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Indications and Purposes

1 Indications & Usage Nevirapine Is Indicated For Combination Antiretroviral Treatment Of Hiv-1 Infection In Adults And In Pediatric Patients 15 Days And Older [See Clinical Studies ( 14.1 ), 14.2 )]. Additional Important Information Regarding The Use Of Nevirapine For The Treatment Of Hiv-1 Infection: • Based On Serious And Life-Threatening Hepatotoxicity Observed In Controlled And Uncontrolled Trials, Nevirapine Should Not Be Initiated In Adult Females With Cd4 + Cell Counts Greater Than 250 Cells/mm 3 Or In Adult Males With Cd4 + Cell Counts Greater Than 400 Cells/mm 3 Unless The Benefit Outweighs The Risk [See Boxed Warning And Warnings And Precautions (5.1) ]. • The 14-Day Lead-In Period With Nevirapine 200 Mg Daily Dosing Must Be Strictly Followed, It Has Been Demonstrated To Reduce The Frequency Of Rash [See Dosage And Administration (2.4) And Warnings And Precautions (5.2) ]. • If Rash Persists Beyond The 14-Day Lead-In Period, Do Not Dose Escalate To 200 Mg Twice Daily. The 200 Mg Once-Daily Dosing Regimen Should Not Be Continued Beyond 28 Days At Which Point An Alternative Regimen Should Be Sought. • Nevirapine Tablet, Usp Is An Nnrti Indicated For Combination Antiretroviral Treatment Of Hiv-1 Infection In Adults And In Pediatric Patients 15 Days And Older. ( 1 ) Important Considerations: • Initiation Of Treatment Is Not Recommended In The Following Populations Unless The Benefits Outweigh The Risks ( 1 , 5.1 )  Adult Females With Cd4 + Cell Counts Greater Than 250 Cells/mm 3  Adult Males With Cd4 + Cell Counts Greater Than 400 Cells/mm 3 • The 14-Day Lead-In Period Must Be Strictly Followed; It Has Been Demonstrated To Reduce The Frequency Of Rash ( 2.4 , 5.2 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Nevirapine NEVIRAPINE ZINC4778

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