MYCOPHENOLIC ACID tablet, delayed release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

MYCOPHENOLATE SODIUM (UNII: WX877SQI1G) (mycophenolic acid - UNII:HU9DX48N0T)

から入手可能:

Major Pharmaceuticals

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Mycophenolic acid are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.  Mycophenolic acid 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 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 reports [see Adverse Reactions (6)] . Pregnancy Exposure Registry Ther

製品概要:

Mycophenolic acid delayed-release tablets, USP are supplied as: 180 mg tablet: Light green, round, slightly biconvex beveled edge enteric coated tablet.  Engraved “MYC” over “180” on one side, “APO” on the other side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium. Cartons of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6785-04 Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6785-61 360 mg tablet: Light pink, oval, biconvex enteric coated tablet. Engraved “APO” on one side, “MYC 360” on the other side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium. Cartons of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6786-04 Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6786-61 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 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, 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 must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

MYCOPHENOLIC ACID- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE
Major Pharmaceuticals
----------
MEDICATION GUIDE
Mycophenolic Acid Delayed-Release Tablets, USP
(my-co-fen-o-lic acid)
Medication Guide available at www1.apotex.com/products/us
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:
1.
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.
1.
If you are a female who can become pregnant:
1.
your doctor must talk with you about acceptable birth control methods
(contraceptive
counseling) while taking mycophenolic acid delayed-release tablets.
2.
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.
3.
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

製品の特徴

MYCOPHENOLIC ACID- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE
MAJOR PHARMACEUTICALS
----------
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_
5.
6.
7.
8.
RECENT MAJOR CHANGES
Warnings and Precautions, New or Reactivated Viral Infections (5.5)
03/2022
Warnings and Precautions, Acute Inflammatory Syndrome Associated with
Mycophenolate Products (5.7)
03/2022
INDICATIONS AND USAGE
3.
4.
Limitations of Use:
2.
DOSAGE AND ADMINISTRATION
4.
5.
6.
DOSAGE FORMS AND STRENGTHS
Mycophenolic acid are available as 180 mg and 360 mg tablets. (3)
CONTRAINDICATIONS
Known hypersensitivity to mycophenolate sodium, mycophenolic acid
(MPA), mycophenolate mofetil, or to
any of its excipients. (4.1)
WARNINGS AND PRECAUTIONS
8.
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)
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