MYCOPHENOLATE MOFETIL capsule MYCOPHENOLATE MOFETIL tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Zydus Pharmaceuticals (USA) Inc.

INN (International Name):

MYCOPHENOLATE MOFETIL

Sammensetning:

MYCOPHENOLATE MOFETIL 250 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Mycophenolate mofetil capsules and mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate mofetil capsules and/or tablets should be used concomitantly with cyclosporine and corticosteroids. Mycophenolate mofetil Intravenous is an alternative dosage form to mycophenolate mofetil capsules, mycophenolate mofetil 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 capsules and mycophenolate mofetil tablets have been observed; therefore, mycophenolate mofetil capsules and mycophenolate mofetil tablets are contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any com

Produkt oppsummering:

Mycophenolate Mofetil Capsules, 250 mg are white granular powder filled in size ‘1’ hard gelatin capsules with opaque blue colored cap and opaque white colored body printed with '130' in black ink and are supplied as follows: NDC 68382-130-01 in bottle of 100 capsules NDC 68382-130-19 in bottle of 120 capsules NDC 68382-130-05 in bottle of 500 capsules NDC 68382-130-10 in bottle of 1000 capsules Mycophenolate Mofetil Tablets, 500 mg are white to off-white, capsule-shaped, biconvex film-coated tablets imprinted with "ZA49" on one side and the other side plain and are supplied as follows: NDC 68382-131-01 in bottle of 100 tablets NDC 68382-131-05 in bottle of 500 tablets NDC 68382-131-10 in bottle of 1000 tablets

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
Zydus Pharmaceuticals (USA) Inc.
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Mycophenolate Mofetil Capsules
Mycophenolate Mofetil Tablets
Read the Medication Guide that comes with mycophenolate mofetil
capsules and mycopheolate 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 healthcare provider
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:
•
Possible loss of a pregnancy and higher risk of birth defects. Women
who take mycophenolate
mofetil during pregnancy have a higher risk of losing a pregnancy
(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 and are able to become pregnant
• your healthcare provider must talk with you about effective birth
control methods (contraceptive
counseling)
• you should have a negative pregnancy test within 1 week before you
start to take mycophenolate
mofetil
• you must use 2 different types of effective birth control at the
same time, for 4 weeks before you
start taking mycophenolate mofetil, during your entire mycophenolate
mofetil therapy and for 6 weeks
after stopping mycophenolate mofetil, unless you choose to avoid
sexual intercourse completely
(abstinence). 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 plan to become pregnant, talk with your healthcare provider.
Your healthcare provider will decide
if other medicines to prevent rejection may be right for you. In
certain situations, you and your healthcare
provider may decide that taking mycophenolat

Preparatomtale

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
ZYDUS PHARMACEUTICALS (USA) INC.
----------
MYCOPHENOLATE MOFETIL CAPSULES
MYCOPHENOLATE MOFETIL TABLETS
WARNING
IMMUNOSUPPRESSION MAY LEAD TO INCREASED SUSCEPTIBILITY TO INFECTION
AND THE POSSIBLE
DEVELOPMENT OF LYMPHOMA. ONLY PHYSICIANS EXPERIENCED IN
IMMUNOSUPPRESSIVE THERAPY
AND MANAGEMENT OF RENAL, CARDIAC OR HEPATIC TRANSPLANT PATIENTS SHOULD
USE MYCOPHENOLATE
MOFETIL CAPSULES AND MYCOPHENOLATE MOFETIL TABLETS. 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
MYCOPHENOLATE
MOFETIL CAPSULES AND MYCOPHENOLATE MOFETIL TABLETS DURING PREGNANCY IS
ASSOCIATED WITH
INCREASED RISK OF PREGNANCY LOSS AND CONGENITAL MALFORMATIONS.
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 molecular
formula of C
H NO , a molecular weight of 433.50, and the following structural
formula:
Mycophenolate mofetil, USP is a white or almost 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 pK
values for mycophenolate
mofetil are 5.6 for the morpholino group and 8.5 for the phenolic
group.
Each mycophenolate mofetil capsule intended for oral administration
contains 250 mg o