Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
MYCOPHENOLATE SODIUM (UNII: WX877SQI1G) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)
PD-Rx Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
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
360 mg tablet: Orange, film-coated ovaloid tablet with “T161” debossed on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium. Bottles of 120…………………………………………………………………NDC 72789-246-98 180 mg tablet: White, film-coated round tablet and “T160” imprinted on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium. Bottles of 120…………………………………………………………………NDC 72789-247-98 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 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.
Abbreviated New Drug Application
PD-Rx Pharmaceuticals, Inc. ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 03/22 MEDICATION GUIDEMycophenolic Acid Delayed-Release Tablets, USP (mye koe fe nole′ ik as′ id) 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. Прочитајте комплетан документ
MYCOPHENOLIC ACID- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE PD-RX 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 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 by mouth, twice daily (1,440 mg total daily dose) on an empty stomach, 1 hour before or 2 hours after food intake. ( 2.1) In children: 5 years of age and older (who are at least 6 months post kidney transplant), 400 mg/m by mouth, twice daily (up to a maximum of 720 mg twice daily). ( 2.2) Do not crush, chew, or cut tablet prior to ingestion. ( 2.3) 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 New or Reactivated Viral Infections: Consider reducing immunosuppression. ( 5.5) Blood Dyscrasias, including Pure Red Cell Aplasia (PRCA): Monitor for neutropenia or anemia; consider treatmen Прочитајте комплетан документ