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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:  10/03/2001
 
Trade Name:  Diprolene AF, Diprosone, Lotrisone
 
Generic Name or Proper Name (*):  betamethason;betamethasone/ clotrimazole
 
Indications Studied:  Diprolene AF and Diprosone - Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses Lotrisone- Treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis
 
Label Changes Summary:  Diprolene AF Cream In an open-label study for the treatment of atopic dermatitis, 19 of 60 (32%) evaluable patients (ages 3 mo-12 years) showed HPA axis suppression. The younger the age group, the greater the proportion of patients with adrenal suppression. Indicated in patients 13 years and older. Not recommended in pediatric patients 12 years and younger Strengthened labeling in Clinical Pharmacology, Precautions- General and Pediatric Use subsections Local adverse reactions including signs of skin atrophy (telengiectasia, bruising, shininess) occurred in 10% of pediatric patients (3mo-12 years) Diprosone Cream, Ointment, Lotion A separate open-label study was performed in pediatric patients with atopic dermatitis for each Diprosone formulation Testing for HPA axis suppression was positive with each formulation in the age groups studied: Cream - 23% (ages 2yr-12yr); Ointment - 28% (ages 6mo-12yr); and Lotion - 73% (ages 6yr-12yr) Indicated in patients 13 years and older. Not recommended in pediatric patients 12 years and younger Strengthened labeling in Clinical Pharmacology, Precautions- General and Pediatric Use subsections Local adverse reactions including signs of skin atrophy (telengiectasia, bruising, shininess) occurred in the cream and ointment studies Lotrisone Not recommended for patients under the age of 17 years and not recommended for diaper dermatitis; previously not recommended for patients under the age of 12 years In an open-label study of Lotrisone cream for the treatment of tinea pedis, 17 of 43 (39.5%) evaluable patients (ages 12-16 years) demonstrated adrenal suppression as determined by cosyntropin testing In an open-label study of Lotrisone cream for the treatment of tinea cruris, 8 of 17 (47.1%) evaluable patients (ages 12-16 years) demonstrated adrenal suppression by cosyntropin testing Indicated in patients 17 years and older
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Schering
 
NNPS:  FALSE'
 
Therapeutic Category:  Anti-inflammatory, topical
 
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