Mometasone Ointment

Name: Mometasone Ointment

Dosage & administration

Apply a thin film of Mometasone Furoate, USP 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.

Safety and efficacy of Mometasone Furoate, USP Ointment 0.1% in pediatric patients for more than 3 weeks of use have not been established [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

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.

Mometasone Furoate, USP Ointment 0.1% is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Avoid use on the face, groin, or axillae.

Warnings and Precautions

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 dressings, 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 ointment on the HPA axis, 15 grams were applied twice daily for 7 days to 6 adult subjects with psoriasis or atopic dermatitis. The results show that the drug caused a slight lowering of adrenal corticosteroid secretion.

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)].

Allergic Contact Dermatitis

If irritation develops, Mometasone Furoate, USP Ointment 0.1% 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.

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, USP Ointment 0.1% should be discontinued until the infection has been adequately controlled.

Adverse Reactions

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, USP 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, USP Ointment 0.1% have been reported.

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 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, USP Ointment 0.1% in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; and thinness, 1.

The following additional local adverse reactions have been reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are: irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

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

Clinical Studies

The safety and efficacy of Mometasone Furoate, USP Ointment 0.1% for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle-controlled trials, one in psoriasis and one in atopic dermatitis. A total of 218 subjects received Mometasone Furoate, USP Ointment 0.1% (109 subjects) or the vehicle ointment applied once daily for 21 days.

Principal display panel

NDC 0713-0635-15
15 g carton

 



MOMETASONE FUROATE  
mometasone furoate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0713-0635
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mometasone Furoate (Mometasone) Mometasone Furoate 1 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Hexylene Glycol  
Phosphoric Acid  
Propylene Glycol Stearate  
White Wax  
Water  
Petrolatum  
Packaging
# Item Code Package Description
1 NDC:0713-0635-15 1 TUBE in 1 CARTON
1 15 g in 1 TUBE
2 NDC:0713-0635-37 1 TUBE in 1 CARTON
2 45 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077401 03/04/2014
Labeler - G&W Laboratories, Inc. (001271188)
Registrant - G&W Laboratories, Inc. (001271188)
Establishment
Name Address ID/FEI Operations
G&W Laboratories, Inc. 001271188 MANUFACTURE(0713-0635)
Revised: 08/2016   G&W Laboratories, Inc.
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