tacrolimus 0.5 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.
Mylan Pharmaceuticals Inc.
CAPSULE MYLAN 2045
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1
TACROLIMUS capsules
TACROLIMUS capsules, USP are available containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous
TACROLIMUS, USP. The 0.5 mg capsules are hard-shell gelatin capsules with a light orange opaque cap and a gray opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 2045 in black ink on both the cap and the body. They are available as follows: NDC 0378-2045-01 bottles of 100 capsules The 1 mg capsules are hard-shell gelatin capsules with a light blue opaque cap and a gray opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 2046 in black ink on both the cap and the body. They are available as follows: NDC 0378-2046-01 bottles of 100 capsules The 5 mg capsules are hard-shell gelatin capsules with a rubine red opaque cap and a gray opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 2047 in black ink on both the cap and the body. They are available as follows: NDC 0378-2047-01 bottles of 100 capsules Store and Dispense: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. 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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