nevirapine
Drug Details
- Generic Name
- nevirapine
- Brand Names
- Nevirapine
- Application Number
- ANDA205651
- Sponsor
- Mylan Pharmaceuticals Inc.
- NDC Codes
- 2
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET
- Routes
- ORAL
- Active Ingredients
- NEVIRAPINE
Indications and Usage
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 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 or adult males with CD4 + cell counts greater than 400 cells/mm 3 [see Warnings and Precautions (5.1) ]. Nevirapine 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 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 )