Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1040
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ELOCON (Cream)
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| dailymed-instance:dosage |
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 . 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.
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| dailymed-instance:descripti... |
ELOCON (mometasone furoate cream) Cream 0.1% contains mometasone furoate, USP for dermatologic use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9��,21-Dichloro-11��,17-dihydroxy-16��-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula CHClO, a molecular weight of 521.4 and the following structural formula: Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of ELOCON Cream 0.1% contains: 1 mg mometasone furoate, USP in a cream base of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), stearyl alcohol and ceteareth-20, titanium dioxide, aluminum starch octenylsuccinate (Gamma Irradiated), white wax, white petrolatum, and purified water.
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| dailymed-instance:clinicalP... |
Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase Ainhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A.<br/>Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Studies in humans indicate that approximately 0.4% of the applied dose of ELOCON Cream 0.1% enters the circulation after 8 hours of contact on normal skin without occlusion. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Studies performed with ELOCON Cream 0.1% indicate that it is in the medium range of potency as compared with other topical corticosteroids. In a study evaluating the effects of mometasone furoate cream on the hypothalamic-pituitary-adrenal (HPA) axis, 15 grams were applied twice daily for 7 days to six adult patients with psoriasis or atopic dermatitis. The cream was applied without occlusion to at least 30% of the body surface. The results show that the drug caused a slight lowering of adrenal corticosteroid secretion. In a pediatric trial, 24 atopic dermatitis patients, of which 19 patients were age 2 to 12 years, were treated with ELOCON Cream 0.1% once daily. The majority of patients cleared within 3 weeks. Ninety-seven pediatric patients ages 6 to 23 months, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study. ELOCON Cream 0.1% was applied once daily for approximately 3 weeks over a mean body surface area of 41% (range 15% to 94%). In approximately 16% of patients who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observedat the end of treatment with ELOCON Cream 0.1%. The criteria for suppression were: basal cortisol level of���5 mcg/dL, 30-minute post-stimulation level of���18 mcg/dL, or an increase of<7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 5 of the patients, demonstrated suppressed HPA axis function in one patient, using these same criteria.
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| dailymed-instance:contraind... |
ELOCON Cream 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
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| dailymed-instance:supply |
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 at 25��C (77��F); excursions permitted to 15���30��C (59���86��F) [see USP Controlled Room Temperature]
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Topically applied ELOCON Cream 0.1% can be absorbed in sufficient amounts to produce systemic effects .
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| dailymed-instance:genericMe... |
mometasone furoate
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| dailymed-instance:fullName |
ELOCON (Cream)
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| dailymed-instance:adverseRe... |
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.
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| dailymed-instance:indicatio... |
ELOCON Cream 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ELOCON (mometasone furoate cream) Cream 0.1% may be used in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established . Since safety and efficacy of ELOCON Cream 0.1% have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended.
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ELOCON
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