Mometasone Furoate

Description

11 DESCRIPTION Mometasone Furoate Ointment USP, 0.1% contains mometasone furoate for topical 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 27 H 30 Cl 2 O 6 , 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 of Mometasone Furoate Ointment USP, 0.1% contains 1 mg mometasone furoate in a white to off-white uniform ointment base of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), purified water, white wax, and white petrolatum.

What Is Mometasone Furoate Used For?

1 INDICATIONS AND USAGE Mometasone Furoate Ointment, 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 Ointment, 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

Dosage and Administration

2 DOSAGE AND ADMINISTRATION Apply a thin film of Mometasone Furoate Ointment, 0.1% to the affected skin areas once daily. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1)]. Do not use Mometasone Furoate Ointment, 0.1% with occlusive dressings unless directed by a physician. Do not apply Mometasone Furoate Ointment, 0.1% in the diaper area, as diapers or plastic pants constitute occlusive dressing. Avoid use on the face, groin, or axillae. Avoid contact with eyes. Wash hands after each application. Mometasone Furoate Ointment, 0.1% is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS Most common adverse reactions are burning, pruritus, skin atrophy, tingling/stinging and furunculosis. (6) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 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. In controlled clinical trials involving 812 subjects, the incidence of adverse reactions associated with the use of mometasone furoate ointment, 0.1% was 4.8%. Reported reactions included burning, pruritus, skin atrophy, tingling/stinging, and furunculosis. Cases of rosacea associated with the use of mometasone furoate ointment, 0.1% have been reported. The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate ointment, 0.1% during a clinical study in 5% of 63 pediatric subjects 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 subjects treated with mometasone furoate ointment, 0.1% in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; and thinness, 1. 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. These adverse reactions may occur more frequently with the use of occlusive dressings. Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.

Drug Interactions

7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with Mometasone Furoate Ointment, 0.1%.

Contraindications

4 CONTRAINDICATIONS Mometasone Furoate Ointment, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Pregnancy and Breastfeeding

8.1 Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, Mometasone Furoate Ointment, 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy. In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate ointment, 0.1% on a mcg/m 2 basis). In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate ointment, 0.1% on a mcg/m 2 basis). In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate ointment, 0.1% on a mcg/m 2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head...

8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mometasone Furoate Ointment, 0.1% is administered to a nursing woman.

Overdosage

10 OVERDOSAGE Topically applied Mometasone Furoate Ointment, 0.1% can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)] .

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING Mometasone Furoate Ointment USP, 0.1% is a white to off-white uniform ointment NDC: 72162-1393-4: 15 g in a TUBE NDC: 72162-1393-2: 45 g in a TUBE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504