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CLOBETASOL PROPIONATE
TOPICAL SOLUTION USP, 0.05%

(Potency expressed as clobetasol propionate)

Rx only

FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC USE

DESCRIPTION:

Clobetasol propionate topical solution, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid for topical dermatological use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula:

Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 466.98. It is a white to cream-colored crystalline powder insoluble in water.

Clobetasol propionate topical solution 0.05% contains: 0.5 mg/g clobetasol propionate in a base composed of purified water, isopropyl alcohol (39.3%), carbomer 934P and sodium hydroxide.

CLINICAL PHARMACOLOGY:

The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids such as clobetasol propionate are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain.

Clobetasol propionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

INDICATIONS AND USAGE:

Clobetasol propionate topical solution, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL per week because of the potential for the drug to suppress the HPA axis.

This product is not recommended for use in children under 12 years of age.

CONTRAINDICATIONS:

Clobetasol propionate topical solution is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.

PRECAUTIONS:

ADVERSE REACTIONS:

Clobetasol propionate topical solution is generally well tolerated when used for 2-week treatment periods.

The most frequent adverse events reported for clobetasol propionate topical solution have been local and have included burning and/or stinging sensation, which occurred in approximately 10% of the patients; scalp pustules, which occurred in approximately 1% of the patients; and tingling and folliculitis, each of which occurred in 0.7% of the patients. Less frequent adverse events were itching and tightness of the scalp, dermatitis, tenderness, headache, hair loss, and eye irritation.

The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are uled in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have exacerbated the disease or provoked the pustular form of the disease, so careful patient supervision is recommended.

OVERDOSAGE:

Topically applied clobetasol propionate solution can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION:

Clobetasol propionate topical solution should be applied to the affected scalp areas twice daily, once in the morning and once at night.

Clobetasol propionate topical solution is potent; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 mL per week should not be used.

Clobetasol propionate topical solution is not to be used with occlusive dressings.

HOW SUPPLIED:

Clobetasol Propionate Topical Solution USP, 0.05% is supplied in plastic squeeze bottle as follows:

                NDC 0168-0269-50                50 mL plastic bottle

Store at controlled room temperature, 15°- 30°C (59°-86°F). Do not refrigerate.
Do not use near an open flame.

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747

I2269B
R8/06
#244

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