tolbutamide) and phenytoin. When given concurrently, a dose reduction of these agents may be necessary.Plasma concentrations of chloramphenicol may be reduced with concomitant usage of phenobarbital and rifampicin.
4.6 Pregnancy And Lactation The use of chloramphenicol is contra-indicated in pregnancy and whilst breastfeeding. 4.7 Effects On Ability To Drive And Use Machines None stated. 4.8 Undesirable Effects The following may become apparent after chloramphenicol treatment: dryness of the mouth, nausea and vomiting, diarrhoea, urticaria, optic neuritis with blurring or temporary loss of vision, peripheral neuritis, headache and depression.Superinfection by fungi e.g. C. albicans in the gastro-intestinal tract or vagina, may also occur due to the disturbance of normal bacterial flora.
Chloramphenicol may also impede the development of immunity and should therefore not be given during active immunisation.
The “Grey syndrome” may occur after administration in patients with immature hepatic metabolic capacity, i.e. infants and neonates, usually in those treated with doses substantially in excess of those recommended.
4.9 OverdoseGeneral supportive therapy.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesAfter administration chloramphenicol is rapidly released from chloramphenicol sodium succinate. Chloramphenicol is active against many gram-positive and gram negative organisms, Spirillae and Rickettsia. It acts b interfering with bacterial protein synthesis. Chloramphenicol is widely distributed in body tissues and fluids and enters the cerebrospinal fluid.
Chloramphenicol sodium succinate, free chloramphenicol and metabolites are excreted in the urine.
5.2 Pharmacokinetic Properties After intravenous administration of chloramphenicol succinate every 6 hours elimination half-lives were 4.03 hours for chloramphenicol and 2.65 hours for chloramphenicol succinate. After intravenous chloramphenicol sodium succinate, steady state peak concentrations were reached on average 18.0 minutes after cessation of the infusion.In infants and children aged 3 days to 16 years the apparent half-life was extremely variable ranging from 1.7 to 12.0 hours.
5.3 Preclinical Safety Data None stated. 6. Pharmaceutical Particulars 6.1 List Of ExcipientsThere are no excipients.
6.2 IncompatibilitiesNone stated.
6.3 Shelf Life48 months.
6.4 Special Precautions For StorageKeep container in the outer carton.
6.5 Nature And Contents Of Container Type III colourless glass vials with grey chlorobutyl rubber bung and aluminium seal.Pack size : 1, 20 or 25 vials.
6.6 Special Precautions For Disposal And Other Handling To be reconstituted with Water for Injection, Sodium Chloride Injection or Dextrose Injection 5%. 7. Marketing Authorisation Holder Pharmacia LimitedRamsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
8. Marketing Authorisation Number(S)PL 00032/0341
9. Date Of First Authorisation/Renewal Of The Authorisation 13th September 2002/ 2nd March 2009 10. Date Of Revision Of The TextMarch 2009
LEGAL CATEGORYPOM
Company Ref: KM4_0
Human Papillomavirus
Pronunciation: PAP-i-LO-ma-VYE-rus
Generic Name: Human Papillomavirus
Brand Name: Cervarix
Human Papillomavirus is used for:
Preventing certain types of cervical cancer caused by HPV infection in females 10 to 25 years old.
Human Papillomavirus is a vaccine. It works by stimulating the body to produce antibodies against HPV infection.
Do NOT use Human Papillomavirus if: you are allergic to any ingredient in Human PapillomavirusContact your doctor or health care provider right away if this applies to you.
Before using Human Papillomavirus:Some medical conditions may interact with Human Papillomavirus. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances (including latex) if you have or have recently had a fever if you have HIV infection, cancer, a weakened immune system, or you take medicines that affect your immune system if you have bleeding or blood problems (eg, hemophilia, low blood platelet levels) if you are receiving radiation therapy or cancer chemotherapy if you are scheduled to receive any other vaccines if you had an allergic reaction to a previous dose of Human PapillomavirusSome MEDICINES MAY INTERACT with Human Papillomavirus. Tell your health care provider if you are taking any other medicines, especially any of the following:
Alkylating agents (eg, cyclophosphamide), antimetabolites (eg, fluorouracil, methotrexate), corticosteroids (eg, prednisone), or cytotoxics (eg, cisplatin) because they may decrease Human Papillomavirus's effectivenessThis may not be a complete list of all interactions that may occur. Ask your health care provider if Human Papillomavirus may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Human Papillomavirus:Use Human Papillomavirus as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Human Papillomavirus. Talk to your pharmacist if you have questions about this information. Human Papillomavirus is usually given as an injection at your doctor's office, hospital, or clinic. Human Papillomavirus is given as a series of 3 separate injections. The first dose is given on a date chosen by you and your doctor. The second dose is given 1 month after the first dose. The third dose is given 6 months after the first dose. Be sure to keep all doctor appointments. If you miss a dose of Human Papillomavirus, contact your doctor to reschedule your vaccine.Ask your health care provider any questions you may have about how to use Human Papillomavirus.
Important safety information: Human Papillomavirus may cause dizziness or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use Human Papillomavirus with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Fainting with jerking movements, seizure-like activity, and falling with injury has occurred following vaccination with Human Papillomavirus. Your doctor may ask you to sit or lie down for 15 minutes after you receive this vaccine. Human Papillomavirus may not provide protection against HPV infection in all recipients. Discuss any questions or concerns with your doctor. Human Papillomavirus is only effective against certain types of HPV. Discuss any questions or concerns with your doctor. Human Papillomavirus is not a treatment for patients already infected with HPV. It does not cure cervical cancer caused by HPV infection. Human Papillomavirus does not prevent or treat diseases that are not caused by HPV. Continue to have regular Pap smears and routine cervical cancer screenings as directed by your doctor, even after you receive Human Papillomavirus. Human Papillomavirus should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Human Papillomavirus if you are pregnant. If you think you may be pregnant, tell your doctor before you receive Human Papillomavirus. It is not known if Human Papillomavirus is found in breast milk. If you are or will be breast-feeding while you use Human Papillomavirus, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Human Papillomavirus:All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dizziness; headache; mild fever; mild pain, redness, itching, bruising, or swelling at the injection site; muscle or joint aches; nausea; tiredness; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting with jerking movements or seizure-like activity.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Human Papillomavirus side effects (in more detail)
If OVERDOSE is suspected:Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Human Papillomavirus:Human Papillomavirus is usually handled and stored by a health care provider. If you are using Human Papillomavirus at home, store Human Papillomavirus as directed by your pharmacist or health care provider. Keep Human Papillomavirus out of the reach of children and away from pets.
General information: If you have any questions about Human Papillomavirus, please talk with your doctor, pharmacist, or other health care provider. Human Papillomavirus is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.This information is summary only. It does not contain all information about Human Papillomavirus. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Human Papillomavirus resources Human Papillomavirus Side Effects (in more detail) Human Papillomavirus Use in Pregnancy & Breastfeeding Human Papillomavirus Drug Interactions Human Papillomavirus Support Group 13 Reviews for Human Papillomavirus - Add your own review/rating Compare Human Papillomavirus with other medications Human Papillomavirus ProphylaxisImmuzim
Dosage Form: FOR ANIMAL USE ONLY
Immuzim
Echinacea Sp.
Active Ingredients:Echinacea [Echinacea angustifolia] 7.5mg per ml
Echinacea [Echinacea pallida] 7.5mg per ml
Acetic acid glacial and Propionic acid [organic preservatives[Salt,Water
FOR USE ON ANIMALS ONLY
Immuzim contains NO animal parts or residues
Imported to the USA by :
Emerald Valley Natural Health Inc, Exeter, NH 03833
Batch No: 94414
Use by Date: 03/12/11
Immuzim is manufactured in the UK by
SCA Nutec [Provimi Ltd]
Nutec Mill, Eastern Avenue
Lichfield, Staffordshire, WS13 7SE, UK
Exported by :
Equiglobal Ltd
Manningtree, Essex, CO11 1UT, UK
20 Litres/5.283 gallons [US]
Immuzim
echinacea angustifolia root and echinacea pallida root extract Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 52338-398 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ECHINACEA ANGUSTIFOLIA ROOT (ECHINACEA ANGUSTIFOLIA ROOT) ECHINACEA ANGUSTIFOLIA ROOT 7.5 in 1 mL ECHINACEA PALLIDA ROOT (ECHINACEA PALLIDA ROOT) ECHINACEA PALLIDA ROOT 7.5 in 1 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 52338-398-20 20000 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2010
Labeler - SCA NuTec (233072193) Establishment Name Address ID/FEI Operations SCA NuTec 233072193 manufacture Revised: 04/2010SCA NuTec
Betadine Dry Powder Spray (Molnlycke Health Care )
1. Name Of The Medicinal Product
Betadine Dry Powder Spray.
2. Qualitative And Quantitative CompositionPovidone Iodine 2.5% w/w.
3. Pharmaceutical FormPressurised aerosol spray.
4. Clinical Particulars 4.1 Therapeutic IndicationsAntiseptic for the treatment and prevention of infection in wounds including ulcers, burns, cuts and other minor injuries.
4.2 Posology And Method Of AdministrationFor topical use only. Adults and children aged 2 years and over: Shake the can well before use. Spray the required area from a distance of 15-25cm (6-10 inches) until a dusting of powder is deposited. If necessary, the treated area may be covered with a dressing.
4.3 ContraindicationsHypersensitivity to iodine. Betadine Dry Powder Spray should not be used in serous cavities. Do not use this product regularly if the patient suffers from thyroid disorders or is receiving concurrent lithium therapy. Do not use on children under two years of age.
4.4 Special Warnings And Precautions For UseAvoid inhaling or spraying into the eyes. Avoid use on patients with renal impairment. Should evidence of local irritation or sensitivity occur, use of the product should cease. If no improvement occurs, a doctor should be consulted.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionUse with concurrent lithium therapy has been shown to exhibit additive hypothyroidic effects.
4.6 Pregnancy And LactationUse in pregnancy or lactation should be limited. Although no adverse effects are anticipated from such limited usage, caution is recommended and therapeutic benefit must be balanced against the possible effects of the absorption of iodine on foetal thyroid function and development.
4.7 Effects On Ability To Drive And Use MachinesNone known.
4.8 Undesirable EffectsIodine is absorbed through burns and broken skin and to a lesser extent through intact skin. Following prolonged application of Betadine Dry Powder Spray to severe burns or large areas of denuded skin, systemic effects such as metabolic acidosis, parametrical renal impairment and thyroid dysfunction may occur.
4.9 OverdoseExcess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns may lead to a number of adverse effects: metallic taste in mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia and renal impairment.
Treatment: In the case of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesPovidone iodine is a complex of iodine which retains the broad-spectrum germicidal activity of the elemental iodine without its disadvantages. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue.
5.2 Pharmacokinetic PropertiesNot applicable.
5.3 Preclinical Safety DataNone stated.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsIsopropyl myristate; n-pentane; butane 40; soya lecithin.
6.2 IncompatibilitiesNone known.
6.3 Shelf Life36 months unopened.
6.4 Special Precautions For StorageStore at or below 25oC.
6.5 Nature And Contents Of ContainerAerosol cans containing 100ml of product.
6.6 Special Precautions For Disposal And Other HandlingNone.
7. Marketing Authorisation HolderMedlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.
8. Marketing Authorisation Number(S)PL 21248/0005.
9. Date Of First Authorisation/Renewal Of The Authorisation19th April 2006.
10. Date Of Revision Of The TextApril 2006.
norethindrone, ethinyl estradiol, and ferrous fumarate
ETH-i-nil es-tra-DYE-ol, nor-ETH-in-drone AS-e-tate, ETH-i-nil es-tra-DYE-ol, FER-us FUE-ma-rate
Oral route(Tablet)Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke .
Commonly used brand name(s)In the U.S.
Lo Loestrin FeAvailable Dosage Forms:
Tablet Uses For norethindrone, ethinyl estradiol, and ferrous fumarateNorethindrone, ethinyl estradiol, and ferrous fumarate combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and norethindrone, and when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.
norethindrone, ethinyl estradiol, and ferrous fumarate also contains ferrous fumarate. Ferrous fumarate is an iron supplement.
No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.
norethindrone, ethinyl estradiol, and ferrous fumarate does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.
norethindrone, ethinyl estradiol, and ferrous fumarate is available only with your doctor's prescription.
Before Using norethindrone, ethinyl estradiol, and ferrous fumarateIn deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For norethindrone, ethinyl estradiol, and ferrous fumarate, the following should be considered:
AllergiesTell your doctor if you have ever had any unusual or allergic reaction to norethindrone, ethinyl estradiol, and ferrous fumarate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
PediatricAppropriate studies on the relationship of age to the effects of norethindrone, ethinyl estradiol, and ferrous fumarate combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. norethindrone, ethinyl estradiol, and ferrous fumarate may be used for birth control in teenage females but should not be used before the start of menstruation.
GeriatricAppropriate studies on the relationship of age to the effects of norethindrone, ethinyl estradiol, and ferrous fumarate combination have not been performed in the geriatric population. norethindrone, ethinyl estradiol, and ferrous fumarate should not be used in elderly women.
Pregnancy Pregnancy Category Explanation All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. Breast Feeding Ethinyl EstradiolStudies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.
Ethinyl EstradiolNorethindrone AcetateIronThere are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with MedicinesAlthough certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking norethindrone, ethinyl estradiol, and ferrous fumarate, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using norethindrone, ethinyl estradiol, and ferrous fumarate with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Boceprevir Eltrombopag Felbamate Isotretinoin Paclitaxel Paclitaxel Protein-Bound Theophylline Tizanidine Tranexamic AcidUsing norethindrone, ethinyl estradiol, and ferrous fumarate with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Alprazolam Amoxicillin Ampicillin Amprenavir Aprepitant Atazanavir Bacampicillin Betamethasone Bexarotene Bosentan Carbamazepine Cefdinir Colesevelam Cyclosporine Darunavir Delavirdine Demeclocycline Doxycycline Efavirenz Etravirine Fosamprenavir Fosaprepitant Fosphenytoin Gatifloxacin Ginseng Grepafloxacin Griseofulvin Lamotrigine Levodopa Levofloxacin Levothyroxine Licorice Lomefloxacin Methyldopa Minocycline Modafinil Moxifloxacin Mycophenolate Mofetil Mycophenolic Acid Nelfinavir Nevirapine Norfloxacin Ofloxacin Omeprazole Oxcarbazepine Oxytetracycline Penicillamine Phenobarbital Phenytoin Pioglitazone Prednisolone Primidone Rifabutin Rifampin Rifapentine Ritonavir Roflumilast Rosuvastatin Rufinamide Selegiline St John's Wort Telaprevir Temafloxacin Tetracycline Tipranavir Topiramate Troglitazone Troleandomycin Trovafloxacin Mesylate Valdecoxib Voriconazole Warfarin Zinc Interactions with Food/Tobacco/AlcoholCertain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using norethindrone, ethinyl estradiol, and ferrous fumarate with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use norethindrone, ethinyl estradiol, and ferrous fumarate, or give you special instructions about the use of food, alcohol, or tobacco.
Caffeine Dairy Food Grapefruit Juice Phytic Acid Containing Food Other Medical ProblemsThe presence of other medical problems may affect the use of norethindrone, ethinyl estradiol, and ferrous fumarate. Make sure you tell your doctor if you have any other medical problems, especially:
Abnormal or unusual vaginal bleeding or Blood clots, or history of or Breast cancer, active or history of or Diabetes with kidney, eye, nerve, or blood vessel damage or Heart attack, history of or Heart or blood vessel disease or Heart rhythm problems or Hypertension (high blood pressure), uncontrolled or Liver disease, including tumors or cancer or Migraine headache, new or worse or a new kind of headache or Problems with circulation or blood clots, now or in the past or Problems with heart valves or Stroke, history of—Should not be used in patients with these conditions. Angioedema (swelling of the face, tongue, or throat), inherited or Cervical cancer or intraepithelial neoplasia or Chloasma gravidarum (skin disorder during pregnancy), history of or Cholestasis (bile problem) during pregnancy, history of or Depression, history of or Diabetes or Dyslipidemia (high cholesterol or fats in the blood), uncontrolled or Gallbladder disease or Hypertension (high blood pressure), controlled—Use with caution. May make these conditions worse. Proper Use of norethindrone, ethinyl estradiol, and ferrous fumarateTo make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.
norethindrone, ethinyl estradiol, and ferrous fumarate comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
norethindrone, ethinyl estradiol, and ferrous fumarate is available in blister packs. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.
When you begin using norethindrone, ethinyl estradiol, and ferrous fumarate, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.
Take norethindrone, ethinyl estradiol, and ferrous fumarate at the same time each day. You may take norethindrone, ethinyl estradiol, and ferrous fumarate with or without food.
Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.
You may have light bleeding or spotting when you first take the pill.
