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These highlights do not include all the information needed to use NEVIRAPINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for NEVIRAPINE EXTENDED-RELEASE TABLETS. NEVIRAPINE extended-release tablets, for oral use Initial U.S. Approval: 1996
Medication labelWhy this: Advisory · dailymed-prescription
Nevirapine extended-release tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (BSA) of 1.17 m2 or greater [see Clinical Studies (14.1, 14.2)]. Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in: • adult females with CD4+ cell counts greater than 250 cells/mm3 or • adult males with CD4+ cell counts greater than 400 cells/mm3 [see Warnings and Precautions (5.1)].
- generic_name
- nevirapine
- product_names
- NEVIRAPINE
- ndc
- 33342-238, 33342-238-07
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en