Alclometasone Dipropionate

ALCLOMETASONE DIPROPIONATE — alclometasone dipropionate cream
Physicians Total Care, Inc.

Prescribing Information

For Dermatologic Use Only —
Not for Ophthalmic Use.

DESCRIPTION

Alclometasone dipropionate cream USP, 0.05% and alclometasone dipropionate ointment USP, 0.05% contain alclometasone dipropionate USP (7α-chloro-11ß,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 USP is C28 H37 ClO7 . It has the following structural formula:

alclometason dipropionate structure

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.

Each gram of alclometasone dipropionate cream USP contains 0.5 mg of alclometasone dipropionate USP in a hydrophilic, emollient cream base of propylene glycol, white petrolatum, cetearyl alcohol, Cithrol GMS 0400 (mono- and di-glycerides), PEG 100 stearate, Ceteth-20, monobasic sodium phosphate monohydrate, chlorocresol, phosphoric acid, and purified water.

Each gram of alclometasone dipropionate ointment USP contains 0.5 mg of alclometasone dipropionate USP in an ointment base of hexylene glycol, white wax, propylene glycol stearate, and white petrolatum.

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 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 .

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.

INDICATIONS AND USAGE

Alclometasone dipropionate cream USP and alclometasone dipropionate ointment USP are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream USP and 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 have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of alclometasone dipropionate cream USP and alclometasone dipropionate ointment USP have not been established in pediatric patients below 1 year of age, their use in this age-group is not 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.

PRECAUTIONS

General

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. Patients applying a topical steroid to a large surface area or to 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.

The effects of alclometasone dipropionate cream and ointment on the HPA axis have been evaluated. In one study, alclometasone dipropionate cream and ointment were applied to 30% of the body twice daily for 7 days, and occlusive dressings were used in selected patients either 12 hours or 24 hours daily. In another study, alclometasone dipropionate cream was applied to 80% of the body surface of normal subjects twice daily for 21 days with daily 12-hour periods of whole body occlusion. Average plasma and urinary free cortisol levels and urinary levels of 17-hydroxysteroids were decreased (about 10%), suggesting suppression of the HPA axis under these conditions. Plasma cortisol levels have also been demonstrated to decrease in pediatric patients treated twice daily for 3 weeks without occlusion.

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 area to body mass ratios (see PRECAUTIONS: Pediatric Use).

If irritation develops, alclometasone dipropionate cream or ointment should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a 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 alclometasone dipropionate cream or ointment should be discontinued until the infection has been adequately controlled.

In a transgenic mouse study, chronic use of alclometasone dipropionate cream led to an increased number of animals with benign neoplasms of the skin at the treatment site (see PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility). The clinical relevance of the findings in animal studies to humans is not clear.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2. This medication should not be used for any disorder other than that for which it was prescribed.
  3. The treated skin area should not be bandaged, otherwise covered or wrapped so as to be occlusive, unless directed by the physician.
  4. Patients should report to their physician any signs of local adverse reactions.
  5. Parents of pediatric patients should be advised not to use alclometasone dipropionate cream or ointment in the treatment of diaper dermatitis. Alclometasone dipropionate cream or ointment should not be applied in the diaper area as diapers or plastic pants may constitute occlusive dressing (see DOSAGE AND ADMINISTRATION).
  6. This medication should not be used on the face, underarms, or groin areas unless directed by the physician.
  7. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
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