Application Nr Approved Date Route Status External Links
ANDA202523 2012-05-22 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Nevirapine Tablets Are Indicated For Use In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection. This Indication Is Based On One Principal Clinical Trial (bi 1090) That Demonstrated Prolonged Suppression Of Hiv-1 Rna And Two Smaller Supportive Trials, One Of Which (bi 1046) Is Described Below. Additional Important Information Regarding The Use Of Nevirapine Tablets For The Treatment Of Hiv-1 Infection: Based On Serious And Life Threatening Hepatotoxicity Observed In Controlled And Uncontrolled Trials, Nevirapine Tablets Should Not Be Initiated In Adult Females With Cd4+ Cell Counts Greater Than 250 Cells/mm3 Or In Adult Males With Cd4+ Cell Counts Greater Than 400 Cells/mm3 Unless The Benefit Outweighs The Risk [see Boxed Warning And Warnings And Precautions (5.1) ]. The 14-Day Lead-In Period With Nevirapine Tablets 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 Tablets Are An Nnrti Indicated For Combination Antiretroviral Treatment Of Hiv-1 Infection (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/mm3 Adult Males With Cd4+ Cell Counts Greater Than 400 Cells/mm3 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 (4 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

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

Comments