AHFS Class:

• Corticosteroids 84:06.08

Generic Name(s):

• Betamethasone

• Betamethasone Dipropionate

• Betamethasone Valerate

Betamethasone is a synthetic fluorinated corticosteroid.101,102,103,104,105,106,108,112,113,114,115,116,117

Betamethasone shares the actions of the other topical corticosteroids and is used for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.101,102,104,105,107,108,109,110,111,112,113,114,116,117

Betamethasone dipropionate and valerate are applied topically.101,102,103,104,105,106,112,113,114,116,117 Betamethasone dipropionate preparations101,102,103,104,105,115,116,117 and betamethasone valerate preparations108,112,113,114 should not be used with occlusive dressings and patients should be warned that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive, unless directed by a clinician.

Concentrations of the dipropionate and valerate preparations usually are expressed in terms of betamethasone.101,102,103,104,105,112,113,114,115,116,117 Concentration of betamethasone valerate foam is expressed in terms of betamethasone valerate.108

Topical preparations of betamethasone dipropionate usually are applied sparingly in thin films and are rubbed gently into the affected area once or twice daily.101,102,103,104,105,106,107,109,111 Because betamethasone dipropionate preparations formulated in an optimized (augmented) vehicle are among the most potent topical corticosteroid preparations currently available, the manufacturers state that dosage of betamethasone dipropionate 0.05% ointments, creams, gels, or lotions in optimized (augmented) vehicles should not exceed 45 g, 45 g, 50 g, or 50 mL per week, respectively.104,105,106,107 Some manufacturers also state that duration of therapy with these optimized preparations should not exceed 2 weeks.105,106

Topical betamethasone 0.1% creams and ointments (as valerate) usually are applied sparingly in thin films and are rubbed gently into the affected area 1-3 times daily.110,112,113 However, once- or twice-daily administration of these preparations often is effective. 110,112,113 Topical betamethasone valerate 0.1% solutions are applied sparingly (e.g., a few drops) and are rubbed gently into the affected area twice daily, in the morning and evening.110,114 Dosage of the topical solution may be increased in patients with resistant dermatoses. 110,114 However, dosing frequency should be decreased to once daily following clinical improvement. 110,114

For relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp, betamethasone valerate 0.12% foam should be applied twice daily, in the morning and evening.108 For application to the scalp, the can containing betamethasone valerate foam should be inverted and small amounts of the preparation placed on a saucer or other cool surface.108 The foam should not be dispensed directly to the hands since the foam will begin to melt immediately upon contact with warm skin.108 Small amounts of the preparation should be massaged gently into the scalp until the foam disappears and entire scalp area has been treated.108

For the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, or tinea corporis caused by Trichophyton mentagrophytes , T. rubrum , or Epidermophyton floccosum , the fixed-combination cream or lotion containing betamethasone 0.05% and clotrimazole 1% should be applied sparingly and rubbed gently into the affected area twice daily, in the morning and evening.115 If clinical improvement does not occur after 1 week in the treatment of tinea cruris or tinea corporis or after 2 weeks in the treatment of tinea pedis, the diagnosis should be reevaluated.115 The manufacturer states that dosage of the combination cream or lotion should not exceed 45 g or 45 mL per week, respectively, and duration of therapy with these combination preparations should not exceed 2 weeks in the treatment of tinea cruris or tinea corporis or 4 weeks in the treatment of tinea pedis.115 Occlusive dressings should not be used with these combination preparations.115

For the topical treatment of plaque psoriasis (psoriasis vulgaris) in adults 18 years of age or older, the fixed-combination ointment containing betamethasone 0.05% and calcipotriene 0.005% should be applied and rubbed gently into the affected area until absorbed once daily.116 The combination ointment should not be applied to greater than 30% of body surface area.116 The manufacturer states that dosage of the combination ointment should not exceed 100 g per week, and duration of therapy should not exceed 4 consecutive weeks.116 Occlusive dressings should not be used with the combination preparation, unless directed by a clinician.116 The fixed-combination ointment should not be applied to the face, axillae, or groin area.116 The fixed-combination ointment should not be used in patients with erythrodermic, exfoliative, or pustular psoriasis or in patients with preexisting atrophy at the treatment site.116 Contact with the eyes should be avoided.116 If irritation occurs, therapy with the fixed-combination ointment should be discontinued and appropriate treatment instituted.116 Patients should wash their hands after applying the drug.116 The fixed-combination ointment is not for ophthalmic, oral, or intravaginal use.116

