nevirapine tablet
1 INDICATIONS AND USAGE Nevirapine tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1 , 14.2) ] . Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets are not recommended to be initiated, unless the benefit outweighs the risk, in: adult females with CD4 + cell counts greater than 250 cells/mm 3 or adult males with CD4 + cell counts greater than 400 cells/mm3 [see Warnings and Precautions (5.1) ] . Nevirapine tablet is an NNRTI indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older. ( 1 ) Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablet is not recommended to be initiated, unless the benefit outweighs the risk, in: adult females with CD4 + cell counts greater than 250 cells/mm 3 adult males with CD4 + cell counts greater than 400 cells/mm 3 ( 1 , 5.1 )
camber pharmaceuticals, inc.
OVAL WHITE H 7
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16 HOW SUPPLIED/STORAGE AND HANDLING
NEVIRAPINE Tablets, USP 200 mg, off-white to pale yellow colored, capsule shaped, biconvex tablets debossed with ‘H’ on one side and ‘7’ on other side with a break line on both sides.
NEVIRAPINE Tablets, USP are supplied in bottles of 60 tablets (NDC 68554-3005-0), 100 tablets (NDC 68554-3005-1), 500 tablets (NDC 68554-3005-2), 1000 tablets (NDC 68554-3005-3) Dispense in tight container as defined in the USP/NF. Storage
NEVIRAPINE Tablets, USP should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] . Store in a safe place out of the reach of children.
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