clobetasol (Temovate, Temovate E, Cormax, Clobex, Clobex Spray, Clarelux, Cormax Ointment, Cormax Scalp Application, Olux, Olux-E, Olux-E Foam)

Dosing and uses of Temovate, Temovate E (clobetasol)

• Adult
• Pediatric

 

Adult dosage forms and strengths

cream, gel, ointment, shampoo, liquid, lotion, solution, spray, or foam

• 0.05%

 

Corticosteroid-responsive Dermatoses

Cream/foam: Apply thin layer to affected areas q12hr and rub in gently and completely; not to exceed 50 g/week

 

Corticosteroid-responsive Dermatoses of the Scalp

Foam: Apply to affected area in scalp q12hr for up to 2 weeks; not to exceed 50 g or 50 mL/week

 

Scalp Psoriasis

Shampoo: Apply thin film to dry scalp qDay; leave in place for 15 min; add water, lather, and then rinse thoroughly

 

Mild to Moderate Plaque-type Psoriasis of Nonscalp Areas

Foam: Apply to affected area in scalp q12hr for up to 2 weeks; not to exceed 50 g/week

 

Moderate to Severe Plaque-type Psoriasis

Emollient/cream/lotion: Apply to affected area in scalp q12hr for up to 2 weeks if area is less than 10% of the body surface area; not to exceed 50 g/week

Spray: Apply by spraying onto affected area q12hr; rub into skin; should not be used for more than 4 weeks

 

Pediatric dosage forms and strengths

cream, gel, ointment, shampoo, liquid, lotion, solution, spray, or foam

• 0.05%

 

Corticosteroid-responsive Dermatoses

<12 years

• Safety & efficacy not established

>12 years

• Cream/foam: Apply thin layer to affected areas q12hr and rub in gently and completely; not to exceed 50 g/week

 

Corticosteroid-responsive Dermatoses of the Scalp

<12 years

• Safety & efficacy not established

>12 years

• Foam: Apply to affected area in scalp q12hr for up to 2 weeks; not to exceed 50 g or 50 mL/week

 

Scalp Psoriasis

<12 years

• Safety & efficacy not established

>12 years

• Shampoo: Apply thin film to dry scalp qDay; leave in place for 15 min; add water, lather, and then rinse thoroughly

 

Mild to Moderate Plaque-type Psoriasis of Nonscalp Areas

<12 years

• Safety & efficacy not established

>12 years

• Foam: Apply to affected area in scalp q12hr for up to 2 weeks; not to exceed 50 g/week

 

Temovate, Temovate E (clobetasol) adverse (side) effects

Frequency not defined

Skin atrophy

Striae

Burning

Cracking/fissuring of the skin

Erythema

Folliculitis

Irritation

Numbness

Pruritus

Stinging

Hypopigmentation (high potency topical steroids)

Intracranial hypertension reported in children with use of topical formulation

Adrenal suppression, Cushing syndrome, hyperglycemia

Acneform lesions

Secondary infection

Pigmentation changes

HPA suppression (with higher potency used >2 weeks); doses as low as 2 g/day can produce HPA suppression

 

Warnings

Contraindications

Viral, fungal, or tubercular skin lesions

Hypersensitivity

Ophthalmic use

 

Cautions

Chronic topical corticosteroid therapy may interfere with growth and development in children

May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, especially in younger children or patients receiving high doses for prolonged periods

Allergic contact dermatitis reported with use; diagnosed by failure to heal rather than clinical exacerbation

Kaposi's sarcoma reported with prolonged corticosteroid treatment

Percutaneous absorption of corticosteroids may cause manifestations of Cushing's syndrome

Use lower potency in children; may absorb proportionally larger amounts after topical application and may cause systemic effects

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Excretion in milk unknown; use with caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Temovate, Temovate E (clobetasol)

Mechanism of action

Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; and reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation

 

Pharmacokinetics

Absorption: Percutaneously

Metabolism: Hepatic

Excretion: Urine and feces