For the topical treatment of moderate to severe plaque psoriasis (psoriasis vulgaris) of the scalp in adults 18 years of age or older, the fixed-combination suspension containing betamethasone 0.05% and calcipotriene 0.005% should be applied to the affected area(s) on the scalp once daily for 2 weeks or until cleared.117 The manufacturer states that dosage of the combination suspension should not exceed 100 g per week, and duration of therapy should not exceed 8 weeks.117 Occlusive dressings should not be used with the combination preparation, unless directed by a clinician.117 The combination suspension should not be applied to the face, axillae, or groin area.117 In addition, the suspension should not be used in patients with erythrodermic, exfoliative, or pustular psoriasis or in patients with preexisting atrophy at the treatment site.117 Contact with the eyes should be avoided; eye irritation may occur.117 The bottle containing the suspension should be shaken prior to each use;117 patients should wash their hands after applying the drug.117 The fixed-combination suspension is not for ophthalmic, oral, or intravaginal use.117

Because calcipotriene may increase the effect of ultraviolet radiation to induce skin tumors,116,117,118,119 patients who apply the fixed-combination ointment or suspension to exposed areas of the body should avoid exposure to natural or artificial (e.g., sunlamps, tanning booths) sunlight and limit or avoid phototherapy.116,117

Betamethasone shares the toxic potentials of other topical corticosteroids, and the usual precautions of corticosteroid therapy should be observed. If fixed combinations of betamethasone with calcipotrinene or with clotrimazole are used, the precautions and contraindications associated with calcipotrinene or clotrimazole must be considered.115,116,117

Betamethasone dipropionate gels, lotions, creams, and ointments, particularly those in optimized (augmented) vehicles, are some of the most potent topical corticosteroid preparations currently available. Because of their potency, these preparations can suppress the hypothalamic-pituitary-adrenal (HPA) axis following topical application, and reversible HPA-axis suppression has occurred following topical dosages as low as 7 g, 7 mL, or 7 g of the 0.05% betamethasone dipropionate gel, lotion, or cream, respectively, in optimized (augmented) vehicles (3.5 mg of betamethasone) daily. Reversible HPA-axis suppression also has occurred following repeated topical dosages of 14 g of the 0.05% ointment in an optimized (augmented) vehicle (7 mg of betamethasone) daily in patients with psoriasis, and minimal suppression has occurred following 3.5 g of this ointment (1.75 mg of betamethasone) twice daily for 2-3 weeks in healthy individuals and in patients with psoriasis or eczema.

Pediatric Precautions

Lotrisone^® preparations are not recommended for use in the treatment of diaper dermatitis or for use in children younger than 17 years of age.115 Use of Diprosone^® or Diprolene^® preparations in children 12 years of age or younger is not recommended.101,102,103,104,105,106,107 In addition, the safety and efficacy of Luxiq^® foam,108 Taclonex^® ointment,116 and Taclonex Scalp^®117 topical suspension in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic adverse effects than are adults when treated with topical agents; 116 pediatric patients younger than 12 years of age may be at particular risk of systemic adverse effects when treated with topical corticosteroids.117

In open-label studies in pediatric patients receiving topical betamethasone dipropionate preparations for 2-3 weeks for treatment of atopic dermatitis, HPA-axis or adrenal suppression occurred in 73% of children 6-12 years of age who received the 0.05% lotion,103 32% of children 3 months to 12 years of age who received the 0.05% cream in an optimized [augmented] vehicle,104 28% of children 6 months to 12 years of age who received the 0.05% ointment,102 and 23% of children 2-12 years of age who received the 0.05% cream.101 The proportion of patients with adrenal suppression in these studies increased with decreasing age.101,102,104 If betamethasone dipropionate or betamethasone valerate is used for topical treatment of corticosteroid-responsive dermatoses in children, the usual precautions associated with topical corticosteroid therapy in pediatric patients should be observed.101,102,104

