Betamethasone is a synthetic glucocorticoid.
Betamethasone and its derivatives are used principally as anti-inflammatory or immunosuppressant agents. Because betamethasone has only minimal mineralocorticoid properties, the drug is inadequate alone for the management of adrenocortical insufficiency. If betamethasone is used in the treatment of this condition, concomitant therapy with a mineralocorticoid is also required.
The route of administration and dosage of betamethasone and its derivatives depend on the condition being treated and the response of the patient. Dosage for infants and children should be based on the severity of the disease and the response of the patient rather than on strict adherence to the dosage indicated by age, body weight, or body surface area. After a satisfactory response is obtained, dosage should be decreased in small decrements to the lowest level that maintains an adequate clinical response, and the drug should be discontinued gradually as soon as possible. Lack of satisfactory response after a reasonable trial of betamethasone or betamethasone sodium phosphate in fixed combination with betamethasone acetate should lead to discontinuance of therapy and transfer to other appropriate therapy. Patients should be continually monitored for signs that indicate dosage adjustment is necessary, such as remissions or exacerbations of the disease and stress (surgery, infection, trauma). Following long-term therapy, betamethasone should be withdrawn gradually. (See the Corticosteroids General Statement 68:04.)
Betamethasone is administered orally.
Betamethasone Sodium Phosphate and Betamethasone Acetate
A suspension containing betamethasone sodium phosphate in fixed combination with betamethasone acetate may be administered IM or locally by intra-articular, intrasynovial, intralesional (intradermal, not subcutaneous), or soft tissue injection. This injectable suspension should not be administered IV. The injectable suspension of betamethasone sodium phosphate and betamethasone acetate has been administered by epidural injection†, although the safety of epidural injections using preserved glucocorticoid formulations is controversial and epidural administration of these formulations is not recommended by the manufacturer. (See Uses: Low Back Pain and also see Cautions: Nervous System Effects, in the Corticosteroids General Statement in 68:04.)
The manufacturer states that the initial dosage of betamethasone may range from 0.6-7.2 mg daily depending on the disease and the severity of the disease being treated.105
Betamethasone Sodium Phosphate and Betamethasone Acetate
Dosage of betamethasone sodium phosphate is expressed in terms of betamethasone. Each mL of the fixed-combination injectable suspension contains 3 mg of betamethasone (as betamethasone sodium phosphate) and 3 mg of betamethasone acetate. IM injection of the fixed combination of betamethasone sodium phosphate and betamethasone acetate is indicated when oral therapy is not feasible. Absorption of betamethasone sodium phosphate from IM injection sites is rapid; absorption of the acetate is much slower. Anti-inflammatory effects may appear within 1-3 hours and may persist for 7 days after IM administration of the fixed combination. Therefore, this preparation should not be used when an immediate effect of short duration is appropriate. Parenteral dosage depends on the condition being treated and may vary from 0.5-9 mg daily (0.08-1.5 mL of the suspension). In life-threatening situations, extremely high parenteral dosage may be justified and may be a multiple of the usual oral dosage of the drug.
For intra-articular, intrasynovial, intralesional, or soft tissue injection, the dosage of the suspension of betamethasone sodium phosphate and betamethasone acetate depends on the degree of inflammation and the size and location of the affected area. Following intra-articular or intrasynovial injection, anti-inflammatory effects usually persist for at least 1-2 weeks. Intra-articular injection may produce systemic as well as local effects. A local anesthetic, such as 1 or 2% lidocaine hydrochloride, may be mixed in the syringe with the suspension prior to administration. Local anesthetic formulations containing preservatives such as parabens or phenol should be avoided.
The usual dose of the fixed combination of betamethasone and betamethasone acetate for acute bursitis of the subdeltoid, subacromial, olecranon, or prepatellar bursae is 6 mg (i.e., 3 mg of betamethasone as the sodium phosphate and 3 mg of betamethasone acetate in 1 mL of suspension), given by direct injection into the bursa as a single dose. Several intrabursal injections of a corticosteroid usually are required for the treatment of recurrent acute bursitis or acute exacerbations of chronic bursitis. Chronic bursitis may be treated at a reduced dosage once the acute condition is controlled. For the treatment of bursae under heloma durum or molle, the usual dosage is 1.5-3 mg (0.25-0.5 mL) given by direct injection and repeated every 3 days to 1 week. For treatment of bursae over hallux rigidus or digiti quinti varus or under calcaneal spur, the usual dosage is 3 mg (0.5 mL) repeated every 3 days to 1 week.
