Tacrolimus 1 MG Oral Capsule
1 INDICATIONS and USAGE Tacrolimus 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) ], or 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.
Accord Healthcare Inc.
CAPSULE WHITE TCR 1
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tacrolimus 0.5 mg
Accord Healthcare Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1
TACROLIMUS capsules, USP Strength 0.5 mg (containing 0.5 mg
TACROLIMUS) 1 mg (containing 1 mg
TACROLIMUS) 5 mg (containing 5 mg
TACROLIMUS) Shape/color capsule/light yellow capsule/white capsule/pink Branding on capsule cap/body “TCR” on cap and “0.5” on body “TCR” on cap and “1” on body “TCR” on cap and “5” on body 100 count bottle comes with a child-resistant package NDC 16729-041-01 NDC 16729-042-01 NDC 16729-043-01 Store and Dispense Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. 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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