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LOTRISONE (BETAMETHASONE DIPROPIONATE, CLOTRIMAZOLE) CREAM AND LOTION: USE IN SPECIFIC POPULATIONS

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lotrisone cream or lotion is administered to a nursing woman.

Pediatric Use

Adverse events consistent with corticosteroid use have been observed in patients under 12 years of age treated with Lotrisone cream. In open-label studies, 17 of 43 (39.5%) evaluable pediatric patients (aged 12 - 16 years old) using Lotrisone cream for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing. In another open-label study, 8 of 17 (47.1%) evaluable pediatric patients (aged 12 - 16 years old) using Lotrisone cream for treatment of tinea cruris demonstrated adrenal suppression as determined by cosyntropin testing. The use of Lotrisone cream or lotion in the treatment of patients under 17 years of age or patients with diaper dermatitis is not recommended.

Because of higher ratio of skin surface area to body mass, pediatric patients under the age of 12 years are at a higher risk with Betamethasone Dipropionate, Clotrimazole cream and lotion (Lotrisone). The studies described above suggest that pediatric patients under the age of 17 years may also have this risk. They are at increased risk of developing Cushing's syndrome while on treatment and adrenal insufficiency after withdrawal of treatment. Adverse effects, including striae and growth retardation, have been reported with inappropriate use of Lotrisone cream in infants and children.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

Clinical studies of Lotrisone cream and lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Postmarket adverse event reporting for Lotrisone cream in patients aged 65 and above includes reports of skin atrophy and rare reports of skin ulceration. Caution should be exercised with the use of these corticosteroid-containing topical products on thinning skin. The use of Lotrisone cream or lotion under occlusion, such as in diaper dermatitis, is not recommended.

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