MYCOPHENOLATE MOFETIL- 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:

A-S Medication Solutions

INN (International Name):

MYCOPHENOLATE MOFETIL

Composition:

MYCOPHENOLATE MOFETIL 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mycophenolate mofetil is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate mofetil should be used concomitantly with cyclosporine and corticosteroids. Mycophenolate mofetil Intravenous is an alternative dosage form to mycophenolate mofetil tablets, capsules and oral suspension. Mycophenolate mofetil Intravenous should be administered within 24 hours following transplantation. Mycophenolate mofetil Intravenous can be administered for upto 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:

Product: 50090-2246 NDC: 50090-2246-0 180 TABLET, FILM COATED in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
A-S Medication Solutions
----------
MEDICATION GUIDE
Mycophenolate mofetil capsules, USP
Mycophenolate mofetil tablets, USP
(mye'' koe fen' oh late moe' fe til)
Read the Medication Guide that comes with mycophenolate mofetil 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?
Mycophenolate mofetil can cause serious side effects:
•
Increased risk ofloss of a pregnancy( miscarriage) and higher risk of
birth defects . Females who
take mycophenolate mofetil during pregnancy have a higher risk
ofmiscarriage 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:
•
your doctor must talk with you about acceptable birth control methods
(contraceptive counseling)
to use while taking mycophenolate mofetil.
•
you should have a one pregnancy test immediately before starting
mycophenolate mofetil and
another pregnancy test 8 to10 days laters. 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.
•
you must use acceptable birth control during your entire mycophenolate
mofetil therapy and for 6
weeks after stopping mycophenolate mofetil, unless at any time you
choose to avoid sexual
intercourse (abstinence) with a man completely. 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 take birth control pills while using mycophenolate mofetil you
must also use another form of birth
control. Talk to your doctor about other birth control methods

Summary of Product characteristics

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
MYCOPHENOLATE MOFETIL TABLETS, USP
MYCOPHENOLATE MOFETIL CAPSULES, USP
RX ONLY
08/2016
RX ONLY
BOXED WARNING
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 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
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 hydrochlor