You may feel sick or nauseous, especially during the first few months that you take norethindrone, ethinyl estradiol, and ferrous fumarate. If your nausea is continuous and does not go away, call your doctor.
If you vomit or have diarrhea within 3 to 4 hours of taking norethindrone, ethinyl estradiol, and ferrous fumarate, follow the instructions in the patient leaflet or call your doctor.
If you are switching from a combination hormonal method (e.g., another pill, patch, vaginal ring) to using Lo Loestrin Fe®, take the medicine on the day you would have taken your next pill. If you do not start your period, see your doctor for a pregnancy test. If you have used a vaginal ring or patch, finish the 21 days of use, and wait 7 days after the ring or patch is removed before you start taking norethindrone, ethinyl estradiol, and ferrous fumarate. You must also use a second method of birth control (e.g., condom, diaphragm, spermicide) for the first 7 days you take norethindrone, ethinyl estradiol, and ferrous fumarate.
If you are switching from a progestin-only method (e.g., progestin-only pill, implant, injection, intrauterine system) to using Lo Loestrin Fe®, take the medicine on the day you would have taken your next progestin-only pill, or on the day your implant is removed, or on the day you would have your next injection. If you switch from an IUD, talk to your doctor when to start taking norethindrone, ethinyl estradiol, and ferrous fumarate. You must also use a second method of birth control (e.g., condom, diaphragm, spermicide) for the first 7 days you take norethindrone, ethinyl estradiol, and ferrous fumarate.
DosingThe dose of norethindrone, ethinyl estradiol, and ferrous fumarate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of norethindrone, ethinyl estradiol, and ferrous fumarate. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 Start) or on the first Sunday after your menstrual period starts (called Sunday Start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (e.g., condom, diaphragm, spermicide) for the first 7 days.
For oral dosage form (tablets): For contraception (to prevent pregnancy): Adults and teenagers—One tablet taken at the same time each day for 28 days. Children—Use and dose must be determined by your doctor. Missed DoseCall your doctor or pharmacist for instructions.
StorageStore the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using norethindrone, ethinyl estradiol, and ferrous fumarateIt is very important that your doctor check your progress at regular visits to make sure norethindrone, ethinyl estradiol, and ferrous fumarate is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often.
Although you are using norethindrone, ethinyl estradiol, and ferrous fumarate to prevent pregnancy, you should know that using norethindrone, ethinyl estradiol, and ferrous fumarate while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.
If this should occur, continue with your regular dosing schedule. The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week. If bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more blue tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.
If you suspect that you may be pregnant, stop using norethindrone, ethinyl estradiol, and ferrous fumarate immediately and check with your doctor.
Do not use norethindrone, ethinyl estradiol, and ferrous fumarate if you smoke cigarettes or if you are over 35 years old. If you smoke while using birth control pills, you increase your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
Stop using norethindrone, ethinyl estradiol, and ferrous fumarate and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves; difficulty with breathing; a sudden, severe headache; slurred speech; a sudden, unexplained shortness of breath; a sudden loss of coordination; or vision changes while using norethindrone, ethinyl estradiol, and ferrous fumarate.
Check with your doctor immediately if you have trouble wearing contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Stop using norethindrone, ethinyl estradiol, and ferrous fumarate and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.
Make sure any doctor or dentist who treats you knows that you are using norethindrone, ethinyl estradiol, and ferrous fumarate. You may need to stop using norethindrone, ethinyl estradiol, and ferrous fumarate several days before having surgery or certain medical tests.
norethindrone, ethinyl estradiol, and ferrous fumarate may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.
norethindrone, ethinyl estradiol, and ferrous fumarate Side EffectsAlong with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common Breast tenderness heavy non-menstrual vaginal bleeding irregular menstrual periods longer or heavier menstrual periods normal menstrual bleeding occurring earlier, possibly lasting longer than expected Incidence not known Chest pain chills clay-colored stools confusion dark urine diarrhea difficulty with speaking dizziness double vision fast or irregular heartbeat fever headache inability to move the arms, legs, or facial muscles inability to speak indigestion itching loss of appetite nausea pain, redness, or swelling in the arm or leg pains in the chest, groin, or legs, especially in the calves of the legs rash severe headaches of sudden onset severe nausea or vomiting slurred speech stomach pain sudden loss of coordination sudden onset of shortness of breath for no apparent reason sudden onset of slurred speech sudden vision changes tightness in the chest unpleasant breath odor unusual tiredness or weakness unusual warmth or flushing of the skin unusually heavy or unexpected menstrual bleeding vaginal bleeding or spotting vomiting of blood yellow eyes or skinSome side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common Vomiting Less common Anxiety blemishes on the skin cramps depression heavy bleeding pain pimples weight changesOther side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
More norethindrone, ethinyl estradiol, and ferrous fumarate resources Norethindrone, ethinyl estradiol, and ferrous fumarate Dosage Norethindrone, ethinyl estradiol, and ferrous fumarate Use in Pregnancy & Breastfeeding Norethindrone, ethinyl estradiol, and ferrous fumarate Drug Interactions Norethindrone, ethinyl estradiol, and ferrous fumarate Support Group 654 Reviews for Norethindrone, ethinyl estradiol, and ferrous fumarate - Add your own review/rating Compare norethindrone, ethinyl estradiol, and ferrous fumarate with other medications Abnormal Uterine Bleeding Acne Birth Control Endometriosis Gonadotropin Inhibition Menstrual Disorders Polycystic Ovary Syndrome Postmenopausal Symptoms Prevention of OsteoporosisMeropenem 1 g, powder for solution for injection
1. Name Of The Medicinal Product
Meropenem 1 g, powder for solution for injection
2. Qualitative And Quantitative CompositionEach vial contains meropenem trihydrate equivalent to 1000 mg anhydrous meropenem.
The sodium content of each vial is 4.0 mmol (90 mg).
After reconstitution with 20 ml diluent the concentration of meropenem amounts to 50 mg/ml.
For full list of excipients, see section 6.1.
3. Pharmaceutical FormPowder for solution for injection or infusion.
White to pale yellow crystalline powder.
4. Clinical Particulars 4.1 Therapeutic IndicationsMeropenem is indicated for the treatment of the following infections in adults and children over 3 months of age (see sections 4.4 and 5.1):
• Pneumonia, including community acquired pneumonia and nosocomial pneumonia.
• Broncho-pulmonary infections in cystic fibrosis
• Complicated urinary tract infections
• Complicated intra-abdominal infections
• Intra- and post-partum infections
• Complicated skin and soft tissue infections
• Acute bacterial meningitis
Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 Posology And Method Of AdministrationThe tables below provide general recommendations for dosing.
The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response.
A dose of up to 2 g three times daily in adults and adolescents and a dose of up to 40 mg/kg three times daily in children may be particularly appropriate when treating some types of infections, such as nosocomial infections due to Pseudomonas aeruginosa or Acinetobacter spp.
Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below).
Adults and adolescents
Infection
Dose to be administered every 8 hours
Pneumonia including community-acquired pneumonia and nosocomial pneumonia.
500 mg or 1 g
Broncho-pulmonary infections in cystic fibrosis
2 g
Complicated urinary tract infections
500 mg or 1 g
Complicated intra-abdominal infections
500 mg or 1 g
Intra- and post-partum infections
500 mg or 1 g
Complicated skin and soft tissue infections
500 mg or 1 g
Acute bacterial meningitis
2 g
Management of febrile neutropenic patients1 g
Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see section 6.2, 6.3 and 6.6).
Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection.
Renal impairment
The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below. There are limited data to support the application of these dose adjustments for a unit dose of 2 g.
Creatinine clearance
(ml/min)
Dose
(based on “unit” dose range of 500 mg or 1 g or 2 g, see table above)
Frequency
26-50
one unit dose
every 12 hours
10-25
half of one unit dose
every 12 hours
< 10
half of one unit dose
every 24 hours
Meropenem is cleared by haemodialysis and haemofiltration. The required dose should be administered after completion of the haemodialysis cycle.
There are no established dose recommendations for patients receiving peritoneal dialysis.
Hepatic impairment
No dose adjustment is necessary in patients with hepatic impairment (see section 4.4).
Dose in elderly patients
No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min.
Paediatric population
Children under 3 months of age
The safety and efficacy of meropenem in children under 3 months of age have not been established and the optimal dose regimen has not been identified. However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen (see section 5.2).
Children from 3 months to 11 years of age and up to 50 kg body weight
The recommended dose regimens are shown in the table below:
Infection
Dose to be administered every 8 hours
Pneumonia including community-acquired pneumonia and nosocomial pneumonia
10 or 20 mg/kg
Broncho-pulmonary infections in cystic fibrosis
40 mg/kg
Complicated urinary tract infections
10 or 20 mg/kg
Complicated intra-abdominal infections
10 or 20 mg/kg
Complicated skin and soft tissue infections
10 or 20 mg/kg
Acute bacterial meningitis
40 mg/kg
Management of febrile neutropenic patients
20 mg/kg
Children over 50 kg body weight
The adult dose should be administered.
There is no experience in children with renal impairment.
Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection.
4.3 ContraindicationsHypersensitivity to the active substance or to any of the excipients.
Hypersensitivity to any other carbapenem antibacterial agent.
Severe hypersensitivity (eg anaphylactic reaction, severe skin reaction) to any other type of betalactam antibacterial agent (e.g. penicillins or cephalosporins).
4.4 Special Warnings And Precautions For UseThe selection of meropenem to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the infection, the prevalence of resistance to other suitable antibacterial agents and the risk of selecting for carbapenem-resistant bacteria.
As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8).
Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken.
Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all anti-bacterial agents, including meropenem, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of meropenem (see section 4.8). Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8).
Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis) (see section 4.8).
Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem. There is no dose adjustment necessary (see section 4.2).
A positive direct or indirect Coombs test may develop during treatment with meropenem.
The concomitant use of meropenem and valproic acid/sodium valproate is not recommended (see section 4.5).
Meropenem 1 g, powder for solution for injection contains sodium.
This medicinal product contains approximately 4.0 mEq of sodium per 1.0 g dose which should be taken into consideration by patients on a controlled sodium diet.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionNo specific medicinal product interaction studies other than probenecid were conducted.
Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem with the effect of increasing the elimination half-life and plasma concentration of meropenem. Caution is required if probenecid is co-administered with meropenem.
The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism.
Decreases in blood levels of valproic acid have been reported when it is co-administered with carbapenem agents resulting in a 60-100 % decrease in valproic acid levels in about two days. Due to the rapid onset and the extent of the decrease, co-administration of valproic acid with carbapenem agents is not considered to be manageable and therefore should be avoided (see section 4.4).
Oral anti-coagulants
Simultaneous administration of antibiotics with warfarin may augment its anti-coagulant effects. There have been many reports of increases in the anti-coagulant effects of orally administered anti-coagulant agents, including warfarin in patients who are concomitantly receiving antibacterial agents. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the antibiotic to the increase in INR (international normalised ratio) is difficult to assess. It is recommended that the INR should be monitored frequently during and shortly after co-administration of antibiotics with an oral anti-coagulant agent.
4.6 Pregnancy And LactationPregnancy
There are no or limited amount of data from the use of meropenem in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy.
Lactation
It is unknown whether meropenem is excreted in human milk. Meropenem is detectable at very low concentrations in animal breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from meropenem therapy taking into account the benefit of therapy for the woman.
4.7 Effects On Ability To Drive And Use MachinesNo studies on the effect on the ability to drive and use machines have been performed.
4.8 Undesirable EffectsIn a review of 4,872 patients with 5,026 meropenem treatment exposures, meropenem-related adverse reactions most frequently reported were diarrhoea (2.3 %), rash (1.4 %), nausea/vomiting (1.4 %) and injection site inflammation (1.1 %). The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6 %) and increased hepatic enzymes (1.5-4.3 %).
Adverse reactions listed in the table with a frequency of “not known” were not observed in the 2,367 patients who were included in pre-authorisation clinical studies with intravenous and intramuscular meropenem but have been reported during the post-marketing period.
In the table below all adverse reactions are listed by system organ class and frequency: very common (
Table 1
System Organ Class
Frequency
Event
Infections and infestations
Uncommon
oral and vaginal candidiasis
Blood and lymphatic system disorders
Common
thrombocythaemia
Uncommon
eosinophilia, thrombocytopenia, leucopenia, neutropenia
Not known
agranulocytosis, haemolytic anaemia
Immune system disorders
Not known
angioedema, anaphylaxis (see sections 4.3 and 4.4)
Nervous system disorders
Common
headache
Uncommon
paraesthesiae
Rare
convulsions (see section 4.4)
Gastrointestinal disorders
Common
diarrhoea, vomiting, nausea, abdominal pain
Not known
antibiotic-associated colitis (see section 4.4)
Hepatobiliary disorders
Common
transaminases increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased.
Uncommon
blood bilirubin increased
Skin and subcutaneous tissue disorders
Common
rash, pruritis
Uncommon
urticaria
Not known
toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme.
Renal and urinary disorders
Uncommon
blood creatinine increased, blood urea increased
General disorders and administration site conditions
Common
inflammation, pain
Uncommon
thrombophlebitis
Not known
pain at the injection site
4.9 OverdoseRelative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2. Limited post-marketing experience indicates that if adverse reactions occur following overdose, they are consistent with the adverse reaction profile described in section 4.8, are generally mild in severity and resolve on withdrawal or dose reduction. Symptomatic treatments should be considered.
In individuals with normal renal function, rapid renal elimination will occur.
Haemodialysis will remove meropenem and its metabolite.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesPharmacotherapeutic group: antibacterials for systemic use, carbapenems, ATC code: J01DH02
Mode of action
Meropenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs).
Pharmacokinetic/Pharmacodynamic (PK/PD) relationship
Similar to other beta-lactam antibacterial agents, the time that meropenem concentrations exceed the MIC (T>MIC) has been shown to best correlate with efficacy. In preclinical models meropenem demonstrated activity when plasma concentrations exceeded the MIC of the infecting organisms for approximately 40 % of the dosing interval. This target has not been established clinically.
Mechanism of resistance
Bacterial resistance to meropenem may result from: (1) decreased permeability of the outer membrane of Gram-negative bacteria (due to diminished production of porins) (2) reduced affinity of the target PBPs (3) increased expression of efflux pump components, and (4) production of beta-lactamases that can hydrolyse carbapenems.
Localised clusters of infections due to carbapenem-resistant bacteria have been reported in the European Union.
There is no target-based cross-resistance between meropenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes. However, bacteria may exhibit resistance to more than one class of antibacterials agents when the mechanism involved include impermeability and/or an efflux pump(s).
Breakpoints
European Committee on Antimicrobial Susceptibility Testing (EUCAST) clinical breakpoints for MIC testing are presented below.
EUCAST clinical MIC breakpoints for meropenem (2009-06-05, v 3.1)
Organism
Susceptible (S)
(mg/l)
Resistant (R)
(mg/l)
Enterobacteriaceae
> 8
Pseudomonas
> 8
Acinetobacter
> 8
Streptococcus groups A, B, C, G
> 2
Streptococcus pneumoniae1
> 2
Other streptococci
2
2
Enterococcus--
--
Staphylococcus2
note 3
note 3
Haemophilus influenzae1 and Moraxella catarrhalis
> 2
Neisseria meningitidis2,4
> 0.25
Gram-positive anaerobes
> 8
Gram-negative anaerobes
> 8
Non-species related breakpoints5
> 8
1 Meropenem breakpoints for Streptococcus pneumoniae and Haemophilus influenzae in meningitis are 0.25/1 mg/L.
2 Strains with MIC values above the S/I breakpoint are rare or not yet reported. The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate sent to a reference laboratory. Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint (in italics) they should be reported as resistant.
3 Susceptibility of staphylococci to meropenem is inferred from the methicillin susceptibility.
4 Meropenem breakpoints in Neisseria meningitidis relates to meningitis only.
5 Non-species related breakpoints have been determined mainly from PK/PD data and are independent of the MIC distributions of specific species. They are for use for species not mentioned in the table and footnotes.
-- = Susceptibility testing not recommended as the species is a poor target for therapy with the medicinal product.
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
The following table of pathogens listed is derived from clinical experience and therapeutic guidelines.
Commonly susceptible species
Gram-positive aerobes
Enterococcus faecalis$
Staphylococcus aureus (methicillin-susceptible) ?
