alclometasone dipropionate 0.0005 MG/MG Topical Ointment

INDICATIONS AND USAGE Alclometasone dipropionate cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream and 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 cream and ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.

DOSAGE AND ADMINISTRATION Apply a thin film of alclometasone dipropionate cream or ointment to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears. Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate cream or 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 cream or ointment should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate cream or 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 cream or ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

CONTRAINDICATIONS Alclometasone dipropionate cream and ointment are contraindicated in those patients with a history of hypersensitivity to any of the components in these preparations.

CLINICAL PHARMACOLOGY 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 A 2 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 2 . 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 cream and ointment indicate that these products are in the low to medium range of potency as compared with other topical corticosteroids.