מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
Mycophenolate Mofetil (UNII: 9242ECW6R0) (mycophenolic acid - UNII:HU9DX48N0T)
Lake Erie Medical DBA Quality Care Products LLC
Mycophenolate Mofetil
Mycophenolate Mofetil 500 mg
PRESCRIPTION DRUG
New Drug Application
CELLCEPT- MYCOPHENOLATE MOFETIL TABLET, FILM COATED LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- CELLCEPT (MYCOPHENOLATE MOFETIL CAPSULES) (MYCOPHENOLATE MOFETIL TABLETS) CELLCEPT ORAL SUSPENSION (MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION) CELLCEPT INTRAVENOUS (MYCOPHENOLATE MOFETIL HYDROCHLORIDE FOR INJECTION) WARNING 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 USE CELLCEPT. 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 CELLCEPT DURING PREGNANCY IS ASSOCIATED WITH INCREASED RISK OF PREGNANCY LOSS AND CONGENITAL MALFORMATIONS . DESCRIPTION CellCept (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 an empirical 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 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 pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Inject קרא את המסמך השלם