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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:  08/29/2014
 
Trade Name:  Taclonex
 
Generic Name or Proper Name (*):  calcipotriene/ betamethasone dipropionate
 
Indications Studied:  Plaque psoriasis of the scalp
 
Label Changes Summary:  Expanded the indication from adults to pediatric patients 12 – 17 years Safety and effectiveness have not been established in pediatric patients less than 12 years In a trial to evaluate the effect on HPA axis suppression in pediatric patients 12 – 17 years, adrenal suppression was identified in 1 of 30 patients (3.3%) after 4 weeks of treatment Rare systemic toxicities such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids Local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients Information on dose and maximum weekly dose, adverse reactions, and clinical trials Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  LEO Pharma
 
NNPS:  FALSE'
 
Therapeutic Category:  Anti-inflammatory, topical
 
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