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alclometasone dipropionate ointment
----------Alclometasone Dipropionate Ointment USP, 0.05%
Alclometasone dipropionate ointment USP contains alclometasone dipropionate (7 α-chloro-11β,17,21-trihydroxy-16 α-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.
Alclometasone dipropionate USP has the molecular weight of 521. It is a white powder, insoluble in water, slightly soluble in propylene glycol, and moderately soluble in hexylene glycol.
Like other topical corticosteroids, alclometasone dipropionate 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 A2 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 A2.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. A study utilizing a radiolabeled alclometasone dipropionate ointment formulation was performed to measure systemic absorption and excretion. Results indicated that approximately 3% of the steroid was absorbed during 8 hours of contact with intact skin of normal volunteers.
INDICATIONS AND USAGE
Alclometasone dipropionate ointment USP is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment USP may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks has not been established (see PRECAUTIONS: Pediatric Use : ). Since the safety and efficacy of alclometasone dipropionate ointment USP has not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.
Alclometasone dipropionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components in these preparations.
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 syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
Information for Patients :
Patients using topical corticosteroids should receive the following information and instructions:
Laboratory Tests :
The following tests may be helpful in evaluating patients for HPA axis suppression:
Carcinogenesis, Mutagenesis, Impairment of Fertility :
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
Teratogenic Effects :
Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women. Alclometasone dipropionate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers :
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of topical corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when alclometasone dipropionate ointment is administered to a nursing woman.
Pediatric Use :
Alclometasone dipropionate ointment may be used with caution in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Use of alclometasone dipropionate ointment is supported by results from adequate and well-controlled studies in pediatric patients with corticosteroid-responsive dermatoses. Since the safety and efficacy of alclometasone dipropionate ointment has not been established in pediatric patients below 1 year of age, its use in this age-group is not recommended. 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 syndrome when they are treated with topical corticosteroids. They are therefore also at a greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects, including striae have been reported with inappropriate use of topical corticosteroids in infants and children. Pediatric patients applying alclometasone dipropionate ointment to > 20% of the body surface area are at higher risk for HPA axis suppression.
Geriatric Use :
Clinical studies of alclometasone dipropionate ointment in US clinical trials did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious.
The following local adverse reactions have been reported with alclometasone dipropionate ointment in approximately 1% of patients: itching, burning, and erythema.
Topically applied alclometasone dipropionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
DOSAGE AND ADMINISTRATION
Apply a thin film of alclometasone dipropionate ointment to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears.
Alclometasone dipropionate ointment USP,0.05% is supplied in:
Glenmark Generics Inc., USA
Questions? 1 (888)721-7115
Revised: 02/2011 Glenmark Generics Inc., USA
Reproduced with permission of U.S. National Library of Medicine
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