MYCOPHENOLIC ACID tablet, delayed release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

MYCOPHENOLIC ACID (UNII: HU9DX48N0T) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)

Tilgjengelig fra:

Mylan Pharmaceuticals Inc.

INN (International Name):

MYCOPHENOLIC ACID

Sammensetning:

MYCOPHENOLIC ACID 180 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Mycophenolic Acid Delayed-Release Tablets, USP are available containing mycophenolate sodium, USP equivalent to 180 mg or 360 mg of mycophenolic acid. The 180 mg tablets are sage green, film-coated, round, unscored tablets with M over MC1 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4201-78 bottles of 120 tablets The 360 mg tablets are reddish-orange, film-coated, modified capsule-shaped, unscored tablets with M MC2 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4202-78 bottles of 120 tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. 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. 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.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Mycophenolic Acid* Delayed-Release Tablets, USP
(mye″ koe fe nole′ ik as′ id)
*as mycophenolate sodium
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.
o
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 a

Preparatomtale

MYCOPHENOLIC ACID- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE
MYLAN 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_
•
•
•
•
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
•
•
Limitations of Use:
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Mycophenolic acid delayed-release tablets 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
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)
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)
Mycophenolic acid delayed-release tablets are an antimetabolite