MYCOPHENOLATE MOFETIL- mycophenolate mofetil capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)

Available from:

American Health Packaging

INN (International Name):

MYCOPHENOLATE MOFETIL

Composition:

MYCOPHENOLATE MOFETIL 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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).

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

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

Summary of Product characteristics

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