INDICATION: Clodan® (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. There were insufficient numbers of non-Caucasian patients to determine whether they responded differently than Caucasian patients with regards to efficacy and safety.
IMPORTANT SAFETY INFORMATION FOR CLODAN™ Shampoo: Use of Clodan® is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation.
Clobetasol propionate has been shown to suppress the HPA axis at the lowest doses tested. Treatment should be limited to four consecutive weeks because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. The total dosage should not exceed 50g (50 mL or 1.75 fl. oz.) per week. The scalp area should not be covered while the medication is on the scalp (e.g., shower cap, bathing cap) so as to be occlusive unless directed by the physician. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Patients should be instructed to use Clodan®, for the minimum time period necessary to achieve the desired results. Use in patients younger than 18 years of age is not recommended. Patients should inform their physician(s) that they are using Clodan™ if surgery is contemplated.
In clinical trials with clobetasol propionate shampoo, 0.05%, the following adverse reactions have been reported: burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia.
For external use only; not for ophthalmic use. Avoid contact with eyes. Clodan™ should not be used on the face, groin or axillae. This safety information is not all-inclusive.