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Betamethasone (topical) Clinical Information

a topical steroid

Generic Name: betamethasone topical

Uses

Corticosteroid-responsive Dermatoses

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Generally most effective in acute or chronic dermatoses (e.g., seborrheic or atopic dermatitis, localized neurodermatitis, anogenital pruritus, psoriasis, late phase of allergic contact dermatitis, inflammatory phase of xerosis).

Topical therapy generally preferred over systemic therapy; fewer associated adverse systemic effects.

Topical therapy generally only controls manifestations of dermatoses; eliminate cause if possible.

Topical efficacy may be increased by using a higher concentration or occlusive dressing therapy. (See Administration with Occlusive Dressing under Dosage and Administration.)

Response may vary from one topical corticosteroid preparation to another.

Anti-inflammatory activity may vary considerably depending on the vehicle, drug concentration, site of application, disease, and individual patient.

Cream and lotion (0.05% betamethasone dipropionate; 0.1% betamethasone valerate) are considered to have medium-range potency.

Foam (0.12% betamethasone valerate) is considered to have medium-range potency.

Ointment (0.05% betamethasone dipropionate) is considered to have high-range potency.

Cream, lotion, and ointment (0.05% betamethasone dipropionate) in optimized (augmented) vehicle are considered to have high-range potency.

Fixed-combination cream or lotion containing betamethasone dipropionate 0.05% and clotrimazole 1% is considered to have high-range potency.

Gel (0.05% betamethasone dipropionate) in optimized (augmented) vehicle is considered to have super-high range potency.

Inflammatory Tinea Pedis, Tinea Cruris, or Tinea Corporis

Used in fixed combination with clotrimazole in the treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis caused by Epidermophyton floccosum, Trichophyton rubrum, and T. mentagrophytes.

Safety and efficacy of topical betamethasone preparations in fixed combination with clotrimazole for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis) have not been established.

Treatment failure of topical betamethasone preparations in fixed combination with clotrimazole in the treatment of M. canis infections has been reported.

Psoriasis

Used in fixed combination with calcipotriene for the topical treatment of plaque psoriasis (psoriasis vulgaris) in adults.

Used in fixed combination with calcipotriene for the topical treatment of chronic, moderate to severe plaque psoriasis (psoriasis vulgaris) of the scalp in adults.

Dosage and Administration

General

  • Consider location of the lesion and the condition being treated when choosing a dosage form.
  • Creams are suitable for most dermatoses, but ointments may also provide some occlusion and are usually used for the treatment of dry, scaly lesions.
  • Lotions are probably best for treatment of weeping eruptions, especially in areas subject to chafing (e.g., axilla, foot, groin). Lotions, gels, and aerosols may be used on hairy areas, particularly the scalp.
  • Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercially available products with another vehicle may decrease effectiveness.
  • Patients applying a topical corticosteroid to a large surface area and/or to areas under occlusion should be evaluated periodically for evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression by appropriate endocrine testing (e.g., ACTH stimulation, plasma cortisol, urinary free cortisol). (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also see Systemic Effects, under Cautions.)

Administration

Topical Administration

For dermatologic use only; avoid contact with eyes.

Betamethasone dipropionate gel in optimized (augmented) vehicle and fixed-combination ointment or suspension containing betamethasone dipropionate and calcipotriene should not be used on the face, groin, or in the axillae.

Cream or lotion containing betamethasone dipropionate in fixed combination with clotrimazole or, alternatively, ointment or suspension containing betamethasone dipropionate in fixed combination with calcipotriene is not intended for ophthalmic, oral, or intravaginal use.

The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating.

Apply cream or ointment in a thin film to the affected area.

Apply gel in a thin film and rub gently into affected area until absorbed.

Apply betamethasone dipropionate and calcipotriene fixed-combination ointment and rub gently and completely into affected area. Wash hands thoroughly after application process.

Apply foam to affected areas of the scalp. To dispense foam, invert container; dispense small amount of foam onto a cool surface (e.g., saucer) to prevent melting. Foam will melt immediately upon contact with warm skin; do not dispense directly onto hands. Gently massage foam into the entire affected area of scalp.

Apply betamethasone dipropionate and calcipotriene fixed-combination suspension to affected areas of the scalp. Wash hands thoroughly after application process. Shake fixed-combination suspension well before each use.

Apply a few drops of lotion to the affected area by holding the nozzle of the bottle close to the affected area and squeezing gently; massage lightly until absorbed.

Shake lotion containing betamethasone valerate and lotion containing betamethasone dipropionate in fixed combination with clotrimazole well before each use.

After a favorable response is achieved, frequency of application may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible.

Administration with Occlusive Dressing

Topical preparations of betamethasone dipropionate alone or in fixed combination with clotrimazole or calcipotriene should not be used with occlusive dressings. However, when appropriate, occlusive dressings may be used as directed by a clinician to augment efficacy of betamethasone valerate preparations when treating resistant dermatoses. (See Occlusive Dressings under Cautions.)

Soak or wash the affected area to remove scales; apply a thin film of cream, lotion, or ointment; rub gently into the lesion; and apply another thin film. Cover affected area with a thin, pliable plastic film and seal it to adjacent normal skin with adhesive tape or hold in place with a gauze or elastic bandage.

If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape. For added moisture in dry lesions, apply cream, ointment, or lotion and cover with a dampened cloth before the plastic film is applied or briefly soak the affected area in water before application of the drug and plastic film.

Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.

The frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of the corticosteroid are essential at each dressing change.