Staphylococcus species (methicillin-susceptible) including Staphylococcus epidermidis
Streptococcus agalactiae (Group B)
Streptococcus milleri group (S. anginosus, S. constellatus, and S. intermedius)
Streptococcus pneumoniae
Streptococcus pyogenes (Group A)
Gram-negative aerobes
Citrobacter freudiiCitrobacter koseri
Enterobacter aerogenes
Enterobacter cloacae
Escherichia coli
Haemophilus influenzae
Klebsiella oxytoca
Klebsiella pneumoniae
Morganella morganii
Neisseria meningitidis
Proteus mirabilis
Proteus vulgaris
Serratia marcescens
Gram-positive anaerobes
Clostridium perfringens
Peptoniphilus asaccharolyticus
Peptostreptococcus species (including P. micros, P anaerobius, P. magnus)
Bacteroides caccae Bacteroides fragilis group Prevotella bivia
Prevotella disiens
Species for which acquired resistance may be a problem
Gram-positive aerobes
Enterococcus faecium$†
Gram-negative aerobes
Acinetobacter species
Burkholderia cepacia
Pseudomonas aeruginosa
Inherently resistant organisms
Gram-negative aerobesStenotrophomonas maltophilia
Legionella species
Other micro-organisms
Chlamydophila pneumoniae
Chlamydophila psittaci
Coxiella burnetii
Mycoplasma pneumoniae
$Species that show natural intermediate susceptibility
?All methicillin-resistant staphylococci are resistant to meropenem
†Resistance rate
5.2 Pharmacokinetic PropertiesIn healthy subjects the mean plasma half-life is approximately 1 hour; the mean volume of distribution is approximately 0.25 l/kg (11-27 l) and the mean clearance is 287 ml/min at 250 mg falling to 205 ml/min at 2 g. Doses of 500, 1000 and 2000 mg doses infused over 30 minutes give mean Cmax values of approximately 23, 49 and 115 ?g/ml respectively, corresponding AUC values were 39.3, 62.3 and 153 ?g.h/ml. After infusion over 5 minutes Cmax values are 52 and 112 ?g/ml after 500 and 1000 mg doses respectively. When multiple doses are administered 8-hourly to subjects with normal renal function, accumulation of meropenem does not occur.
A study of 12 patients administered meropenem 1000 mg 8 hourly post-surgically for intra-abdominal infections showed a comparable Cmax and half-life to normal subjects but a greater volume of distribution 27 l.
Distribution
The average plasma protein binding of meropenem was approximately 2 % and was independent of concentration. After rapid administration (5 minutes or less) the pharmacokinetics are biexponential but this is much less evident after 30 minutes infusion. Meropenem has been shown to penetrate well into several body fluids and tissues: including lung, bronchial secretions, bile, cerebrospinal fluid, gynaecological tissues, skin, fascia, muscle, and peritoneal exudates.
Metabolism
Meropenem is metabolised by hydrolysis of the beta-lactam ring generating a microbiologically inactive metabolite. In vitro meropenem shows reduced susceptibility to hydrolysis by human dehydropeptidase-I (DHP-I) compared to imipenem and there is no requirement to co-administer a DHP-I inhibitor.
Elimination
Meropenem is primarily excreted unchanged by the kidneys; approximately 70 % (50 –75 %) of the dose is excreted unchanged within 12 hours. A further 28% is recovered as the microbiologically inactive metabolite. Faecal elimination represents only approximately 2% of the dose. The measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion.
Renal insufficiency
Renal impairment results in higher plasma AUC and longer half-life for meropenem. There were AUC increases of 2.4 fold in patients with moderate impairment (CrCL 33-74 ml/min), 5 fold in severe impairment (CrCL 4-23 ml/min) and 10 fold in haemodialysis patients (CrCL <2 ml/min) when compared to healthy subjects (CrCL >80 ml/min). The AUC of the microbiologically inactive ring opened metabolite was also considerably increased in patients with renal impairment. Dose adjustment is recommended for patients with moderate and severe renal impairment (see section 4.2).
Meropenem is cleared by haemodialysis with clearance during haemodialysis being approximately 4 times higher that in anuric patients.
Hepatic insufficiency
A study in patients with alcoholic cirrhosis shows no effect of liver disease on the pharmacokinetics of meropenem after repeated doses.
Adult patients
Pharmacokinetic studies performed in patients have not shown significant pharmacokinetic differences versus healthy subjects with equivalent renal function. A population model developed from data in 79 patients with intra-abdominal infection or pneumonia, showed a dependence of the central volume on weight and the clearance on creatinine clearance and age.
Paediatrics
The pharmacokinetics in infants and children with infection at doses of 10, 20 and 40 mg/kg showed Cmax values approximating to those in adults following 500, 1000 and 2000 mg doses, respectively. Comparison showed consistent pharmacokinetics between the doses and half-lives similar to those observed in adults in all but the youngest subjects (<6 months t1/2 1.6 hours). The mean meropenem clearance values were 5.8 ml/min/kg (6-12 years), 6.2 ml/min/kg (2-5 years), 5.3 ml/min/kg (6-23 months) and 4.3 ml/min/kg (2-5 months). Approximately 60 % of the dose is excreted in urine over 12 hours as meropenem with a further 12 % as metabolite. Meropenem concentrations in the CSF of children with meningitis are approximately 20 % of concurrent plasma levels although there is significant inter-individual variability.
The pharmacokinetics of meropenem in neonates requiring anti-infective treatment showed greater clearance in neonates with higher chronological or gestational age with an overall average half-life of 2.9 hours. Monte Carlo simulation based on a population PK model showed that a dose regimen of 20 mg/kg 8 hourly achieved 60 %T>MIC for P. aeruginosa in 95 % of pre-term and 91 % of full term neonates.
Elderly
Pharmacokinetic studies in healthy elderly subjects (65-80 years) have shown a reduction in plasma clearance, which correlated with age-associated reduction in creatinine clearance, and a smaller reduction in non-renal clearance. No dose adjustment is required in elderly patients, except in cases of moderate to severe renal impairment (see section 4.2).
5.3 Preclinical Safety DataAnimal studies indicate that meropenem is well tolerated by the kidney. Histological evidence of renal tubular damage was seen in mice and dogs only at doses of 2000 mg/kg and above after a single administration and above and in monkeys at 500 mg/kg in a 7-day study.
Meropenem is generally well tolerated by the central nervous system. Effects were seen in acute toxicity studies in rodent at doses exceeding 1000 mg/kg.
The IV LD50 of meropenem in rodents is greater that 2000 mg/kg.
In repeat dose studies of up to 6 months duration only minor effects were seen including a decrease in red cell parameters in dogs.
There was no evidence of mutagenic potential in a conventional test battery and no evidence of reproductive toxicity including teratogenic potential in studies in rats up to 750 mg/kg and in monkeys up to 360 mg/kg.
There was increased evidence of abortions at 500 mg/kg in a preliminary study in monkeys.
There was no evidence of increased sensitivity to meropenem in juveniles compared to adult animals. The intravenous formulation was well tolerated in animal studies.
The sole metabolite of meropenem had a similar profile of toxicity in animal studies.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsAnhydrous sodium carbonate.
6.2 IncompatibilitiesThis medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf LifeUnopened:
2 years
After reconstitution:
The reconstituted solutions for intravenous injection or infusion should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous injection or infusion should not exceed one hour.
6.4 Special Precautions For StorageT
Tranexamic Acid 500mg Tablets (Sandoz Limited )
1. Name Of The Medicinal Product
Tranexamic Acid 500 mg Tablets
2. Qualitative And Quantitative CompositionEach tablet contains 500mg Tranexamic Acid.
For excipients, see 6.1.
3. Pharmaceutical FormTablet.
White, capsule shaped tablet embossed with 'T500' on one side and a break line on the other side.
4. Clinical Particulars 4.1 Therapeutic IndicationsTranexamic Acid 500mg Tablets are indicated for short term use for haemorrhage or risk of haemorrhage in those with increased fibrinolysis or fibrinogenolysis. Local fibrinolysis as occurs in the following conditions:
1. a) Prostatectomy and bladder surgery
b) Menorrhagia
c) Epistaxis
d) Conisation of the cervix
e) Traumatic hyphaema
2. Management of dental extraction in haemophiliacs.
3. Hereditary angioneurotic oedema.
4.2 Posology And Method Of AdministrationRoute of administration: Oral.
Adults:
Local Fibrinolysis: The recommended standard dose is 15-25mg/kg bodyweight (i.e. 2-3 tablets) two to three times daily. For the indications listed below the following doses may be used:
1a Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk patients should commence per- or post-operatively with tranexamic acid injection; thereafter 2 tablets three to four times daily until macroscopic haematuria is no longer present.
1b Menorrhagia: Recommended dosage is 2 tablets 3 times daily as long as needed for up to 4 days. If very heavy menstrual bleeding, dosage may be increased. A total dose of 4g daily (8 tablets) should not be exceeded. Treatment with Tranexamic acid should not be initiated until menstrual bleeding has started.
1c Epistaxis: When repeated bleeding is anticipated oral therapy (2 tablets three times daily) should be administered for 7 days.
1d Cervix Conisation: 3 tablets three times daily.
1e Traumatic Hyphaema: 2-3 tablets 3 times daily. The dose is based on 25mg/kg three times a day.
2. Haemophilia: In the management of dental extractions 2-3 tablets every eight hours. The dose is based on 25mg/kg.
3. Hereditary angioneurotic oedema: Some patients are aware of the onset of illness; suitable treatment for these patients is intermittently 2-3 tablets two to three times daily for some days. Other patients are treated continuously at this dosage.
Children:
In children, for current approved indications as described in section 4.1, the dosage is in the region of 20 mg/kg/day. However, data on efficacy, posology and safety for these indications are limited.
Elderly:
No reduction in dosage is necessary unless there is evidence of renal failure (see guidelines below).
Renal Impairment
By extrapolation from clearance data relating to the intravenous dosage form, the following reduction in the oral dosage is recommended for patients with mild to moderate renal insufficiency:
Serum Creatinine (?mol/l)
Oral Dose
Dose Frequency
120-249
15 mg/kg body weight
twice daily
250-500
15 mg/kg body weight
daily
4.3 Contraindications• Hypersensitivity to tranexamic acid or any of the other ingredients.
• Active thromboembolic disease.
• History of venous or arterial thrombosis.
• Fibrinolytic conditions following consumption coagulopathy.
• Severe renal impairment (risk of accumulation).
• History of convulsions.
4.4 Special Warnings And Precautions For UseCaution is advised in treating those with massive haematuria from the upper urinary tract, especially in haemophiliacs, as there have been some cases of ureteric obstruction.
Not to be used when disseminated intravascular coagulation is in progress.
The blood levels are increased in patients with renal insufficiency. Therefore a dose reduction is recommended (see Section 4.2, Posology and Method of Administration).
In those patients requiring long term administration of tranexamic acid, such as those with hereditary angioneurotic oedema, regular eye examinations (e.g. visual acuity, slit lamp, intraocular pressure, visual fields) and liver function tests should be performed.
Patients who experience visual disturbance should be withdrawn from treatment.
Patients with irregular menstrual bleeding should not use tranexamic acid until the cause of irregular bleeding has been established. If menstrual bleeding is not adequately reduced by Tranexamic Acid Tablets, an alternative treatment should be considered.
Patients with a previous thromboembolic event and a family history of thromboembolic disease (patients with thrombophilia) should use Tranexamic Acid Tablets only if there is a strong medical indication and under strict medical supervision.
The use of tranexamic acid in cases of increased fibrinolysis due to disseminated intravascular coagulation is not recommended.
Clinical experience with Tranexamic Acid Tablets in menorrhagic children under 15 years of age is not available.
The indications and method of administration indicated above should be followed strictly:
• In case of haematuria of renal origin, there is a risk of mechanical anuria due to formation of a ureteral clot.
• In renal insufficiency leading to a risk of accumulation, the dosage of tranexamic acid should be reduced according to the serum creatinine level.
- serum creatinine between120 and 250 ?mol/l,: TXA iv 10 mg/kg twice daily.
- serum creatinine between 250 and 500 ?mol/l: TXA iv 10 mg/kg once daily (every 24 hours).
- serum creatinine > 500 ?mol/l, TXA iv 10 mg/kg every other day (every 48 hours).
• Before use of TXA, risk factors of thromboembolic disease should be investigated.
• Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionTranexamic Acid will counteract the thrombolytic effect of fibrinolytic preparations.
4.6 Pregnancy And LactationPregnancy: There is no evidence from animal studies that tranexamic acid has any teratogenic effect, however, the usual caution with use of drugs in pregnancy should be observed.
Tranexamic acid crosses the placenta.
Lactation: Tranexamic acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.
4.7 Effects On Ability To Drive And Use MachinesTranexamic Acid has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable EffectsAdverse events are listed below by system organ class and frequency.
Frequencies are defined as: very common (=1/l0), common (=1/100 to <1/10), uncommon (=1/1000 to <1/100), rare ( =1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from the available data).
Immune system disorders
Very rare: Hypersensitivity reactions including anaphylaxis
Nervous System Disorders
Very rare: convulsions, particularly in case of misuse
Eye disorders
Rare: Colour vision disturbances, retinal vein/artery occlusion
Vascular disorders
Rare: Thromboembolic events
Very rare: Arterial or venous thrombosis at any sites. Malaise with hypotension, with or without loss of consciousness (generally following a too fast intravenous injection, exceptionally after oral administration).
Gastro-intestinal disorders
Very rare: Digestive effects such as nausea, vomiting and diarrhoea.
Skin and subcutaneous tissue disorders
Rare: Allergic skin reactions
4.9 OverdoseNo cases of overdosage have been reported. Symptoms may be nausea, vomiting, orthostatic symptoms and/or hypotension. Initiate vomiting, then stomach lavage, and charcoal therapy. Maintain a high fluid intake to promote renal excretion. There is a risk of thrombosis in predisposed individuals. Anticoagulant treatment should be considered.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesTranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the activation of plasminogen to plasmin. At much higher concentrations it is a non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen activation by urokinase has been reported to be 6-100 times and by streptokinase 6-40 times greater than that of aminocaproic acid. The antifibrinolytic activity of tranexamic acid is approximately ten times greater than that of aminocaproic acid.
5.2 Pharmacokinetic PropertiesFollowing oral administration, 1.13% and 39% of the administered dose were recovered after 3 and 24 hours respectively. Tranexamic acid administered parenterally is distributed in a two-compartment model. Tranexamic acid crosses the placenta, and may reach one hundredth of the serum peak concentration in the milk of lactating women. Tranexamic acid crosses the blood brain barrier.
Following intravenous administration, the biological half-life of tranexamic acid has been determined to be 1.9 hours and 2.7 hours.
5.3 Preclinical Safety DataNo additional information.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsMicrocrystalline cellulose
Hydroxypropyl cellulose L-HPC LH11
Purified talc
Hydrogenated vegetable Oil
Magnesium stearate
Silica, colloidal anhydrous
Povidone
6.2 IncompatibilitiesNot applicable.
6.3 Shelf Life3 years.
6.4 Special Precautions For StorageDo not store above 25°C. Store in the original container.
6.5 Nature And Contents Of ContainerBlister strips of aluminium foil and PVC/PVdC, 12 tablets per blister.
Pack size of 60.
6.6 Special Precautions For Disposal And Other HandlingNot applicable.
7. Marketing Authorisation HolderSandoz Ltd
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR.
United Kingdom
8. Marketing Authorisation Number(S)PL 04416/0391
9. Date Of First Authorisation/Renewal Of The Authorisation12 March 2003
10. Date Of Revision Of The Text06/2011 (To be amended after approval)
Certain Dri Solution
Pronunciation: a-LOO-mi-num
Generic Name: Aluminum Chloride
Brand Name: Examples include Certain Dri and Drysol
Certain Dri Solution is used for:
Treating excess perspiration (sweating) problems.
Certain Dri Solution is an antiperspirant. It is thought to work by altering the sweat-producing cells in the body.
Do NOT use Certain Dri Solution if: you are allergic to any ingredient in Certain Dri SolutionContact your doctor or health care provider right away if any of these apply to you.
Before using Certain Dri Solution:Some medical conditions may interact with Certain Dri Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substancesSome MEDICINES MAY INTERACT with Certain Dri Solution. However, no specific interactions with Certain Dri Solution are known at this time.
Ask your health care provider if Certain Dri Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Certain Dri Solution:Use Certain Dri Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Certain Dri Solution is to be used only at bedtime because sweat glands are most inactive during sleep. This allows application for 6 to 8 hours when sweating does not occur. Do not apply to broken, irritated, or recently shaved skin. Wash and completely dry the affected area. Using a hair dryer on a warm setting for a few minutes can help ensure dry skin. Assemble the applicator according to package instructions. Some packages provide an applicator; others instruct you to use cotton balls. For underarms - To minimize irritation, let the alcohol evaporate (if needed, blow dry with a hair dryer on a cold air setting), leaving an evenly distributed film of medicine on the skin. Wear a T-shirt while sleeping to prevent the medicine from being rubbed off on bed linens. For hands or feet - Apply Certain Dri Solution to both palms or soles. Let the alcohol evaporate, leaving a thin film on the skin. Cover the treated area with plastic wrap held in place by a mitten, cotton glove, or sock to prevent the medicine from being rubbed off on bed linens during sleep. Do not use tape. For scalp - Apply Certain Dri Solution evenly to the scalp. Let the alcohol evaporate, leaving a thin film on the skin. Wear a plastic shower cap to keep the medicine from being rubbed off during sleep. Wash the treated area the next morning thoroughly with soap or shampoo to remove excess medicine and prevent skin irritation. Towel dry the skin or scalp. Do not use other deodorants or antiperspirants while using Certain Dri Solution. Repeat use of Certain Dri Solution for 2 or 3 nights until the desired lack of sweating is achieved. After that, usually once or twice a week should maintain the desired effect. Avoid contact with your eyes. If contact occurs, wash eyes thoroughly with water. If you miss a dose of Certain Dri Solution and you are using it regularly, skip the missed dose and go back to your regular dosing schedule.Ask your health care provider any questions you may have about how to use Certain Dri Solution.
