Clobetasol Solution, USP, 0.05%
Brand and Other Names:
TEMOVATE
Mechanism of Action:
Clobetasol propionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.
Indications:
TEMOVATE® Scalp Application 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/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.
Route:
Topical
Dose:
TEMOVATE® Scalp Application should be applied to the affected scalp areas twice daily, once in the morning and once at night.
Adverse Reactions:
The most frequent adverse events reported for TEMOVATE® Scalp Application have been local and have included burning and/or stinging sensation, which occurred in 29 of 294 patients; scalp pustules, which occurred in 3 of 294 patients; and tingling and folliculitis, each of which occurred in 2 of 294 patients. Less frequent adverse events were itching and tightness of the scalp, dermatitis, tenderness, headache, hair loss, and eye irritation, each of which occurred in 1 of 294 patients.
Contraindication:
TEMOVATE® Scalp Application 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.
Warnings and Precautions:
Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g (of ointment) per day. Systemic absorption of topical corticosteroids has resulted in reversible HPA axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glucosuria in some patients.
See package insert for full prescribing information.