Elocon Pomet Metrhem 0.1% (mometasone furoate) Cream, 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-diene3,20-dione 17-(2-furoate), with the empirical formula C27 H30CI2O6, 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 Elocon Pomet Cream, 0.1% contains 1 mg mometasone furoate in a white to off-white cream base of aluminum starch octenylsuccinate (Gamma Irradiated), hexylene glycol, hydrogenated soybean lecithin, phosphoric acid, purified water, titanium dioxide, white soft paraffin, and white wax.
Apply a thin film of Elocon Pomet Cream to the affected skin areas once daily. Elocon Pomet Cream may be used in pediatric patients 2 years of age or older. Since safety and efficacy of Elocon Pomet Cream have not been established in pediatric patients below 2 years of age
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 Elocon Pomet Cream in pediatric patients for more than 3 weeks of use have not been established.
Elocon Pomet Cream should not be used with occlusive dressings unless directed by a physician. Elocon Pomet Cream should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.
Elocon Pomet Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
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 319 subjects, the incidence of adverse reactions associated with the use of Elocon 0.1% Cream was 1.6%. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of Elocon 0.1% Cream have also been received. In controlled clinical trials (n=74) involving pediatric subjects 2 to 12 years of age, the incidence of adverse experiences associated with the use of Elocon 0.1% 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 0.1% Cream during clinical trials in 4% of 182 pediatric subjects 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 subjects treated with Elocon 0.1% Cream in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; thinness, 1; and bruising, 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, striae, and miliaria.