displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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 C27H30CI2O6, 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.
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
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 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
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
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.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Mometasone Furoate, USP Ointment 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
In controlled clinical studies involving 812 patients, the incidence of adverse reactions associated with the use of Mometasone Furoate, USP Ointment 0.1% was 4.8%. Reported reactions included burning, pruritus, skin atrophy, tingling/ stinging, and furunculosis. Reports of rosacea associated with the use of Mometasone Furoate, USP Ointment 0.1% have been received. In controlled clinical studies (n=74) involving pediatric patients 2 to 12 years of age, the incidence of adverse experiences associated with the use of Mometasone Furoate Cream is approximately 7%. Reported reactions included stinging, pruritus, and furunculosis.
The following adverse reactions were reported to be possibly or probably related to treatment with Mometasone Furoate, USP Ointment 0.1% during a clinical study, in 5% of 63 pediatric patients 6 months to 2 years of age: decreased glucocorticoid levels, 1; an unspecified skin disorder, 1; and a bacterial skin infection, 1. The following signs of skin atrophy were also observed among 63 patients treated with Mometasone Furoate, USP Ointment 0.1% in a clinical study: shininess 4, telangiectasia 1, loss of elasticity 4, loss of normal skin markings 4, thinness 1. Striae 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, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Topically applied Mometasone Furoate, USP Ointment 0.1% can be absorbed in sufficient amounts to produce systemic effects (see
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Apply a thin film of Mometasone Furoate, USP Ointment 0.1% to the affected skin areas once daily. Mometasone Furoate, USP Ointment 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of Mometasone Furoate, USP Ointment 0.1% have not been adequately established in pediatric patients below 2 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. Safety and efficacy of Mometasone Furoate, USP Ointment 0.1% in pediatric patients for more than 3 weeks of use have not been established.
Mometasone Furoate, USP Ointment 0.1% should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate, USP Ointment 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
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
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4