Betamethasone
AHFS Class: Adrenals (68:04)
VA Class: HS051
ATC Class: H02AB01
Flubenisolone
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 View the associated Essentials monograph.
Introduction
Betamethasone is a synthetic glucocorticoid.
See Uses in the associated General Statement for more information.
Uses
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.
See Dosage and Administration in the associated General Statement for more information.
Dosage and Administration
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.731 Lack of satisfactory response after a reasonable trial of betamethasone or betamethasone sodium phosphate in fixed combination with bethamethasone acetate should lead to discontinuance of therapy and transfer to other appropriate therapy.731 762 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 Following long-term therapy, betamethasone should be withdrawn gradually.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
Betamethasone is administered orally. 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.762
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.731 757 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, in the Corticosteroids General Statement in 68:04)
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.731 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.731 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. (See Chemistry and Stability: Stability.)
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.731 Several intrabursal injections of a corticosteroid usually are required for the treatment of recurrent acute bursitis or acute exacerbations of chronic bursitis.731 Chronic bursitis may be treated at a reduced dosage once the acute condition is controlled.731 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.731 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.731
For very large joints such as the hip, 6–12 mg (1–2 mL of the suspension) is recommended.731 For large joints such as the knee, ankle, or shoulder, 6 mg (1 mL) is recommended.731 For medium-sized joints, such as the elbow or wrist, 3–6 mg (0.5–1 mL) is recommended.731 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.731
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.731 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.731 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.731
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.731
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.731
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.
See Cautions in the associated General Statement for more information.
See Drug Interactions in the associated General Statement for more information.
See Lab Test Interferences in the associated General Statement for more information.
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 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.731 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.731 The sterile suspension of betamethasone sodium phosphate and betamethasone acetate has a pH of 6.8–7.2.
Stability
The sterile suspension containing betamethasone sodium phosphate and betamethasone acetate (Celestone® Soluspan®) should be protected from light and stored at 2–25°C but may be exposed to 15–30°C.731 Betamethasone oral solution should be protected from light and stored at 25°C but may be exposed to temperatures ranging from 15–30°C.762
Celestone® Soluspan® should not be mixed with diluents or local anesthetics containing preservatives (such as parabens or phenol) because flocculation of the suspension may result. Specialized references should be consulted for more specific compatibility information.
For further information on chemistry, pharmacology, pharmacokinetics, uses, cautions, drug interactions, laboratory test interferences, and dosage and administration of betamethasone, see the Corticosteroids General Statement 68:04. For topical use, see 84:06.
Preparations
Betamethasone
| Routes | Forms | Strengths | Brand Names | Manufacturer |
|---|
| Oral |
Solution |
0.6 mg/5 mL |
Celestone® Syrup (with alcohol and propylene glycol) |
Schering |
Betamethasone Sodium Phosphate and Betamethasone Acetate
| Routes | 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® (with edetate disodium and benzalkonium chloride) |
Schering-Plough |
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
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Selected Revisions January 2007, © Copyright, May 1978, American Society of Health-System Pharmacists, Inc. 7272 Wisconsin Avenue, Bethesda, MD 20814. |
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References
101. Fox ER, Mullin S. Drug shortages resource center: Injectable corticosteroid suspensions; 2004 Sep 17. From American Society of Health-System Pharmacists website (http://ashp.org/shortage/celestone.cfm?CFID=3351917&CFTOKEN=16867778.
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 (http://www.fda.gov/cder/drug/shortages/celestone.htm. Accessed 2004 Nov 17.
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