Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3704
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Mometasone Furoate (Ointment)
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| dailymed-instance:dosage |
Apply a thin film of Mometasone Furoate Ointment to the affected skin areas once daily. Mometasone Furoate Ointment may be used in pediatric patients 2 years of age or older. Since safety and efficacy of Mometasone Furoate Ointment 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 Mometasone Furoate Ointment in pediatric patients for more than 3 weeks have not been established. Mometasone Furoate Ointment should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate Ointment 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... |
Mometasone Furoate Ointment USP, 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 contains: 1 mg mometasone furoate, USP in an ointment base of hexylene glycol; propylene glycol stearate; white petrolatum and white wax.
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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 0.7% of the applied dose of Mometasone Furoate Ointment, 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 Mometasone Furoate Ointment 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 ointment 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 ointment 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 Mometasone Furoate Cream, 0.1%, once daily. The majority of patients cleared within 3 weeks. Sixty-three pediatric patients ages 6 to 23 months, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study. Mometasone Furoate Ointment was applied once daily for approximately 3 weeks over a mean body surface area of 39% (range 15% to 99%). In approximately 27% of patients who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with Mometasone Furoate Ointment. 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 8 of the patients, demonstrated suppressed HPA axis function in 3 patients, using these same criteria.
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Mometasone Furoate Ointment, USP 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 |
Mometasone Furoate Ointment USP, 0.1%, is supplied in 15 g and 45 g tubes; boxes of one. Store Mometasone Furoate Ointment at 20��- 25��C (68��- 77��F) [see USP Controlled Room Temperature].
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Topically applied Mometasone Furoate Ointment can be absorbed in sufficient amounts to produce systemic effects .
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Mometasone Furoate
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Mometasone Furoate (Ointment)
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| dailymed-instance:adverseRe... |
In controlled clinical studies involving 812 patients, the incidence of adverse reactions associated with the use of Mometasone Furoate Ointment was 4.8%. Reported reactions included burning, pruritus, skin atrophy, tingling/stinging, and furunculosis. Reports of rosacea associated with the use of Mometasone Furoate Ointment 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 Mometasone Furoate 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 Mometasone Furoate Ointment 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 ofskin atrophy were also observed among 63 patients treated with Mometasone Furoate Ointment 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.
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| dailymed-instance:indicatio... |
Mometasone Furoate Ointment USP, 0.1%, is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Mometasone Furoate Ointment, 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 Mometasone Furoate Ointment have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended.
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Mometasone Furoate
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