CLOBEX SHAMPOO 0.05% [SIN13239P]

Product Info

CLOBEX SHAMPOO 0.05%

[SIN13239P]

INDICATIONS AND USAGE: CLOBEX® (clobetasol propionate) Shampoo, 0.05%, is a 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 per week (see DOSAGE and ADMINISTRATION).
Patients should be instructed to use CLOBEX® Shampoo, 0.05%, for the minimum time period necessary to achieve the desired results (see PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

DOSAGE AND ADMINISTRATION: CLOBEX® Shampoo should be applied onto dry (not wet) scalp one application per day to the affected areas only, and left in place without covering for 15 minutes before rinsing with water.
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.
Hands should be washed carefully after applications.
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.
The treatment is limited to maximum 4 weeks. As with other corticosteroids, therapy should be discontinued when control is achieved. Clobetasol propionate belongs to the most potent class of topical corticosteroids and prolonged use may result in serious undesirable effects (see Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If complete disease control is not achieved after 4 weeks of treatment with CLOBEX Shampoo 0.05%, and treatment with a topical corticosteroid is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered. Repeated but short courses of clobetasol propionate may be used to control exacerbations. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary. CLOBEX® Shampoo should not be used with occlusive dressings unless directed by a physician.

CONTRAINDICATIONS: Use of CLOBEX® (clobetasol propionate) Shampoo, 0.05%, is contraindicated in:

• Patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation.

• Skin areas affected by bacterial, viral, fungal, parasitic infections or ulcerous wounds.

• Children under 2 years of age

• Application to the eyes and eyelids (risk of glaucoma, risk of cataract)