Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Mometasone Furoate Topical Solution USP, 0.1% (Lotion) is clear transparent slightly viscous solution and supplied in 30 mL (NDC 68462-385-37) and 60 mL (NDC 68462-385-02) bottles. Store Mometasone Furoate Topical Solution USP, 0.1% (Lotion) at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-30 ML NDC 68462-385-37 Mometasone Furoate Topical Solution, USP 0.1% (Lotion) 30 ml- Carton carton-30-ml; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-60 ML NDC 68462-385-02 Mometasone Furoate Topical Solution, USP 0.1% (Lotion) 60 ml- Carton 60-ml-carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING Mometasone Furoate Topical Solution USP, 0.1% (Lotion) is clear transparent slightly viscous solution and supplied in 30 mL (NDC 68462-385-37) and 60 mL (NDC 68462-385-02) bottles. Store Mometasone Furoate Topical Solution USP, 0.1% (Lotion) at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-30 ML NDC 68462-385-37 Mometasone Furoate Topical Solution, USP 0.1% (Lotion) 30 ml- Carton carton-30-ml
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-60 ML NDC 68462-385-02 Mometasone Furoate Topical Solution, USP 0.1% (Lotion) 60 ml- Carton 60-ml-carton
Overview
Mometasone Furoate Topical Solution USP, 0.1% (Lotion) 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 521.43 g/mol and the following structural formula: Mometasone furoate, USP is a white to off-white powder soluble in acetone and methylene chloride. Each gram of Mometasone Furoate Topical Solution USP, 0.1% (Lotion) contains: 1 mg mometasone furoate, USP in a lotion base of hydroxypropyl cellulose, isopropyl alcohol (40%), propylene glycol, sodium phosphate monobasic monohydrate and purified water. Also contains phosphoric acid used to adjust the pH to approximately 4.5. chemical-structure
Indications & Usage
Mometasone furoate topical solution, 0.1% (lotion) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older. Mometasone furoate topical solution (lotion) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥12 years of age. ( 1 )
Dosage & Administration
Apply a few drops of mometasone furoate topical solution to the affected skin areas once daily and massage lightly until it disappears. 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 ) and Use in Specific Populations ( 8.4 )] . Do not use mometasone furoate topical solution with occlusive dressings unless directed by a physician. Do not apply mometasone furoate topical solution in the diaper area if the patient requires diapers or plastic pants, as these garments constitute occlusive dressing. Mometasone furoate topical solution is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Avoid use on the face, groin, or axillae. Avoid contact with eyes. Wash hands after each application. • Apply a few drops to the affected skin areas once daily and massage lightly until it disappears. ( 2 ) • Discontinue therapy when control is achieved. ( 2 ) • If no improvement is seen within 2 weeks, reassess diagnosis. ( 2 ) • Do not use with occlusive dressings unless directed by a physician. ( 2 )
Warnings & Precautions
• Reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment, Cushing’s syndrome, and hyperglycemia may occur due to systemic absorption. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. Modify use should HPA axis suppression develop. ( 5.1 , 8.4 ) • Pediatric patients may be more susceptible to systemic toxicity. ( 5.1 , 8.4 ) • May increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( Error! Hyperlink reference not valid. ) 5.1 Effects on Endocrine System Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure, and young age. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a study evaluating the effects of mometasone furoate topical solution on the HPA axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to 4 adult subjects with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the 4 subjects remained within the normal range and changed little from baseline. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [ see Use in Specific Populations ( 8.4 )] . 5.2 Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products, including the topical mometasone products [ see Adverse Reactions ( Error! Hyperlink reference not valid. ) ]. Avoid contact of mometasone furoate topical solution with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 5.3 Allergic Contact Dermatitis If irritation develops, mometasone furoate topical solution should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. 5.4 Concomitant Skin Infections If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of mometasone furoate topical solution should be discontinued until the infection has been adequately controlled.
Contraindications
Mometasone furoate topical solution is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. • Mometasone furoate topical solution is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. ( 4 )
Adverse Reactions
Most common adverse reactions included are acneiform reaction, burning, itching and folliculitis. ( 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. In clinical trials involving 209 subjects, the incidence of adverse reactions associated with the use of mometasone furoate topical solution 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 topical solution during a clinical trial in 14% of 65 pediatric subjects 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 subjects treated with mometasone furoate topical solution in a clinical trial: shininess, 4; telangiectasia, 2; loss of elasticity, 2; and loss of normal skin markings, 3. 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
No drug-drug interaction studies have been conducted with mometasone furoate topical solution.
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