Momexin

Generic name: mometasone furoate
Dosage form: cream

DESCRIPTION: MomexinTM Mometasone Furoate Cream 0.1% contains mometasone furoate, USP for dermatologic use. Mometasone furoate
is a synthetic corticosteroid with antiinflammatory activity.

Chemically, mometasone furoate is 9a,21-Dichloro-11b,17- dihydroxy-16a-methylpregna-1, 4-diene-3,20-dione 17-(2-furoate), with the empirical formula
C27H30CI2O6, 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 0.1% contains: 1 mg mometasone furoate, USP in a cream base of hexylene glycol,
phosphoric acid, propylene glycol stearate, stearyl alcohol and ceteareth-20, titanium dioxide, aluminum starch octenylsuccinate,
white wax, white petrolatum, and purified water.

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.

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 Mometasone Furoate 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 Mometasone Furoate 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 wi