Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1248
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Mometasone Furoate (Solution)
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Apply a few drops of mometasone furoate topical solution to the affected 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 mometasone furoate topical solution have not been established in pediatric patients below 12 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. Mometasone furoate topical solution should not be used with occlusive dressings unless directed by a physician. Mometasone furoate topical solution should not be applied in the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.
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| dailymed-instance:descripti... |
Mometasone Furoate Topical Solution USP, 0.1% (Lotion) 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 insoluble in water, freely soluble in acetone and in methylene chloride and sparingly soluble in heptane. Each gram of Mometasone Furoate Topical Solution USP, 0.1% (Lotion) contains: 1 mg mometasone furoate, USP in a solution base of hydroxypropylcellulose, isopropyl alcohol, phosphoric acid, propylene glycol, purified water and sodium phosphate monobasic.
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Like other topical corticosteroids, mometasone furoate has anti-inflammatory, anti-pruritic, 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. A similar minimal degree of absorption of the corticosteroid from the topical solution formulation would be anticipated. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Studies performed with mometasone furoate topical solution 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 topical solution on the hypothalamic-pituitary-adrenal (HPA) axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to 4 adult patients with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the 4 patients remained within the normal range and changed little from baseline. Sixty-five 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 topical solution was applied once daily for approximately 3 weeks over a mean body surface area of 40% (range 16% to 90%). In approximately 29% of patients who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end oftreatment with mometasone furoate topical solution. 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 one patient, using these same criteria.
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Mometasone furoate topical solution 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 Topical Solution USP, 0.1% (Lotion) is supplied in 30 mL (NDC 51672-1305-3) and 60 mL (NDC 51672-1305-4) bottles; boxes of one. Store at 20��- 25��C (68��- 77��F) [see USP Controlled Room Temperature].
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Topically applied mometasone furoate topical solution can be absorbed in sufficient amounts to produce systemic effects .
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Mometasone Furoate
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Mometasone Furoate (Solution)
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| dailymed-instance:adverseRe... |
In clinical studies involving 209 patients, the incidence of adverse reactions associated with the use of mometasone furoate topical solution 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 mometasone furoate topical solution 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 mometasone furoate topical solution 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.
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Mometasone Furoate Topical Solution USP, 0.1% (Lotion) is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Since safety and efficacy of mometasone furoate topical solution have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended. .
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Mometasone Furoate
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