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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:  05/29/2003
Trade Name:  Prinivil
Generic Name or Proper Name (*):  lisinopril
Indications Studied:  Hypertension
Label Changes Summary:  * Labeling for 6-16 years of age * Not recommended for pediatric patients with glomerular filtration rate < 30ml/min/1.73m2 * Information on dose, efficacy and pharmacokinetics * No relevant differences were identified between adverse experience profile for pediatric patients and that previously reported for adult patients * Information on preparation of a suspension
Product Labeling:  Labeling  Opens a new window
Sponsor:  Merck
Pediatric Exclusivity Granted Date:  11/19/2001
Therapeutic Category:  Antihypertensive