Overview
11 DESCRIPTION Mometasone Furoate Cream USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate, USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27 H 30 Cl 2 O 6 , a molecular weight of 521.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 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 2 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 2 . 12.
Indications
- 1 INDICATIONS AND USAGE Mometasone furoate cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. Mometasone furoate cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥ 2 years of age. ( 1 )
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION Apply a thin film of mometasone furoate cream, 0.1% to the affected skin areas once daily. Mometasone furoate cream, 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of mometasone furoate cream, 0.1% have not been established in pediatric patients below 2 years of age; use in this age group is not recommended [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )]. Therapy should be discontinued when control is achieved.
Contraindications
- 4 CONTRAINDICATIONS Mometasone furoate cream, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. Mometasone furoate cream, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. ( 4 )
Side Effects
- 6 ADVERSE REACTIONS Most common adverse reactions are: burning, pruritus, and skin atrophy. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888)721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Interactions
- 7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with mometasone furoate cream.