Important safety information: Avoid contact of Certain Dri Solution with cotton fabrics or metals. Do not use near open flame. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Certain Dri Solution while you are pregnant. It is not known if Certain Dri Solution is found in breast milk. If you are or will be breast-feeding while you use Certain Dri Solution, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Certain Dri Solution:All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Temporary burning, itching, prickling, or tingling in treated areas.
Seek medical attention right away if any of these SEVERE side effects occur:Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Certain Dri side effects (in more detail)
If OVERDOSE is suspected:Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Certain Dri Solution may be harmful if swallowed
Proper storage of Certain Dri Solution:Store Certain Dri Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep the cap tightly closed when not in use to prevent evaporation. Keep Certain Dri Solution out of the reach of children and away from pets.
General information: If you have any questions about Certain Dri Solution, please talk with your doctor, pharmacist, or other health care provider. Certain Dri Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.This information is a summary only. It does not contain all information about Certain Dri Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Certain Dri resources Certain Dri Side Effects (in more detail) Certain Dri Use in Pregnancy & Breastfeeding Certain Dri Support Group 1 Review for Certain Dri - Add your own review/rating Compare Certain Dri with other medications HyperhidrosisGeneric Name: amiodarone (injection) (A mi OH da rone)
Brand Names: Nexterone
Amiodarone is an antiarrhythmic medication that affects the rhythm of heartbeats.
Amiodarone is used to help keep the heart beating normally in people with life-threatening heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart). Amiodarone is used to treat or prevent ventricular tachycardia or ventricular fibrillation.
Amiodarone may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Cordarone I.V. (amiodarone (injection))? Amiodarone injection is for use only in life-threatening situations. This medication has the potential to cause side effects that could be fatal, and you will receive your injection in a hospital setting. You should not receive this medication if you are allergic to amiodarone or iodine, or if you have a serious heart condition such as "AV block" (unless you have a pacemaker) or a history of slow heart beats. Do not receive amiodarone if you are pregnant. It could harm the unborn baby.In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast-feeding. Make sure any doctor caring for you afterward knows that you have received this medication.
To be sure this medication is not causing harmful effects, your blood will need to be tested often. Your thyroid and liver function may also need to be tested, and you may need eye exams and chest x-rays. Visit your doctor regularly.
You may continue to have side effects from amiodarone after you stop using it. It could take up to several months for the medicine to completely clear from your body.
What should I discuss with my healthcare provider before using Cordarone I.V. (amiodarone (injection))? Amiodarone injection is for use only in life-threatening situations. This medication has the potential to cause side effects that could be fatal, and you will receive your injection in a hospital setting.You may continue to have side effects from amiodarone after you stop using it. It could take up to several months for the medicine to completely clear from your body.
You should not receive this medication if you are allergic to amiodarone or iodine, or if you have:certain serious heart conditions, especially "AV block" (unless you have a pacemaker); or
a history of slow heart beats that have caused you to faint.
If possible before you receive amiodarone injection, tell your doctor if you have:breathing problems or lung disorder;
liver disease;vision problems;
high or low blood pressure;
a thyroid disorder;
an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
if you have recently been ill with vomiting or diarrhea; or
if you have a pacemaker or defibrillator implanted in your chest.
FDA pregnancy category D. Do not use amiodarone if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Amiodarone can pass into breast milk and may harm a nursing baby. You should not breast-feed while receiving this medication.In an emergency situation, it may not be possible before you are treated with amiodarone injection to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.
How is amiodarone injection given?Amiodarone is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting where your heart can be monitored in case the medication causes serious side effects. Amiodarone injection must be given slowly through an IV infusion, and can take from 48 to 96 hours or longer to complete. Amiodarone injection is often given directly into a large vein in the upper chest (central IV line).
To be sure this medication is not causing harmful effects, your blood will need to be tested often. Your thyroid and liver function may also need to be tested, and you may need eye exams and chest x-rays. Visit your doctor regularly.
If you need surgery (including laser eye surgery), tell the surgeon ahead of time that you have received amiodarone injection.This medication can cause unusual results with certain thyroid tests, even after you stop using it. Tell any doctor who treats you that you have received amiodarone injection.
After treatment with amiodarone injection, your doctor may switch you to a tablet form of this medication. Be sure to read the medication guide or patient instructions for amiodarone oral.
What happens if I miss a dose?Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.Overdose symptoms may include weakness, slow heart rate, feeling light-headed, or fainting.
What should I avoid while using Cordarone I.V. (amiodarone (injection))? Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.Grapefruit and grapefruit juice may interact with amiodarone and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
Avoid exposure to sunlight or tanning beds. Amiodarone can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors. Cordarone I.V. (amiodarone (injection)) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects, even if they occur up to several months after you stop using amiodarone:a new or a worsening irregular heartbeat pattern;
fast, slow, or pounding heartbeats;
feeling like you might pass out;
wheezing, cough, chest pain, trouble breathing, coughing up blood;
feeling short of breath, even with mild exertion, swelling, rapid weight gain;
blurred vision, vision loss, headache or pain behind your eyes, sometimes with vomiting;
swelling, pain, redness, or irritation around your IV needle;
weight loss, thinning hair, feeling too hot or too cold, increased sweating, irregular menstrual periods, swelling in your neck (goiter);
pain in your upper stomach, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
urinating less than usual or not at all.
Less serious side effects may include:
low fever;
slight dizziness; or
mild nausea, vomiting.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Cordarone I.V. (amiodarone (injection))?Many drugs can interact with amiodarone. Below is only a partial list. Tell your doctor if you are using:
cimetidine (Tagamet);
clopidogrel (Plavix);
cyclosporine (Gengraf, Neoral, Sandimmune);
dextromethorphan (an over-the-counter cough medicine);
digoxin (digitalis, Lanoxin, Lanoxicaps);
fentanyl (Actiq, Duragesic, Fentora);
loratadine (Claritin Alavert);
phenytoin (Dilantin);
St. John's wort;
a blood thinner such as warfarin (Coumadin, Jantoven);
a diuretic (water pill);
an antibiotic such as azithromycin (Zithromax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), rifampin (Rifadin, Rimactane, Rifater, Rifamate), telithromycin (Ketek), and others;
an antifungal medication such as itraconazole (Sporanox), or ketoconazole (Nizoral, Xolegal);
an antidepressant such as nefazodone or trazodone (Desyrel);
arthritis medication such as diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze) or piroxicam (Feldene);
cholesterol-lowering medicines such as cholestyramine (Prevalite, Questran), simvastatin (Zocor), and others;
heart or blood pressure medication such as diltiazem (Cardizem, Cartia), nicardipine (Cardene), propranolol (Inderal, InnoPran), verapamil (Calan, Covera, Isoptin, Verelan), and others;
heart rhythm medication such as disopyramide (Norpace), flecainide (Tambocor), quinidine (Quin-G), or procainamide (Procan, Pronestyl);
insulin or diabetes medication you take by mouth; or
medication to treat HIV or AIDS.
This list is not complete and there are many other medicines that can cause serious drug interactions with amiodarone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.Amiodarone takes a long time to completely clear from your body, and drug interactions are possible for up to several months after you stop using amiodarone injection. Talk to your doctor before taking any medication during this time. Keep track of how long it has been since your last dose of amiodarone.
More Cordarone I.V. resources Cordarone I.V. Side Effects (in more detail) Cordarone I.V. Use in Pregnancy & Breastfeeding Cordarone I.V. Drug Interactions Cordarone I.V. Support Group 0 Reviews for Cordarone I.V. - Add your own review/rating Compare Cordarone I.V. with other medications Arrhythmia Supraventricular Tachycardia Ventricular Fibrillation Ventricular Tachycardia Where can I get more information? Your doctor or pharmacist can provide more information about amiodarone injection.See also: Cordarone I.V. side effects (in more detail)
Generic Name: hydrocodone and phenylephrine (high droe KOE dohn and fen ill EH frin)
Brand Names: Lortuss HC, Nalex-DH
Hydrocodone is a narcotic. It is a pain reliever and a cough suppressant.
Phenylephrine is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in the body. Constriction of blood vessels in the sinuses and nose decreases congestion.
Hydrocodone and phenylephrine is used to treat cough and nasal congestion associated with the common cold, sinus infections, the flu, and bronchitis.
Hydrocodone and phenylephrine may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Nalex-DH (hydrocodone and phenylephrine)? Use caution when driving, operating machinery, or performing other hazardous activities. Hydrocodone and phenylephrine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking hydrocodone and phenylephrine.Hydrocodone and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other medicine without first talking to your doctor.
Hydrocodone is habit forming. It is possible become physically and/or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if hydrocodone and phenylephrine is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose. What should I discuss with my healthcare provider before taking Nalex-DH (hydrocodone and phenylephrine)?Do not take hydrocodone and phenylephrine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), or selegiline (Eldepryl) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Before taking hydrocodone and phenylephrine, tell your doctor if you have
epilepsy or another seizure disorder;
been diagnosed with sleep apnea (periods of not breathing during sleep);
thyroid problems;
asthma;
a head injury;
Addison's disease;
diabetes;
glaucoma;
bladder problems or difficulty urinating;
an enlarged prostate;high blood pressure, irregular heartbeats, or any type of heart disease;
kidney problems; or liver problems.You may not be able to take hydrocodone and phenylephrine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Hydrocodone and phenylephrine is in the FDA pregnancy category C. This means that it is not known whether hydrocodone and phenylephrine will be harmful to an unborn baby. Do not take hydrocodone and phenylephrine without first talking to your doctor if you are pregnant or could become pregnant during treatment. Hydrocodone and phenylephrine passes into breast milk and may be harmful to a nursing baby. Do not take hydrocodone and phenylephrine without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from hydrocodone and phenylephrine. Your doctor may prescribe a lower dose of this medication. How should I take Nalex-DH (hydrocodone and phenylephrine)?Take hydrocodone and phenylephrine exactly as directed by your doctor. If you do not understand the directions on your prescription bottle, ask your pharmacist, nurse, or doctor to explain the instructions to you.
Hydrocodone and phenylephrine can be taken with or without food.
Take the oral tablets and capsules with a full glass of water.To ensure that you get a correct dose, measure the liquid form of hydrocodone and phenylephrine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
Do not take more of this medication or take it for longer than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor. Hydrocodone is habit forming. It is possible become physically and/or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if hydrocodone and phenylephrine is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose. Store hydrocodone and phenylephrine at room temperature away from moisture and heat. What happens if I miss a dose?Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.
What happens if I overdose? Seek emergency medical attention if an overdose is suspected.Symptoms of a hydrocodone and phenylephrine overdose may include extreme drowsiness, dizziness, headache, seizures, dry mouth, cold and clammy skin, flushing, nausea, vomiting, difficult or decreased breathing, and unconsciousness.
What should I avoid while taking Nalex-DH (hydrocodone and phenylephrine)? Use caution when driving, operating machinery, or performing other hazardous activities. Hydrocodone and phenylephrine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking hydrocodone and phenylephrine.Hydrocodone and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other medicine without first talking to your doctor.
Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking hydrocodone and phenylephrine without first talking to your pharmacist or doctor. Other medications may also contain hydrocodone, phenylephrine, or other similar drugs, and you may accidentally take too much of these medicines.
Nalex-DH (hydrocodone and phenylephrine) side effects If you experience any of the following serious side effects, stop taking hydrocodone and phenylephrine and seek emergency medical attention or contact your doctor immediately:a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or
confusion, hallucinations, or unusual behavior.
Other, less serious side effects may be more likely to occur. Continue to take hydrocodone and phenylephrine and talk to your doctor if you experience
dizziness, drowsiness, or sleepiness;
restlessness or irritability;
blurred vision;
constipation;
dry mouth;
nausea, vomiting, or decreased appetite;
muscle twitches;
sweating;
itching; or
decreased urination.
Hydrocodone is habit forming. It is possible become physically and/or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if hydrocodone and phenylephrine is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Nalex-DH (hydrocodone and phenylephrine)?Do not take hydrocodone and phenylephrine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), or selegiline (Eldepryl) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Hydrocodone and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.
Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking hydrocodone and phenylephrine without first talking to your pharmacist or doctor. Other medications may also contain hydrocodone, phenylephrine, or other similar drugs, and you may accidentally take too much of these medicines.
Drugs other than those listed here may also interact with hydrocodone and phenylephrine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
More Nalex-DH resources Nalex-DH Side Effects (in more detail) Nalex-DH Use in Pregnancy & Breastfeeding Nalex-DH Drug Interactions Nalex-DH Support Group 0 Reviews for Nalex-DH - Add your own review/rating Lortuss HC Liquid MedFacts Consumer Leaflet (Wolters Kluwer) Compare Nalex-DH with other medications Cough and Nasal Congestion Where can I get more information? Your pharmacist has more information about hydrocodone and phenylephrine written for health professionals that you may read.See also: Nalex-DH side effects (in more detail)
Acetaminophen/Caffeine/Pyrilamine
Pronunciation: a-SEET-a-MIN-oh-fen /KAF-een/pir-IL-a-meen
Generic Name: Acetaminophen/Caffeine/Pyrilamine
Brand Name: Midol Maximum Strength Menstrual
Acetaminophen/Caffeine/Pyrilamine is used for:
Relieving symptoms of menstrual periods such as minor cramps, headache, bloating, backache, muscle aches, and fatigue. It may also be used for other conditions as determined by your doctor.
Acetaminophen/Caffeine/Pyrilamine is an analgesic and diuretic combination. It works by raising the pain threshold and by decreasing water-weight gain caused by menstrual periods.
Do NOT use Acetaminophen/Caffeine/Pyrilamine if: you are allergic to any ingredient in Acetaminophen/Caffeine/Pyrilamine you are taking sodium oxybate (GHB)Contact your doctor or health care provider right away if any of these apply to you.
Before using Acetaminophen/Caffeine/Pyrilamine:Some medical conditions may interact with Acetaminophen/Caffeine/Pyrilamine. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of alcohol abuse or you drink 3 or more alcohol-containing drinks every day if you have anxiety; asthma or other breathing problems (eg, chronic bronchitis, chronic obstructive pulmonary disease [COPD], emphysema, sleep apnea); a blockage of your stomach, bladder, or intestines; blood vessel problems; enlarged prostate or other prostate problems; glaucoma or increased eye pressure; heart problems; high blood pressure; kidney problems; liver problems (eg, hepatitis); an overactive thyroid; seizures; trouble sleeping; or trouble urinatingSome MEDICINES MAY INTERACT with Acetaminophen/Caffeine/Pyrilamine. Tell your health care provider if you are taking any of the following medicines, especially any of the following:
Anticoagulants (eg, warfarin) because the risk of bleeding may be increased Isoniazid or quinolones (eg, ciprofloxacin) because they may increase the risk of Acetaminophen/Caffeine/Pyrilamine's side effects Sodium oxybate (GHB) or theophyllines (eg, aminophylline) because the risk of their side effects may be increased by Acetaminophen/Caffeine/PyrilamineThis may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Caffeine/Pyrilamine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Acetaminophen/Caffeine/Pyrilamine:Use Acetaminophen/Caffeine/Pyrilamine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Acetaminophen/Caffeine/Pyrilamine by mouth with or without food. Take Acetaminophen/Caffeine/Pyrilamine with a full glass of water (8 oz/240 mL). If you miss a dose of Acetaminophen/Caffeine/Pyrilamine and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.Ask your health care provider any questions you may have about how to use Acetaminophen/Caffeine/Pyrilamine.