Chemistry and Stability

Chemistry

Betamethasone is a synthetic fluorinated corticosteroid.101,102,103,104,105,106,108,112,113,114,115,116,117 Betamethasone occurs as a white to practically white, crystalline powder and is insoluble in water and sparingly soluble in alcohol. Betamethasone currently is commercially available for topical use only as its dipropionate and valerate esters. Betamethasone dipropionate occurs as a white to cream-white powder and is insoluble in water. Betamethasone valerate occurs as a white to practically white powder and is practically insoluble in water and soluble in alcohol.

Stability

Betamethasone preparations should be stored as directed by the manufacturer.

Additional Information

For further information on chemistry, pharmacology, absorption, uses, cautions, methods of application, and use of occlusive dressings in therapy with betamethasone, see the Topical Corticosteroids General Statement 84:06.08.The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Only references cited for selected revisions after 1984 are available electronically.

101. Schering Corporation. Diprosone^® (betamethasone dipropionate) 0.05% cream prescribing information. Kenilworth, NJ; undated.

102. Schering Corporation. Diprosone^® (betamethasone dipropionate) 0.05% ointment prescribing information. Kenilworth, NJ; 2001 May.

103. Schering Corporation. Diprosone^® (betamethasone dipropionate) 0.05% lotion prescribing information. Kenilworth, NJ; 2001 May.

104. Schering Corporation. Diprolene^® AF (augmented betamethasone dipropionate) 0.05% cream prescribing information. Kenilworth, NJ; 2001 May.

105. Schering Corporation. Diprolene^® (augmented betamethasone dipropionate) 0.05% gel prescribing information. Kenilworth, NJ; 2000 Jan.

106. Schering Corporation. Diprolene^® (augmented betamethasone dipropionate) 0.05% lotion prescribing information. Kenilworth, NJ; 1999 Dec.

107. Alpharma USPD Inc. Betamethasone dipropionate (augmented) 0.05% ointment prescribing information. Baltimore, MD; 2001 Jul.

108. Connectics Corporation. Luxiq^® (betamethasone valerate) 0.12% foam prescribing information. Palo Alto, CA; 2002.

109. Savage Laboratories. Alphatrex^® (betamethasone dipropionate) 0.05% cream, ointment, lotion prescribing information. Melville, NY; 1997 Nov.

110. Teva Pharmaceuticals USA. Beta-Val^® (betamethasone valerate) 0.1% cream and lotion prescribing information. Sellersville, PA; 1998 Jul.

111. Westwood-Squibb Pharmaceuticals. Maxivate^® (betamethasone dipropionate) 0.05% cream, ointment, lotion prescribing information. Princeton, NJ; 2000 Sep.

112. Savage Laboratories. Betatrex^® (betamethasone valerate) 0.1% cream prescribing information. Melville, NY; 1988 Aug.

113. Savage Laboratories. Betatrex^® (betamethasone valerate) 0.1% ointment prescribing information. Melville, NY; 1988 Aug.

114. Savage Laboratories. Betatrex^® (betamethasone valerate) 0.1% lotion prescribing information. Melville, NY; 1988 Aug.

115. Schering Corporation. Lotrisone^® (clotrimazole and betamethasone dipropionate) cream and lotion prescribing information. Kenilworth, NJ; 2001 Oct.

116. Warner Chilcott (US), LLC. Taclonex^® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment prescribing information. Rockaway, NJ; 2008 Jul.

117. Warner Chilcott (US), LLC. Taclonex Scalp^® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) topical suspension prescribing information. Rockaway, NJ; 2008 May.

118. Warner Chilcott (US), LLC. Dovonex^® (calcipotriene) 0.005% cream prescribing information. Rockaway, NJ; 2008 Feb.

119. Warner Chilcott (US), LLC. Dovonex^® (calcipotriene) 0.005% scalp solution prescribing information. Rockaway, NJ; 2008 Jan.