Elocon Information
Elocon (Mometasone) Description
Elocon (Mometasone) Ointment, 0.1% brand of (mometasone furoate ointment USP) contains mometasone furoate USP for dermatologic 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 CHCIO, 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 contains: 1 mg mometasone furoate USP in an ointment base of hexylene glycol; phosphoric acid; propylene glycol stearate (55% monoester); white wax; white petrolatum; and purified water.
Elocon (Mometasone) Clinical Pharmacology
Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A.
Elocon (Mometasone) Indications And Usage
Elocon (Mometasone) Ointment, 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Elocon (Mometasone) Ointment, 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 section). Since safety and efficacy of Elocon (Mometasone) Ointment, 0.1% have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended.
Elocon (Mometasone) Contraindications
Elocon (Mometasone) Ointment, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
Elocon (Mometasone) Precautions
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency 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.
Patients applying a topical steroid to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary-free cortisol tests.
In a study evaluating the effects of mometasone furoate ointment on the hypothalamic-pituitary-adrenal (HPA) axis, 15 grams were applied twice daily for 7 days to six adult patients with psoriasis or atopic dermatitis. The ointment was applied without occlusion to at least 30% of the body surface. The results show that the drug caused a slight lowering of adrenal corticosteroid secretion.
If HPA axis suppression is noted, an attempt should be made to 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. For information on systemic supplementation, see Prescribing Information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see section).
If irritation develops, Elocon (Mometasone) 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 as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
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 Elocon (Mometasone) Ointment, 0.1% should be discontinued until the infection has been adequately controlled.
Long-term animal studies have not been performed to evaluate the carcinogenic potential of Elocon (Mometasone) Ointment, 0.1%. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from Elocon (Mometasone) Ointment, 0.1% on an mcg/m basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from Elocon (Mometasone) Ointment, 0.1% on an mcg/m basis).
Mometasone furoate increased chromosomal aberrations in an Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in rat hepatocytes.
In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from Elocon (Mometasone) Ointment, 0.1% on an mcg/m basis).
Elocon (Mometasone) Ointment, 0.1% may be used with caution 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. Use of Elocon (Mometasone) Ointment, 0.1% is supported by results from adequate and well-controlled studies in pediatric patients with corticosteroid-responsive dermatoses. Since safety and efficacy of Elocon (Mometasone) Ointment, 0.1% have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended.
Elocon (Mometasone) Ointment, 0.1% caused HPA axis suppression in approximately 27% of pediatric patients ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 39% (range 15%–99%). The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of
Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of glucocorticosteroid insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Elocon (Mometasone) Ointment, 0.1% should not be used in the treatment of diaper dermatitis.
Elocon (Mometasone) Adverse Reactions
In controlled clinical studies involving 812 patients, the incidence of adverse reactions associated with the use of Elocon (Mometasone) Ointment, 0.1% was 4.8%. Reported reactions included burning, pruritus, skin atrophy, tingling/stinging, and furunculosis. Reports of rosacea associated with the use of Elocon (Mometasone) Ointment, 0.1% have 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 (Mometasone) Cream is 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 (Mometasone) Ointment, 0.1% during a clinical study, in 5% of 63 pediatric patients 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 patients treated with Elocon (Mometasone) Ointment, 0.1% in a clinical study: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; and thinness, 1. Striae and bruising 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.
Elocon (Mometasone) Overdosage
Topically applied Elocon (Mometasone) Ointment, 0.1% can be absorbed in sufficient amounts to produce systemic effects (see ).
Elocon (Mometasone) Dosage And Administration
Apply a thin film of Elocon (Mometasone) Ointment, 0.1% to the affected skin areas once daily. Elocon (Mometasone) Ointment, 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of Elocon (Mometasone) Ointment, 0.1% have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended (see section).
As with other corticosteroids, 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 (Mometasone) Ointment, 0.1% in pediatric patients for more than 3 weeks have not been established.
Elocon (Mometasone) Ointment, 0.1% should not be used with occlusive dressings unless directed by a physician.
Elocon (Mometasone) 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.
Elocon (Mometasone) How Supplied
Elocon (Mometasone) Ointment, 0.1% is supplied in 15-g (NDC 0085-0370-01) and 45-g (NDC 0085-0370-02) tubes; boxes of one.
Elocon (Mometasone)
Elocon (Mometasone) Principal Display Panel - G Tube Carton
For dermatologicuse only.
Not forophthalmic use.
