mycophenolic acid 360 mg
1 INDICATIONS AND USAGE Mycophenolic acid is 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 tablet is 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.
Accord Healthcare Inc.
OVAL ORANGE M2
M2 OVAL ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING
MYCOPHENOLIC ACID delayed release tablets, USP 360 mg tablet: peach colored, oblong shaped, biconvex, enteric-coated tablets imprinted with M2 on one side and plain on the other side, containing 360 mg
MYCOPHENOLIC ACID (MPA) as mycophenolate sodium. Bottles of 120’s count comes with a child-resistant closure……………………NDC 16729-189-29 Bottles of 500's count……………………………………………………………NDC 16729-189-16 180 mg tablet: Lime green colored, round shaped, biconvex, beveled edged enteric-coated tablets imprinted with M3 on one side and plain on the other side, containing 180 mg
MYCOPHENOLIC ACID (MPA) as mycophenolate sodium. Bottles of 120’s count comes with a child-resistant closure……………………NDC 16729-261-29 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.
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