Alclometasone Dipropionate

Prescription

Tên thương mại: Alclometasone Dipropionate

Dạng bào chế

Topical

Đường dùng

TOPICAL

Nhà sản xuất

Sun Pharmaceutical Industries, Inc.

About This Medication

DESCRIPTION Alclometasone Dipropionate Ointment USP, 0.05% contains alclometasone dipropionate (7α-chloro-11β,17,21-trihydroxy-16α-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. Chemically, alclometasone dipropionate is C 28 H 37 ClO 7 . It has the following structural formula: Alclometasone dipropionate 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. Each gram of alclometasone dipropionate ointment contains 0.5 mg of alclometasone dipropionate in an ointment base of hexylene glycol, propylene glycol stearate, white petrolatum and white wax. Chemical Structure

Hoạt chất

Thành phần	Hàm lượng
Alclometasone Dipropionate	-

Chỉ định & Cách dùng

INDICATIONS AND USAGE Alclometasone Dipropionate Ointment USP, 0.05% is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment 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 have not been established (see PRECAUTIONS: Pediatric Use ). Since the safety and efficacy of alclometasone dipropionate ointment has not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.

Liều dùng & Cách dùng

DOSAGE AND ADMINISTRATION Apply a thin film of Alclometasone Dipropionate Ointment USP, 0.05% to the affected skin areas two or three times daily; massage gently until the medication disappears. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate ointment in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended. 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. Alclometasone dipropionate ointment should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate ointment should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing. Geriatric Use In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with alclometasone dipropionate ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

Side Effects Overview

ADVERSE REACTIONS The following local adverse reactions have been reported with alclometasone dipropionate ointment in approximately 1% of patients: itching, burning, and erythema. 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 approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Chống chỉ định

CONTRAINDICATIONS Alclometasone Dipropionate Ointment USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in this preparation.

Dược động học

Pharmacokinetics 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 radio labeled 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. Studies performed with alclometasone dipropionate ointment indicate that this product is in the low to medium range of potency as compared with other topical corticosteroids.

Frequently Asked Questions

INDICATIONS AND USAGE Alclometasone Dipropionate Ointment USP, 0.05% is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment 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 have not been established (see PRECAUTIONS: Pediatric Use ). Since the safety and efficacy of alclometasone dipropionate ointment has not been established in pediatric …

DOSAGE AND ADMINISTRATION Apply a thin film of Alclometasone Dipropionate Ointment USP, 0.05% to the affected skin areas two or three times daily; massage gently until the medication disappears. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate ointment in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended. As with other …

CONTRAINDICATIONS Alclometasone Dipropionate Ointment USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in this preparation.

Alclometasone Dipropionate is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

References & Data Sources

• DailyMed — Alclometasone Dipropionate drug label (National Library of Medicine)
• openFDA — Alclometasone Dipropionate label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 855480 (NLM Normalized Drug Names)
• NDC Directory — Alclometasone Dipropionate (FDA National Drug Code)

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Nguồn dữ liệu: DailyMed (NLM), openFDA, MFDS