Tretinoin 10 MG Oral Capsule
1 INDICATIONS AND USAGE Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. Tretinoin capsules are a retinoid indicated for induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL), characterized by presence of t(15;17) translocation or presence of PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. ( 1 )
glenmark pharmaceuticals inc., usa
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16 HOW SUPPLIED/STORAGE AND HANDLING
TRETINOIN capsules are available as: 10 mg: pink, oval, soft-gelatin capsule printed with black ‘T 10’ filled with yellow to orange, opaque, viscous suspension. NDC 68462-792-01 Bottle of 100 capsules with child-resistant closure 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]. Keep bottle tightly closed. Protect from light.
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