Clobetasol Cream Emulsion

Cream, 0.05%. Each gram of clobetasol propionate emollient cream, 0.05% contains 0.5 mg of clobetasol propionate in a smooth, white cream base.

Pregnancy

Pregnancy Category C.

There are no adequate and well-controlled studies in pregnant women. Therefore, clobetasol propionate emollient cream, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 to laboratory animals.

Clobetasol propionate has not been tested for teratogenicity by this route; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 0.33 and 0.01 times, respectively, the human topical dose of clobetasol propionate emollient cream, 0.05%. Abnormalities seen included cleft palate and skeletal abnormalities.

In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.001 and 0.003 times, respectively, the human topical dose of clobetasol propionate emollient cream, 0.05%. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when clobetasol propionate emollient cream, 0.05% is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of clobetasol propionate emollient cream, 0.05% in pediatric patients have not been established and its use in pediatric patients under 12 years of age is not recommended. In a study including 12 subjects ages18 years and older with psoriasis or atopic dermatitis involving at least 30% body surface area (BSA), adrenal suppression was identified in 3 out of 12 subjects (25%) following 1 week of treatment. Four-week HPA axis suppression studies with clobetasol propionate emollient cream, 0.05% in pediatric subjects have not been conducted.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

The use of clobetasol propionate emollient cream, 0.05% for 4 consecutive weeks has not been studied in pediatric patients under 16 years of age.

Geriatric Use

Clinical studies of clobetasol propionate emollient cream, 0.05% did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.

Inform patients using topical corticosteroids of the following information and instructions:

• Clobetasol propionate emollient cream, 0.05% is for external use only. Avoid contact with the eyes. • Use as directed. Do not use clobetasol propionate emollient cream, 0.05% for any disorder other than that for which it was prescribed. Do not use longer than the prescribed time period. • Do not use other corticosteroid-containing products while using clobetasol propionate emollient cream, 0.05% unless directed by the physician. • The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. • Wash hands after applying the medication. • Report any signs of local or systemic adverse reactions to the physician. • Inform their physicians that they are using clobetasol propionate emollient cream, 0.05% if surgery is contemplated. If you go to another doctor for illness, injury or surgery, tell the doctor you are using clobetasol propionate emollient cream, 0.05%. • Do not use clobetasol propionate emollient cream, 0.05% on the face, underarms or groin areas. • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician. • Use no more than 50 grams per week of clobetasol propionate emollient cream, 0.05%. • •Store between 59°F and 86° (15°C and 30°C). Do not refrigerate.

Rx Only

  Rev. 270:03 03/15   Manufactured by:   Hi-Tech Pharmacal Co., Inc.   Amityville, NY 11701