Treatment of human immunodeficiency virus (HIV) infection and AIDS in combination with NRTIs.
Skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, hepatitis, granulocytopaenia, fever, ulcerative somatitis, diarrhea, nausea, headache.
Severe hepatotoxicity and skin reactions have been reported with Nevirapine. It is essential that patients be monitored intensively during the first 18 weeks of therapy to detect potentially life-threatening hepatotoxicity or skin reactions. Nevirapine should not be restarted following severe hepatic, skin or hypersensitivity reactions.
Pregnancy: Category C; Lactation: Nevirapine is distributed in breast milk. Nevirapine treated mothers should not breast-feed;
Nevirapine is an inducer of CYP450 enzymes. Cimetidine and macrolides antibiotics elevate steady-state Nevirapine trough concentrations. Nevirapine may decrease the plasma concentrations of oral contraceptives, ketokonazole, Rifampicin, indinavir and Saquinavir.
Hypersensitivity to any of the components of the formulation
Nevirapine is initiated with a 14-day period of 200mg/day before increasing the dose too 400-mg per day. In patients who develop liver abnormalities, therapy may be restarted with a 14-day period of 200mg/day before increasing the dose to 400mg/day when liver function tests return to baseline.
Patients who interrupt nevirapine therapy for more than 7 days should restart dosing with 200mg/day for the first 14 days, then increase the dose to 200mg twice daily. Nevirapine oral suspension and tablets are bioequivalent and interchangeable at doses up to 200mg.
Store between 15° and 30°C (59° and 86° F).