Occlusive dressing usually is left in place for 12–24 hours and therapy is repeated as needed. Although occlusive dressing may be left in place for 3–4 days at a time in resistant conditions, most clinicians recommend intermittent use of occlusive dressings for 12 hours daily to reduce the risk of adverse effects (particularly infection) and systemic absorption and for greater convenience.

The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.

In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion. (See Occlusive Dressings under Cautions.)

Dosage

Available as betamethasone dipropionate and betamethasone valerate; dosage usually expressed in terms of betamethasone.

Foam available as betamethasone valerate; dosage expressed in terms of betamethasone valerate.

Pediatric Patients

Administer the least amount of topical preparations that provides effective therapy. (See Pediatric Use under Cautions.)

Corticosteroid-responsive Dermatoses

Topical (Betamethasone Dipropionate)

Children ≥13 years of age: Apply 0.05% cream in a thin film to affected area, usually once daily or, if necessary, twice daily.

Children ≥13 years of age: Apply 0.05% cream in optimized (augmented) vehicle or 0.05% ointment in a thin film to affected area once or twice daily.

Children ≥13 years of age: Apply a few drops of 0.05% lotion to affected area once or twice daily.

Children ≥12 years of age: Apply 0.05% gel in optimized (augmented) vehicle or 0.05% ointment in optimized (augmented) vehicle in a thin film to affected area once or twice daily.

Children ≥12 years of age: Apply a few drops of 0.05% lotion in optimized (augmented) vehicle to affected area once or twice daily.

Topical (Betamethasone Valerate)

Apply 0.1% cream or ointment to affected area 1–3 times daily; once- or twice-daily application often is effective.

Apply a few drops of 0.1% lotion to affected area twice daily, in the morning and evening. Dosage may be increased in patients with resistant dermatoses; decrease frequency to once daily following clinical improvement.

Adults

Corticosteroid-responsive Dermatoses

Topical (Betamethasone Dipropionate)

Apply 0.05% cream in a thin film to affected area, usually once daily or, if necessary, twice daily.

Apply 0.05% cream in optimized (augmented) vehicle, 0.05% gel in optimized (augmented) vehicle, 0.05% ointment or ointment in optimized (augmented) vehicle in a thin film to affected area once or twice daily.

Apply a few drops of 0.05% lotion or 0.05% lotion in optimized (augmented) vehicle to affected area once or twice daily.”

Topical (Betamethasone Valerate)

Apply 0.1% cream or ointment to affected area 1–3 times daily; once- or twice-daily application is often effective.

Apply 0.12% foam twice daily in the morning and evening. Discontinue when control is achieved; if response is inadequate within a 2-week course of therapy, consider reevaluation of diagnosis.

Apply a few drops of 0.1% lotion to affected area twice daily, in the morning and evening. Dosage may be increased in patients with resistant dermatoses; decrease frequency to once daily following clinical improvement.

Symptomatic Inflammatory Tinea Pedis, Tinea Cruris, or Tinea Corporis

Topical (Betamethasone Dipropionate and Clotrimazole)

Apply cream or lotion containing betamethasone 0.05% and clotrimazole 1% twice daily in the morning and evening.

If response is inadequate within a 1-week (tinea corporis or tinea cruris) or 2-week (tinea pedis) course of therapy with the combination of betamethasone 0.05% and clotrimazole 1%, reevaluate diagnosis or discontinue combination preparation and consider clotrimazole alone.

Plaque Psoriasis

Topical (Betamethasone Dipropionate and Calcipotriene)

Apply ointment containing betamethasone 0.05% and calcipotriene 0.005% to the affected area(s) once daily.

Apply suspension containing betamethasone 0.05% and calcipotriene 0.005% to affected area(s) of the scalp once daily for 2 weeks or until cleared.

Prescribing Limits

Pediatric Patients

Corticosteroid-responsive Dermatoses

Topical (Betamethasone Dipropionate)

Maximum 45 g weekly with 0.05% cream in optimized (augmented) vehicle or with 0.05% ointment in optimized (augmented) vehicle.

Maximum 50 g weekly with 0.05% gel in optimized (augmented) vehicle or 50 mL weekly with 0.05% lotion in optimized (augmented) vehicle; do not exceed 2 consecutive weeks of therapy.

Adults

Corticosteroid-responsive Dermatoses

Topical (Betamethasone Dipropionate)

Maximum 45 g weekly with 0.05% cream in optimized (augmented) vehicle or with 0.05% ointment in optimized (augmented) vehicle.

Maximum 50 g weekly with 0.05% gel in optimized (augmented) vehicle or 50 mL weekly with 0.05% lotion in optimized (augmented) vehicle; do not exceed 2 consecutive weeks of therapy.

Symptomatic Inflammatory Tinea Pedis, Tinea Cruris, or Tinea Corporis

Topical (Betamethasone Dipropionate and Clotrimazole)

Maximum 45 g (cream) or 45 mL (lotion) weekly of the fixed combination of betamethasone 0.05% and clotrimazole 1%; do not exceed 2 consecutive weeks of therapy in the treatment of tinea cruris or tinea corporis or 4 weeks in the treatment of tinea pedis.

Plaque Psoriasis

Topical (Betamethasone Dipropionate and Calcipotriene)

Maximum 100 g weekly of the fixed-combination betamethasone 0.05% and calcipotriene 0.005% ointment. Do not apply to >30% of body surface area. Do not exceed 4 consecutive weeks of therapy.

Maximum 100 g weekly of the fixed-combination betamethasone 0.05% and calcipotriene 0.005% suspension. Do not exceed 8 consecutive weeks of therapy.


Last Updated: June 01, 2009
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