Mycophenolic Acid 360 MG Delayed Release Oral Tablet
1 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 ) 1.1 Prophylaxis of Organ Rejection in Kidney Transplant 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. 1.2 Limitations of Use 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.
Mylan Pharmaceuticals Inc.
OVAL RED M MC2
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
16 HOW SUPPLIED/STORAGE AND HANDLING 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.
More pills like OVAL M MC2