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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:  03/02/2004
 
Trade Name:  Lotensin
 
Generic Name or Proper Name (*):  benazepril
 
Indications Studied:  Hypertension
 
Label Changes Summary:  * Information on dose, PK in pediatric patients 6-16 years of age * Not recommended for pediatric patients less than 6 years or with glomerular filtration rate < 30mL/min/1.73 m2 due to insufficient data * Infants below the age of 1 year should not be given ACE inhibitors due to concerns over possible effects on kidney development * The clearance rate was substantially higher in hypertensive children and adolescents than that of healthy adults * The terminal half life (t1/2) in pediatric patients was one third of that observed in adults * Adverse event profile in pediatric patients was similar to that seen in adults * Information on preparation of a suspension
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Novartis
 
Pediatric Exclusivity Granted Date:  07/02/2003
 
NNPS:  FALSE
 
Therapeutic Category:  Antihypertensive
 
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