Aclovate

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

It is not likely that other drugs you take orally or inject will have an effect on topically applied alclometasone. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Rx only

For Dermatologic Use Only–
Not for Ophthalmic Use.

Aclovate® (alclometasone dipropionate cream) Cream, 0.05% and Aclovate® (alclometasone dipropionate ointment) Ointment, 0.05% contain 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 C28H37CIO7. 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 Aclovate® Cream contains 0.5 mg of alclometasone dipropionate in a hydrophilic, emollient cream base of propylene glycol, white petrolatum, cetearyl alcohol, glyceryl stearate, PEG 100 stearate, Ceteth-20, monobasic sodium phosphate, chlorocresol, phosphoric acid, and purified water.

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

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 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.

Studies performed with Aclovate® Cream and Ointment indicate that these products are in the low to medium range of potency as compared with other topical corticosteroids.

The following local adverse reactions have been reported with Aclovate® Cream in approximately 2% of patients: itching and burning, erythema, dryness, irritation, and papular rashes.

The following local adverse reactions have been reported with Aclovate® 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.

Aclovate® (alclometasone dipropionate cream) Cream, 0.05% is supplied in:

Aclovate® (alclometasone dipropionate ointment) Ointment, 0.05% is supplied in:

Store between 2° and 30°C (36° and 86°F).

PharmaDerm®
A division of Nycomed US Inc.
Melville, NY 11747 USA
www.pharmaderm.com

R4/11

NDC 0462-0263-60

PHARMADERM®

Aclovate® Cream, 0.05%

(alclometasone dipropionate cream)

For dermatologic use only – Not for ophthalmic use.

Rx only 60 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G LABEL

NDC 0462-0264-60

PharmaDerm®

Aclovate® Ointment, 0.05%

(alclometasone dipropionate ointment)

For dermatologic use only – Not for ophthalmic use.

Rx only

60 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CARTON

NDC 0462-0264-60

PharmaDerm®

Aclovate® Ointment, 0.05%

(alclometasone dipropionate ointment)

For dermatologic use only – Not for ophthalmic use.

Rx only

60 g

• Cheshire Pharm. Systems

• Compumed Pharmaceuticals, Inc.

• PharmaDerm

• PHARMADERM., A division of Nycomed US Inc.

• Sandoz Inc.

Contraindications

Hypersensitivity

Underlying infection

Herpes simplex, varicella, vaccinia

Acne, rosacea, perioral dermatitis

Ophthalmic use

Cautions

Chronic topical corticosteroid therapy may interfere with growth and development in children

Pregnancy

Breastfeeding

Development of Kaposi's sarcoma with prolonged use reported (discontinue therapy if it occurs)

Use medium to very high potency for <2 wk to reduce local and systemic side effects

Use low potency for chronic therapy

Adrenal suppression may occur in younger patients or patients receiving high doses for prolonged periods

Avoid medium to very high potency on face, folds, groin because can increase steroid absorption

Use lower potency for peds (ie, increase BSA/kg, therefore increase systemic absorption)