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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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