Class: Anti-inflammatory Agents
Note: This monograph also contains information on Betamethasone, Betamethasone Valerate
ATC Class: D07BC01
VA Class: DE200
CAS Number: 378-44-9
Brands: Alphatrex, Betatrex, Beta-Val, Diprolene, Lotrisone, Luxiq, Maxivate, Taclonex
Introduction
A synthetic fluorinated corticosteroid.101 102 103 104 105 106 108 112 113 114 115 116 117 b
Uses for Betamethasone Dipropionate
Corticosteroid-responsive Dermatoses
Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.101 102 104 106 105 107 108 109 110 111 112 113 114
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).e
Topical therapy generally preferred over systemic therapy; fewer associated adverse systemic effects.e
Topical therapy generally only controls manifestations of dermatoses; eliminate cause if possible.e
Topical efficacy may be increased by using a higher concentration or occlusive dressing therapy.e (See Administration with Occlusive Dressing under Dosage and Administration.)
Response may vary from one topical corticosteroid preparation to another.e
Anti-inflammatory activity may vary considerably depending on the vehicle, drug concentration, site of application, disease, and individual patient.e
Cream and lotion (0.05% betamethasone dipropionate; 0.1% betamethasone valerate) are considered to have medium-range potency.101 103
Foam (0.12% betamethasone valerate) is considered to have medium-range potency.108
Ointment (0.05% betamethasone dipropionate) is considered to have high-range potency.102
Cream, lotion, and ointment (0.05% betamethasone dipropionate) in optimized (augmented) vehicle are considered to have high-range potency.104 106 b
Fixed-combination cream or lotion containing betamethasone dipropionate 0.05% and clotrimazole 1% is considered to have high-range potency.115
Gel (0.05% betamethasone dipropionate) in optimized (augmented) vehicle is considered to have super-high range potency.104
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.115
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.115
Treatment failure of topical betamethasone preparations in fixed combination with clotrimazole in the treatment of M. canis infections has been reported.115
Psoriasis
Used in fixed combination with calcipotriene for the topical treatment of plaque psoriasis (psoriasis vulgaris) in adults.116
Used in fixed combination with calcipotriene for the topical treatment of chronic, moderate to severe plaque psoriasis (psoriasis vulgaris) of the scalp in adults.117
Betamethasone Dipropionate Dosage and Administration
General
Consider location of the lesion and the condition being treated when choosing a dosage form.e
Creams are suitable for most dermatoses, but ointments may also provide some occlusion and are usually used for the treatment of dry, scaly lesions.e
Lotions are probably best for treatment of weeping eruptions, especially in areas subject to chafing (e.g., axilla, foot, groin).e Lotions, gels, and aerosols may be used on hairy areas, particularly the scalp.e
Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercially available products with another vehicle may decrease effectiveness.e
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).101 102 103 104 105 106 b (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also see Systemic Effects, under Cautions.)
Administration
Topical Administration
For dermatologic use only; avoid contact with eyes.101 102 103 104 105 106 112 113 114 116 117 b
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.105 116 117
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.115 116 117
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.e
Apply cream or ointment in a thin film to the affected area.101 102 104 112 113 b
Apply gel in a thin film and rub gently into affected area until absorbed.105
Apply betamethasone dipropionate and calcipotriene fixed-combination ointment and rub gently and completely into affected area.116 Wash hands thoroughly after application process.116
Apply foam to affected areas of the scalp.108 To dispense foam, invert container; dispense small amount of foam onto a cool surface (e.g., saucer) to prevent melting.108 Foam will melt immediately upon contact with warm skin; do not dispense directly onto hands.108 Gently massage foam into the entire affected area of scalp.108
Apply betamethasone dipropionate and calcipotriene fixed-combination suspension to affected areas of the scalp.117 Wash hands thoroughly after application process.117 Shake fixed-combination suspension well before each use.117
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.103 106 114
Shake lotion containing betamethasone valerate and lotion containing betamethasone dipropionate in fixed combination with clotrimazole well before each use.114 115
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.d
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.101 102 103 104 105 115 116 117 b However, when appropriate, occlusive dressings may be used as directed by a clinician to augment efficacy of betamethasone valerate preparations when treating resistant dermatoses.108 112 113 114 (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.e 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.e
If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape.e 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.e
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.e
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.e
Occlusive dressing usually is left in place for 12–24 hours and therapy is repeated as needed.e 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.e
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.e
In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion.e (See Occlusive Dressings under Cautions.)
