Clocortolone Pivalate

Description

DESCRIPTION Clocortolone pivalate cream USP, 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of benzyl alcohol, carbomer homopolymer Type B (carbopol 974P), edetate disodium, methylparaben, mineral oil, polyoxyl 40 stearate (MYRJ 40S), propylparaben, purified water, sodium hydroxide, stearyl alcohol and white petrolatum. Chemically, clocortolone pivalate is 9-chloro-6α-fluoro-11β, 21-dihydroxy-16αmethylpregna-1, 4-diene-3, 20-dione 21-pivalate. Its structure is as follows: Chemical Structure

What Is Clocortolone Pivalate Used For?

INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage and Administration

DOSAGE AND ADMINISTRATION Apply clocortolone pivalate cream USP, 0.1% sparingly to the affected areas three times a day and rub in gently. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate anti-microbial therapy instituted.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin atrophy Striae Miliaria

Contraindications

CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Pregnancy and Breastfeeding

Pregnancy Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Overdosage

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

How Supplied

HOW SUPPLIED Clocortolone Pivalate Cream USP, 0.1% is supplied in 45 gram and 90 gram tubes. 45 gram tube NDC 51672-4166-6 90 gram tube NDC 51672-4166-8 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.