MYCOPHENOLIC ACID- mycophenilic acid tablet, delayed release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Archis Pharma LLC

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

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 72819-155-08 bottle 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 72819-156-08 bottle of 120 tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. 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.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

Archis Pharma LLC
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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.
•
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
dela

מאפייני מוצר

MYCOPHENOLIC ACID- MYCOPHENILIC ACID TABLET, DELAYED RELEASE
ARCHIS PHARMA LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS
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)
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:
Mycophenolic acid delaye