Clobex Shampoo

INDICATIONS

CLOBEX® (clobetasol propionate) Shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older (see PRECAUTIONS). Treatment should be limited to 4 consecutive weeks because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week (see DOSAGE AND ADMINISTRATION).

Patients should be instructed to use CLOBEX® Shampoo (clobetasol propionate shampoo) , 0.05%, for the minimum time period necessary to achieve the desired results (see PRECAUTIONS).

Use in patients younger than 18 years of age is not recommended due to numerically high rates of HPA axis suppression (see PRECAUTIONS, Pediatric Use).

There were insufficient numbers of non-Caucasian patients to determine whether they responded differently than Caucasian patients with regards to efficacy and safety.

DOSAGE AND ADMINISTRATION

CLOBEX® Shampoo (clobetasol propionate shampoo) should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing.

Move the hair away from the scalp so that one of the affected areas is exposed. Position the bottle over the lesion. Apply a small amount of the shampoo directly onto the lesion, letting the product naturally flow from the bottle (gently squeeze the bottle), avoiding any contact of the product with the facial skin, eyes or lips. In case of contact, rinse thoroughly with water. Spread the product so that the entire lesion is covered with a thin uniform film. Massage gently into the lesion and repeat for additional lesion(s). Wash your hands after applying CLOBEX® Shampoo (clobetasol propionate shampoo) .

Leave the shampoo in place for 15 minutes, then add water, lather and rinse thoroughly all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck and shoulders). Avoid contact with eyes and lips. Minimize contact to non-affected areas of the body. Although no additional shampoo is necessary to cleanse your hair, you may use a non-medicated shampoo if desired.

Treatment should be limited to 4 consecutive weeks. As with other corticosteroids, therapy should be discontinued when control is achieved. If complete disease control is not achieved after four weeks of treatment with CLOBEX® Shampoo (clobetasol propionate shampoo) , 0.05%, treatment with a less potent topical steroid may be substituted. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary.

CLOBEX® Shampoo (clobetasol propionate shampoo) should not be used with occlusive dressings unless directed by a physician.

HOW SUPPLIED

CLOBEX® Shampoo (clobetasol propionate shampoo) is supplied in 4 fl.oz. (118 mL) bottles.

NDC 0299-3847-04

Storage: Keep tightly closed. Store at controlled room temperature 68°F to 77°F (20°C-25°C).

Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177, USA. Manufactured by: DPT Laboratories, Ltd. San Antonio, Texas 78215, USA. www.clobex.com. Revised: September, 2004. FDA rev date: 2/5/2004

Last reviewed on RxList: 12/1/2008
This monograph has been modified to include the generic and brand name in many instances.

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