MYCOPHENOLATE MOFETIL- mycophenolate mofetil tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

American Health Packaging

INN (International Name):

MYCOPHENOLATE MOFETIL

Sammensetning:

MYCOPHENOLATE MOFETIL 500 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Mycophenolate mofetil tablet, USP is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate mofetil tablets, 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).

Produkt oppsummering:

Mycophenolate mofetil tablets are available as follows: 500 mg, lavender colored, film-coated biconvex tablets with ‘SZ’ on one side and ‘327’ on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-801-01

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET
American Health Packaging
----------
MEDICATION GUIDE
8280101/0416
Mycophenolate Mofetil Tablets
Read the Medication Guide that comes with mycophenolate 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 doctor about your medical
condition or your treatment.
What is the most important information I should know about
mycophenolate mofetil tablets?
Mycophenolate mofetil tablets can cause serious side effects:
•
Increased risk of loss of a pregnancy (miscarriage) and higher risk of
birth defects. Females who
take mycophenolate mofetil tablets 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
•
your doctor must talk with you about acceptable birth control methods
(contraceptive counseling)
to use while taking mycophenolate mofetil tablets.
•
you should have one pregnancy test immediately before starting
mycophenolate mofetil
tablets 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.
•
you must use acceptable birth control, during your entire
mycophenolate mofetil tablets
therapy and for 6 weeks after stopping mycophenolate mofetil tablets,
unless at any time
you choose to avoid sexual intercourse (abstinence) with a man
completely.
•
Mycophenolate mofetil tablets 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
tablets, and you could become pregnant. If you take birth control
pills while using mycophenolate
mofetil tablets you must also use another form of birth control. Talk
to your doctor about other
birt

Preparatomtale

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET
AMERICAN HEALTH PACKAGING
----------
MYCOPHENOLATE MOFETIL TABLETS
8280101/0416
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 tablets are available for oral administration,
as tablets contains 500 mg of
myco