MOMETASONE FUROATE ointment

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

Product summary:

Mometasone Furoate, USP Ointment 0.1% is supplied in 45 g (NDC 42254-175-45) 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MOMETASONE FUROATE- MOMETASONE FUROATE OINTMENT
REBEL DISTRIBUTORS CORP
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MOMETASONE FUROATE OINTMENT 0.1%
FOR DERMATOLOGIC USE ONLY- NOT FOR OPHTHALMIC USE
DESCRIPTION
Mometasone Furoate, USP Ointment 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 contains: 1 mg mometasone furoate USP in an ointment base of
hexylene glycol, phosphoric
acid, propylene glycol stearate, 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
27
30
2
6
2
2
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 0.7% of the applied dose of Mometasone