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Treatment Guidelines
v Adults & Adolescents
    (January 29, 2008)
v Pediatrics
    (February 28, 2008)
v Perinatal Guidelines
    (Nov 2, 2007)
v TB/HIV A Clinical Manual
PRODUCTS :: PEDIATRIC FORMULATIONS :: NNRTI :: NEVIRAPINE ORAL SUSPENSION
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

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