MYCOPHENOLATE MOFETIL tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Aphena Pharma Solutions - Tennessee, LLC

INN (שם בינלאומי):

MYCOPHENOLATE MOFETIL

הרכב:

MYCOPHENOLATE MOFETIL 500 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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. 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.

leaflet_short:

Mycophenolate Mofetil Tablets, USP are available containing 500 mg of mycophenolate mofetil, USP. The 500 mg tablet is a light pink film-coated, oval, unscored tablet debossed with MYLAN on one side of the tablet and 472 on the other side. They are available as follows: NDC 71610-033-70 bottles of 120 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
MYCOPHENOLATE MOFETIL
CAPSULES USP, 250 MG
AND
MYCOPHENOLATE MOFETIL TABLETS
USP, 500 MG
(MYE'' KOE FEN' OH LATE MOE' FE TIL)
Read the Medication Guide that comes with mycophenolate mofetil
capsules and 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?
Mycophenolate mofetil can cause serious side effects:
•
Increased risk of loss of a pregnancy (miscarriage) and higher risk of
birth defects.Females who
take mycophenolate mofetil during pregnancy have a higher risk of
miscarriageduring 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.
2.
you should have one pregnancy test immediately before starting
mycophenolate mofetil
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 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 anothe

מאפייני מוצר

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
MYCOPHENOLATE MOFETIL, USP
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 WARNINGSAND 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 WARNINGSAND 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 is 2-Morpholinoethyl (
_E_)-6-(4-hydroxy-6-
methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate. It has a
molecular
formula of C
H
NO
, a molecular weight of 433.5, and the following structural
formula:
Mycophenolate mofetil, USP is a white to almost white crystalline
powder. It is practically
insoluble 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 anhydrous 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 is available for oral administration as capsules
containing 250 mg
of mycophen