Important safety information: Drowsiness may occur while you take Acetaminophen/Caffeine/Pyrilamine. This effect may be worse if you take it with alcohol or certain medicines. Use Acetaminophen/Caffeine/Pyrilamine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Acetaminophen/Caffeine/Pyrilamine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Acetaminophen/Caffeine/Pyrilamine contains acetaminophen, caffeine, and pyrilamine. Do not take additional acetaminophen for pain or fever without checking with your doctor or pharmacist. Ask your doctor or pharmacist if you have any questions about which medicines contain acetaminophen, caffeine, and pyrilamine. Acetaminophen/Caffeine/Pyrilamine may harm your liver. Your risk may be greater if you drink alcohol while you are using Acetaminophen/Caffeine/Pyrilamine. Talk to your doctor before you take Acetaminophen/Caffeine/Pyrilamine or other fever reducers if you drink more than 3 drinks with alcohol per day. Avoid large amounts of food or drink that have caffeine (eg, chocolate, cocoa, cola, coffee, tea). This includes any medicines that contain caffeine. Check with your doctor if you have pain that does not get better within 10 days or gets worse, have redness or swelling, or if new symptoms develop. Tell your doctor or dentist that you take Acetaminophen/Caffeine/Pyrilamine before you receive any medical or dental care, emergency care, or surgery. Acetaminophen/Caffeine/Pyrilamine may cause the results of some in-home test kits for blood cholesterol to be wrong. Check with your doctor or pharmacist if you are taking Acetaminophen/Caffeine/Pyrilamine and need to check your blood cholesterol at home. Acetaminophen/Caffeine/Pyrilamine should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acetaminophen/Caffeine/Pyrilamine while you are pregnant. Acetaminophen/Caffeine/Pyrilamine is found in breast milk. If you are or will be breast-feeding while you use Acetaminophen/Caffeine/Pyrilamine, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Acetaminophen/Caffeine/Pyrilamine:All medicines may cause side effects, but many people have no, or minor side effects. No COMMON side effects have been reported with Acetaminophen/Caffeine/Pyrilamine. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; fast heartbeat; nervousness or irritability; unusual tiredness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Acetaminophen/Caffeine/Pyrilamine side effects (in more detail)
If OVERDOSE is suspected:Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dark urine; excessive sweating; extreme fatigue; irregular heartbeat; low blood pressure; stomach pain; vomiting; yellowing of the skin or eyes.
Proper storage of Acetaminophen/Caffeine/Pyrilamine:Store Acetaminophen/Caffeine/Pyrilamine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Caffeine/Pyrilamine out of the reach of children and away from pets.
General information: If you have any questions about Acetaminophen/Caffeine/Pyrilamine, please talk with your doctor, pharmacist, or other health care provider. Acetaminophen/Caffeine/Pyrilamine is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.This information is a summary only. It does not contain all information about Acetaminophen/Caffeine/Pyrilamine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Acetaminophen/Caffeine/Pyrilamine resources Acetaminophen/Caffeine/Pyrilamine Side Effects (in more detail) Acetaminophen/Caffeine/Pyrilamine Use in Pregnancy & Breastfeeding Drug Images Acetaminophen/Caffeine/Pyrilamine Drug Interactions Acetaminophen/Caffeine/Pyrilamine Support Group 0 Reviews for Acetaminophen/Caffeine/Pyrilamine - Add your own review/rating Compare Acetaminophen/Caffeine/Pyrilamine with other medications Premenstrual Dysphoric Disorder Premenstrual SyndromeGeneric Name: benzocaine (Oral route, Oromucosal route)
BEN-zoe-kane
Commonly used brand name(s)In the U.S.
Anbesol Babee Teething Benzodent Benz-O-Sthetic Bi-Zets/Benzo-Troches Dentemp's Dent-O-Kain/20 Detane Gumsol HAD Hurricaine Hurricane Spray Kit Kank-A Soft Brush Larynex Miradyne-3 Mycinette Orabase-B Oracaine Ora film Orajel OraMagic Plus Orasol Red Cross Canker Sore Thorets Trocaine Zetts Zilactin Zilactin-BIn Canada
Anbesol Extra Strength Anbesol Liquid Baby Anbesol Baby Orajel Baby Orajel Liquid Maximum Strength Orajel Pm Orajel Extra StrengthAvailable Dosage Forms:
Liquid Gel/Jelly Solution Lozenge/Troche Film Lotion Ointment Powder for Suspension Cream Tablet, Disintegrating Swab Spray Gum PasteTherapeutic Class: Anesthetic, Local
Chemical Class: Amino Ester
Uses For MycinetteBenzocaine lozenges are used to relieve pain and irritation caused by sore throat, sore mouth, or canker sores.
This medicine is available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.
Before Using MycinetteIn deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
AllergiesTell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
PediatricNo information is available on the relationship of age to the effects of benzocaine lozenges in the pediatric population. Safety and efficacy have not been established in children below 5 years of age.
GeriatricNo information is available on the relationship of age to the effects of benzocaine in geriatric patients.
Interactions with MedicinesAlthough certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with Food/Tobacco/AlcoholCertain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical ProblemsThe presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Infection in or around your mouth or Large sores in or around your mouth—The chance of side effects may be increased. Proper Use of benzocaineThis section provides information on the proper use of a number of products that contain benzocaine. It may not be specific to Mycinette. Please read with care.
Use this medicine exactly as directed by your doctor. Do not use more of this medicine, do not use it more often, and do not use it for a longer time than directed. To do so may increase the chance of absorption into the body and the risk of side effects.
This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present.
Do not use this medicine for more than 2 days without checking first with your doctor.
DosingThe dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (lozenges): For sore throat and mouth pain: Adults, teenagers, and children 5 years of age and older—One lozenge, dissolved slowly in the mouth every 2 hours as needed. Children younger than 5 years of age—Use is not recommended. Missed DoseIf you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
StorageStore the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using MycinetteIf your condition does not improve within 7 days, or if it becomes worse, check with your doctor.
Call your doctor right away if you start to have a severe sore throat or sore throat that occurs with a high fever, headache, nausea, or vomiting. These maybe signs of an infection.
Mycinette Side EffectsAlong with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known Headache high fever nausea vomiting worsening of pain, redness, swelling, or irritation in or around the mouthOther side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
More Mycinette resources Mycinette Use in Pregnancy & Breastfeeding Mycinette Support Group 6 Reviews for Mycinette - Add your own review/rating Compare Mycinette with other medications Anal Itching Anesthesia Aphthous Ulcer Burns, External Cold Sores Hemorrhoids Oral and Dental Conditions Pain Pruritus Sunburn Tonsillitis/PharyngitisNorgestrel/Ethinyl Estradiol
Pronunciation: nor-JES-trel/ETH-in-il es-tra-DYE-ole
Generic Name: Norgestrel/Ethinyl Estradiol
Brand Name: Examples include Lo/Ovral and Ogestrel
Smoking cigarettes while using Norgestrel/Ethinyl Estradiol increases your chance of having heart problems. Do not smoke while using Norgestrel/Ethinyl Estradiol. The risk of heart problems increases with age and with frequent smoking. Women older than 35 years of age and women who smoke 15 or more cigarettes per day are at a greater risk for heart problems.
Norgestrel/Ethinyl Estradiol is used for:
Preventing pregnancy. It may also be used for other conditions as determined by your doctor.
Norgestrel/Ethinyl Estradiol is a combination birth control pill. It works by preventing ovulation, altering the cervical mucus, and changing the lining of the uterus.
Do NOT use Norgestrel/Ethinyl Estradiol if: you are allergic to any ingredient in Norgestrel/Ethinyl Estradiol you have a history of blood clotting problems; heart disease; irregular heartbeat due to clotting problems; blood vessel problems (eg, blood flow problems in the brain or heart, stroke); chest pain (eg, heart attack, angina); certain types of headaches or migraines; uncontrolled high blood pressure; diabetes that affects circulation; breast cancer; endometrial, cervical, or vaginal cancer; estrogen-dependent growths; undiagnosed vaginal bleeding; yellowing of the eyes or skin due to pregnancy or prior birth control use; or liver disease or tumors you know or suspect that you are pregnant you have had surgery and are confined to a bed or a chair for an extended period of timeContact your doctor or health care provider right away if any of these apply to you.
Before using Norgestrel/Ethinyl Estradiol:Some medical conditions may interact with Norgestrel/Ethinyl Estradiol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have endometriosis, growths in the uterus, abnormal mammogram, irregular menstrual periods, a lump in the breast, heart problems, diabetes, headaches or migraines, gallbladder problems, high blood pressure, high blood cholesterol or lipid levels, kidney problems, blood problems (eg, porphyria), blood in the urine, depression or other mental/mood problems, lupus, chorea, high blood calcium levels, yellowing of the eyes or skin, pancreas problems (eg, pancreatitis), seizures (eg, epilepsy), or a history of cancer if you are overweight, you have not yet had your first menstrual period, or you use tobaccoSome MEDICINES MAY INTERACT with Norgestrel/Ethinyl Estradiol. Tell your health care provider if you are taking any other medicines, especially any of the following:
Aprepitant, azole antifungals (eg, ketoconazole, itraconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, dexamethasone, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, amoxicillin), rifabutin, rifampin, phenylbutazone, primidone, tetracyclines (eg, doxycycline), topiramate, troglitazone, or St. John's wort because the effectiveness of Norgestrel/Ethinyl Estradiol may be decreased, resulting in breakthrough bleeding or pregnancy Atorvastatin, indinavir, or troleandomycin because they may increase the risk of Norgestrel/Ethinyl Estradiol's side effects. Beta-blockers (eg, propranolol), corticosteroids (eg, prednisolone), cyclosporine, or theophylline because the risk of their side effects may be increased by Norgestrel/Ethinyl Estradiol Clofibric acid, morphine, lamotrigine, salicylic acid, or temazepam because their effectiveness may be decreased by Norgestrel/Ethinyl EstradiolThis may not be a complete list of all interactions that may occur. Ask your health care provider if Norgestrel/Ethinyl Estradiol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Norgestrel/Ethinyl Estradiol:Use Norgestrel/Ethinyl Estradiol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Norgestrel/Ethinyl Estradiol by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Begin taking Norgestrel/Ethinyl Estradiol on the first Sunday following the start of your period, unless otherwise directed by your doctor. If your period begins on a Sunday, begin taking Norgestrel/Ethinyl Estradiol on that day. Try to take Norgestrel/Ethinyl Estradiol at the same time every day, not more than 24 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day. Norgestrel/Ethinyl Estradiol works best if it is taken at the same time each day. Do not skip doses. If you miss 1 dose of Norgestrel/Ethinyl Estradiol, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. If you miss more than 1 dose of Norgestrel/Ethinyl Estradiol, read the extra patient information leaflet that comes with Norgestrel/Ethinyl Estradiol or contact your doctor for instructions. If you miss 1 or more doses of Norgestrel/Ethinyl Estradiol, you must use a backup form of birth control for 7 days after you start to take it again. If you are not sure about how to handle miss doses, use an extra form of birth control (eg, condoms) and talk with your doctor.Ask your health care provider any questions you may have about how to use Norgestrel/Ethinyl Estradiol.
Important safety information: Norgestrel/Ethinyl Estradiol may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Norgestrel/Ethinyl Estradiol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Follow your doctor's instructions for examining your own breasts and report any lumps immediately. If you will be having surgery or will be confined to a bed or chair for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks ahead of time. Special precautions may need to be taken in these circumstances while taking Norgestrel/Ethinyl Estradiol. Norgestrel/Ethinyl Estradiol may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protected clothing when exposed to the sun, sunlamps, or tanning booths. Use of Norgestrel/Ethinyl Estradiol will not prevent the spread of sexually transmitted diseases (STDs). Bleeding or spotting may occur while taking Norgestrel/Ethinyl Estradiol. Do not stop taking Norgestrel/Ethinyl Estradiol if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor. Norgestrel/Ethinyl Estradiol may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke. Norgestrel/Ethinyl Estradiol may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Norgestrel/Ethinyl Estradiol. Taking certain antibiotics, anticonvulsants, or other medicines, as listed in the interactions section, while you are using Norgestrel/Ethinyl Estradiol may decrease the effectiveness of Norgestrel/Ethinyl Estradiol. To prevent pregnancy, use an extra form of birth control until your next period. If you wear contact lens and you develop problems with them, contact your doctor. If you miss your period during the week of inactive pills, call your doctor immediately. A missed period may indicate that you are pregnant. Norgestrel/Ethinyl Estradiol may take time to wear off after your last dose. You may not be able to become pregnant for several months after stopping Norgestrel/Ethinyl Estradiol. Discuss any concerns with your doctor or pharmacist. Lab tests, including PAP tests, may be performed while you use Norgestrel/Ethinyl Estradiol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Norgestrel/Ethinyl Estradiol is not recommended for use in CHILDREN who have not had their first menstrual period. Safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Norgestrel/Ethinyl Estradiol if you are pregnant. If you think you may be pregnant, contact your doctor right away. Norgestrel/Ethinyl Estradiol is found in breast milk. Do not breast-feed while taking Norgestrel/Ethinyl Estradiol. Possible side effects of Norgestrel/Ethinyl Estradiol:All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Acne; breast tenderness or enlargement; changes in appetite; changes in weight; dizziness; headache; mild hair loss; nausea; nervousness; stomach cramps or bloating; vaginal spotting or breakthrough bleeding.
Seek medical attention right away if any of these SEVERE side effects occur:Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); absent menstrual period; breast discharge; breast lumps; calf or leg pain, swelling, or tenderness; change in the amount of urine produced; chest pain or heaviness; confusion; coughing of blood; dark urine; fainting; mental or mood changes (eg, depression); migraines; numbness of an arm or leg; one-sided weakness; pale stools; persistent, severe, or recurring headache or dizziness; persistent vaginal spotting; severe pain or tenderness in the stomach; shortness of breath; slurred speech; sudden severe headache or vomiting; swelling of the fingers, hands, legs, or ankles; unusual or severe vaginal bleeding; unusual tiredness or weakness; vaginal irritation, discharge, or change in secretions; vision changes (eg, sudden vision loss, double vision); yellowing of the skin or eyes (with or without fever).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include nausea; vaginal bleeding; vomiting.
Proper storage of Norgestrel/Ethinyl Estradiol:Store Norgestrel/Ethinyl Estradiol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Norgestrel/Ethinyl Estradiol out of the reach of children and away from pets.
General information: If you have any questions about Norgestrel/Ethinyl Estradiol, please talk with your doctor, pharmacist, or other health care provider. Norgestrel/Ethinyl Estradiol is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.This information is a summary only. It does not contain all information about Norgestrel/Ethinyl Estradiol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Norgestrel/Ethinyl Estradiol resources Norgestrel/Ethinyl Estradiol Dosage Norgestrel/Ethinyl Estradiol Use in Pregnancy & Breastfeeding Norgestrel/Ethinyl Estradiol Drug Interactions Norgestrel/Ethinyl Estradiol Support Group 45 Reviews for Norgestrel/Ethinyl Estradiol - Add your own review/rating Compare Norgestrel/Ethinyl Estradiol with other medications Abnormal Uterine Bleeding Birth Control Emergency Contraception Endometriosis Gonadotropin InhibitionEquell
Dosage Form: FOR ANIMAL USE ONLY
Equell®
(ivermectin)
Paste 1.87%
Anthelmintic and Boticide
FOR ORAL USE IN HORSES ONLY
Removes worms and bots with a single dose.
Contents will treat up to 1320 lb body weight.
Net Weight: 0.225 oz (6.42 g)
INDICATIONSConsult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. Equell (ivermectin) Paste provides effective control of the following parasites in horses:
Large Strongyles (adults)
Strongylus vulgaris (also early forms in blood vessels)
S. edentatus (also tissue stages)
S. equinus
Triodontophorus spp. including T. brevicauda, T. serratus
Craterostomum acuticaudatum
Small Strongyles (adults, including those resistant to some benzimidazole class compounds)
Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus
Cyathostomum spp. including C. catinatum, C. pateratum
Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, C. brevicapsulatus
Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, C. minutus
Cylicodontophorus spp.
Petrovinema poculatum
Small Strongyles (fourth-stage larvae)
Pinworms (adults and fourth-stage larvae)
Oxyuris equi
Ascarids (adults and third- and fourth-stage larvae)
Parascaris equorum
Hairworms (adults)
Trichostrongylus axei
Large-mouth Stomach Worms (adults)
Habronema muscae
Bots (oral and gastric stages)
Gasterophilus spp. including G. intestinalis and G. nasalis
Lungworms (adults and fourth-stage larvae)
Dictyocaulus arnfieldi
Intestinal Threadworms (adults)
Strongyloides westeri
Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae
Dermatitis caused by Neck Threadworm microfilariae, Onchocerca sp.
Equell Dosage and AdministrationThis syringe contains sufficient paste to treat one 1320-lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) of body weight. Each weight marking on the syringe plunger delivers enough paste to treat 250 lb (114 kg) of body weight.
