MYCOPHENOLIC ACID tablet, delayed release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Lupin Pharmaceuticals, Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

360 mg tablet: Pink to light pink colored, enteric coated, ovaloid biconvex tablet, debossed with "C2" on one side and plain on other side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium. Bottles of 120 with child resistance closure, NDC 70748-218-16 180 mg tablet: Lime green colored, enteric coated, round biconvex tablet, debossed with "C1" on one side and plain on other side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium. Bottles of 120 with child resistance closure, NDC 70748-217-16 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container (USP). Handling Keep out of reach and sight of children. Mycophenolic acid delayed-release tablets 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 must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

MYCOPHENOLIC ACID - MYCOPHENOLIC ACID TABLET, DELAYED RELEASE
Lupin Pharmaceuticals, Inc.
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MEDICATION GUIDE
Mycophenolic Acid Delayed-Release Tablets
(mye" koe fe nol′ ik as′ id)
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
decreases blood
levels of the hormones in birth control pills that you take by mouth.
Birth control pills
may not work as we

Lastnosti izdelka

MYCOPHENOLIC ACID - MYCOPHENOLIC ACID TABLET, DELAYED RELEASE
LUPIN PHARMACEUTICALS, INC.
----------
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. (5.1, 8.1, 8.3)
ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND
MANAGEMENT OF
ORGAN TRANSPLANT PATIENTS SHOULD PRESCRIBE MYCOPHENOLIC ACID
DELAYED-RELEASE
TABLETS. (5.2)
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)
RECENT MAJOR CHANGES
Warnings and Precautions, New or Reactivated Viral Infections (5.5)
3/2022
Warnings and Precautions, Acute Inflammatory Syndrome Associated with
Mycophenolate Products (5.7)
3/2022
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:
Mycophenolic acid delayed-release tablets and mycophenolate mofetil
tablets and capsules should not
be used interchangeably. (1.2)
DOSAGE AND ADMINISTRATION
In adults: 720 mg by mouth, twice daily (1,44