tacrolimus 1 mg oral capsule
1 INDICATIONS AND USAGE Tacrolimus capsules are 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 allogenic 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 )], and 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.
sandoz inc
CAPSULE BROWN S 644
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1
TACROLIMUS capsules, USP
TACROLIMUS capsules, USP containing white to off-white powder equivalent to 0.5 mg of anhydrous
TACROLIMUS, are hard gelatin capsules with white opaque body and ivory cap. The body is imprinted ‘643’ and cap is imprinted ‘ ’ in black ink. They are supplied as follows: NDC 0781-2102-01, bottle of 100 capsules with child-resistant closure
TACROLIMUS capsules, USP containing white to off-white powder equivalent to 1 mg of anhydrous
TACROLIMUS, are hard gelatin capsules with white opaque body and brown cap. The body is imprinted ‘644’ and cap is imprinted ‘ ’ in black ink. They are supplied as follows: NDC 0781-2103-01, bottle of 100 capsules with child-resistant closure
TACROLIMUS capsules, USP containing white to off-white powder equivalent to 5 mg of anhydrous
TACROLIMUS, are hard gelatin capsules with white opaque body and orange cap. The body is imprinted ‘645’ and cap is imprinted ‘ ’ in black ink. They are supplied as follows: NDC 0781-2104-01, bottle of 100 capsules with child-resistant closure Store and Dispense
TACROLIMUS capsules, USP should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. 'S' 'S' 'S' 16.4 Handling and Disposal
TACROLIMUS can cause fetal harm.
TACROLIMUS capsules should not be opened or crushed. 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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