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:

Ascend Laboratories, LLC

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 marketi

Povzetek izdelek:

Mycophenolic Acid Delayed-Release Tablets, USP : 360 mg tablet: Pale orange-red colored, oval shaped, biconvex, film coated tablets imprinted “MA 360" with black ink on one side and plain on other side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium. Bottles of 120 Tablets……………………………………………………………NDC 67877-427-12 Bottles of 500 Tablets ……………………………………………………………NDC 67877-427-05 Unit-Dose Blister Packages of 100 (10×10)………………………………………NDC 67877-427-38 180 mg tablet: Lime green colored, round shaped, biconvex, film coated tablets, imprinted "MA 180'' with black ink on one side and plain on other side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium. Bottles of 120 Tablets……………………………………………………………NDC 67877-426-12 Bottles of 500 Tablets ……………………………………………………………NDC 67877-426-05 Unit-Dose Blister Packages of 100 (10×10)………………………………………NDC 67877-426-38 Storage  Store at 20°C to 25°C (68°F to 77°F);  excursions permitted to 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 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
Ascend Laboratories, LLC
----------
MEDICATION GUIDE
mycophenolic acid (mye" koe fe nol' ik as' id)
delayed-release tablets, USP
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 well

Lastnosti izdelka

MYCOPHENOLIC ACID - MYCOPHENOLIC ACID TABLET, DELAYED RELEASE
ASCEND LABORATORIES, LLC
----------
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 b