Fluocinolone Acetonide Topical Solution USP, 0.01%

Clinical summary

Indications and usage INDICATIONS AND USAGE Fluocinolone acetonide topical solution USP, 0.01% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Dosage and administration DOSAGE AND ADMINISTRATION Fluocinolone acetonide topical solution USP, 0.01% is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. In hairy sites, the hair should be parted to allow direct contact with the lesion. 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 antimicrobial therapy instituted. Pregnancy Pregnancy Category C 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.