MOMETASONE FUROATE - mometasone furoate cream
Global Pharmaceuticals, Division of Impax Laboratories Inc.
Rx Only
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 9?,21-dichloro-11�,17-dihydroxy-16?-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27 H30 Cl2 O6 , a molecular weight of 521.4 and the following structural formula:
927ae87a-figure-01
(click image for full-size original)
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, NF; phosphoric acid, NF; propylene glycol monostearate; stearyl alcohol/ceteareth-20; aluminum starch octenylsuccinate; white wax, NF; white petrolatum, USP; and purified water, USP.
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 A2 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 A2 . Mometasone Furoate Indications and Usage
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 adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended.
