MYCOPHENOLIC ACID tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MYCOPHENOLATE SODIUM (UNII: WX877SQI1G) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)

Available from:

AMTA LABS LIMITED

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mycophenolic Acid Delayed-Release Tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. Mycophenolic Acid Delayed-Release Tablets are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant. Mycophenolic Acid Delayed-Release Tablets are to be used in combination with cyclosporine and corticosteroids. Mycophenolic Acid Delayed-Release Tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent. Mycophenolic Acid Delayed-Release Tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients. Reactions like rash, pruritus, hypotension, and chest pain have been observed in clinical trials and post marketing

Product summary:

180 mg tablet: Green film-coated round tablets, debossed with “A” and “122” on one side and plain on the other side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.       Bottles of 120 tablets with child-resistant closure, NDC 72322-1048-1       Bottles of 1,000 tablets, NDC 72322-1048-2 360 mg tablet: Orange film-coated ovaloid tablets, debossed with “A121” on one side and plain on the other side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.       Bottles of 120 tablets with child-resistant closure, NDC 72322-1049-1       Bottles of 1,000 tablets, NDC 72322-1049-2 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted  to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.  Dispense in a tight, light resistant container as defined in the USP with a child-resistant closure. Handling Keep out of reach and sight of children. Mycophenolic Acid Delayed-Release Tablets, USP should not be crushed or cut in order to maintain the integrity of the enteric coating [see Dosage and Administration ( 2.3)] . Teratogenic effects have been observed with mycophenolate sodium [see Warnings and Precautions ( 5.1)] . If for any reason, the Mycophenolic Acid Delayed-Release Tablets, USP must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AMTA LABS LIMITED
----------
MEDICATION GUIDE
Mycophenolic Acid Delayed-Release Tablets, USP
(my-co-fen-o-lic acid)
Read the Medication Guide that comes with mycophenolic acid
delayed-release tablets before you start
taking it and each time you get a refill. There may be new
information. This Medication Guide does not take
the place of talking with your healthcare provider about your medical
condition or treatment. If you have any
questions about mycophenolic acid delayed-release tablets, ask your
doctor.
What is the most important information I should know about
mycophenolic acid delayed-release tablets?
Mycophenolic acid delayed-release tablets can cause serious side
effects, including:
•
Increased risk of loss of pregnancy (miscarriage) and higher risk of
birth defects. Females who
take mycophenolic acid delayed-release 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) while taking mycophenolic acid delayed-release tablets.
•
you should have a pregnancy test immediately before starting
mycophenolic acid
delayed-release 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 mycophenolic
acid delayed-
release tablets therapy and for 6 weeks after stopping mycophenolic
acid delayed-
release tablets, unless at any time you choose to avoid sexual
intercourse (abstinence)
with a man completely. Mycophenolic acid delayed-release tablets
decrease 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 mycophenolic acid delayed-release
tablets and
you could beco

Summary of Product characteristics

MYCOPHENOLIC ACID- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE
AMTA LABS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYCOPHENOLIC ACID
DELAYED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS.
MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
USE DURING PREGNANCY IS ASSOCIATED WITH INCREASED RISKS OF PREGNANCY
LOSS AND
CONGENITAL MALFORMATIONS. AVOID IF SAFER TREATMENT OPTIONS ARE
AVAILABLE. FEMALES OF
REPRODUCTIVE POTENTIAL MUST BE COUNSELED REGARDING PREGNANCY
PREVENTION AND
PLANNING _[SEE WARNINGS AND PRECAUTIONS ( 5.1), USE IN SPECIFIC
POPULATIONS ( 8.1,_
_8.3)] _.
INCREASED RISK OF DEVELOPMENT OF LYMPHOMA AND OTHER MALIGNANCIES,
PARTICULARLY OF
THE SKIN, DUE TO IMMUNOSUPPRESSION. ( 5.3)
INCREASED SUSCEPTIBILITY TO BACTERIAL, VIRAL, FUNGAL, AND PROTOZOAL
INFECTIONS, INCLUDING
OPPORTUNISTIC INFECTIONS. ( 5.4, 5.5)
ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND
MANAGEMENT OF
ORGAN TRANSPLANT PATIENTS SHOULD PRESCRIBE MYCOPHENOLIC ACID
DELAYED-RELEASE
TABLETS. ( 5.2)
RECENT MAJOR CHANGES
Boxed Warning
4/2020
Warnings and Precautions, Embryo-Fetal Toxicity ( 5.1)
4/2020
Warnings and Precautions, Lymphoma and Other Malignancies ( 5.3)
4/2020
Warnings and Precautions, Immunizations ( 5.8)
4/2020
Warnings and Precautions, Blood Donation ( 5.10)
4/2020
Warnings and Precautions, Semen Donation ( 5.11)
4/2020
INDICATIONS AND USAGE
Mycophenolic Acid Delayed-Release Tablets are an antimetabolite
immunosuppressant indicated for
prophylaxis of organ rejection in adult patients receiving kidney
transplants and in pediatric patients at
least 5 years of age and older who are at least 6 months post kidney
transplant. ( 1.1)
Use in combination with cyclosporine and corticosteroids. ( 1.1)
Limitations of Use: