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.
teva pharmaceuticals usa, inc.
OVAL ORANGE Teva 7032
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16 HOW SUPPLIED/STORAGE AND HANDLING Mycophenolic Acid Delayed-release Tablets USP, 180 mg are available as green, round, film-coated, unscored, biconvex tablets imprinted in black ink with “TEVA” and “7031” on one side and blank on the other side, packaged in bottles of 120 (NDC 0093-7031-89) tablets. Mycophenolic Acid Delayed-release Tablets USP, 360 mg are available as orange, modified-capsule shaped, film-coated, unscored, biconvex tablets, imprinted in black ink with “TEVA” and “7032” on one side and blank on the other side, packaged in bottles of 120 (NDC 0093-7032-89) tablets. Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Handling Keep out of reach and sight of children. Mycophenolic acid 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 tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.
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