While holding plunger, turn the knurled ring on the plunger 1/4 turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking. Lock the ring in place by making a 1/4 turn to the right. Make sure that the horse’s mouth contains no feed. Remove the cover from the tip of the syringe. Insert the syringe tip into the horse’s mouth at the space between the teeth. Depress the plunger as far as it will go, depositing paste on the back of the tongue. Immediately raise the horse's head for a few seconds after dosing. Parasite Control ProgramAll horses should be included in a regular parasite control program with particular attention being paid to mares, foals, and yearlings. Foals should be treated initially at 6 to 8 weeks of age, and routine treatment repeated as appropriate. Consult your veterinarian for a control program to meet your specific needs. Equell Paste effectively controls gastrointestinal nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by Strongylus vulgaris.
Product Advantages Broad-spectrum ControlEquell Paste kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a single dose. Equell Paste is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.
ANIMAL SAFETYEquell Paste may be used in horses of all ages, including mares at any stage of pregnancy. Stallions may be treated without adversely affecting their fertility.
WarningsDo not use in horses intended for human consumption.
Not for use in humans. Keep this and all drugs out of reach of children. Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes.
The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain a MSDS, contact Bimeda, Inc. at 1-888-524-6332.
PrecautionsEquell Paste has been formulated specifically for use in horses only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.
Environmental SafetyIvermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of the syringe in an approved landfill or by incineration.
Store at room temperature (25°C/77°F), with excursions permitted between 15°- 30°C (59°- 86°F).
INFORMATION FOR HORSE OWNERSSwelling and itching reactions after treatment with ivermectin paste have occurred in horses carrying heavy infections of neck threadworm (Onchocerca sp. microfilariae). These reactions were most likely the result of microfilariae dying in large numbers. Symptomatic treatment may be advisable. Consult your veterinarian should any such reactions occur. Healing of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with treatment with Equell Paste. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.
ANADA 200-320, Approved by FDA
Manufactured by:
Virbac AH Inc.
3200 Meacham Blvd
Fort Worth, Texas 76137
Distributed by:
Bimeda, Inc.
Le Sueur, MN 56058
Equell is a Registered Trademark of Virbac SA.
November 2009
301981-01
PRINCIPAL DISPLAY PANEL - 6.42 g Syringe CartonEquell®
(ivermectin)
Paste 1.87%
Anthelmintic and Boticide
Removes worms and bots with a single dose.
Contents will treat up to 1320 lb. body weight.
FOR ORAL USE IN HORSES ONLY
Net Weight: 0.225 oz (6.42 g)
ANADA 200-320, Approved by FDA
Bimeda
Equell
ivermectin paste Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 61133-7010 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ivermectin (Ivermectin) Ivermectin 200 ug Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 61133-7010-1 1 SYRINGE In 1 CARTON None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200320 01/14/2010
Labeler - Bimeda Inc (043653216) Registrant - Virbac AH Inc (131568396) Establishment Name Address ID/FEI Operations Virbac Bridgeton 808558100 MANUFACTURE Revised: 01/2010Bimeda Inc
Generic Name: zinc oxide topical (ZINK OX ide)
Brand Names: ARC, Balmex, Boudreaux Butt Paste, Caldesene, Calmol-4 Suppository, Critic-Aid Skin Paste, Delazinc, Dermagran BC, Desitin, Desitin Maximum Strength Original, Desitin Rapid Relief Creamy, Diaper Rash Ointment, Diaper Relief, Dr. Smith's Diaper, Flanders Buttocks Ointment, Geri-Protect, Medi-Paste, PeriGuard, Pinxav, Rash Relief, RVPaque, Seniortopix Healix, Soothe & Cool Skin Paste, Sportz Block Dark, Sportz Block Light, Sportz Block Medium, Triple Paste, Tronolane Suppositories, Unna-Flex Elastic Unna Boot 3 inch, Unna-Flex Elastic Unna Boot 4 inch, Znlin
Zinc oxide is a mineral.
Zinc oxide topical (for the skin) is used to treat diaper rash, minor burns, severely chapped skin, or other minor skin irritations.
Zinc oxide rectal suppositories are used to treat itching, burning, irritation, and other rectal discomfort caused by hemorrhoids or painful bowel movements.
Zinc oxide topical may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Critic-Aid Skin Paste (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.
Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.
Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.Avoid using other medications on the areas you treat with zinc oxide unless you doctor tells you to.
What should I discuss with my health care provider before using Critic-Aid Skin Paste (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.
It is not known whether zinc oxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether zinc oxide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby. How should I use Critic-Aid Skin Paste (zinc oxide topical)?Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Apply enough of this medication to cover the entire area to be treated. Zinc oxide often leaves a thin white residue that may not be entirely rubbed in.
To treat chapped skin, minor burn wounds, or other skin irritations, use the medication as often as needed. Apply a thin layer to the affected area and rub in gently.
To treat diaper rash, use this medication each time the diaper is changed. It is especially important to apply the medication at bedtime or whenever there will be a long period of time between diaper changes.
Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.
When using the powder form of this medicine, pour the powder slowly to avoid a large puff into the air. Do not allow a baby to handle a powder bottle during use. Always close the lid after using the powder.Zinc oxide rectal suppositories come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Wash your hands before and after inserting a rectal suppository.Try to empty your bowel and bladder just before using the suppository. Cleanse and dry your rectal area thoroughly.
Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.
For best results, stay lying down after inserting the suppository and hold it in your rectum for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.
Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Store at room temperature away from moisture and heat. Keep the tube cap tightly closed when not in use. You may store zinc oxide rectal suppositories in a refrigerator to prevent melting. What happens if I miss a dose?Since zinc oxide is used on an as needed basis, you are not likely to miss a dose. Using extra zinc oxide to make up a missed dose will not make the medication more effective.
What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Critic-Aid Skin Paste (zinc oxide topical)? Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury. Critic-Aid Skin Paste (zinc oxide topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using zinc oxide rectal suppositories if you have rectal bleeding or continued pain.This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Critic-Aid Skin Paste (zinc oxide topical)?Avoid applying other skin medications on the same treatment area with zinc oxide, unless your doctor has told you to.
There may be other drugs that can interact with zinc oxide topical or rectal suppositories. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More Critic-Aid Skin Paste resources Critic-Aid Skin Paste Side Effects (in more detail) Critic-Aid Skin Paste Use in Pregnancy & Breastfeeding Critic-Aid Skin Paste Support Group 0 Reviews for Critic-Aid Skin - Add your own review/rating Arcalyst Monograph (AHFS DI) Caldesene Topical Advanced Consumer (Micromedex) - Includes Dosage Information Desitin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Critic-Aid Skin Paste with other medications Anal Itching Dermatologic Lesion Where can I get more information? Your pharmacist can provide more information about zinc oxide topical.See also: Critic-Aid Skin side effects (in more detail)
ESTRADERM MX 25, 50, 75 and 100
(estradiol)
These patches will usually be referred to as Estraderm MX in this leaflet
What you need to know about Estraderm MXYour doctor has decided that you need this medicine to help treat your condition.
Please read this leaflet carefully before you start to use the patches. It contains important information. Keep the leaflet in a safe place because you may want to read it again.
If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet: 1. What Estraderm MX patches are, and what they are used for 2. Things to consider before you start to use Estraderm MX patches 3. How to use Estraderm MX patches 4. Possible side effects 5. How to store the patches 6. Further information What Estraderm MX patches are and what they are used forEstraderm MX is a patch which you stick on your skin. The patch contains a supply of estradiol which is released from the patch and absorbed through the skin into your blood stream. This is called a transdermal patch.
The active ingredient in the patches is estradiol. This is one of a group of hormones called estrogens which are the natural female sex hormone produced in large amounts by the ovaries before the menopause. After the menopause the ovaries produce less estrogen.
Estraderm MX is used as hormone replacement therapy (HRT) to relieve the symptoms of the menopause. The menopause can occur naturally or as the result of surgery.
Estraderm MX 50 and 75 patches can also be used to prevent osteoporosis (thinning of the bones), when you have a high risk of future fractures, and if you are unable to take other medicines for this purpose.
To relieve the symptoms of the menopause:Estraderm MX is used to help relieve the uncomfortable symptoms which you sometimes get during and after the menopause (the time when menstrual periods stop). Menopause occurs naturally in all women, usually between the ages of 45 and 55. It also occurs in younger women who have had their ovaries removed by surgery. The reduced levels of estrogen can cause unpleasant symptoms such as hot face, neck and chest, hot flushes (sudden waves of heat and sweating all over), sleep problems, irritability and depression.
Some women also have problems with urine control, or with a dry vagina which may cause discomfort during or after sexual intercourse. Taking estrogens can reduce or eliminate these symptoms.
To prevent osteoporosis:After the age of 40, and especially after the menopause, some women are at risk of developing osteoporosis. This is when the bones become thinner and weaker and more likely to break, especially the bones of the spine, hip and wrist. Lack of estrogens increases the risk of osteoporosis. Taking estrogens after the menopause slows down bone loss and can help to prevent it. The protective effects on the bone cease once treatment is stopped. You should discuss the benefits and risks of Estraderm MX and other therapies with your doctor.
Things to consider before you start to use Estraderm MXRead this section carefully because, there are some conditions your doctor should know about before you start your treatment.
Medical check-upsBefore you start using HRT, your doctor should ask you about your own, and your family’s, medical history. Your doctor may decide to examine your breasts and/or your abdomen and may do an internal examination - but only if these examinations are necessary for you, or you have any special concerns. Once you have started HRT, you should see your doctor for regular check-ups (at least once a year). At these check-ups your doctor may discuss with you the benefits and risks of continuing with HRT.
While you are using HRT make sure that you:
Go for regular breast screening and cervical smear tests. Regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, a discharge from the nipple, or any lumps you can see or feel.Some people MUST NOT use Estraderm MX. Talk to your doctor if:
you have ever had any unusual or allergic reaction to estrogens or to any other components of the patch, (These are listed at the end of the leaflet.) you have, or have ever had, breast cancer, (See the section below on breast cancer.) you have, or have ever had, cancer of the endometrium (lining of the womb) or any other cancer which is sensitive to estrogens, (See the sections below on endometrial and ovarian cancer.) you have a blood disease called porphyria, you have, or have ever had, a blood clot in a vein in your leg or anywhere else (a deep vein thrombosis) or a clot that has travelled to your lung or another part of your body (an embolus), (See the section below on blood clots.) you have ever had a heart attack, stroke or angina, (See the sections below on heart disease and stroke.) you have had any unexpected bleeding or very heavy bleeding from the vagina, you have a history of liver disease, you have a condition called endometrial hyperplasia (thickening of the lining of the womb), you are pregnant or breastfeeding.Estraderm MX should not be used in children.
You should also ask yourself these questions before using the patch. If the answer to any of these questions is YES, tell your doctor or pharmacist because Estraderm MX might not be the right medicine for you.
Has anyone in your immediate family had breast cancer? Do you have fibroids or any other growths in your womb? Have you had a hysterectomy? Do you have endometriosis (a condition which causes painful periods)? Do you have high blood pressure? Do you have any problems with your liver? Do you have diabetes, epilepsy or asthma? Do you get migraine or other bad headaches? Do you have a condition called lupus (SLE)? Do you have problems with your hearing? Do you have any of the conditions which put you at increased risk of blood clots (see below)? Do you have a high level of cholesterol or other fats in your blood? Do you have heart or kidney problems? Have you ever had problems with your gall bladder, such as gallstones? Are you over 65? Are you taking other medicines?Some medicines can interfere with your treatment. Tell your doctor or pharmacist if you are taking any of the following:
medicines to treat epilepsy such as phenobarbital, phenytoin and carbamazepine, antibiotics and other medicines to treat infections (e.g. rifampicin, rifabutin, nevirapine, efavirenz, ritonavir, nelfinavir), the herbal medicine St John’s Wort (also known as Hypericum perforatum).Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.
Before you have a blood test remind your doctor that you are using Estraderm MX as it may affect the result.
Will there be any problems with driving or using machinery?No problems have been reported.
Using contraception whilst taking Estraderm MXEstraderm MX is not a contraceptive, nor a fertility treatment.
If you are using an oral or other hormone contraceptive, e.g. the pill or depot injection, you must change to a non-hormone contraceptive, for example, a diaphragm or condom, BEFORE starting Estraderm MX.
If you have been told that you don’t need to use a contraceptive any longer, you won’t need one while you are using Estraderm MX even if you have a monthly bleed.
Other special warningsHRT will not help to prevent heart disease.
As well as benefits, HRT has some risks which you need to consider when you are deciding whether to use it, or whether to carry on using it. These are:
Effects on your heart or circulation
i. Heart diseaseHRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be using HRT.
Studies with one type of HRT (containing conjugated estrogen plus a progestogen) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.
If you get:
A pain in your chest that spreads to your arm or neck,
See a doctor as soon as possible and do not use any more HRT until your doctor says you can. This pain could be a sign of heart disease.
ii. StrokeRecent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:
Getting older High blood pressure Smoking Drinking too much alcohol An irregular heartbeatIf you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you ought to be using HRT.
If you get:
Unexplained migraine-type headaches, with or without disturbed vision,See a doctor as soon as possible and do not use any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.
iii. Blood clotsUsing HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year. These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE.
DVT and PE are examples of a condition called venous thromboembolism, or VTE.
You are more likely to get a blood clot if:
You are seriously overweight You have had a blood clot before Any of your close family have had blood clots You have had one or more miscarriages You have any blood clotting problem that needs treatment with a medicine such as warfarin You’re off your feet for a long time because of major surgery, injury or illness You are going on a long journey and will be immobile for some time You have a rare condition called systemic lupus erythematosus (SLE – a connective tissue disease).If any of these things apply to you, talk to your doctor to see if you should be using HRT.
If you get:
Painful swelling in your leg Sudden chest pain Difficulty breathingSee a doctor as soon as possible and do not use any more HRT until your doctor says you can. These may be signs of a blood clot.
If you’re going to have surgery, make sure your doctor knows about it. You may need to stop using HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start using HRT again.
A comparison – the approximate risk of stroke or blood clots in women not using, or using, HRT over a 5 year period
Women in their 50s
Stroke has been reported in 3 in 1,000 women not using HRT, compared to 4 in 1,000 women using HRT.
Blood clots have been reported in 3 in 1,000 women not using HRT, compared to 7 in 1,000 women using HRT.
Women in their 60s
Stroke has been reported in 11 in 1,000 women not using HRT, compared to 15 in 1,000 women using HRT.
Blood clots have been reported in 8 in 1,000 women not using HRT, compared to 17 in 1,000 women using HRT.
Effects on your risk of developing cancer
i. Breast cancerWomen who have breast cancer, or have had breast cancer in the past, should not use HRT.
Using HRT slightly increases the risk of breast cancer; so does having a late menopause.
The risk for a post-menopausal woman using estrogen-only HRT for 5 years is about the same as for a woman of the same age who’s still having periods over that time and not using HRT. The risk for a woman who is using combined HRT (estrogen plus progestogen) is higher than for estrogen-only HRT (but combined HRT is beneficial for the endometrium, see Endometrial cancer, below).
For all kinds of HRT, the extra risk of breast cancer goes up the longer you use it, but returns to normal within about 5 years of stopping HRT.
Your risk of breast cancer is also higher if:
You have a close relative (mother, sister or grandmother) who has had breast cancer You are seriously overweight.If you notice any changes in your breast, such as:
Dimpling of the skin Changes in the nipple or a discharge from the nipple Any lumps you can see or feelMake an appointment to see your doctor as soon as possible.
A comparison – the risk of developing breast cancer: the number of women aged 50 who will get breast cancer by the time they are 65.
32 in 1,000 of these women who are not using HRT, will get breast cancer.
33.5 in 1,000 of these women who have used estrogen-only HRT for 5 years, will get breast cancer.
37 in 1,000 of these women who have used estrogen-only HRT for 10 years, will get breast cancer.
38 in 1,000 of these women who have used combined HRT for 5 years, will get breast cancer.
51 in 1,000 of these women who have used combined HRT for 10 years, will get breast cancer.
Estraderm MX is an estrogen-only product.
Using estrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb. Taking a progestogen as well as the estrogen helps to lower the extra risk.
If you still have your womb, your doctor may prescribe a progestogen as well as estrogen.
They can be prescribed separately, or as a combined HRT product.
If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take estrogen without a progestogen.
If you’ve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an estrogen.
A comparison – the risk of developing endometrial cancer
Women who still have their uterus and who do not use HRT
About 5 in 1,000 women aged 50 will get endometrial cancer by the time they are 65.
Women who have used estrogen-only HRT
The number will be 2-12 times higher depending on the dose and length of use.
Women who have used estrogen plus progestogen HRT
The risk of endometrial cancer is substantially reduced.
If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, especially during the first few months of taking HRT.
But if the bleeding or spotting:
Carries on for more than the first few months Starts after you’ve been on HRT for a while Carries on even after you’ve stopped using HRTMake an appointment to see your doctor. It could be a sign that your endometrium has become thicker.
iii. Ovarian cancer (cancer of the ovaries)Cancer of the ovaries is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.
Some studies have indicated that using estrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.
