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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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