MOMETASONE FUROATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Mometasone Furoate (UNII: 04201GDN4R) (Mometasone Furoate - UNII:04201GDN4R)

Available from:

Rebel Distributors Corp

INN (International Name):

Mometasone Furoate

Composition:

Mometasone Furoate 1 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mometasone Furoate Cream 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Mometasone Furoate Cream 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 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 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Product summary:

Mometasone Furoate Cream 0.1% is supplied in 15 g (NDC 21695-786-15) and 45 g (NDC 21695-786-45) tubes; boxes of one. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature] G&W Laboratories, Inc. South Plainfield, NJ 07080 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MOMETASONE FUROATE- MOMETASONE FUROATE CREAM
REBEL DISTRIBUTORS CORP
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MOMETASONE FUROATE CREAM 0.1%
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Mometasone Furoate Cream 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 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.
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 .
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30
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6
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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 enhan