MOMETASONE FUROATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE FUROATE - UNII:04201GDN4R)

Available from:

Physicians Total Care, Inc.

INN (International Name):

MOMETASONE FUROATE

Composition:

MOMETASONE FUROATE 1 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Since safety and efficacy of Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended. (see PRECAUTIONS - Pediatric Use ). Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Product summary:

Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) is supplied in: Store between 2° and 30°C (36° and 86°F). January 2008 E. FOUGERA & CO. A division of Nycomed US Inc. Melville. NEW YORK 11747 I2272A- R1/08 Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MOMETASONE FUROATE - MOMETASONE FUROATE SOLUTION
PHYSICIANS TOTAL CARE, INC.
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MOMETASONE FUROATE LOTION
(MOMETASONE FUROATE TOPICAL SOLUTION USP 0.1%)
RX ONLY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Mometasone Furoate Lotion (Mometasone Furoate Topical Solution 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 C
H Cl
O , a
molecular weight of 521.4 and the following structural formula:
Mometasone furoate is a white to off-white powder insoluble in water,
freely soluble in acetone and in
methylene chloride and sparingly soluble in heptane. Each gram of
Mometasone Furoate Lotion
(Mometasone Furoate Topical Solution USP 0.1%) contains: 1 mg of
mometasone furoate, USP in a
lotion base of isopropyl alcohol (40%), propylene glycol,
hydroxypropyl-cellulose, sodium phosphate
monobasic monohydrate and water. May also contain phosphoric acid and
sodium hydroxide used to
adjust the pH to approximately 4.5.
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 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 including the vehicle and the integrity of the epidermal
barrier. Occlusive dr