Product Details

Clobetasol Propionate

Class: Synthetic fluorinated corticosteroid

Actions

• High-range corticosteroid activity.

• Produces anti-inflammatory, antipruritic, and vasoconstrictor actions, possibly resulting in part from steroid receptor binding.

• Precise mechanism of action for topical anti-inflammatory activity is unknown; therapeutic benefit in the management of corticosteroid-responsive dermatoses mediated primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions.

• Anti-inflammatory effects may occur through induction of phospholipase A2 inhibitory proteins (lipocortins); decreased arachidonic acid release from membrane phospholipids.

• Decreased arachidonic acid precursors may downregulate biosynthesis of potent inflammatory mediators (e.g., prostaglandins, leukotrienes).

Pharmacokinetics:

Absorption

Bioavailability

Topically applied clobetasol propionate can be absorbed through normal intact skin.

Percutaneous penetration of clobetasol propionate varies among individuals and can be altered by using different vehicles.

Percutaneous penetration can be increased by use of occlusive dressings and by presence of inflammation and/or other disease of the epidermal barrier (e.g., psoriasis, eczema).

Distribution

Extent

Not known whether topical clobetasol is distributed into milk.

Elimination

Metabolism

Once absorbed through the skin, topically applied corticosteroids are metabolized primarily in the liver.

Adverse Effects:

Burning, stinging, irritation, itching, skin atrophy, dry skin, cracking or fissuring of the skin, erythema, folliculitis, numbness of fingers, tenderness in the elbow, telangiectasia.

Clobetasol propionate solution or shampoo: pustules on the scalp, tingling, folliculitis, tightening of the scalp, tenderness, dermatitis (e.g., irritant), urticaria, edema, acne, alopecia, headache.

Prescribing Limits

Pediatric Patients

Corticosteroid-responsive Dermatoses: Topical

• Maximum 50 g of 0.05% cream, ointment, or gel per week for no more than 2 consecutive weeks.
• Maximum 1 1/2 capfuls of foam per application; maximum 50 g per week for no more than 2 consecutive weeks.
• Maximum 50 mL (50 g) of 0.05% solution per week for no more than 2 consecutive weeks.

Adults

Corticosteroid-responsive Dermatoses: Topical

• Maximum 50 g of 0.05% cream, ointment, gel, or lotion per week for no more than 2 consecutive weeks.
• Maximum 1 1/2 capfuls of foam per application; maximum 50 g per week for no more than 2 consecutive weeks.
• Maximum 50 mL (50 g) of 0.05% solution per week for no more than 2 consecutive weeks.
• In patients with plaque psoriasis, maximum 50 g of 0.05% emollient cream, shampoo, or lotion per week for no more than 4 consecutive weeks.
• In patients with psoriasis of the scalp, maximum 4 consecutive weeks of therapy with shampoo.

Advice to Patients:

• Importance of using only as directed, only for the disorder for which it was prescribed, and for no longer than prescribed; avoid contact with the eyes and only apply externally as directed.

• Importance of informing patients that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a clinician.

• Importance of reporting any local adverse reactions, especially those occurring under occlusive bandage, to a clinician.

• Importance of patients informing clinician that they are receiving topical clobetasol propionate therapy, if surgery is contemplated.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

• Importance of informing patients of other important precautionary information.

SOURCE: DRUG.COM