weighing machine [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 3 patients, 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 glucocorticosteroid 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 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. ELOCON (mometasone furoate ointment, USP) Ointment 0.1% should not be used in the treatment of diaper dermatitis. Geriatric Use Clinical studies of ELOCON Ointment 0.1% included 310 subjects who were 65 years of age and over and 57 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 812 patients, the incidence of adverse reactions associated with the use of ELOCON Ointment 0.1% was 4.8%. Reported reactions included burning, pruritus, skin atrophy, tingling/stinging, and furunculosis. Reports of rosacea associated with the use of ELOCON Ointment 0.1% have 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 is 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 Ointment 0.1% during a clinical study, in 5% of 63 pediatric patients 6 months to 2 years of age: decreased glucocorticoid levels, 1; an unspecified skin disorder, 1; and a bacterial skin infection, 1. The following signs of skin atrophy were also observed among 63 patients treated with ELOCON Ointment 0.1% in a clinical study: shininess 4, telangiectasia 1, loss of elasticity 4, loss of normal skin markings 4, thinness 1. Striae 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, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria. Overdosage Topically applied ELOCON Ointment 0.1% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ). Dosage and Administration Apply a thin film of ELOCON Ointment 0.1% to the affected skin areas once daily. ELOCON Ointment 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of ELOCON Ointment 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 ). 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 Ointment 0.1% in pediatric patients for more than 3 weeks have not been established. ELOCON Ointment 0.1% should not be used with occlusive dressings unless directed by a physician. ELOCON Ointment 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 Ointment 0.1% is supplied in 15 g (NDC 0085-0370-01) and 45 g (NDC 0085-0370-02) tubes; boxes of one. Store at 25 C (77 F); excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature] Schering Corporation Kenilworth, NJ 07033 USA Rev. 11/02 17969544 18724235T Copyright 1987, 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. 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