Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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
 
-
-