DESCRIPTION
id: 624920E8-089D-C66E-39BB-12F5DB1F8C06
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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 C27H30Cl2O6, 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
id: 397EC58D-345C-608B-AC94-3B7487CD85E3
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
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
id: 8F61669C-5A11-5E11-DE12-6098608B5BDC
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
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).
CONTRAINDICATIONS
id: DFD8CD85-A019-0C55-2FA7-FF1A2A491F1D
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
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.
PRECAUTIONS
id: CD3836D2-3C76-6AFD-7658-577B1EA6AA95
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
ADVERSE REACTIONS
id: 3BA1ED4E-D053-533D-1EC2-EE595ADD8096
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
In clinical studies involving 209 patients, the incidence of adverse reactions associated with the use of Mometasone Furoate Lotion 0.1% (mometasone furoate topical solution USP) was 3%. Reported reactions included acneiform reaction, 2; burning, 4; and itching, 1. In an irritation/sensitization study involving 156 normal subjects, the incidence of folliculitis was 3% (4 subjects).The following adverse reactions were reported to be possibly or probably related to treatment with Mometasone Furoate Lotion 0.1% during a clinical study, in 14% of 65 pediatric patients 6 months to 2 years of age: decreased glucocorticoid levels, 4; paresthesia, 2; dry mouth,1; an unspecified endocrine disorder, 1; pruritus, 1; and an unspecified skin disorder, 1. The following signs of skin atrophy were also observed among 65 patients treated with Mometasone Furoate Lotion 0.1% in a clinical study: shininess 4, telangiectasia 2, loss of elasticity 2, and loss of normal skin markings 3. Striae, thinness and bruising 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 listed in an approximate decreasing order of occurrence: irritation, dryness, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
OVERDOSAGE
id: F405279E-79FC-ACA2-5903-5B5BC76018D5
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Topically applied Mometasone Furoate Lotion 0.1% (mometasone furoate topical solution USP) can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
DOSAGE AND ADMINISTRATION
id: 809BE52D-6219-8E50-B075-A66AC8B10C5F
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Apply a few drops of Mometasone Furoate Lotion 0.1% (mometasone furoate topical solution USP) to the affected skin areas once daily and massage lightly until it disappears. For the most effective and economical use, hold the nozzle of the bottle very close to the affected areas and gently squeeze. 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).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.Mometasone Furoate Lotion 0.1% should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate Lotion 0.1% should not be applied in the diaper area if the patient still requires diapers or plastic pants as these garments may constitute occlusive dressing.
HOW SUPPLIED
id: D6234A4F-353C-233F-8305-E91D6DA5F14D
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
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]
