hydrocortisone valerate cream

Clinical summary

Indications and usage INDICATIONS AND USAGE Hydrocortisone valerate cream USP, 0.2% is medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients. Dosage and administration DOSAGE AND ADMINISTRATION Hydrocortisone valerate cream USP, 0.2% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Hydrocortisone valerate cream USP, 0.2% should not be used with occlusive dressings unless directed by a physician. Hydrocortisone valerate cream USP, 0.2% should not be applied in the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing. Pregnancy Pregnancy Teratogenic Effects Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Dermal embryofetal developmental studies were conducted in rabbits and rats with hydrocortisone valerate cream, 0.2%. Hydrocortisone valerate cream, 0.2%, was administered topically for 4 hours/day, rather than the preferred 24 hours/day, during the period of organogenesis in rats (gestational days 5-16) and rabbits (gestational days 6-19). Topical doses of hydrocortisone valerate up to 9 mg/kg/day (54 mg/m2/day) were administered to rats and 5 mg/kg/day (60 mg/m 2 /day) were administered to rabbits. In the absence of maternal toxicity, a significant increase in delayed skeletal ossification in foetuses was noted at 9 mg/kg/day [2.5× the Maximum Recommended Human Dose (MRHD) based on body surface area (BSA) comparisons] in the rat study. No malformations in the fetuses were noted at 9 mg/kg/day (2.5× MRHD based on BSA comparisons) in the rat study. Indicators of embryofetal toxicity, significant decrease in fetal weight at 2 mg/kg/day (1× MRHD based on BSA) and a significant increase in post-implantation loss and embryo resorption at 5 mg/kg (3× MRHD based on BSA), were noted in the rabbit study. A significant increase in delayed skeletal ossification in fetuses was noted at 5 mg/kg/day (3× the MRHD based on BSA comparisons) in the rabbit study. Increased numbers of fetal malformations (e.g., cleft palate, omphalocele and clubbed feet) were noted at 5 mg/kg/day (3× MRHD based on BSA comparisons) in the rabbit study. There are no adequate and well-controlled studies in pregnant women. Hydrocortisone valerate cream USP, 0.2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.