Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
MYCOPHENOLATE SODIUM (UNII: WX877SQI1G) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)
AvPAK
ORAL
PRESCRIPTION DRUG
Mycophenolic acid is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. Mycophenolic acid is 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 is 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)
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. NDC 50268-559-12 (10 tablets per card, 2 cards per carton). 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. For Institutional Use Only. Dispensed in Unit Dose Package. 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.
Abbreviated New Drug Application
MYCOPHENOLIC ACID- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE AvPAK ---------- MEDICATION GUIDE Mycophenolic Acid Delayed-Release Tablets, USP (my-co-fen-o-lic acid) 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 while you take mycophenol read_full_document
MYCOPHENOLIC ACID- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE AVPAK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION MYCOPHENOLIC ACID DELAYED RELEASE TABLETS, USP RX ONLY 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. 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 delayed release tablets and mycophenolate mofetil tablets and read_full_document