mometasone furoate- mometasone furoate lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

mometasone furoate (UNII: 04201GDN4R) (mometasone - UNII:8HR4QJ6DW8)

Available from:

Warrick Pharmaceuticals Corporation

INN (International Name):

mometasone furoate

Pharmaceutical form:

LOTION

Composition:

1 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mometasone Furoate Lotion 0.1% (mometasone furoate topical solution USP) 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 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 0.1% (mometasone furoate topical solution USP) is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Product summary:

Mometasone Furoate Lotion 0.1% (mometasone furoate topical solution USP) is supplied in 30-mL (27.5 g) (NDC 59930-1547-2) and 60-mL (55 g) (NDC 59930-1547-3) bottles; boxes of one. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]

Summary of Product characteristics

MOMETASONE FUROATE- MOMETASONE FUROATE LOTION
WARRICK PHARMACEUTICALS CORPORATION
----------
MOMETASONE FUROATE
LOTION 0.1%
(MOMETASONE FUROATE TOPICAL SOLUTION USP)
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Mometasone Furoate Lotion 0.1% (mometasone furoate topical solution
USP) contains mometasone
furoate, USP for dermatologic use. Mometasone Furoate Lotion 0.1% 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 Lotion 0.1% 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 Lotion 0.1%, contains: 1 mg mometasone
furoate, USP in a lotion
base of isopropyl alcohol (40%), propylene glycol,
hydroxypropylcellulose, sodium phosphate
monobasic monohydrate R and water. May also contain phosphoric acid
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
27
30
2
6
2
2
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