astagraf xl tacrolimus extendedrelease capsules capsule coated extended release
1 INDICATIONS AND USAGE ASTAGRAF XL ® is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients who can swallow capsules intact [see Use in Specific Populations ( 8.4 ) and Clinical Studies ( 14.1 ), ( 14.2 )]. ASTAGRAF XL is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients who can swallow capsules intact. ( 1 , 8.4 , 14.1 , 14.2 )
astellas pharma us, inc.
CAPSULE ORANGE 1 mg 677
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16 HOW SUPPLIED/STORAGE AND HANDLING ASTAGRAF XL (tacrolimus) extended-release capsules are supplied in short, square bottles (see Table 19 ). Table 19: Strengths of ASTAGRAF XL 0.5 mg oblong capsule with a light yellow cap and orange body. capsule is branded with red “ 647” on capsule body and “0.5 mg” on the capsule cap. The bottle packaging is branded with a brown stripe. • 30-count in short, square bottles with a brown cap (NDC 0469-0647-73) 1 mg oblong capsule with a white cap and orange body. capsule is branded with red “ 677” on capsule body and “1 mg” on the capsule cap. The bottle packaging is branded with a blue stripe. • 30-count in short, square bottles with a blue cap (NDC 0469-0677-73) 5 mg oblong capsule with a grayish-red cap and orange body. capsule is branded with red “ 687” on capsule body and “5 mg” on the capsule cap. The bottle packaging is branded with an orange stripe. • 30-count in short, square bottles with an orange cap (NDC 0469-0687-73) Store and Dispense Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. astellas-logo-01 astellas-logo-02 astellas-logo-03
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