clobetasol

Clobetasol is a synthetic topical corticosteroid used for temporary relief from symptoms of plaque psoriasis and other inflammatory skin conditions.

Corticosteroids are potent anti-inflammatory drugs and clobetasol topical applications control skin inflammation and relieve associated itching and pain. Clobetasol is a prescription drug available in various formulations such as cream, gel, spray, lotion, ointment, and shampoo.

Clobetasol is absorbed through the skin, binds to and activates glucocorticoid receptors in the skin cells, which results in a cascade of multiple anti-inflammatory processes that include the following:

• Promotes the synthesis of anti-inflammatory proteins and inhibits the synthesis of pro-inflammatory proteins
• Inhibits the activity of phospholipase A2, an enzyme that induces the release of arachidonic acid, a substance that initiates the inflammatory process
• Inhibits the release of inflammatory substances such as kinins, histamine, and prostaglandins
• Reduces capillary permeability to prevent the leakage of inflammatory cells and proteins (cytokines) into the inflammation site
• Prevents migration and aggregation of leukocytes, immune cells that release inflammatory substances
• Stabilizes the membranes of leukocyte lysosomes, the organelles inside the leukocytes that contain destructive enzymes
• Inhibits migration of fibroblasts, cells that form extracellular matrix, the supportive structure of tissue, and prevents scar tissue formation

• Do not use clobetasol if you have hypersensitivity to clobetasol, other corticosteroids, or any component of the formulation.
• Do not apply clobetasol on viral, fungal, or tubercular skin lesions.
• Prolonged use in children can affect their growth and development.
• Children’s skin may absorb higher amounts of clobetasol, use low potency products
• May suppress the hypothalamic-pituitary-adrenal (HPA) axis which can result in reduced production of the stress hormone cortisol and consequently, impaired stress response and reduced defense against infections. Risk factors for HPA suppression include:
  • Prolonged use of potent steroids over a large area of skin
  • Use on altered skin barrier
  • Used under occlusive dressing
  • Young age
  • Concurrent use with other steroid products
  • Patients with liver failure
• Clobetasol may increase the risk of eye conditions such as glaucoma and cataracts.
• Clobetasol can cause local reactions such as dermatitis, folliculitis, acneiform eruptions, and other reactions, particularly with the use of high potency corticosteroids with occlusive dressings.
• Clobetasol can cause allergic contact dermatitis.
• Systemic absorption of topical clobetasol can cause Cushing’s syndrome, a disorder with high cortisol levels, hyperglycemia and glycosuria.
• Kaposi sarcoma, a type of cancer, has been reported with prolonged corticosteroid therapy. Discontinue clobetasol if Kaposi sarcoma develops.
• Concomitant skin infections can develop with clobetasol therapy. If the infections are not resolved with antimicrobial treatment, discontinue clobetasol.

Common side effects of clobetasol include:

• Hypothalamic-pituitary-adrenal (HPA) axis suppression
• Application site reactions such as:
  • Irritation
  • Discomfort
  • Burning
• Skin reactions including:
  • Eczema
  • Redness (erythema)
  • Stinging
  • Dry skin (xeroderma)
  • Spider veins (telangiectasia)
  • Inflammation of hair follicles (folliculitis)
  • Loss of skin color (hypopigmentation)
  • Itching (pruritus)
  • Thinning of skin (skin atrophy)
  • Skin fissure
• Upper respiratory tract infection
• Inflammation of nose and throat (nasopharyngitis)
• Streptococcal pharyngitis
• Headache
• Numbness of fingers

Less common side effects of clobetasol include:

• Skin rash
• Hives (urticaria)
• Skin tenderness
• Dermatitis
• Acneiform eruptions
• Scalp pustules
• Hair loss (alopecia)
• Scalp tightness
• Tingling of scalp
• Eye irritation

Rare side effects of clobetasol include:

• Contact dermatitis
• Skin lesion
• Skin pain
• Skin peeling (desquamation)
• Exacerbation of psoriasis
• Exfoliation of skin
• Excessive hair growth (hypertrichosis)
• Stretch marks due to thinning skin (atrophic striae)
• Thickening and scaling of skin
• Lichen planus-like eruption
• Heat rash (miliaria)
• Raised bumps on skin (papules)
• Inflamed skin around the mouth (perioral dermatitis)
• Secondary infection
• Systemic absorption effects with high doses such as:
  • Cushing’s syndrome
  • High blood glucose levels (hyperglycemia)
  • Excessive glucose in urine (glycosuria)
  • Adrenal suppression
• Eye disorders including:
  • Cataracts
  • Glaucoma
  • Increased intraocular pressure
  • Retinal disease (retinopathy)
• Fracture due to osteoporosis

Seek medical care or call 911 at once if you have the following serious side effects while using this drug:

• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug.

Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Cream, Topical

• 0.025% (Impoyz)
• 0.05% (Temovate)

Foam, Topical

• 0.05% (Olux, Olux E)

Gel, Topical

• 0.05%

Lotion, Topical

• 0.05% (Clobex)

Ointment, Topical

• 0.05% (Temovate)

Shampoo, Topical

• 0.05% (Clobex Shampoo, Clodan Shampoo, Clodan Kit)

Solution, Topical

• 0.05%

Spray, Topical

• 0.05% (Clobex Spray)

Adult:

Corticosteroid-responsive Dermatoses

Indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

• Cream/foam: Apply thin layer to affected areas every 12 hours and rub in gently and completely; not to exceed 50 g/week
• Lotion: Apply to affected skin areas twice daily and rub in gently and completely; not to exceed 50 g/week;

Scalp

• Foam: Apply to affected area on scalp every 12 hours for up to 2 weeks; not to exceed 50 g or 50 mL/week

Scalp Psoriasis

Indicated for moderate-to-severe forms of scalp psoriasis

• Shampoo: Apply thin film to dry scalp once daily; leave in place for 15 minutes; add water, lather, and then rinse thoroughly; limit treatment to 4 consecutive weeks because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis
• Foam: Apply to affected area in scalp every 12 hours for up to 2 weeks; not to exceed 50 g/week

Plaque Psoriasis

Mild-to-moderate

• Foam: Apply to affected area in scalp every 12 hours for up to 2 weeks; not to exceed 50 g/week

Moderate-to-severe

• Emollient cream/lotion: Apply to affected area twice daily for up to 2 weeks (cream) or up to 4 weeks if needed (emollient cream, lotion) when application is less than 10% of body surface area; not to exceed 50 g/week or 50 mL/week; treatment with lotion longer 2 weeks should be limited to localized lesions (less than 10% body surface area), which have not improved sufficiently with therapy; not to exceed 50 g or 50 mL/week;
• Cream 0.025%: Apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks
• Spray
  • Indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA)
  • Apply by spraying onto affected area every 12 hours; rub into skin; should not be used for more than 4 weeks; treatment with spray beyond 2 weeks should be limited to localized lesions that have not improved sufficiently

Dosing Considerations

Cream 0.025%

• Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 gram/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis

Clobex Lotion, 0.05%

• Should not be used with occlusive dressings
• Limitations of use
  • Should not be used on the face, axillae, or groin and should not be used if there is atrophy at treatment site
  • Should not be used in the treatment of rosacea or perioral dermatitis

Shampoo

• Limitations of use
  • Should not be used on the face, groin or axillae
  • Avoid any contact with the eyes and lips
  • In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo

Foam

• Limitations of use
  • Avoid face, axillae, and groin
  • Avoid use if skin atrophy is present at treatment site

Pediatric:

Children younger than 12 years:

• Safety and efficacy not established

Children older than 12 years:

Corticosteroid-responsive Dermatoses

Cream/foam

• Apply thin layer to affected areas every 12 hours and rub in gently and completely; not to exceed 50 g/week

Corticosteroid-responsive Dermatoses of the Scalp

Foam

• Apply to affected area on scalp every 12 hours for up to 2 weeks; not to exceed 50 g or 50 mL/week

Scalp Psoriasis

Shampoo

• Apply thin film to dry scalp once daily; leave in place for 15 minutes; add water, lather, and then rinse thoroughly

Mild to Moderate Plaque-type Psoriasis of Nonscalp Areas

Foam

• Apply to affected area on scalp every 12 hours for up to 2 weeks; not to exceed 50 g/week

• Overdose of clobetasol topical corticosteroid can lead to systemic absorption and lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression and glucocorticoid insufficiency.
• Chronic use of high doses can affect almost all body systems.
• Overdose may be treated by adjusting the dose or stopping clobetasol and initiating symptomatic and supportive treatment.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of clobetasol include:
  • Aldesleukin
• Clobetasol has no known serious, moderate or mild interaction with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There is limited information on clobetasol use during pregnancy. In general, topical corticosteroids are not associated with fetal risks, however, there is an increased risk for low-birth-weight infants if potent topical corticosteroids are used during pregnancy.
• Animal studies show evidence of fetal risks with systemic absorption of corticosteroids.
• If use during pregnancy cannot be avoided, use clobetasol on the smallest area of skin and for the shortest duration possible.
• It is not known if topical clobetasol can result in sufficient systemic absorption to appear in breast milk. Systemic corticosteroid is present in breast milk and can suppress growth and cause other adverse effects in the breastfeeding infant.
• Limit use of clobetasol on the smallest area of skin and for the shortest duration possible while breastfeeding. Avoid applying clobetasol on the nipple and surrounding areas to prevent exposure to the infant.

• Use clobetasol exactly as prescribed. Do not apply more often or on larger areas than necessary.
• Do not use clobetasol for a longer period than prescribed. If there is no improvement within 2 weeks, contact your physician.
• Avoid contact with eyes. In case of any visual symptoms, report to your physician.
• Do not apply on face, scalp, underarm, or groin.
• Do not use for the treatment of pimples (acne vulgaris), rosacea, dermatitis around the mouth, or genital and anal itching.
• Do not wrap, cover or bandage the treated area, unless directed by your physician.
• Clobetasol foam and spray are flammable. Avoid fire, flame, or smoking during and immediately following application.
• Keep safely out of reach of children.
• In case of overdose, immediately seek medical help or contact Poison Control.