Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)
Zydus Pharmaceuticals (USA) Inc.
MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL 250 mg
ORAL
PRESCRIPTION DRUG
Mycophenolate mofetil capsules and mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate mofetil capsules and/or tablets should be used concomitantly with cyclosporine and corticosteroids. Mycophenolate mofetil Intravenous is an alternative dosage form to mycophenolate mofetil capsules, mycophenolate mofetil 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 capsules and mycophenolate mofetil tablets have been observed; therefore, mycophenolate mofetil capsules and mycophenolate mofetil tablets are contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any com
Mycophenolate Mofetil Capsules, 250 mg are white granular powder filled in size ‘1’ hard gelatin capsules with opaque blue colored cap and opaque white colored body printed with '130' in black ink and are supplied as follows: NDC 68382-130-01 in bottle of 100 capsules NDC 68382-130-19 in bottle of 120 capsules NDC 68382-130-05 in bottle of 500 capsules NDC 68382-130-10 in bottle of 1000 capsules Mycophenolate Mofetil Tablets, 500 mg are white to off-white, capsule-shaped, biconvex film-coated tablets imprinted with "ZA49" on one side and the other side plain and are supplied as follows: NDC 68382-131-01 in bottle of 100 tablets NDC 68382-131-05 in bottle of 500 tablets NDC 68382-131-10 in bottle of 1000 tablets
Abbreviated New Drug Application
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED Zydus Pharmaceuticals (USA) Inc. ---------- Mycophenolate Mofetil Capsules Mycophenolate Mofetil Tablets Read the Medication Guide that comes with mycophenolate mofetil capsules and mycopheolate mofetil tablets 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 healthcare provider about your medical condition or your treatment. What is the most important information I should know about mycophenolate mofetil? Mycophenolate mofetil can cause serious side effects: • Possible loss of a pregnancy and higher risk of birth defects. Women who take mycophenolate mofetil during pregnancy have a higher risk of losing a pregnancy (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 and are able to become pregnant • your healthcare provider must talk with you about effective birth control methods (contraceptive counseling) • you should have a negative pregnancy test within 1 week before you start to take mycophenolate mofetil • you must use 2 different types of effective birth control at the same time, for 4 weeks before you start taking mycophenolate mofetil, during your entire mycophenolate mofetil therapy and for 6 weeks after stopping mycophenolate mofetil, unless you choose to avoid sexual intercourse completely (abstinence). Mycophenolate mofetil 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, and you could become pregnant If you plan to become pregnant, talk with your healthcare provider. Your healthcare provider will decide if other medicines to prevent rejection may be right for you. In certain situations, you and your healthcare provider may decide that taking mycophenolat Belgenin tamamını okuyun
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED ZYDUS PHARMACEUTICALS (USA) INC. ---------- MYCOPHENOLATE MOFETIL CAPSULES MYCOPHENOLATE MOFETIL TABLETS WARNING IMMUNOSUPPRESSION MAY LEAD TO INCREASED SUSCEPTIBILITY TO INFECTION AND THE POSSIBLE DEVELOPMENT OF LYMPHOMA. ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND MANAGEMENT OF RENAL, CARDIAC OR HEPATIC TRANSPLANT PATIENTS SHOULD USE MYCOPHENOLATE MOFETIL CAPSULES AND MYCOPHENOLATE MOFETIL TABLETS. 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. FEMALE USERS OF CHILDBEARING POTENTIAL MUST USE CONTRACEPTION. USE OF MYCOPHENOLATE MOFETIL CAPSULES AND MYCOPHENOLATE MOFETIL TABLETS DURING PREGNANCY IS ASSOCIATED WITH INCREASED RISK OF PREGNANCY LOSS AND CONGENITAL MALFORMATIONS. 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 molecular formula of C H NO , a molecular weight of 433.50, and the following structural formula: Mycophenolate mofetil, USP is a white or almost white crystalline powder. It is slightly soluble in water (43 µg/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 pK values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group. Each mycophenolate mofetil capsule intended for oral administration contains 250 mg o Belgenin tamamını okuyun