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Pronunciation
(kloe BAY ta sol)
Generic Available (U.S.)
Yes: Excludes lotion, shampoo, spray
Index Terms
U.S. Brand Names
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Short-term relief of inflammation of moderate-to-severe corticosteroid-responsive dermatoses (very high potency topical corticosteroid)
Use: Dental
Short-term relief of oral mucosal inflammation
Pregnancy Risk Factor
C
Pregnancy Considerations
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
Breast-Feeding Considerations
It is not known if topical application will result in detectable quantities in breast milk.
Contraindications
Hypersensitivity to clobetasol or any component of the formulation; viral, fungal, or tubercular skin lesions
Warnings/Precautions
Concerns related to adverse effects:
• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypothalamic-pituitary-adrenal (HPA) axis suppression (reversible) particularly in younger children. HPA axis suppression may lead to adrenal crisis. Risk is increased when used over large surface areas, for prolonged periods, or with occlusive dressings.
• Contact dermatitis: Allergic contact dermatitis can occur, it is usually diagnosed by failure to heal rather than clinical exacerbation.
• Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered.
• Systemic effects: Adverse systemic effects including hyperglycemia, glycosuria, fluid and electrolyte changes, and HPA suppression may occur when used on large surface areas, for prolonged periods, or with an occlusive dressing.
Special populations:
• Pediatrics: Use in children <12 years of age is not recommended.
Other warnings/precautions:
• Application site: Do not use on the face, axillae, or groin.
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
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy
Storage
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, shampoo, spray: Store at room temperature of 20°C to 25°C (68°F to 77°F). Spray is flammable; do not use near open flame.
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:
Oral mucosal inflammation, dental (unlabeled use): Cream: Apply twice daily for up to 2 weeks (maximum dose: 50 g/week); discontinue application when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary
Steroid-responsive dermatoses:
Cream, emollient cream, gel, ointment: Apply twice daily for up to 2 weeks (maximum dose: 50 g/week)
Foam (Olux-E™): Apply to affected area twice daily for up to 2 weeks (maximum dose: 50 g/week); do not apply to face or intertriginous areas
Steroid-responsive dermatoses: Foam (Olux®), 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 (Olux®): 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)
Children ≥18 years and Adults:
Moderate-to-severe plaque-type psoriasis: Spray: Apply by spraying directly onto affected area twice daily; should be gently rubbed into skin. Should be used for not longer than 4 weeks; treatment beyond 2 weeks should be limited to localized lesions which have not improved sufficiently. Total dose should not exceed 50 g/week or 59 mL/week.
Scalp psoriasis: Shampoo: Apply thin film to dry scalp once daily; leave in place for 15 minutes, then add water, lather; rinse thoroughly
Steroid-responsive dermatoses: Lotion: Apply twice daily for up to 2 weeks (maximum dose: 50 g/week)
Dental Usual Dosing
Oral mucosal inflammation: Children ≥12 years and Adults: Cream: Apply twice daily for up to 2 weeks (maximum dose: 50 g/week); discontinue application when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary
Administration: Topical
Cream, gel, lotion, ointment, shampoo, 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, shampoo, 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.
Spray: Spray directly onto affected area of skin. Gently and completely rub into skin after spraying.
Monitoring Parameters
Adrenal suppression with extensive/prolonged use (ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test)
Patient Education
Notify prescriber 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 prescriber 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.
Spray: Spray directly onto affected area of skin. Gently and completely rub into skin after spraying.
Geriatric Considerations
Due to age-related changes in skin, limit use of topical glucocorticosteroids.
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
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Aerosol, topical, as propionate [combination package/foam]:
Olux®/Olux-E™ CP: Olux-E™: 0.05% (50 g) and Olux® 0.05% (50 g) [contains ethanol 60%] (1s [DSC]); Olux-E™: 0.05% (10 g) and Olux® 0.05% (100 g) [contains ethanol 60%] (1s [DSC])
Aerosol, topical, as propionate [foam]: 0.05% (50 g, 100 g)
Olux-E™: 0.05% (50 g, 100 g) [ethanol free]
Olux®: 0.05% (50 g, 100 g) [contains ethanol 60%; for scalp application]
Cream, topical, as propionate: 0.05% (15 g, 30 g, 45 g, 60 g)
Temovate®: 0.05% (30 g [DSC], 60 g [DSC])
Cream, topical, as propionate [emollient-based]: 0.05% (15 g, 30 g, 60 g)
Temovate E®: 0.05% (60 g)
Cream, topical, as propionate [emulsion-based]: 0.05% (15 g [DSC], 30 g [DSC], 60 g [DSC])
Gel, topical, as propionate: 0.05% (15 g, 30 g, 60 g)
Temovate®: 0.05% (60 g)
Lotion, topical, as propionate:
Clobex®: 0.05% (30 mL, 59 mL, 118 mL)
Ointment, topical, as propionate: 0.05% (15 g, 30 g, 45 g, 60 g)
Cormax®: 0.05% (15 g, 45 g)
Temovate®: 0.05% (15 g, 30 g)
Shampoo, topical, as propionate:
Clobex®: 0.05% (118 mL) [contains ethanol]
Solution, topical, as propionate [for scalp application]: 0.05% (25 mL, 50 mL)
Cormax®: 0.05% (25 mL, 50 mL) [contains isopropyl alcohol 40%]
Temovate®: 0.05% (50 mL) [contains isopropyl alcohol 39.3%]
Solution, topical, as propionate [spray]:
Clobex®: 0.05% (59 mL, 125 mL) [contains ethanol]
Pricing: U.S. (www.drugstore.com)
Cream (Clobetasol Propionate)
0.05% (15): $15.99
0.05% (45): $24.99
0.05% (60): $29.99
Cream (Clobetasol Propionate E)
0.05% (60): $25.99
Cream (Temovate)
0.05% (60): $219.98
Cream (Temovate E)
0.05% (15): $40.99
0.05% (60): $213.98
Foam (Clobetasol Propionate)
0.05% (100): $229.99
Foam (Olux)
0.05% (50): $239.06
0.05% (100): $465.01
Foam (Olux-E)
0.05% (100): $363.99
Gel (Clobetasol Propionate)
0.05% (15): $25.99
0.05% (30): $29.99
0.05% (60): $42.99
Gel (Temovate)
0.05% (15): $39.99
0.05% (60): $205.99
Liquid (Clobex Spray)
0.05% (59): $268.49
0.05% (125): $470.96
Lotion (Clobex)
0.05% (59): $287.00
0.05% (118): $533.28
Ointment (Clobetasol Propionate)
0.05% (45): $25.99
0.05% (60): $29.99
Ointment (Temovate)
0.05% (15): $93.99
0.05% (30): $117.98
Shampoo (Clobex)
0.05% (118): $389.97
Solution (Clobetasol Propionate)
0.05% (25): $25.99
0.05% (50): $35.99
Solution (Cormax)
0.05% (50): $79.99
Solution (Temovate)
0.05% (50): $190.98
References
Goedert JJ, Vitale F, Lauria C, et al, “Risk Factors for Classical Kaposi's Sarcoma,” J Natl Cancer Inst, 2002, 94(22):1712-8.
International Brand Names
Lexi-Comp.com
Last full review/revision May 2011
Content last modified May 2011
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