Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP is a sterile aqueous suspension delivering 3 mg/mL betamethasone sodium phosphate and 3 mg/mL betamethasone acetate (6 mg/mL total) in a 30 mg/5 mL multiple-dose vial. Indicated when oral corticosteroid therapy is not feasible, this dual-ester formulation provides both prompt and sustained anti-inflammatory activity via intramuscular, intra-articular, intralesional, intrabursal, soft tissue, and intradermal routes.

Key Benefits

• Dual-Phase Anti-Inflammatory Action: Soluble betamethasone sodium phosphate provides rapid onset; sparingly soluble betamethasone acetate delivers sustained activity from a single injection.
• Broad Clinical Indications: Indicated for allergic, rheumatologic, dermatologic, endocrine, hematologic, ophthalmic, and respiratory conditions when oral therapy is not feasible.
• Versatile Administration Routes: Approved for intramuscular, intra-articular, intralesional, intrabursal, soft tissue, and intradermal use.
• Multiple-Dose Vial Format: 5 mL vial (NDC 0517-0720-01) supports efficient, repeated clinical dosing.
• Sterile USP-Grade Formulation: Manufactured by American Regent, Inc. to USP standards; pH 6.8–7.2 with benzalkonium chloride preservative.

Dosage and Administration

Dosage must be individualized by indication and patient response. Initial parenteral doses range from 0.25 to 9 mg/day; higher doses may be warranted in acute, life-threatening situations. Taper gradually to the lowest effective maintenance dose. Not for intravenous use. Shake well before using.

• General IM Use: 0.25 to 9 mg/day based on disease and severity.
• Multiple Sclerosis (Acute Exacerbations): 30 mg/day for one week, then 12 mg every other day for one month.
• Intra-Articular: 0.25–0.5 mL (small joints); 0.5–1 mL (medium); 1 mL (large); 1–2 mL (very large, e.g., hip).
• Intralesional: 0.2 mL/cm² intradermally; maximum 1 mL per weekly interval via 25-gauge, ½-inch needle.
• Bursitis / Tenosynovitis: 1 mL intrabursal for acute bursitis; three to four injections at 1–2 week intervals for tenosynovitis.
• Pediatric: 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m² BSA/day).
• Local Anesthetic Admixture: May be mixed with paraben-free 1% or 2% lidocaine hydrochloride. Do not inject anesthetic directly into the vial.

Why Choose Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension?

• Prompt and Prolonged Efficacy: Dual-ester design delivers immediate and extended anti-inflammatory control in a single administration.
• Multi-Route Flexibility: Supports intra-articular, intramuscular, intralesional, intrabursal, and intradermal use across diverse indications.
• Established Regulatory Standing: Distributed by American Regent, Inc. under ANDA090747; in continuous clinical use since 2010.

Warnings

• Not for Intravenous or Epidural Use: IV administration is contraindicated. Serious neurologic events including paraplegia, quadriplegia, cortical blindness, and stroke have been reported with epidural corticosteroid injection; this route is not approved.
• Infection Risk: Corticosteroids suppress immune function, increasing susceptibility to viral, bacterial, fungal, and parasitic infections. Do not inject into infected sites. Use caution in patients with latent tuberculosis or Strongyloides infestation.
• HPA Axis Suppression: Prolonged use may cause reversible HPA suppression and adrenal insufficiency upon withdrawal. Taper doses gradually. Use with caution in renal insufficiency, congestive heart failure, and hypertension.

Disclaimer

Disclaimer: This product description was generated by AI and is intended for informational purposes only. Please consult the latest package insert.