Betamethasone
AHFS Class: Anti-inflammatory Agents (84:06)
ATC Class: D07BC01
VA Class: DE200
Flubenisolone
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Introduction
Betamethasone is a synthetic fluorinated corticosteroid.
See Uses in the associated General Statement for more information.
Uses
Betamethasone shares the actions of the other topical corticosteroids and is used for the relief of the inflammatory manifestations of corticosteroid-responsive dermatoses.
For systemic uses of betamethasone, see 68:04.
See Dosage and Administration in the associated General Statement for more information.
Dosage and Administration
Betamethasone dipropionate and valerate are applied topically. Betamethasone dipropionate preparations and betamethasone valerate foam preparations 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. Concentration of betamethasone valerate foam is expressed in terms of betamethasone valerate.
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, 50 g, 45 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 valerate 0.1% creams and ointments 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 dipropionate 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
See Cautions in the associated General Statement for more information.
Cautions
Betamethasone shares the toxic potentials of other topical corticosteroids, and the usual precautions of corticosteroid therapy should be observed. (See Cautions in the Topical Corticosteroids General Statement 84:06.)
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 has also 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 in pediatric patients have not been established.108
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 (See Cautions: Pediatric Precautions, in the Topical Corticosteroids General Statement 84:06.)
See Pharmacology in the associated General Statement for more information.
See Pharmacokinetics in the associated General Statement for more information.
See Chemistry and Stability in the associated General Statement for more information.
Chemistry and Stability
Chemistry
Betamethasone is a synthetic fluorinated corticosteroid. 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.
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.
Preparations
Betamethasone Dipropionate
| Routes | Forms | Strengths | Brand Names | Manufacturer |
|---|
| Topical |
Cream |
0.05% (of betamethasone)* |
Alphatrex® |
Savage |
| | |
Diprolene® AF (with propylene glycol in an optimized [augmented] vehicle) |
Schering-Plough |
| | |
Maxivate® |
Westwood-Squibb |
|
Gel |
0.05% (of betamethasone) |
Diprolene® (with propylene glycol in an optimized [augmented] vehicle) |
Schering-Plough |
|
Lotion |
0.05% (of betamethasone)* |
Alphatrex® (with isopropyl alcohol) |
Savage |
| | |
Diprolene® Lotion (with isopropyl alcohol 30% and propylene glycol in an optimized [augmented] vehicle) |
Schering-Plough |
| | |
Maxivate® (with isopropyl alcohol) |
Westwood-Squibb |
|
Ointment |
0.05% (of betamethasone)* |
Alphatrex® |
Savage |
| | |
Betamethasone Dipropionate Augmented Ointment |
Actavis, Fougera, Warrick |
| | |
Diprolene® (with propylene glycol in an optimized [augmented] vehicle) |
Schering-Plough |
| | |
Maxivate® |
Westwood-Squibb |
* available by nonproprietary name
Betamethasone Valerate
| Routes | Forms | Strengths | Brand Names | Manufacturer |
|---|
| Powder* |
|
Betamethasone Valerate Powder micronized for Prescription Compounding |
Paddock |
| Topical |
Cream |
0.1% (of betamethasone)* |
Betatrex® |
Savage |
| | |
Beta-Val® |
Teva |
|
Foam |
0.12% (of betamethasone valerate) |
Luxiq® |
Connetics |
|
Lotion |
0.1% (of betamethasone)* |
Betatrex® (with isopropyl alcohol) |
Savage |
| | |
Beta-Val® |
Teva |
|
Ointment |
0.1% (of betamethasone)* |
Betatrex® |
Savage |
* available by nonproprietary name
Betamethasone Dipropionate Combinations
| Routes | Forms | Strengths | Brand Names | Manufacturer |
|---|
| Topical |
Cream |
0.05% (of betamethasone) with Clotrimazole 1%* |
Lotrisone® (with benzyl alcohol and propylene glycol) |
Schering-Plough |
* available by nonproprietary name
Comparative Pricing
Pricing information provided by drugstore.com.
AlphaTrex 0.05% Gel (PHARMADERM): 15/$43.99 or 45/$123.88
Aug Betamethasone Dipropionate 0.05% Cream (PERRIGO): 50/$59.99 or 150/$149.97
Aug Betamethasone Dipropionate 0.05% Cream (PERRIGO): 15/$31.99 or 45/$80.97
Aug Betamethasone Dipropionate 0.05% Gel (FOUGERA): 15/$34.15 or 45/$102.44
Aug Betamethasone Dipropionate 0.05% Gel (FOUGERA): 50/$55.99 or 150/$160.97
Aug Betamethasone Dipropionate 0.05% Lotion (FOUGERA): 60/$89.99 or 180/$249.97
Aug Betamethasone Dipropionate 0.05% Ointment (ACTAVIS MID ATLANTIC): 15/$28.99 or 45/$79.97
Aug Betamethasone Dipropionate 0.05% Ointment (ACTAVIS MID ATLANTIC): 45/$53.99 or 135/$153.98
Betamethasone Dipropionate 0.05% Cream (FOUGERA): 15/$12.99 or 45/$29.97
Betamethasone Dipropionate 0.05% Cream (FOUGERA): 45/$11.99 or 135/$31.97
Betamethasone Dipropionate 0.05% Lotion (TEVA PHARMACEUTICALS USA): 60/$21.99 or 180/$61.97
Betamethasone Dipropionate 0.05% Ointment (ACTAVIS MID ATLANTIC): 15/$12.99 or 45/$26.97
Betamethasone Dipropionate 0.05% Ointment (ACTAVIS MID ATLANTIC): 45/$11.99 or 135/$31.97
Beta-Val 0.1% Cream (TEVA PHARMACEUTICALS USA): 15/$11.99 or 45/$15.97
Beta-Val 0.1% Cream (TEVA PHARMACEUTICALS USA): 45/$12.99 or 135/$25.97
Beta-Val 0.1% Lotion (TEVA PHARMACEUTICALS USA): 60/$14.99 or 180/$35.96
Diprolene 0.05% Gel (SCHERING): 15/$49.99 or 45/$139.97
Diprolene 0.05% Gel (SCHERING): 50/$103.99 or 150/$299.97
Diprolene 0.05% Ointment (SCHERING): 15/$64 or 45/$181.14
Diprolene 0.05% Ointment (SCHERING): 50/$135.99 or 150/$390.95
Diprolene AF 0.05% Cream (SCHERING): 15/$64 or 45/$181.14
Diprolene AF 0.05% Cream (SCHERING): 50/$135.62 or 150/$390.59
Taclonex 0.005-0.064% Ointment (WARNER CHILCOTT PROF PROD DIV): 100/$689.69 or 300/$2006.25
Taclonex 0.005-0.064% Ointment (WARNER CHILCOTT PROF PROD DIV): 60/$429.91 or 180/$1187.37
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Selected Revisions August 2005, © Copyright, January 1980, American Society of Health-System Pharmacists, Inc. 7272 Wisconsin Avenue, Bethesda, MD 20814. |
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References
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 Oct.
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.
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