Prescription Required
In stock
Manufacturer
TARO PHARM USA
SKU
51672131603

alclometasone dipr 0.05% oint

Generic
$39.10 / tube
$118.73 / tube
$79.63 / tube
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1,000 tubes Available
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Uses

Alclometasone dipropionate shares the actions of other topical corticosteroids and is used for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage and Administration

Topical alclometasone dipropionate cream and ointment are applied sparingly in thin films and are rubbed gently into the affected area 2 or 3 times daily. The duration of a course of alclometasone therapy may vary from 2-6 weeks, although more prolonged therapy with appropriate monitoring occasionally may be necessary in patients with resistant or chronic conditions. Occlusive dressings may be used for severe or resistant dermatoses.

Cautions

Alclometasone dipropionate shares the toxic potentials of other topical corticosteroids, and the usual precautions of corticosteroid therapy should be observed. In animal studies, there was no evidence of local irritation or anesthetic effect, phototoxicity or photosensitization, or local immunogenic or antigenic effects induced by topical application of alclometasone dipropionate 0.1% ointment or the ointment base.

Alclometasone dipropionate does not appear to suppress the hypothalamic-pituitary-adrenal (HPA) axis following topical application of usual doses. In patients with psoriasis or atopic dermatitis, 15 g of the 0.05% ointment (7.5 mg of alclometasone dipropionate) applied to 30% of the body twice daily for 7 days, including daily 12- or 24-hour periods during which occlusive dressings were applied in some patients, did not affect plasma cortisol concentrations. In children 3 months to 12 years of age undergoing topical therapy with the drug for various dermatoses (i.e., atopic eczema, seborrheic eczema, diaper dermatitis or psoriasis), plasma cortisol concentrations remained essentially unchanged during therapy with usual dosages of the drug compared with concentrations prior to therapy and after discontinuance of the drug. Slight HPA-axis suppression has occurred following topical application of higher than usual dosages. In healthy individuals with normal skin, a 30-g dose of 0.05% alclometasone dipropionate cream applied topically to 80% of the body twice daily for 21 days, including daily 12-hour periods during which occlusive dressings were applied, slightly decreased plasma cortisol concentrations and urinary free cortisol and 17-hydroxysteroid concentrations; however, treatment values were still within the normal ranges.

Like other topical corticosteroids, alclometasone should not be used in the treatment of acne, rosacea, or perioral dermatitis. Alclometasone dipropionate preparations are contraindicated in individuals with known hypersensitivity to the drug, other corticosteroids, or any ingredient in the respective formulation.

Pediatric Precautions

Alclometasone dipropionate has been used safely and effectively in children undergoing topical therapy for various corticosteroid-responsive dermatoses, but the usual precautions associated with topical corticosteroid therapy in children should be observed.

Mutagenicity and Carcinogenicity

No evidence of alclometasone-induced mutagenesis was seen in the Ames microbial mutagen test with or without metabolic activation and in several in vitro mammalian cell systems (i.e., mouse lymphoma and mouse erythrocyte assays), and studies have not shown several other topical corticosteroids (e.g., hydrocortisone, prednisolone) to be mutagenic. Long-term studies to determine the carcinogenic potential of topical corticosteroids have not been performed to date.

Pregnancy, Fertility, and Lactation

The teratogenic potential of topical alclometasone dipropionate is not known; however, potent corticosteroids have been shown to be teratogenic in animals following topical application. Reproduction studies in rabbits using oral or topical alclometasone dipropionate dosages up to 1.2 g/kg or 0.75 mg/kg, respectively, have shown maternal toxicity, including failure to maintain pregnancy, increased resorptions and decreased litter size, inhibition of weight gain, and death. Evidence of fetal harm (e.g., developmental retardation, increased malformations such as flexed paws and cleft palate), possibly secondary to maternal toxicity induced by the drug, was shown in these studies. For additional information, .

Pharmacokinetics

Absorption

Percutaneous penetration of alclometasone dipropionate varies among individuals and can be altered by using different vehicles; percutaneous penetration can be increased by the use of occlusive dressings and by inflammation and/or other diseases of the epidermal barrier (e.g., psoriasis, eczema).

Following topical application of alclometasone dipropionate to normal skin, only small amounts of the drug appear to reach the dermis and subsequently the systemic circulation with the usual dosage; about 3% of the drug reportedly reached systemic circulation during the 8-hour period after a single application of 0.5 g of a 0.05% ointment in healthy individuals with normal skin. However, systemic absorption may be increased when the skin is inflamed or diseased.

Elimination

Following percutaneous penetration of alclometasone dipropionate, drug that is systemically absorbed probably follows the metabolic pathways of systemically administered corticosteroids. Systemic metabolism of alclometasone has not been fully characterized or quantified; in animals, drug that is absorbed following topical application does not accumulate in tissues and is extensively metabolized to polar, unidentified metabolites. Following topical application, systemically absorbed alclometasone and its metabolites are excreted in feces via biliary elimination and in urine.

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