charge [7:<7 mcg/dL. Follow-up testing 2 to 4 weeks after study completion, available for 5 of the patients, demonstrated suppressed HPA axis function in one patient, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population (see CLINICAL PHARMACOLOGY - Pharmacokinetics section). Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. ELOCON (mometasone furoate cream, USP) Cream 0.1% should not be used in the treatment of diaper dermatitis. Geriatric Use: Clinical studies of ELOCON Cream 0.1% included 190 subjects who were 65 years of age and over and 39 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Adverse Reactions In controlled clinical studies involving 319 patients, the incidence of adverse reactions associated with the use of ELOCON Cream 0.1% was 1.6%. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of ELOCON Cream 0.1% have also been received. In controlled clinical studies (n=74) involving pediatric patients 2 to 12 years of age, the incidence of adverse experiences associated with the use of ELOCON Cream 0.1% was approximately 7%. Reported reactions included stinging, pruritus, and furunculosis. The following adverse reactions were reported to be possibly or probably related to treatment with ELOCON Cream 0.1% during clinical studies in 4% of 182 pediatric patients 6 months to 2 years of age: decreased glucocorticoid levels, 2; paresthesia, 2; folliculitis,1; moniliasis, 1; bacterial infection, 1; skin depigmentation, 1. The following signs of skin atrophy were also observed among 97 patients treated with ELOCON Cream 0.1% in a clinical study: shininess 4, telangiectasia 1, loss of elasticity 4, loss of normal skin markings 4, thinness 1, and bruising 1. Striae were not observed in this study. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria. Overdosage Topically applied ELOCON Cream 0.1% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS section). Dosage and Administration Apply a thin film of ELOCON Cream 0.1% to the affected skin areas once daily. ELOCON Cream 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of ELOCON Cream 0.1% have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended (see PRECAUTIONS - Pediatric Use section). As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Safety and efficacy of ELOCON Cream 0.1% in pediatric patients for more than 3 weeks of use have not been established. ELOCON Cream 0.1% should not be used with occlusive dressings unless directed by a physician. ELOCON Cream 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing. How Supplied ELOCON Cream 0.1% is supplied in 15-g (NDC 0085-0567-01) and 45-g (NDC 0085-0567-02) tubes; boxes of one. Store ELOCON Cream 0.1% between 2 and 25 C (36 and 77 F). ELOCON brand of mometasone furoate cream, USP Cream 0.1% For Dermatologic Use Only Not for Ophthalmic Use Schering Corporation Kenilworth, NJ 07033 USA Rev. 12/02 17969366 18724332T PRODUCT PHOTO(S): NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size. The product samples shown here have been supplied by the manufacturer. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis. Print this page> ] FDA Consumer Updates Depression: FDA-Approved Medications May Help Dealing with ADHD: What You Need to Know Making Decisions for Your Health: Getting the Info You Need FDA: Cutting-Edge Technology Sheds Light on Antibiotic Resistance More FDA updates motivated
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