For very large joints such as the hip, 6-12 mg (1-2 mL of the suspension) is recommended. For large joints such as the knee, ankle, or shoulder, 6 mg (1 mL) is recommended. For medium-sized joints, such as the elbow or wrist, 3-6 mg (0.5-1 mL) is recommended. For smaller joints such as those in the hand (metacarpophalangeal, interphalangeal) or chest (sternoclavicular), 1.5-3 mg (0.25-0.5 mL) is recommended.
For treatment of ganglions of joint capsules and tendon sheaths, the usual dose of betamethasone in fixed combination with betamethasone acetate is 3 mg (0.5 mL), injected directly into the ganglion cysts. The usual dose for tenosynovitis or tendinitis is 6 mg (1 mL) injected into the tendon sheath; injections may be repeated every 1-2 weeks for a total of 3 or 4 local injections. For the treatment of tenosynovitis or periostitis of the cuboid bone, the usual dosage is 3 mg (0.5 mL) every 3 days to 1 week.
For treatment of acute gouty arthritis of the foot, the usual dosage of betamethasone in fixed combination with betamethasone acetate is 3-6 mg (0.5-1 mL) every 3 days to 1 week.
For intralesional injection, the usual dose of betamethasone in fixed combination with betamethasone acetate is 1.2 mg (0.2 mL) per cm2 of skin surface area injected intradermally (not subcutaneously); a single dose should not exceed 6 mg (1 mL) per week.
To prevent hyaline membrane disease (respiratory distress syndrome [RDS]) in premature infants†, 2 mL (6 mg of betamethasone acetate and 6 mg of betamethasone as the sodium phosphate) of the suspension has been given IM to the mother once daily for 2 or 3 days before delivery.
Betamethasone is a synthetic glucocorticoid. Betamethasone occurs as a white to practically white, odorless, crystalline powder and is insoluble in water and sparingly soluble in alcohol. The acetate ester of the drug occurs as a white to creamy white, odorless powder and is practically insoluble in water, soluble in alcohol and chloroform, and freely soluble in acetone. Betamethasone sodium phosphate occurs as a white to practically white, odorless, hygroscopic powder and is freely soluble in water and methanol, slightly soluble in alcohol, and is practically insoluble in acetone and chloroform. The sterile suspension of betamethasone sodium phosphate and betamethasone acetate has a pH of 6.8-7.2.
The sterile injectable suspension containing betamethasone sodium phosphate and betamethasone acetate should be protected from light and stored at 20-25°C but may be exposed to temperatures ranging from 15-30°C.103, 104 Betamethasone oral solution should be protected from light and stored at 25°C but may be exposed to temperatures ranging from 15-30°C.105
The sterile injectable suspension containing betamethasone sodium phosphate and betamethasone acetate should not be mixed with diluents or local anesthetics containing preservatives (such as parabens or phenol) because flocculation of the suspension may result.103, 104 Specialized references should be consulted for more specific compatibility information.
Additional Information
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.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Solution | 0.6 mg/5 mL | Celestone® Syrup | Schering |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injectable suspension | Betamethasone Sodium Phosphate 3 mg (of betamethasone) per mL with Betamethasone Acetate 3 mg/mL* | Celestone® Soluspan® | Merck |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Only references cited for selected revisions after 1984 are available electronically.
101. Fox ER, Mullin S. Drug shortages resource center: Injectable corticosteroid suspensions; 2004 Sep 17. From American Society of Health-System Pharmacists website.
102. Food and Drug Administration (FDA). Drug shortage: statement on Celestone Soluspan availability. Rockville, MD: Food and Drug Administration; 2004 Aug 26. From FDA website. Accessed 2004 Nov 17.
103. Schering-Plough. Celestone® Soluspan® (betamethasone sodium phosphate and betamethasone acetate) injectable suspension prescribing information. Kenilworth, NJ; 2008 Aug.
104. American Regent, Inc. Betamethasone sodium phosphate and betamethasone acetate injectable suspension prescribing information. Shirley, NY; 2009 Dec.
105. Schering. Celestone® (betamethasone) oral solution prescribing information. Whitehouse Station, NJ; 2010 Oct.
1000. Food and Drug Administration. Epidural corticosteroid injection: Drug safety communication - risk of rare but serious neurologic problems. 2014 Apr 23. From FDA website. Accessed 2014 May 19. [Web]
1001. Food and Drug Administration. FDA drug safety communication: FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain. 2014 Apr 23. From FDA website. Accessed 2014 May 19. [Web]
1002. Rathmell JP. Toward improving the safety of transforaminal injection. Anesth Analg . 2009; 109:8-10. [PubMed 19535690]
1003. Cohen SP, Bicket MC, Jamison D et al. Epidural steroids: a comprehensive, evidence-based review. Reg Anesth Pain Med . 2013 May-Jun; 38:175-200.