Country: United States
Language: English
Source: NLM (National Library of Medicine)
MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8)
Physicians Total Care, Inc.
MOMETASONE FUROATE
MOMETASONE FUROATE 1 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Mometasone furoate cream USP 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Mometasone furoate cream USP 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 (see PRECAUTIONS: Pediatric Use: section). Since safety and efficacy of mometasone furoate cream USP 0.1% have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended. Mometasone furoate cream USP 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
Mometasone furoate cream USP 0.1 % is supplied in 15 g (NDC 54868-5455-0 ) and 45 g (NDC 54868-5455-1 ) tubes; boxes of one.
Abbreviated New Drug Application
MOMETASONE FUROATE - MOMETASONE FUROATE CREAM PHYSICIANS TOTAL CARE, INC. ---------- MOMETASONE FUROATE CREAM USP 0.1% FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE DESCRIPTION Mometasone furoate cream USP 0.1% contains mometasone furoate, USP for dermatologic use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9α, 21-Dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene- 3,20-dione 17-(2-furoate), with the empirical formula C H CI O , 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 mometasone furoate cream USP 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. CLINICAL PHARMACOLOGY 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 A inhibitory 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 . 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 27 30 2 6 2 2 hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, o Read the complete document