Clobetasol

Clobetasol is used in the treatment of:

• Dermatitis
• Facial Dermatoses
• Foot Dermatoses
• Hand Dermatoses
• Inflammation
• Leg Dermatoses
• Scalp Dermatoses

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Clobetasol propionate ointment USP, 0.05% contains the active compound Clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Chemically, Clobetasol propionate is (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula:

Clobetasol propionate, USP has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.

Clobetasol propionate ointment USP, 0.05% contains Clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.

In controlled clinical trials, the most frequent adverse events reported for Clobetasol propionate ointment, 0.05% were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia.

Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol propionate formulations.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.

Apply a thin layer of Clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).

Clobetasol propionate ointment is a super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Clobetasol propionate ointment should not be used with occlusive dressings.

Geriatric Use

In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with Clobetasol propionate ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

Steroid-responsive dermatoses: Short-term relief of inflammation and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer's labeling.

Apply the smallest amount that will cover affected area. For topical use only; avoid contact with eyes and mucous membranes. Do not apply to face or intertriginous areas. Do not use if there is atrophy at the treatment site. Minimize contact to nonaffected areas of the body.

Cream, emollient cream, gel, lotion, ointment, solution: Maximum dose: 50 g/week or 50 mL/week.

Foam: Turn can upside down and spray a small amount (golf-ball size) of foam into the cap or another cool surface. If the can is warm or foam is runny, place can under cold, running water. If fingers are warm, rinse with cool water and dry prior to handling (foam will melt on contact with warm skin). Massage foam into affected area. Maximum dose: 50 g/week.

Shampoo: Limit treatment to 4 consecutive weeks. Maximum dose: 50 g/week or 50 mL/week. Use on dry hair; do not wet hair prior to use. Do not use a shower cap or bathing cap while shampoo is on the scalp. Leave in place for 15 minutes, then wet hair, lather and rinse hair and scalp completely. Although no additional shampoo is necessary to cleanse the hair, a nonmedicated shampoo may be used after application if desired.

Spray: Spray directly onto affected area of skin. Gently and completely rub into skin after spraying. Maximum total dose: 50 g/week or 59 mL/week. Do not use more than 26 sprays per application or 52 sprays per day.

Cream, emollient cream, lotion, ointment: Store between 15°C to 30°C (59°F to 86°F); do not refrigerate or freeze.

Foam: Store between 20ºC and 25ºC (68ºF and 77ºF); do not expose to temperatures >49°C (120°F). Avoid fire, flame, or smoking during and immediately following application.

Gel: Store between 2°C and 30°C (36°F and 86°F).

Shampoo: Store between 20°C and 25°C (68°F and 77°F).

Solution: Do not use near an open flame.

Cormax: Store between 15°C to 30°C (59°F to 86°F).

Temovate: Store between 4°C to 25°C (39°F to 77°F).

Spray: Store at room temperature; do not expose to temperatures >30°C (86°F). Do not freeze or refrigerate. Spray is flammable; do not use near open flame.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience stinging, dry skin, burning, or redness. Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of skin changes (acne, stretch marks, slow healing, or hair growth), or severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.