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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
11/14/2017
Trade Name:
Tekturna
Generic Name or Proper Name (*):
aliskiren
Indications Studied:
Treatment of hypertension in adults and children 6 years of age and older
Label Changes Summary:
*Approved for use in adults and children 6 years and older. *Tekturna was evaluated in two randomized, double-blind clinical studies in pediatric patients 6 to 17 years of age. *Tekturna is contraindicated in children less than 2 years of age. Tekturna should not be used in children 2 to less than 6 years or in children who weigh less than 20 kg. *Preclinical studies indicate a potential for substantial increase in exposure to aliskiren in pediatric patients. *Information on administration of oral pellets. Do not chew or crush the contents of the capsules. *Adverse reactions were similar to those observed in adults. *Information on dosing, PK, and clinical trial. *Postmarketing study.
BPCA(B) and PREA(P):
B, P
Sponsor:
Noden Pharma DAC
NNPS:
FALSE
Therapeutic Category:
Antihypertensive
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