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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:  06/24/2008
 
Trade Name:  Viramune Tablets 200 mg Viramune Oral Suspension 10 mg/mL
 
Generic Name or Proper Name (*):  nevirapine
 
Indications Studied:  Use in combination with other antiretroviral agents for the treatment of HIV-1 infection
 
Label Changes Summary:  Dosing information provided for children ages >15 days to <16 years old Safety was evaluated in children 2 weeks and older in 5 clinical trials and important adverse events (all causality) include rash (21%), neutropenia (8.9%), anemia (7.3%) and hepatotoxicity (2.4%) Safety, pharmacokinetics, and virologic and immunologic responses have been evaluated in HIV-infected pediatric patients age 3 months to 18 years Safety and pharmacokinetics were evaluated in HIV-infected pediatric patients age 15 days to < 3 months Efficacy was evaluated in one clinical study with children 3 months to 16 years of age Post-marketing surveillance has shown anemia to be more commonly observed in children although development of anemia due to concomitant medication use cannot be ruled out Potential drug interaction information is provided for children with respect to lopinavir/ritonavir New dosing regimen
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Boehringer Ingelheim
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral
 
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