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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  11/08/2012
 
Trade Name:  VIRAMUNE XR
 
Generic Name or Proper Name (*):  nevirapine
 
Indications Studied:  Treatment of HIV-1 infection
 
Label Changes Summary:  * 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
 
Product Labeling:  urlLabeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Boehringer Ingelheim
 
NNPS:  False
 
Therapeutic Category:  Antiviral
 
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