Composition:

NEVIRAPINE ORAL SUSPENSION
Each 5 ml contains:Nevirapine - 50 mg

Indications:

Nevirapine is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.


Contraindications:

Hypersensitivity to any of the components contained in the oral suspension.


Warnings and Precautions:

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.


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.


Adverse Effects:

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


Dosage And Administration:

The recommended oral dose of nevirapine for paediatric patients 2 months to 8 years of age is 4 mg/kg once daily for the first 14 days followed by 7 mg/kg twice daily thereafter. For patients 8 years and older the recommended dose is 4 mg/kg once daily for two weeks followed by 4 mg/kg twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.

Dosage Adjustment: Nevirapine should be discontinued if patients experience severe rash or a rash accompanied by constitutional findings. Patients experiencing rash during the 14-day lead-in

period of 4 mg/kg/day in paediatric patients should not have their nevirapine dose increased until the rash has resolved. If a clinical (symptomatic) hepatic event occurs, nevirapine should be permanently discontinued. Do not restart nevirapine after recovery. Patients who interrupt nevirapine dosing for more than 7 days should restart the recommended dosing, 4 mg/kg/day for the first 14 days (lead-in) followed by one 4 or 7 mg/kg twice daily