Tacrolimus 0.5 MG Oral Capsule
1 INDICATIONS AND USAGE Tacrolimus capsule is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, or heart transplants, and pediatric patients receiving allogeneic liver transplants in combination with other immunosuppressants. ( 1.1 ) 1.1 Prophylaxis of Organ Rejection in Kidney, Liver or Heart Transplant Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [see Clinical Studies ( 14.1 )] , liver transplant [see Clinical Studies ( 14.2 )] , heart transplant [ see Clinical Studies ( 14.3 )] , and pediatric patients receiving allogeneic liver transplants [see Clinical Studies ( 14.2) ] in combination with other immunosuppressants. Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
Dr. Reddy's Laboratories Limited
CAPSULE YELLOW 0 5MG RDY525
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1
TACROLIMUS capsules, USP
TACROLIMUS capsules USP, 0.5 mg are white to off white powder filled in hard gelatin capsule of size ‘4’, dark yellow opaque cap imprinted with ‘0.5 MG’ and dark yellow opaque body imprinted with ‘RDY 525’using red ink and are supplied in bottles of 30’s, 100’s and 500’s, and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-525-30 Bottles of 100 NDC 55111-525-01 Bottles of 500 NDC 55111-525-05 Unit Dose Package of 100 (10 x 10) NDC 55111-525-78
TACROLIMUS capsules USP, 1 mg are white to off white powder filled in hard gelatin capsule of size ‘4’, white opaque cap imprinted with ‘1 MG’ and white opaque body imprinted with ‘RDY 526’using red ink and are supplied in bottles of 30’s, 100’s and 500’s, and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-526-30 Bottles of 100 NDC 55111-526-01 Bottles of 500 NDC 55111-526-05 Unit Dose Package of 100 (10 x 10) NDC 55111-526-78
TACROLIMUS capsules USP, 5 mg are white to off white powder filled in hard gelatin capsule of size ‘4’, dark grayish red opaque cap imprinted with ‘5 MG’ and dark grayish red opaque body imprinted with ‘RDY 527’ using white ink and are supplied in bottles of 30’s, 100’s and 500’s, and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-527-30 Bottles of 100 NDC 55111-527-01 Bottles of 500 NDC 55111-527-05 Unit Dose Package of 100 (10 x 10) NDC 55111-527-78 Note:
TACROLIMUS capsules, USP are not filled to maximum capsule capacity. capsule contains labeled amount. Store and Dispense Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. 16.4 Handling and Disposal
TACROLIMUS can cause fetal harm.
TACROLIMUS capsules should not be opened or crushed. Wearing disposable gloves is recommended during dilution of the injection in the hospital and when wiping any spills. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in
TACROLIMUS capsules. If such contact occurs, wash the skin thoroughly with soap and water; if ocular contact occurs, rinse eyes with water. In case a spill occurs, wipe the surface with a wet paper towel. Follow applicable special handling and disposal procedures 1 .
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