Effects on your risk of developing dementia
HRT will not prevent memory loss. In one study of women who started using combined HRT after the age of 65, a small increase in risk of dementia was observed.
How to use Estraderm MX patchesThe doctor will tell you how to use Estraderm MX and what dose you need. Always follow his/her instructions carefully. The information will be on the pharmacist’s label.
Check the label carefully. If you are not sure, ask your doctor or pharmacist. Do not change the dose or stop the treatment without talking to your doctor.
If you have not had a hysterectomy, your doctor will give you tablets containing another hormone called progestogen to offset the effects of estrogens on the lining of the womb. (See the section above on endometrial cancer.) Your doctor will explain to you how to take these tablets. Withdrawal bleeding may occur at the end of the progestogen treatment period. Tell your doctor if you get irregular and/or heavy bleeding (see endometrial cancer).
Starting to use the patchesEstraderm MX patches are applied to the skin. You wear them all the time. You should apply a new patch twice a week i.e. every 3 or 4 days.
If you are not currently using any form of HRT (patch or tablets), if you have had a hysterectomy or if you have been using a continuous combined HRT product (where estrogen and the progestogen are given every day without interruption), you can start to use Estraderm MX on any convenient day. If you are changing from a cyclic or sequential HRT treatment where the progestogen is added for 12-14 days of the cycle, start to use Estraderm MX the day after you complete the cycle. If you are still having periods you should start to use Estraderm MX within 5 days of starting your period, irrespective of how long you bleed. About the patchWhere to apply the patch
Stick the patch on to a hairless area of skin below the waist. Most patients find that the buttock is the best place. Choose an area of the buttock where the skin is not inflamed, broken, or irritated. You could also try the lower back, hip or abdomen.
Never put a patch on or near the breasts.
Choose a clean, dry area of skin. To help the patch stick, the skin should be clean, dry, and free of creams, lotions, oil, or powder. You should use a different area of skin each time. Wait a week before using the same area again. Avoid skin which is red or irritated.
Do not expose the patch to direct sunlight.
Opening the sachets
Each Estraderm MX patch is sealed in an airtight sachet. Tear open one of the sachets at the notch (do not use scissors) and take out the patch. Don’t take the patch out of the sachet until immediately before you intend to use it.
Removing the lining
A stiff, transparent protective lining covers the sticky side of the patch, i.e. the side that will be placed against your skin. First remove the smaller piece of the transparent liner. Then peel off the larger piece. Try to avoid touching the adhesive and remember not to allow the patch to become folded so that the sticky surfaces come in contact with each other. Now apply the patch.
Applying the patch
With the palm of your hand press the sticky side of the patch firmly onto the spot you have chosen. Hold it there for about 10-20 seconds. Make sure that it sticks well, especially around the edges, but once the patch is in place do not pull at it to test that it is sticking properly.
When and how to remove the patch
The patches should be changed twice a week on the same two days of the week, e.g. Mondays and Thursdays. Choose two days which you are likely to remember.
Note the day of the week on which you are starting the treatment.
When the time comes to change the patch, peel it off and fold it in half with the sticky side inside. Dispose of the patch carefully (see Section 5), making sure that it is kept out of the reach of children because it will still contain some medication. Stick a new patch onto a different area of skin.
What to do if a patch comes off
If a patch falls off it will not stick to your skin again. Use another patch on a different area of your skin (see Where to apply the patch). Make sure you choose a clean, dry, lotion-free area of the skin. No matter what day this happens, go back to changing the patch on the same days as usual.
Other useful information Bathing, swimming, showering or exercising should not affect the patch if it has been correctly applied. You may wear the patch under your swimming costume. Never apply a patch on a sweaty area or after a hot bath or shower. Wait until the skin is completely cool and dry. Do not remove the patch and try to put it somewhere else, it will not stick to your skin again. Instead apply a new patch in the usual way. Remember to apply your next patch at the normal time. If you have run out of patches, please contact your doctor straight away. (See also advice on What to do if a patch comes off.) Sunbathing: always make sure your patch is covered by clothing. Using a sunbed: cover up the patch The drug in your patch is contained in the adhesive and not in a special reservoir. The drug in your patch is a gel which is colourless. This does not mean that the patch does not contain any medication. How long to use Estraderm MXEstraderm MX should be used only as long as needed, possibly for several months or more. This will help to control your symptoms.
While you are using Estraderm MX you should go to the doctor regularly to discuss the possible risks and benefits associated with HRT, and whether you still need the treatment.
Your doctor will aim to give you the lowest possible dose for the shortest possible length of time to treat your symptoms.
If you forget to use Estraderm MXIf you forget to apply a patch, apply a new patch as soon as you remember. No matter what day that happens, go back to changing this patch on the same day as you usually do.
There is an increased chance of breakthrough bleeding or spotting if there is a break in treatment.
Estraderm MX Side EffectsEstraderm MX is suitable for most people, but, like all medicines, there are sometimes side effects.
Stop using Estraderm MX immediately and tell your doctor if you develop any of the following: Signs of an allergic reaction (difficulty in breathing, tight chest, itching all over, generalised swelling or itching). Migraine or unusually severe headaches, or signs of stroke You become pregnant Signs of jaundice (yellowing of your skin or eyes). The side effects listed below have also been reported:Up to 1 in 10 people have experienced:
Headache Feeling sick or bloated, stomach ache Redness and itching where the patch has been applied Tender or painful breasts Breakthrough bleeding.Up to 1 in 100 people have experienced:
Breast cancer.Up to 1 in 1,000 people have experienced:
Dizziness Blood clots, bruising, worsening varicose veins, raised blood pressure Abnormal liver function test results, jaundice Rash and itching over large areas of the skin. This sensitivity reaction may become severe if you carry on using the patches without talking to your doctor. Changes in the pigmentation in your skin (lightening or darkening of your skin colour) Unusual weight changes, fluid retention (swelling or accumulation of fluid in the lower legs or ankles), leg pain. Other side effects include: Estrogen-dependent conditions such as cancer of the endometrium, heart attack, stroke, dementia (these are discussed in Section 2) and gall bladder disease.Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Estraderm MX. Ask your doctor or pharmacist to answer any questions you may have.
How to store the patchesKeep Estraderm MX out of the reach and sight of children both before and after use.
Store below 25°C, away from direct sunlight.
Do not use Estraderm MX after the expiry date shown on the pack.
Do not use a new Estraderm MX pack that is damaged or shows signs of tampering.
If your doctor tells you to stop using Estraderm MX, please take any patches left back to your pharmacist to be destroyed. Only keep them if the doctor tells you to. Do not throw them away with your normal household water or waste. This will help to protect the environment.
Further informationThe active substance in Estraderm MX is estradiol. The estradiol is derived from plants and is produced synthetically.
The other ingredients in Estraderm MX are isopropyl palmitate, acrylic adhesive (in solution in ethylacetate/hexane) and ethyl acetate. The backing film consists of ethylene vinyl acetate/polyester film laminate. The protective liner, which is removed before the patch is used, is a siliconized polyester film. The estradiol is released gradually while you are wearing the patch.
Estraderm MX 25 contains 0.75 mg estradiol releasing about 25 micrograms of estradiol a day.
Estraderm MX 50 contains 1.5 mg estradiol releasing about 50 micrograms of estradiol a day.
Estraderm MX 75 contains 2.25 mg estradiol releasing about 75 micrograms of estradiol a day.
Estraderm MX 100 contains 3.0 mg estradiol releasing about 100 micrograms of estradiol a day.
A one month pack contains 8 patches; a 3-month pack contains 24 patches of one size.
The product licence holder is Novartis Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR England Estraderm MX patches are made by Lohmann LTS Lohmannstr. 2 P.O. Box 1525 56605 Andernach GermanyThis leaflet was revised in December 2008.
Fill this in to remind you when to change your patch. Please tick the box for the days of the week when you should change your patch.
Monday + Thursday Tuesday + Friday Wednesday + Saturday Thursday + Sunday Friday + Monday Saturday + Tuesday Sunday + WednesdayIf you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.
ESTRADERM MX is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited
Flexeril
Generic Name: cyclobenzaprine hydrochloride
Dosage Form: tablet, film coated
CYCLOBENZAPRINE HYDROCHLORIDE - cyclobenzaprine hydrochloride tablet
Flexeril Description
Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C20H21N • HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates.
Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:
Each tablet for oral administration contains 10 mg Cyclobenzaprine Hydrochloride, USP.
Each tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, corn starch, crospovidone, hypromellose, magnesium stearate, pregelatinized starch, polyethylene glycol, polysorbate 80, titanium dioxide, D&C yellow #10, FD&C Blue #2,& FD&C yellow#6.
Flexeril - Clinical PharmacologyCyclobenzaprine HCl relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease.
Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models. Animal studies indicate that cyclobenzaprine does not act at the neuromuscular junction or directly on skeletal muscle. Such studies show that cyclobenzaprine acts primarily within the central nervous system at brain stem as opposed to spinal cord levels, although its action on the latter may contribute to its overall skeletal muscle relaxant activity. Evidence suggests that the net effect of cyclobenzaprine is a reduction of tonic somatic motor activity, influencing both gamma (?) and alpha (?) motor systems.
Pharmacological studies in animals showed a similarity between the effects of cyclobenzaprine and the structurally related tricyclic antidepressants, including reserpine antagonism, norepinephrine potentiation, potent peripheral and central anticholinergic effects, and sedation. Cyclobenzaprine caused slight to moderate increase in heart rate in animals.
Cyclobenzaprine is well absorbed after oral administration,but there is a large intersubject variation in plasma levels cyclobenzaprine is eliminated quite slowly with a half-life as long as one to three days.it is highly bound to plasma protein,is extensively metabolised primarily to glucuronide-like conjugates, and is excreted primarily via the kidneys
No significant effect on plasma levels or bioavailability of cyclobenzaprine hydrochloride or aspirin was noted when single or multiple doses of the two drugs were administered concomitantly.concomitant administration of cyclobenzaprine hydrochloride and aspirin is usually well tolerated and no unexpected or serious clinical or laboratory adverse effects have been observed.no studies have been performed to indicate whether cyclobenzaprine enhances the clinical effect of aspirin or other analgesics,or whetheranalgesics enhance the clinical effect of cyclobenzaprine in acute musculoskeletal conditions.
Clinical StudiesControlled clinical studies show that cyclobenzaprine hydrochloride significantly improves the signs and symptoms of skeletal muscle spasm as compared with placebo.The clinical responses include improvement in muscle spasm as determined by palpation,reduction in localpain and tenderness,increased range of motion,and less restriction in activities of daily living.When daily observations were made,clinical improvement was observed as early as the first day of therapy.
Eight double-blind controlled clinical studies were performed in 642 patients comparing cyclobenzaprine hydrochloride, diazepam, and placebo. Muscle spasm, local pain and tenderness, limitation of motion, and restriction in activities of daily living were evaluated. In three of these studies there was a significantly greater improvement with cyclobenzaprine than with diazepam, while in the other studies the improvement following both treatments was comparable.
Although the frequency and severity of adverse reactions observed in patients treated with cyclobenzaprine were comparable to those observed in patients treated with diazepam, dry mouth was observed more frequently in patients treated with cyclobenzaprine and dizziness more frequently in those treated with diazepam. The incidence of drowsiness, the most frequent adverse reaction, was similar with both drugs.
Analysis of the data from controlled studies shows that cyclobenzaprine produces clinical improvement whether or not sedation occurs.
Surveillance ProgramA post-marketing surveillance program was carried out in 7607 patients with acute musculoskeletal disorders, and included 297 patients treated for 30 days or longer. The overall effectiveness of cyclobenzaprine was similar to that observed in the double-blind controlled studies; the overall incidence of adverse effects was less (see ADVERSE REACTIONS).
Indications and Usage for FlexerilCyclobenzaprine hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine HCL has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
ContraindicationsHypersensitivity to the drug.
Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation.
Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
Hyperthyroidism.
WarningsCyclobenzaprine is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. In short term studies for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm, some of the more serious central nervous system reactions noted with the tricyclic antidepressants have occurred (see WARNINGS, below, and ADVERSE REACTIONS).
Cyclobenzaprine may interact with monoamine oxidase(MAO)inhibitors.hyperpyretic crisis,severe convulsions and deaths have occured in patients receiving tricyclic antidepressants and MAO inhibitor drugs.
Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.
Cyclobenzaprine may enhance the effects of alcohol, barbiturates, and other CNS depressants.
Precautions GeneralBecause of its atropine-like action, cyclobenzaprine hydrochloride should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.
Information for PatientsCyclobenzaprine may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.
Drug InteractionsCyclobenzaprine may enhance the effects of alcohol, barbiturates, and other CNS depressants.
Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.
Carcinogenesis, Mutagenesis, Impairment of FertilityIn rats treated with cyclobenzaprine hydrochloride for up to 67 weeks at doses of approximately 5 to 40 times the maximum recommended human dose, pale, sometimes enlarged, livers were noted and there was a dose-related hepatocyte vacuolation with lipidosis. In the higher dose groups this microscopic change was seen after 26 weeks and even earlier in rats which died prior to 26 weeks; at lower doses, the change was not seen until after 26 weeks.
Cyclobenzaprine did not affect the onset, incidence or distribution of neoplasia in an 81-week study in the mouse or in a 105-week study in the rat.
At oral doses of up to 10 times the human dose, cyclobenzaprine did not adversely affect the reproductive performance or fertility of male or female rats. Cyclobenzaprine did not demonstrate mutagenic activity in the male mouse at dose levels of up to 20 times the human dose.
Pregnancy Pregnancy Category B:Reproduction studies have been performed in rats, mice and rabbits at doses up to 20 times the human dose, and have revealed no evidence of impaired fertility or harm to the fetus due to cyclobenzaprine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing MothersIt is not known whether this drug is excreted in human milk. Because cyclobenzaprine hydrochloride is closely related to the tricyclic antidepressants, some of which are known to be excreted in human milk, caution should be exercised when cyclobenzaprine hydrochloride is administered to a nursing woman.
Pediatric UseSafety and effectiveness of cyclobenzaprine hydrochloride in childrens below 15 years of age have not been established.
Adverse ReactionsThe following list of adverse reactions is based on the experience in 473 patients treated with cyclobenzaprine hydrochloride controlled clinical studies, 7607 patients in the post-marketing surveillance program, and reports received since the drug was marketed. The overall incidence of adverse reactions among patients in the surveillance program was less than the incidence in the controlled clinical studies.
The adverse reactions reported most frequently with cyclobenzaprine hydrochloride were drowsiness, dry mouth and dizziness. The incidence of these common adverse reactions was lower in the surveillance program than in the controlled clinical studies:
ClinicalStudies Surveillance
Program Drowsiness 39% 16% Dry Mouth 27% 7% Dizziness 11% 3%
Among the less frequent adverse reactions, there was no appreciable difference in incidence in controlled clinical studies or in the surveillance program. Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.
Incidence in less than 1 in 100The following adverse reactions have been reported in post-marketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg tablet:
Body as a Whole: Syncope; malaise.
Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension.
Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.
Musculoskeletal: Local weakness.
Nervous System and Psychiatric: Ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia;
Skin: Sweating; skin rash; urticaria.
Special Senses: Ageusia; tinnitus.
Urogenital: Urinary frequency and/or retention.
Causal Relationship Unknown
Other reactions, reported rarely for cyclobenzaprine hydrochloride under circumstances where a causal relationship could not be established or reported for other tricyclic drugs, are listed to serve as alerting information to physicians:
Body as a Whole: Chest pain; edema.
Cardiovascular: Hypertension; myocardial infarction; heart block; stroke.
Digestive: Paralytic ileus; tongue discoloration; stomatitis; parotid swelling.
Endocrine: Inappropriate ADH syndrome.
Hematic and Lymphatic: Purpura; bone marrow depression; leukopenia; eosinophilia; thrombocytopenia.
Metabolic, Nutritional and Immune: Elevation and lowering of blood sugar levels; weight gain or loss.
Musculoskeletal: Myalgia.
Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; peripheral neuropathy; Bell's palsy; alteration in EEG patterns; extrapyramidal symptoms.
Respiratory: Dyspnea.
Skin: Photosensitization; alopecia; pruritus.
Urogenital: Impaired urination; dilatation of urinary tract; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea.
Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when cyclobenzaprine hydrochloride is administered, even though they have not been reported to occur with this drug. Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise. These are not indicative of addiction.
Overdosage MANIFESTATIONSHigh doses may cause temporary confusion,disturbed concentration transient visual hallucinations, agitation,hyperactive reflexes,muscle rigidity, vomoting, or hyperpyrexia in addition to anything listed under ADVERSE REACTIONS.
based on the known pharmacologic actions of the drug, overdose may cause drowsiness,hypothermia,tachycardia and other cardiac rhythm abnormalities such as bundle branch block, ECG evidence of impaired conditions, and congestive heart failure.other manifestations may be dilated pupils, convulsions, severe hypotension, stupor and coma.
