CLOBEX LOTION 0.05% [SIN13291P]

Product Info

CLOBEX LOTION 0.05%

[SIN13291P]

INDICATIONS AND CLINICAL USE
Clobex Lotion (clobetasol propionate lotion, 0.05%) is a highly potent corticosteroid with the potential to suppress the HPA axis.

Clobex Lotion is indicated for the treatment of moderate to severe corticosteroid-responsive dermatoses where an anti-inflammatory or anti-pruritic activity is required for the topical management of these conditions.

Treatment should be limited to 2 consecutive weeks, not to exceed 50 grams (50 mL or 1.75 fl. oz.) per week, and be applied to no more than 10% of the body surface area. Use should be restricted to those 18 years or older.

In the treatment of moderate to severe plaque-type psoriasis that has not sufficiently improved after the initial 2 weeks, Clobex Lotion can be used for up to 2 additional weeks. Any additional benefits of extending treatment should be weighed against the risk of HPA axis suppression. Patients should be instructed to use Clobex Lotion for the minimum amount of time necessary.

Use in patients younger than 18 years of age in not recommended due to numerically high rates of HPA axis suppression.

DOSAGE AND ADMINISTRATION
Clobex Lotion (clobetasol propionate lotion, 0.05%) should be applied to the affected skin areas twice daily and rubbed in gently and completely. (See INDICATIONS AND USAGE)
Hands should be washed carefully after application.
Clobex Lotion contains a highly potent topical corticosteroid; therefore, treatment should be limited to:

• 2 consecutive weeks for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses,

• 4 consecutive weeks in the treatment of moderate to severe plaque-type psoriasis.

The total dosage should not exceed 50 grams (50 mL or 1.75 fl. oz.) per week or be used on more than 10% of body surface area because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Therapy should be discontinued when control has been achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary.

The treatment is limited to maximum 2 weeks.

Use is not recommended in patients under 18 years of age since it has not been studied sufficiently and also due to numerically high rates of HPA axis suppression in this age group. Unless directed by physician, Clobex Lotion should not be used with occlusive dressings.

Clobetasol propionate belongs to the most potent class of topical corticosteroids (class IV/class I) and prolonged use may result in serious undesirable effects (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If treatment with a local 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.

CONTRAINDICATIONS
Use of Clobex Lotion (clobetasol propionate lotion, 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 and mycobacterial, 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)

Treatment with topical corticosteroids is not indicated in patients with untreated tubercular, bacterial and fungal infections involving the skin, and in certain viral diseases such as herpes simplex, chickenpox, and vaccinia.