Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)
American Health Packaging
MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL 250 mg
ORAL
PRESCRIPTION DRUG
Mycophenolate mofetil capsule, USP is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate mofetil capsules, USP should be used concomitantly with cyclosporine and corticosteroids. Mycophenolate mofetil intravenous is an alternative dosage form to mycophenolate mofetil capsules, tablets and oral suspension. Mycophenolate mofetil intravenous should be administered within 24 hours following transplantation. Mycophenolate mofetil intravenous can be administered for up to 14 days; patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication. Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. Mycophenolate mofetil intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).
Mycophenolate mofetil capsules, USP are available as follows: 250 mg, hard gelatin capsules with opaque blue cap and opaque white body. The cap and body are imprinted with "655" with black ink. Unit dose packages of 100 (10 x 10) NDC 68084-795-01 Store at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The brands listed are trademarks of their respective owners and are not trademarks of Sandoz Inc. American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Sandoz Inc as follows: (250 mg / 100 UD) NDC 68084-795-01 packaged from NDC 0781-2067 Distributed by: American Health Packaging Columbus, OH 43217 8279501/1216
Abbreviated New Drug Application
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE American Health Packaging ---------- MEDICATION GUIDE 8279501/1216 Mycophenolate Mofetil Capsules, USP Read the Medication Guide that comes with mycophenolate mofetil capsules before you start taking it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about mycophenolate mofetil capsules? Mycophenolate mofetil capsules can cause serious side effects: • Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take mycophenolate mofetil capsules during pregnancy have a higher risk of miscarriage during the first 3 months (first trimester), and a higher risk that their baby will be born with birth defects. • If you are a female who can become pregnant 1. your doctor must talk with you about acceptable birth control methods (contraceptive counseling) to use while taking mycophenolate mofetil capsules. 2. you should have one pregnancy test immediately before starting mycophenolate mofetil capsules and another pregnancy test 8 to 10 days later. Pregnancy tests should be repeated during routine follow-up visits with your doctor. Talk to your doctor about the results of all of your pregnancy tests. 3. you must use acceptable birth control, during your entire mycophenolate mofetil capsules therapy and for 6 weeks after stopping mycophenolate mofetil capsules, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. • Mycophenolate mofetil capsules decreases blood levels of the hormones in birth control pills that you take by mouth. Birth control pills may not work as well while you take mycophenolate mofetil capsules, and you could become pregnant. If you take birth control pills while using mycophenolate mofetil capsules you must also use another form of birth control. Talk to your doctor a Soma hati kamili
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE AMERICAN HEALTH PACKAGING ---------- MYCOPHENOLATE MOFETIL CAPSULES, USP 8279501/1216 RX ONLY WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES AND SERIOUS INFECTIONS USE DURING PREGNANCY IS ASSOCIATED WITH INCREASED RISKS OF FIRST TRIMESTER PREGNANCY LOSS AND CONGENITAL MALFORMATIONS. FEMALES OF REPRODUCTIVE POTENTIAL (FRP) MUST BE COUNSELED REGARDING PREGNANCY PREVENTION AND PLANNING (SEE WARNINGS AND PRECAUTIONS). IMMUNOSUPPRESSION MAY LEAD TO INCREASED SUSCEPTIBILITY TO INFECTION AND POSSIBLE DEVELOPMENT OF LYMPHOMA. ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND MANAGEMENT OF RENAL, CARDIAC OR HEPATIC TRANSPLANT PATIENTS SHOULD PRESCRIBE MYCOPHENOLATE MOFETIL. PATIENTS RECEIVING THE DRUG SHOULD BE MANAGED IN FACILITIES EQUIPPED AND STAFFED WITH ADEQUATE LABORATORY AND SUPPORTIVE MEDICAL RESOURCES. THE PHYSICIAN RESPONSIBLE FOR MAINTENANCE THERAPY SHOULD HAVE COMPLETE INFORMATION REQUISITE FOR THE FOLLOW-UP OF THE PATIENT (SEE WARNINGS AND PRECAUTIONS). DESCRIPTION Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4- hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has a molecular formula of C H NO , a molecular weight of 433.50, and the following structural formula: Mycophenolate mofetil is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1- octanol/water (pH 7.4) buffer solution is 238. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil capsules, USP are available for oral administration as capsules containing Soma hati kamili