Dosage
Available as betamethasone dipropionate and betamethasone valerate; dosage usually expressed in terms of betamethasone.101 102 103 104 105 112 113 114 115 116 117 b
Foam available as betamethasone valerate; dosage expressed in terms of betamethasone valerate.108
Pediatric Patients
Administer the least amount of topical preparations that provides effective therapy.101 (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.101
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.102 104 b
Children ≥13 years of age: Apply a few drops of 0.05% lotion to affected area once or twice daily.103
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.105
Children ≥12 years of age: Apply a few drops of 0.05% lotion in optimized (augmented) vehicle to affected area once or twice daily.106
Topical (Betamethasone Valerate)
Apply 0.1% cream or ointment to affected area 1–3 times daily; once- or twice-daily application often is effective.112 113
Apply a few drops of 0.1% lotion to affected area twice daily, in the morning and evening.114 Dosage may be increased in patients with resistant dermatoses; decrease frequency to once daily following clinical improvement.114
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.101
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.102 104 105 b
Apply a few drops of 0.05% lotion or 0.05% lotion in optimized (augmented) vehicle to affected area once or twice daily.103 106 ”
Topical (Betamethasone Valerate)
Apply 0.1% cream or ointment to affected area 1–3 times daily; once- or twice-daily application is often effective.112 113
Apply 0.12% foam twice daily in the morning and evening.108 Discontinue when control is achieved; if response is inadequate within a 2-week course of therapy, consider reevaluation of diagnosis.108
Apply a few drops of 0.1% lotion to affected area twice daily, in the morning and evening.114 Dosage may be increased in patients with resistant dermatoses; decrease frequency to once daily following clinical improvement.114
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.115
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.115 f
Plaque Psoriasis
Topical (Betamethasone Dipropionate and Calcipotriene)
Apply ointment containing betamethasone 0.05% and calcipotriene 0.005% to the affected area(s) once daily.116
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.117
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.104
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.105
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.104
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.105
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.115
Plaque Psoriasis
Topical (Betamethasone Dipropionate and Calcipotriene)
Maximum 100 g weekly of the fixed-combination betamethasone 0.05% and calcipotriene 0.005% ointment.116 Do not apply to >30% of body surface area.116 Do not exceed 4 consecutive weeks of therapy.116
Maximum 100 g weekly of the fixed-combination betamethasone 0.05% and calcipotriene 0.005% suspension.117 Do not exceed 8 consecutive weeks of therapy.117
Cautions for Betamethasone Dipropionate
Contraindications
Known hypersensitivity to betamethasone dipropionate, betamethasone valerate, other corticosteroids, or any ingredient in the formulation.101 102 103 104 105 106 108 112 113 114 115 116 b
Betamethasone dipropionate and calcipotriene ointment or suspension: Known or suspected disorders of calcium metabolism.116 117
Betamethasone dipropionate and calcipotriene ointment or suspension: Erythrodermic, exfoliative, and pustular psoriasis.116 117
Warnings/Precautions
Sensitivity Reactions
Allergic contact dermatitis may manifest as failure to heal rather than irritation as occurs with other topical preparations that do not contain corticosteroids; confirm with diagnostic patch testing.105 116
Discontinue therapy with betamethasone dipropionate and calcipotriene fixed-combination ointment if irritation occurs.116
Major Toxicities
Risk of Systemic Effects with Highly Active Preparations
Betamethasone is a potent topical corticosteroid and can be absorbed in sufficient amounts to produce systemic effects including HPA axis suppression.102 103 104 105 106 112 113 114 116 117 b (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also see Systemic Effects, under Cautions.)
