DESCRIPTION
ELOCON? (mometasone furoate cream) Cream, 0.1%, contains mometasone furoate, USP for dermatologic use. Mometasone furoate is a synthetic corticosteroid with anti- inflammatory activity.
Each gram of ELOCON Cream, 0.1%, contains: 1 mg mometasone furoate, USP in a cream base of hexylene glycol phosphoric acid propylene glycol stearate (55% monoester) stearyl alcohol and ceteareth-20 titanium dioxide aluminum starch octenylsuccinate (Gamma Irradiated) white wax white petrolatum and purified water.
INDICATIONS
ELOCON Cream, 0.1%, is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses.
ELOCON (mometasone furoate cream) Cream, 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 ELOCON Cream have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended.
SIDE EFFECTS
In controlled clinical studies involving 319 patients, the incidence of adverse reactions associated with the use of ELOCON Cream was 1.6%. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of ELOCON Cream have also 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 ELOCON Cream was approximately 7%. Reported reactions included stinging, pruritus, and furunculosis.
The following adverse reactions were reported to be possibly or probably related to treatment with ELOCON Cream during clinical studies in 4% of 182 pediatric patients 6 months to 2 years of age: decreased glucocorticoid levels, 2 paresthesia, 2 folliculitis, 1 moniliasis, 1 bacterial infection, 1 skin depigmentation, 1. The following signs of skin atrophy were also observed among 97 patients treated with ELOCON Cream in a clinical study: shininess 4, telangiectasia 1, loss of elasticity 4, loss of normal skin markings 4, thinness 1, and bruising 1. Striae 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.
