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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
Sponsor:  Novartis
Pediatric Exclusivity Granted Date:  07/02/2003
Therapeutic Category:  Antihypertensive