General Precautions
Hypothalamic-Pituitary-Adrenal Axis Suppression
Topically applied corticosteroids can be absorbed in sufficient amounts to reversibly suppress the HPA axis.101 102 103 104 105 106 108 112 113 114 116 117 b e HPA-axis suppression has occurred following topical dosages as low as 7 g of the 0.05% betamethasone dipropionate cream in an optimized vehicle (3.5 mg of betamethasone) daily or following repeated application of 14 g of the 0.05% betamethasone dipropionate ointment in an optimized vehicle (7 mg of betamethasone) daily in patients with psoriasis.104 e
Perform periodic HPA-axis evaluation by appropriate testing (e.g., ACTH stimulation, morning plasma cortisol, urinary free cortisol), especially in patients applying a topical corticosteroid to a large surface area or to areas under occlusion.101 102 103 104 105 106 108 112 113 114 116 117 b e
If HPA-axis suppression occurs, withdraw the drug, reduce the frequency of application, discontinue occlusive therapy, and/or substitute a less potent corticosteroid.101 102 103 104 105 106 108 112 113 114 116 117 b e
HPA-axis function recovery generally is prompt and complete following drug discontinuance.101 102 103 104 105 106 108 112 113 114 116 117 b e
Rarely, glucocorticosteroid insufficiency may require systemic corticosteroid therapy.101 102 103 104 105 106 108 112 113 114 b e
Systemic Effects
Systemic absorption following topical administration may result in manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.101 102 103 104 105 106 108 112 113 114 116 117 b e
Risk of adverse systemic effects increases with use of a high-potency topical corticosteroid, especially if applied to large areas of the body, for prolonged periods of time, with an occlusive dressing, and/or concurrently with other corticosteroid-containing preparations.101 102 103 104 105 106 108 112 113 114 116 117 b e
Infants and children may be more susceptible to adverse systemic effects.101 102 103 104 105 106 108 112 113 114 116 117 b e (See Pediatric Use under Cautions.)
Local Effects
Possible adverse local reactions (e.g., irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, miliaria); may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.108 113 114 115 116 117 e
Prolonged use of topical corticosteroids may cause atrophy of the epidermis and subcutaneous tissue;106 these effects are most likely to occur (even with short-term use) in intertriginous, flexor, and facial areas.106 Do not apply betamethasone and calcipotriene ointment or suspension to treatment areas with preexisting skin atrophy.116 117
If irritation occurs, discontinue drug and institute appropriate therapy.101 102 103 104 105 112 113 114 116
Skin Infection
If concurrent skin infection is present or develops, initiate appropriate anti-infective therapy.101 102 103 104 105 106 108 112 113 114 116 117 b If infection does not respond promptly, discontinue topical corticosteroid therapy until the infection has been controlled.101 102 103 104 105 106 108 112 113 114 116 117 b
When topical corticosteroids and topical anti-infectives are used concomitantly, consider that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation.e h In addition, consider the cautions, precautions, and contraindications associated with the anti-infective.e h
Treatment of fungal infections with topical preparations containing betamethasone dipropionate in fixed combination with clotrimazole may lead to clinical worsening and/or decreased cure rate due to suppression of the inflammatory response.115
Fungal infections, especially noninflammatory tinea infections, may be treated effectively without the risk corticosteroid-associated adverse effects by using a topical antifungal agent that does not contain a corticosteroid.115
Do not use occlusive dressings in patients with primary skin infection.e
Some manufacturers state that topical corticosteroids are contraindicated in patients with tuberculosis of the skin, dermatologic fungal infections, and cutaneous or systemic viral infection, including vaccinia and varicella and herpes simplex of the eye or adjacent skin;d however, most clinicians believe topical corticosteroids can be used with caution if the infection is treated.d
Occlusive Dressings
Betamethasone dipropionate preparations should not be used with occlusive dressings.101 103 104 105 115 116 117 b
Betamethasone valerate preparations should not be used with occlusive dressings unless directed by clinician.108 112 113 114
Adverse systemic reactions may occur with use of occlusive dressings on large areas of the body and for prolonged periods of time; monitor accordingly.d (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also see Systemic Effects, under Cautions.)
Adverse local reactions may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.108 113 114 115 117 e (See Local Effects under Cautions.)
