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Clobetasol

Pronunciation

Pronunciation

(kloe BAY ta sol)

Index Terms

  • Clobetasol Propionate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External, as propionate:

Clobetasol Propionate E: 0.05% (15 g, 30 g, 60 g) [contains cetostearyl alcohol, propylene glycol]

Clobetasol Propionate E: 0.05% (15 g, 30 g, 60 g) [contains propylene glycol]

Temovate: 0.05% (30 g, 60 g) [contains cetostearyl alcohol, chlorocresol (chloro-m-cresol), propylene glycol]

Temovate E: 0.05% (60 g)

Generic: 0.05% (15 g, 30 g, 45 g, 60 g)

Foam, External, as propionate:

Olux: 0.05% (50 g, 100 g) [contains cetyl alcohol, propylene glycol]

Olux-E: 0.05% (50 g, 100 g) [contains cetyl alcohol, propylene glycol]

Generic: 0.05% (50 g, 100 g)

Gel, External, as propionate:

Temovate: 0.05% (60 g) [contains propylene glycol]

Generic: 0.05% (15 g, 30 g, 60 g)

Kit, External, as propionate:

Clodan: 0.05% [contains alcohol, usp, cetyl alcohol, edetate disodium, propylene glycol]

Liquid, External, as propionate:

Clobex Spray: 0.05% (59 mL, 125 mL) [contains alcohol, usp]

Generic: 0.05% (59 mL, 125 mL)

Lotion, External, as propionate:

Clobex: 0.05% (59 mL, 118 mL)

Generic: 0.05% (59 mL, 118 mL)

Ointment, External, as propionate:

Temovate: 0.05% (15 g, 30 g) [contains propylene glycol]

Generic: 0.05% (15 g, 30 g, 45 g, 60 g)

Shampoo, External, as propionate:

Clobex: 0.05% (118 mL) [contains alcohol, usp]

Clodan: 0.05% (118 mL) [contains alcohol, usp]

Generic: 0.05% (118 mL)

Solution, External, as propionate:

Cormax Scalp Application: 0.05% (50 mL) [contains isopropyl alcohol]

Temovate: 0.05% (50 mL)

Generic: 0.05% (25 mL, 50 mL)

Brand Names: U.S.

  • Clobetasol Propionate E
  • Clobex
  • Clobex Spray
  • Clodan
  • Cormax Scalp Application
  • Olux
  • Olux-E
  • Temovate
  • Temovate E

Pharmacologic Category

  • Corticosteroid, Topical

Pharmacology

Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Clobetasol has very high range potency.

Absorption

Percutaneous absorption is variable and dependent upon many factors including vehicle used, integrity of epidermis, dose, and use of occlusive dressings (not recommended); absorption is increased by occlusive dressings or with decreased integrity of skin (eg, inflammation or skin disease); gel has greater absorption than cream

Metabolism

Hepatic

Excretion

Urine and feces

Use: Labeled Indications

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

Contraindications

Hypersensitivity to clobetasol, other corticosteroids, or any component of the formulation; primary infections of the scalp (scalp solution only)

Dosing: Adult

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

Oral mucosal inflammation (off-label use): Topical: 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: Topical: Cream, emollient cream, foam, gel, lotion, ointment, solution: Apply 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: Topical: Foam: Apply twice daily for up to 2 weeks (maximum dose: 50 g/week)

Moderate to severe plaque-type psoriasis: Topical:

Emollient cream, lotion: Apply twice daily for up to 2 weeks; can be used for up to 4 weeks when application is <10% of body surface area (maximum dose: 50 g/week or 50 mL/week). Treatment with lotion beyond 2 weeks should be limited to localized lesions (<10% body surface area) which have not improved sufficiently.

Spray: Apply by spraying directly onto affected area twice daily and gently rub into skin. Limit treatment to 4 consecutive weeks; treatment beyond 2 weeks should be limited to localized lesions which have not improved sufficiently. Maximum total dose: 50 g/week or 59 mL/week. Do not use more than 26 sprays per application or 52 sprays per day.

Scalp psoriasis, moderate to severe: Topical:

Foam: Apply twice daily for up to 2 weeks (maximum dose: 50 g/week)

Shampoo: Apply thin film to dry scalp once daily (maximum dose: 50 g/week or 50 mL/week); leave in place for 15 minutes, then add water, lather; rinse thoroughly. Limit treatment to 4 consecutive weeks.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Discontinue when control achieved; if improvement not seen within 2 weeks, reassessment of diagnosis may be necessary. Use in children <12 years is not recommended.

Mild to moderate plaque-type psoriasis of nonscalp areas: Topical: Foam: Children ≥12 years and Adolescents: Refer to adult dosing.

Moderate to severe plaque-type psoriasis: Topical:

Emollient cream: Adolescents ≥16 years: Refer to adult dosing.

Lotion, spray: Adolescents ≥18 years: Refer to adult dosing.

Scalp psoriasis, moderate to severe: Topical:

Foam: Children ≥12 years and Adolescents: Refer to adult dosing.

Shampoo: Adolescents ≥18 years: Refer to adult dosing.

Steroid-responsive dermatoses: Topical:

Cream, emollient cream, foam, gel, ointment, solution: Children ≥12 years and Adolescents: Refer to adult dosing.

Lotion: Adolescents ≥18 years: Refer to adult dosing.

Oral mucosal inflammation (off-label use): Topical: Cream: Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

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

Dosing: Hepatic Impairment

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

Administration

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.

Storage

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.

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

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. 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. Monitor therapy

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

Adverse Reactions

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

Central nervous system: Localized burning (5% to 40%), numbness of fingers (<2%), intracranial hypertension (children; systemic effect reported with topical corticosteroids)

Dermatologic: Stinging of skin (<2% to 5%), pruritus (<2% to 3%), pruritus hiemalis (2%), xeroderma (≤2%), erythema (<2%), folliculitis (<2%), skin atrophy (<2%), skin fissure (<2%), telangiectasia (<2%), atrophic striae (children)

Endocrine & metabolic: Adrenal suppression, Cushing's syndrome, glycosuria, growth suppression, HPA-axis suppression, hyperglycemia

Local: Local irritation (1%), local pain (1%)

Respiratory: Upper respiratory tract infection (8%), nasopharyngitis (5%), streptococcal pharyngitis (1%)

<1% (Limited to important or life-threatening): Alopecia, exfoliation of skin, skin rash, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

• Contact dermatitis: Allergic contact dermatitis may occur, it is usually diagnosed by failure to heal rather than clinical exacerbation.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered.

• Local effects: Local effects may occur, including folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, miliaria, skin atrophy, and telangiectasia; local adverse effects may be irreversible.

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.

Special populations:

• Pediatric: Use in children <12 years of age is not recommended. Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients. Clobex lotion, Clobex shampoo, Clobex spray, and Clodan shampoo are not recommended for use in patients ≤17 years of age.

Dosage form specific issues:

• Emollient cream: Contains imidurea which releases traces of formaldehyde as a breakdown product; formaldehyde may cause allergic sensitization or irritation upon skin contact.

• Foam/Spray: The foam and spray are flammable. Avoid fire, flame, or smoking during and immediately following application.

Other warnings/precautions:

• Appropriate use: Do not use if there is atrophy at the treatment site. Do not use with occlusive dressing. Do not use on the face, axillae, or groin or for the treatment of rosacea or perioral dermatitis.

Monitoring Parameters

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

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Extensive use in pregnant women is not recommended.

Patient Education

• 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.

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