The acute oral LD50 of cyclobenzaprine hydrochloride is approximately 338 and 425 mg/kg in mice and rats, respectively.
TREATMENTTreatment is symptomic and supportive.empty the stomach as quickly as possible by emesis, followed by gastric lavage. after gastric lavage activated charcoal may be administered.twenty to 30g of activated charcoal may be given every four to six hours during the first 24 to 48hours after ingestion. An ECG should be taken and close monitoring of cardiac function must be instituted if there is any evidence of dysrhythmia. maintenance of an open airway,adequate fluid intake, and regulation of body temperature are necessary
The intravenous administration of 1-3mg of physostigmine salicylate is reported to reverse symptoms of poisoning by atropine and other drugs with anticholinergic activity.physostigmine may be helpful in the treatment of cyclobenzaprine overdose because physostigmine is rapidly metabolized,the dosage of physostigmine should be repeated as required,particularly if life-threatening signs such as arrhythmias,convulsions,and deep coma recur or persist after the initial dosage of physostigmine.because physostigmine itself may be toxic,it is not recommented forroutine use.
Standard medicalmeasures should be used to manage circulatory shock and metabolic acidosis.cardiac arrhythmias may be treated with neostigmine,pyridostigmine, or propranolol.when signs of cardiac failure occurs,the use of short-acting digitalis preparation should be considered close monitoring of cardiac function for not less than five days is advisable
Anticonvulsants may be given to control seizure
Dialysis is probably of no value because of low concentrations of the drug.
Since overdosage is often deliberate,patients may attempt suicide by other means during the recovery phase.deaths by deliberate or accidental overdosage have occured with this class of drugs.
Flexeril Dosage and AdministrationThe usual dosage of cyclobenzaprine HCL is 10 mg three times a day.with the range OF 20-40 mg a day in divided doses dosage should not exceed 60 mg a day.use of cyclobenzaprine for periods longer than two or three weeks is noy recommended (see INDICATIONS AND USAGE).
How is Flexeril SuppliedCyclobenzaprine Hydrochloride Tablets, USP 10 mg round, yellow, Round, unscored, filmcoated tablets in bottles of 10, 15, 45.
debossed:PLIVA 563
Store at 20° 25°C(68° TO 77°F)[see USP Controlled Room Temperature]
Dispense in well closed container
Manufactured by:
Pliva®, Inc Pomona, NY 10970
Manufactured for:
Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, Ms 39232
R4
NDC 68387-500-10
Cyclobenzaprine HCL 10 mg;
Generic Flexeril 10mg
10 tablets
Each tablet contain 10 mg cyclobenzaprine HCL
Rx only
PRINCIPAL DISPLAY PANELNDC 68387-500-15
Cyclobenzaprine HCL 10 mg;
Generic Flexeril 10mg
15 tablets
Each tablet contain 10 mg cyclobenzaprine HCL
Rx only
PRINCIPAL DISPLAY PANELNDC 68387-500-45
Cyclobenzaprine HCL 10 mg;
Generic Flexeril 10mg
45 tablets
Each tablet contain 10 mg cyclobenzaprine HCL
Rx only
Flexeril
cyclobenzaprine hydrochloride tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68387-500 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) CYCLOBENZAPRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CARNAUBA WAX STARCH, CORN CROSPOVIDONE HYPROMELLOSE MAGNESIUM STEARATE STARCH, CORN POLYETHYLENE GLYCOL POLYSORBATE 80 TITANIUM DIOXIDE D&C YELLOW NO. 10 FD&C BLUE NO. 2 FD&C YELLOW NO. 6 Product Characteristics Color YELLOW Score no score Shape ROUND Size 7mm Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 68387-500-10 10 TABLET In 1 BOTTLE None 2 68387-500-15 15 TABLET In 1 BOTTLE None 3 68387-500-45 45 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074421 08/24/2006
Labeler - Keltman Pharmaceuticals Inc (362861077) Establishment Name Address ID/FEI Operations PLIVA, Inc 824749340 MANUFACTURE Revised: 02/2010Keltman Pharmaceuticals Inc More Flexeril resources Flexeril Side Effects (in more detail) Flexeril Dosage Flexeril Use in Pregnancy & Breastfeeding Drug Images Flexeril Drug Interactions Flexeril Support Group 92 Reviews for Flexeril - Add your own review/rating Flexeril Monograph (AHFS DI) Flexeril Advanced Consumer (Micromedex) - Includes Dosage Information Flexeril MedFacts Consumer Leaflet (Wolters Kluwer) Flexeril Consumer Overview Amrix Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Compare Flexeril with other medications Fibromyalgia Migraine Muscle Spasm Sciatica Temporomandibular Joint Disorder
Class Name: antifungal, azole (Vaginal route)
Commonly used brand name(s)In the U.S.
3 Day Vaginal Cream Femizol-M Gynazole-1 Gyne-Lotrimin Monistat 1 Mycelex-3 Mycelex-7 Terazol 3 Terazol 7 Tioconazole 1 Vagistat-1 ZazoleIn Canada
Canesten 2 Canesten 3 Canesten 6 Day Canesten Combi-Pak 1 Day Canesten Combi-Pak 3 Day Canesten External Cream Clotrimaderm Gyne Cure Gyno-Trosyd Miconazole 3 Day Ovule Treatment Miconazole Nitrate Monistat 1 Combination Pack Vaginal OvuleAvailable Dosage Forms:
Ointment Kit Cream Suppository Tablet Tampon Uses For This MedicineVaginal azoles are used to treat yeast (fungus) infections of the vagina.
For first-time users, make sure your doctor has checked and confirmed that you have a vaginal yeast infection before you use the vaginal azole antifungal medicines that do not require a prescription. Vaginal yeast infections can reoccur over time and, when the same symptoms occur again, self-treating with these medicines is recommended. However, you should see your doctor if the symptoms occur again within 2 months.
Vaginal antifungal azoles are available both over-the-counter (OTC) and with your doctor's prescription.
Before Using This Medicine AllergiesTell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
PediatricStudies on these medicines have been done only in adult patients, and there is no specific information comparing use of vaginal azoles in children with use in other age groups. It is recommended that these medicines not be used in children up to 12 years of age.
GeriatricMany medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of vaginal azoles in the elderly with use in other age groups, they are not expected to cause different side effects or problems in older people than they do in younger adults.
PregnancyStudies have not been done in humans for use of all azole antifungals during the first trimester of pregnancy. These medicines are safe and effective when used for at least 7 days during the second and third trimesters of pregnancy. However, check with your doctor before using this medicine during the first trimester of pregnancy. Also, use of 1- and 3-day treatments may not be effective during pregnancy.
Breast FeedingIt is not known whether vaginal azoles pass into the breast milk. However, these medicines have not been shown to cause problems in nursing babies.
Interactions with MedicinesAlthough certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with Food/Tobacco/AlcoholCertain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use of This MedicineVaginal azoles usually come with patient directions. Read them carefully before using this medicine.
Use this medicine at bedtime, unless otherwise directed by your doctor. The vaginal tampon form of miconazole should be left in the vagina overnight and removed the next morning.
This medicine is usually inserted into the vagina with an applicator. However, if you are pregnant, check with your doctor before using the applicator.
Some of the vaginal suppositories or tablets come packaged with a small tube of cream. This cream can be applied outside of the vagina in the genital area to treat itching. The packages are called combination, dual, or twin packs.
To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, do not stop using this medicine if your menstrual period starts during the time of treatment.
DosingThe dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For butoconazole For yeast infection: For vaginal cream dosage form: Adults and teenagers— Women who are not pregnant: 100 milligrams (mg) (one full applicator) of 2% cream inserted into the vagina at bedtime for three nights in a row. Pregnant women, after the third month: 100 mg (one full applicator) of 2% cream inserted into the vagina at bedtime for six nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers— Women who are not pregnant: 100 mg (one suppository) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For clotrimazole For yeast infection: For vaginal cream dosage form: Adults and teenagers—The dose depends on the strength of the cream. 1% cream: 50 milligrams (mg) (one full applicator) inserted into the vagina at bedtime for six to fourteen nights in a row. 2% cream: 100 mg (one full applicator) inserted into the vagina at bedtime for three nights in a row. 10% cream: 500 mg (one full applicator) inserted into the vagina at bedtime for one night only. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal tablet dosage form: Adults and teenagers—The dose depends on the strength of the vaginal tablet. Women who are not pregnant: 100-mg tablet: Insert one tablet into the vagina at bedtime for six or seven nights in a row. 200-mg tablet: Insert one tablet into the vagina at bedtime for three nights in a row. 500-mg tablet: Insert one tablet into the vagina at bedtime for one night only. Pregnant women: 100 mg (one vaginal tablet) inserted into the vagina at bedtime for seven nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For econazole For yeast infection: For vaginal suppository dosage form: Adults and teenagers—150 milligrams (mg) (one vaginal suppository) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For miconazole For yeast infection: For vaginal cream dosage form: Adults and teenagers—20 milligrams (one full applicator) inserted into the vagina at bedtime for seven nights in a row. Treatment may be repeated if needed. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers—The dose depends on the strength of the suppository. 100-milligram (mg) suppository: Insert one vaginal suppository into the vagina at bedtime for seven nights in a row. Treatment may be repeated if needed. 200-mg suppository or 400-mg suppository: Insert one vaginal suppository into the vagina at bedtime for three nights in a row. Treatment may be repeated if needed. 1200-mg suppository: Insert one vaginal suppository into the vagina at bedtime for one night. Children up to 12 years of age—Use and dose must be determined by your doctor. For tampon dosage form: Adults and teenagers—100 mg (one tampon) inserted into the vagina at bedtime and then removed the next morning. This is repeated every night for five nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For terconazole For yeast infection: For vaginal cream dosage form: Adults and teenagers—The dose depends on the strength of the cream. 0.4% cream: 20 milligrams (mg) (one full applicator) inserted into the vagina at bedtime for seven nights in a row. 0.8% cream: 40 mg (one full applicator) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers—80 mg (one vaginal suppository) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For tioconazole For yeast infection: For vaginal ointment dosage form: Adults and teenagers—300 milligrams (mg) (one full applicator) of 6.5% ointment inserted into the vagina at bedtime for one night only. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers—300 mg (one vaginal suppository) inserted into the vagina at bedtime for one night only. Children up to 12 years of age—Use and dose must be determined by your doctor. Missed DoseIf you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
StorageKeep out of the reach of children.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not keep outdated medicine or medicine no longer needed.
Keep the vaginal cream, ointment, and suppository forms of this medicine from freezing.
Precautions While Using This MedicineIf your symptoms do not improve within 3 days or have not disappeared in 7 days, or if they become worse, check with your doctor. The 1- or 3-day treatments may take up to 7 days to completely clear up your infection. However, not all vaginal infections are caused by yeast. If symptoms occur again within 2 months, check with your doctor.
Vaginal medicines usually will come out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a minipad or sanitary napkin. The use of nonmedicated tampons (like those used for menstrual periods) is not recommended since they may soak up the medicine.
To help clear up your infection completely and to help make sure it does not return, good health habits are also required.
Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (for example, nylon or rayon) panties. Wear only clean panties.If you have any questions about this, check with your health care professional.
Vaginal yeast infections are not usually spread by having sex and your sex partner does not need to be treated. However, if the sex partner has symptoms of local itching or skin irritation of the penis, he may benefit by being treated also.
If you use latex or rubber birth control devices (condoms, diaphragms, or cervical caps), you should wait 3 days after treatment with azole antifungal agents before using them again. Many brands of vaginal azoles contain oils in the product that can weaken these devices. This increases the chances of a condom breaking during sexual intercourse. The rubber in cervical caps or diaphragms may break down faster and wear out sooner. Check with your health care professional to make sure the vaginal azole product you are using can be used with latex rubber birth control devices.
Check with your doctor before douching to obtain advice about whether you may douche and, if allowed, the proper method.
Side Effects of This MedicineAlong with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Less common Vaginal burning, itching, discharge, or other irritation not present before use of this medicine Rare Skin rash or hivesSome side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common or rare Abdominal or stomach cramps or pain burning or irritation of penis of sexual partner headacheOther side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.
Cuvposa Solution
Pronunciation: GLYE-koe-PIR-oh-late
Generic Name: Glycopyrrolate
Brand Name: Cuvposa
Cuvposa Solution is used for:
Reducing chronic, severe drooling caused by certain conditions (eg, cerebral palsy) in patients 3 to 16 years old. It may also be used for other conditions as determined by your doctor.
Cuvposa Solution is an anticholinergic. It works by blocking the activity of the glands that produce saliva.
Do NOT use Cuvposa Solution if: you are allergic to any ingredient in Cuvposa Solution you have glaucoma, trouble urinating, certain stomach or bowel problems (eg, blockage, bowel muscle problems, severe ulcerative colitis, toxic megacolon), myasthenia gravis, or heart problems caused by bleeding you are taking a solid oral doseform of potassium (eg, tablet)Contact your doctor or health care provider right away if any of these apply to you.
Before using Cuvposa Solution:Some medical conditions may interact with Cuvposa Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have nerve problems (eg, autonomic neuropathy), liver or kidney problems, thyroid problems, eye problems (eg, increased pressure in the eye), or a family history of glaucoma if you have heart problems (eg, coronary heart disease, heart failure), fast or irregular heartbeat, or high blood pressure if you have stomach or bowel problems (eg, ulcerative colitis), a hiatal hernia caused by reflux disease, or if you have an ileostomy or colostomy if you have a history of constipation problemsSome MEDICINES MAY INTERACT with Cuvposa Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
Amantadine because it may increase the risk of Cuvposa Solution's side effects Atenolol, digoxin, or metformin because the risk of their side effects may be increased by Cuvposa Solution Haloperidol or levodopa because their effectiveness may be decreased by Cuvposa SolutionThis may not be a complete list of all interactions that may occur. Ask your health care provider if Cuvposa Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Cuvposa Solution:Use Cuvposa Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Cuvposa Solution. Talk to your pharmacist if you have questions about this information. Take Cuvposa Solution by mouth on an empty stomach at least 1 hour before or 2 hours after eating. Use a measuring cup and oral syringe marked for medicine dosing. Use the measuring cup to measure the correct dose, then use the oral syringe to transfer the medicine from the cup to the mouth. Ask your pharmacist for help if you are unsure of how to measure your dose. Take Cuvposa Solution on a regular schedule to get the most benefit from it. Continue to take Cuvposa Solution even if your condition improves. Do not miss any doses. If you miss a dose of Cuvposa Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.Ask your health care provider any questions you may have about how to use Cuvposa Solution.
Important safety information: Cuvposa Solution may cause drowsiness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Cuvposa Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do NOT take more than the recommended dose without checking with your doctor. Do not become overheated in hot weather or while you are being active; heatstroke may occur. If constipation occurs, contact your doctor for instructions. Cuvposa Solution should be used with extreme caution in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: It is not known if Cuvposa Solution can cause harm to the fetus. If you become pregnant, contact your doctor. Your will need to discuss the benefits and risks of using Cuvposa Solution while you are pregnant. It is not known if Cuvposa Solution is found in breast milk. If you are or will be breast-feeding while you use Cuvposa Solution, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Cuvposa Solution:All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Blurred vision; constipation; drowsiness; dry mouth; flushing; headache; nasal congestion; upper respiratory infection; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); diarrhea; frequent or painful urination; mental or mood changes (eg, irritability, crying); seizures; severe or persistent nausea or vomiting; stomach pain or bloating; symptoms of dehydration (eg, very dry mouth, skin, or eyes; fast or irregular heartbeat); symptoms of heatstroke (eg, fever; hot, red skin; decreased alertness; fast, weak pulse; fast, shallow breathing); trouble urinating.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Cuvposa side effects (in more detail)
If OVERDOSE is suspected:Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; fever; muscle pain; seizures; stomach pain or bloating; uncontrolled muscle movements.
Proper storage of Cuvposa Solution:Store Cuvposa Solution at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cuvposa Solution out of the reach of children and away from pets.
General information: If you have any questions about Cuvposa Solution, please talk with your doctor, pharmacist, or other health care provider. Cuvposa Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.This information is a summary only. It does not contain all information about Cuvposa Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Cuvposa resources Cuvposa Side Effects (in more detail) Cuvposa Use in Pregnancy & Breastfeeding Cuvposa Drug Interactions Cuvposa Support Group 0 Reviews for Cuvposa - Add your own review/rating Compare Cuvposa with other medications Excessive Salivation |
 |
Search |  |
 |
 |
||
 |
 |
Popular Search |  |
|
|
||||
 |
 |
|||
|
|
Partners | |
|
|
|
||||
|
|
|||
RSS | Site Map | Map | PageMap
Copyright © RX Pharmacy Pills List. All rights reserved.