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Approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in children 6 - < 18 years. Use in pediatric patients 6 - < 18 years is based on pharmacokinetic, safety, and antiviral activity data from an open-label trial and supported by previous demonstration of efficacy in adults. Not recommended for children < 6 years since clinical trial did not provide sufficient pharmacokinetic data for children 3 - < 6 years to support the use in this age group. Furthermore, not recommended for children < 3 years because they are not able to swallow tablets. Viramune XR tablets must be swallowed whole and must not be chewed, crushed, or divided. Children should be assessed for their ability to swallow tablets before prescribing No recommendations can be made regarding substitution of four VIRAMUNE XR 100 mg tablets for one VIRAMUNE XR 400 mg tablet Pediatric patients may be dosed using Viramune XR 400 mg or 100 mg tablets. Viramune XR is dosed based on a patients body surface area (BSA). All pediatric patients must initiate therapy with immediate-release Viramune at a dose not to exceed 200 mg per day, administered once daily for the first 14 days because it has been demonstrated to reduce the frequency of rash. This lead-in period is not required if the patient is already on a regimen of twice daily immediate-release formulation Adverse reactions were similar to those observed in adults. In pediatric patients the incidence of Grade 2 or higher drug-related rash was 1%Information on recommended dosing based on BSA, pharmacokinetics, adverse reactions, and clinical trial Postmarketing study
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