the advantages [7:<7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 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 ). 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 absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. ELOCON (mometasone furoate lotion) Lotion 0.1% should not be used in the treatment of diaper dermatitis. Geriatrics Use: Clinical studies of ELOCON Lotion 0.1% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious. Adverse Reactions In clinical studies involving 209 patients, the incidence of adverse reactions associated with the use of ELOCON Lotion 0.1% was 3%. Reported reactions included acneiform reaction, 2; burning, 4; and itching, 1. In an irritation/sensitization study involving 156 normal subjects, the incidence of folliculitis was 3% (4 subjects). The following adverse reactions were reported to be possibly or probably related to treatment with ELOCON Lotion 0.1% during a clinical study, in 14% of 65 pediatric patients 6 months to 2 years of age: decreased glucocorticoid levels, 4; paresthesia, 2; dry mouth, 1; an unspecified endocrine disorder, 1; pruritus, 1; and an unspecified skin disorder, 1. The following signs of skin atrophy were also observed among 65 patients treated with ELOCON Lotion 0.1% in a clinical study: shininess 4, telangiectasia 2, loss of elasticity 2, and loss of normal skin markings 3. Striae, thinness and bruising 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, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. Overdosage Topically applied ELOCON Lotion 0.1% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ). Dosage and Administration Apply a few drops of ELOCON Lotion 0.1% to the affected skin areas once daily and massage lightly until it disappears. For the most effective and economical use, hold the nozzle of the bottle very close to the affected areas and gently squeeze. Since safety and efficacy of ELOCON Lotion 0.1% have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended (see PRECAUTIONS - Pediatric Use ). 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. ELOCON Lotion 0.1% should not be used with occlusive dressings unless directed by a physician. ELOCON Lotion 0.1% should not be applied in the diaper area if the patient still requires diapers or plastic pants as these garments may constitute occlusive dressing. How Supplied ELOCON Lotion 0.1% is supplied in 30-mL (27.5 g) (NDC 0085-0854-01) and 60-mL (55 g) (NDC 0085-0854-02) bottles; boxes of one. Store ELOCON Lotion 0.1% between 2 and 30 C (36 and 86 F). Schering Corporation Kenilworth, NJ 07033 USA Rev. 12/02 17980920 Copyright 1989, 2003, Schering Corporation. All rights reserved. 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 thrust back
slogging away ELOCON (Schering) Lotion 0.1% being attentive to
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