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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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