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MOMETASONE FUROATE CREAM USP, 0.1%

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 9α,21-Dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, 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, stearyl alcohol and ceteareth 20, titanium dioxide, aluminum starch octenylsuccinate, beeswax, white petrolatum, and purified water.

CLINICAL PHARMACOLOGY

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 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.

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 the drug use for longer than 3 weeks have not been established (See PRECAUTIONS - Pediatric Use). 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.

CONTRAINDICATIONS

Mometasone furoate cream USP, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

PRECAUTIONS

ADVERSE REACTIONS

In controlled clinical studies involving 319 patients, the incidence of adverse reactions associated with the use of mometasone furoate cream USP, 0.1% was 1.6%. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of mometasone furoate cream USP, 0.1% have also 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 USP, 0.1% was approximately 7%. Reported reactions included stinging, pruritus, and furunculosis.

The following adverse reactions were reported to be possible or probably related to treatment with mometasone furoate cream USP, 0.1% during clinical studies in 4% of 182 pediatric patients 6 months to 2 years of age: decreased glucocorticoid levels, 2; paresthesia, 2; folliculitis, 1; moniliasis, 1; bacterial infection, 1; skin depigmentation, 1. The following signs of skin atrophy were also observed among 97 patients treated with mometasone furoate cream USP, 0.1% in a clinical study: shininess 4; telangiectasia 1, loss of elasticity 4, loss of normal skin markings 4, thinness 1, and bruising 1. Striae 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 uled in an approximate decreasing order of occurrence: irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.

OVERDOSAGE

Topically applied mometasone furoate cream USP, 0.1% can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Apply a thin film of mometasone furoate cream USP, 0.1% to the affected skin areas once daily. Mometasone furoate cream USP, 0.1% may be used in pediatric patients 2 years of age or older. 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 (see PRECAUTIONS - Pediatric Use section). 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 cream USP, 0.1% in pediatric patients for more than 3 weeks of use have not been established.

Mometasone furoate cream USP, 0.1% should not be used with occlusive dressings unless directed by a physician. Mometasone furoate cream USP, 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

HOW SUPPLIED

Mometasone Furoate Cream USP, 0.1% is supplied as follows:

NDC 0168-0270-1515 gram tubes
NDC 0168-0270-4645 gram tubes

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)[see USP Controlled Room Temperature]

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747

I2270
R2/05
#209

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