CELLCEPT mycophenolate mofetil tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Mycophenolate Mofetil (UNII: 9242ECW6R0) (mycophenolic acid - UNII:HU9DX48N0T)

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

Mycophenolate Mofetil

Composition:

Mycophenolate Mofetil 500 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

CELLCEPT- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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