Nevirapine

). Most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). 1).

51 Page 3 of 55 Pr AURO-NEVIRAPINE Nevirapine Tablets USP 200 mg PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength All Non-medicinal Ingredients Oral Immediate Release Tablet, 200 mg Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.

INDICATIONS AND CLINICAL USE AURO-NEVIRAPINE (nevirapine) is indicated as an alternative for:  treatment of HIV-1 infection in combination with other antiretroviral agents. The decision to use AURO-NEVIRAPINE should take into account liver and skin toxicity, potentially fatal, especially in patients with higher CD4 counts and in women (see WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic and Skin).

Clinical trials have not established equivalence of nevirapine to protease inhibitors or to other NNRTIs. Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled studies, AURO-NEVIRAPINE 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.

2). Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). 1).