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Clobetasol


Pronunciation

 (kloe BAY ta sol)


U.S. Brand Names

 Clobevate®; Clobex™; Cormax®; Embeline™; Embeline™ E; Olux®; Temovate®; Temovate E®


Synonyms

 Clobetasol Propionate


Generic Available

 Yes: Excludes foam


Canadian Brand Names

 Dermovate®; Gen-Clobetasol; Novo-Clobetasol®


Use

 Short-term relief of inflammation of moderate to severe corticosteroid-responsive dermatoses (very high potency topical corticosteroid)


Pregnancy Risk Factor

 C


Pregnancy Implications

 Extensive use in pregnant women is not recommended. There are no adequate and well-controlled studies in pregnant women, however, teratogenic effects were observed in animal studies.


Lactation

 Excretion in breast milk unknown/use caution


Contraindications

 Hypersensitivity to clobetasol or any component of the formulation; viral, fungal, or tubercular skin lesions


Warnings/Precautions

 Clobetasol propionate has been shown to suppress the HPA axis; risk may be decreased by treating small surface areas for <2 continuous weeks. Monitor for HPA axis suppression when large surface areas must be covered or if occlusive dressings are used. Not for use in children <12 years of age; not to be used with occlusive dressings unless directed by healthcare provider.


Adverse Reactions

 Frequency not defined; may depend upon formulation used, length of application, surface area covered, and the use of occlusive dressings.

Endocrine & metabolic: Adrenal suppression, Cushing's syndrome, hyperglycemia

Local: Application site: Burning, cracking/fissuring of the skin, dryness, erythema, folliculitis, irritation, numbness, pruritus, skin atrophy, stinging, telangiectasia

Renal: Glucosuria

Effects reported with other high-potency topical steroids: Acneiform eruptions, allergic contact dermatitis, hypertrichosis, hypopigmentation, maceration of the skin, miliaria, perioral dermatitis, secondary infection


Drug Interactions

 No data reported


Stability

Cream, emollient cream, ointment: Store at room temperature, between 15°C to 30°C (59°F to 86°F); do not refrigerate

Foam: Store at room temperature; do not expose to temperatures >49°C (120°F); avoid fire, flame, or smoking during and immediately following application

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

Lotion: Store at room temperature of 20°C to 25°C (68°F to 77°F).

Solution: Store between 4°C to 25°C (39°F to 77°F); do not use near an open flame


Mechanism of Action

 Stimulates the synthesis of enzymes needed to decrease inflammation, suppress mitotic activity, and cause vasoconstriction


Pharmacodynamics/Kinetics

Absorption: Percutaneous absorption is variable and dependent upon many factors including vehicle used, integrity of epidermis, dose, and use of occlusive dressings

Metabolism: Hepatic

Excretion: Urine and feces


Dosage

 Topical: Discontinue when control achieved; if improvement not seen within 2 weeks, reassessment of diagnosis may be necessary.

Children <12 years: Use is not recommended

Children 12 years and Adults:

Steroid-responsive dermatoses:

Cream, emollient cream, gel, lotion, ointment: Apply twice daily for up to 2 weeks (maximum dose: 50 g/week)

Foam, solution: Apply to affected scalp twice daily for up to 2 weeks (maximum dose: 50 g/week or 50 mL/week)

Mild to moderate plaque-type psoriasis of nonscalp areas: Foam: Apply to affected area twice daily for up to 2 weeks (maximum dose: 50 g/week); do not apply to face or intertriginous areas

Children 16 years and Adults: Moderate to severe plaque-type psoriasis: Emollient cream, lotion: Apply twice daily for up to 2 weeks, has been used for up to 4 weeks when application is <10% of body surface area; use with caution (maximum dose: 50 g/week)


Administration

Cream, gel, lotion, ointment, solution: Apply the smallest amount that will cover affected area. Do not apply to face or intertriginous areas. Total dose should not exceed 50 g/week (or 50 mL/week of lotion or solution).

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.


Monitoring Parameters

 Adrenal suppression with extensive/prolonged use (ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test)


Patient Education

 Do not overuse; use only as prescribed and for no longer than the period prescribed. Notify physician if condition being treated persists or worsens. Do not bandage or wrap affected area unless instructed to do so by prescriber. Wash hands after applying. Advise physician of the use of this medication if surgery is contemplated. This medication is for external use only; avoid use on face, underarms, or groin area unless specifically instructed to use in these areas by prescriber. Avoid contact with eyes or lips.

Cream, gel, lotion, ointment, solution: Apply the smallest amount that will cover affected area. Do not apply to face. A thin film is effective; apply sparingly and rub in lightly.

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). Gently massage foam into affected area until foam disappears.

Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Consult prescriber if breast-feeding.


Nursing Implications

 For external use only; do not use on open wounds; apply sparingly; should not be used in the presence of open or weeping lesions; do not use occlusive dressings unless directed by healthcare provider


Dental Health: Effects on Dental Treatment

 No significant effects or complications reported


Dental Health: Vasoconstrictor/Local Anesthetic Precautions

 No information available to require special precautions


Mental Health: Effects on Mental Status

 None reported


Mental Health: Effects on Psychiatric Treatment

 None reported


Dosage Forms

Cream, as propionate: 0.05% (15 g, 30 g, 45 g, 60 g)

Cormax®: 0.05% (15 g, 30 g, 45 g)

Embeline™, Temovate®: 0.05% (15 g, 30 g, 45 g, 60 g)

Cream, as propionate [in emollient base]: 0.05% (15 g, 30 g, 60 g)

Embeline™ E, Temovate E®: 0.05% (15 g, 30 g, 60 g)

Foam, topical, as propionate [for scalp application] (Olux®): 0.05% (50 g, 100 g) [contains ethanol 60%]

Gel, as propionate (Clobevate®, Embeline™; Temovate®): 0.05% (15 g, 30 g, 60 g)

Lotion, as propionate (Clobex™): 0.05% (30 mL, 59 mL)

Ointment, as propionate: 0.05% (15 g, 30 g, 45 g, 60 g)

Cormax®: 0.05% (15 g, 45 g)

Embeline™, Temovate®: 0.05% (15 g, 30 g, 45 g, 60 g)

Solution, topical, as propionate [for scalp application] (Cormax®, Embeline™, Temovate®): 0.05% (25 mL, 50 mL) [contains isopropyl alcohol 40%]


International Brand Names

 Betasol® (TH); Clobetasol L.CH.® (CL); Clobetasol® (RO); Cloderm® (RO); Dermovate® (CA, EC, RO); Gen-Clobetasol (CA); Novo-Clobetasol® (CA)


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