Therapeutic Category:

Anti-retroviral reverse transcriptase inhibitor.


Composition:

NEVIR
Each tablet contains Nevirapine - 200 mg
Nevirapine - 200 mg

Indications:

Treatment of human immunodeficiency virus (HIV) infection and AIDS in combination with NRTIs.


Adverse Reactions:

Skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, hepatitis, granulocytopaenia, fever, ulcerative somatitis, diarrhea, nausea, headache.


Warnings:

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.


Precautions:

Pregnancy: Category C; Lactation: Nevirapine is distributed in breast milk. Nevirapine treated mothers should not breast-feed;


Drug Interactions:

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.


Contraindications:

Hypersensitivity to any of the components of the formulation


Dosage and Administration:

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.


Storage:

Store between 15° and 30°C (59° and 86° F).