Do not use occlusive dressings on weeping or exudative lesions.e
Do not use occlusive dressings in patients with primary skin infection.e
Remove occlusive dressings covering large areas if body temperature increases; thermal homeostasis may be impaired.e
Use plastic occlusive material with care to avoid the risk of suffocation.e
Inadequate Response
If an adequate response is not achieved when treating tinea with topical preparations containing betamethasone dipropionate in fixed combination with clotrimazole, perform appropriate microbiologic studies (e.g., KOH smear and/or culture) to reconfirm the clinical diagnosis before instituting additional courses of therapy with combination preparation.115
Rosacea or Perioral Dermatitis
Betamethasone dipropionate gel in optimized (augmented) vehicle is not recommended for treatment of rosacea or perioral dermatitis.105
Use of Fixed Combinations
When used in fixed combination with calcipotriene or clotrimazole, consider the cautions, precautions, and contraindications associated with the concomitant agent.115 116 117
Specific Populations
Pregnancy
Category C.101 102 104 105 106 108 112 113 114 115 116 117 b
Lactation
Not known whether topical betamethasone is distributed into milk.101 102 103 104 105 108 112 113 114 115 116 117 b Caution advised if topical betamethasone is used.101 102 103 104 105 106 108 112 113 114 115 116 117 b
Pediatric Use
Use of betamethasone dipropionate cream, cream in optimized (augmented) vehicle, lotion, and ointment not recommended in children ≤12 years of age; these dermatologic preparations may be used with caution in children ≥13 years of age.101 103 104
Use of betamethasone dipropionate gel in optimized (augmented) vehicle, lotion in optimized (augmented) vehicle, and ointment in optimized (augmented) vehicle not recommended in children <12 years of age; these dermatologic preparations may be used with caution in children ≥12 years of age.105 106 b
Safety and efficacy of betamethasone valerate foam not established in pediatric patients.108
Use of preparations containing betamethasone dipropionate in fixed combination with clotrimazole are not recommended for use in the treatment of diaper dermatitis or for use in children <17 years of age; safety and efficacy not established.115
Safety and efficacy of fixed-combination ointment or suspension containing betamethasone dipropionate and calcipotriene not established in pediatric patients.116 117
Adverse effects consistent with corticosteroid use have been observed in patients with diaper dermatitis treated with preparations containing betamethasone dipropionate in fixed combination with clotrimazole.115
Tight-fitting diapers or plastic pants should not be used on a child being treated with betamethasone valerate cream in the diaper area, since they may constitute occlusive dressings.112 113 114
Children are more susceptible to topical corticosteroid-induced HPA-axis suppression and Cushing’s syndrome than mature individuals because of a greater skin surface area-to-body weight ratio, especially when topical corticosteroids are applied to >20% of body surface area.101 102 103 104 105 106 108 112 113 114 116 117 b e The risk of adrenal suppression appears to increase with decreasing age.101 102 104 105 (See Systemic Effects under Cautions.)
Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol concentrations, lack of response to corticotropin (ACTH) stimulation.101 102 104 105 106 108 112 113 114
Children are also at greater risk of glucocorticosteroid insufficiency during and/or after withdrawal of treatment.108 e
Intracranial hypertension has occurred in children; manifestations include bulging fontanelles, headaches, and bilateral papilledema.101 102 104 105 106 108 112 113 114
Children are at greater risk of adverse atrophic dermatologic effects.
Striae has been reported in children treated inappropriately with topical corticosteroids.105 108
Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic efficacy; chronic topical corticosteroid therapy may interfere with growth and development.101 102 103 104 105 108 112 113 114 b
Geriatric Use
Insufficient experience with preparations containing betamethasone dipropionate in fixed combination with clotrimazole in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; skin atrophy and ulceration have been reported.115
Use with caution in geriatric patients with thinning skin; do not use with occlusion and/or for treatment of diaper dermatitis.115 e
No substantial differences in safety or efficacy of fixed-combination ointment or suspension containing betamethasone dipropionate and calcipotriene observed in geriatric patients relative to younger adults.116 117
Common Adverse Effects
Burning, stinging, itching, irritation, dry skin, erythema, folliculitis, hypertrichosis.101 103 104 105 108 112 114 113 115 b
Children: skin atrophy (telangiectasia, bruising, shininess), paresthesia (burning), erythema, erythematous rash.101 102 103 104
Interactions for Betamethasone Dipropionate
Specific Drugs and Laboratory Tests
Drug or Test | Interaction |
|---|---|
Corticosteroids | Potential pharmacologic interaction with other corticosteroid-containing preparations101 102 103 104 115 116 117 |
Nitroblue-tetrazolium test for bacterial infection | Concurrent use of corticosteroids reportedly may result in false-negative resultse |
Betamethasone Dipropionate Pharmacokinetics
Absorption
Bioavailability
Topically applied betamethasone dipropionate and valerate can be absorbed through normal intact skin.101 102 103 104 105 106 108 112 113 114 115 116 b
Extent of systemic absorption of the drug is increased with lotion preparations and those formulated with an optimized (augmented) vehicle.101 102 103 104 105 106 b
Percutaneous penetration can be altered by using different vehicles and increases with decreasing age.101 102 103 104 105 106 108 112 113 114 115 116 b
Percutaneous penetration also can be increased by use of occlusive dressings and by presence of inflammation and/or other disease of the epidermal barrier (e.g., psoriasis, eczema).101 102 103 104 105 106 108 112 113 114 115 116 117 b
Distribution
Extent
Not known whether topical betamethasone is distributed into milk.101
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