Betamethasone Sodium Phosphate + Betamethasone Acetate

Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is a sterile, aqueous glucocorticoid formulation with potent anti-inflammatory and immunosuppressive properties. It contains two esters of betamethasone that provide dual-phase activity: Betamethasone Sodium Phosphate: A highly water soluble ester ensuring rapid onset of action. Betamethasone Acetate: A low-solubility ester offering prolonged therapeutic effect. This combination is effective in the management of various corticosteroid-responsive conditions affecting multiple organ systems, including musculoskeletal, dermatologic, allergic, respiratory, gastrointestinal, and hematologic disorders.

Indication	Route	Dose	Frequency	Notes
Rheumatoid Disorders, Osteoarthritis	Intra-articular	0.5-2 mL Very large joints: 1-2mL Large: 1 mL Medium: 0.5-1 mL Small: 0.25-0.5mL	At intervals of every 1-4 weeks based on individual patients' response	Relief within 2-4 hours, no secondary flare reported.
Bursitis, Tenosynovitis, Peritendinitis	Intra-articular, Intrabursal	0.5-1 mL	At intervals of every 1-2 weeks, once or repeated as needed (up to 3-4 injections)	Typically restore full range of movement within hours. Injection should be made into the affected tendon sheaths, not tendon.
Acute gouty arthritis	Intra-articular	0.5-1 mL	At intervals of 3 days to a week based on individual patients' response	Monitoring of response is needed
Dermatologic lesions	Intralesional	0.2 ml of injection per cm² of lesion, not more than 1 ml per site	At weekly intervals based on individual patients' response	Injection should be made using a tuberculin syringe with a 25-gauge, ½-inch needle
Allergic and Respiratory conditions	Intramuscular	1-2 mL	At weekly intervals based on individual patients' response	Systemic anti-inflammatory effect
Acute exacerbation of multiple sclerosis	Intramuscular	5 mL/day for 1 week, followed by 2 mL every other day	1 month	Taper based on response; short-term high-dose therapy
Neoplastic disorder	Intramuscular	0.25-9mg per day, based on individual patients' response	As required	The dose may be adjusted downward over time to the lowest effective level.

Children: Usual dose 0.02-0.3 mg/kg daily in 3 or 4 divided doses. Dosages is individualized according to the disease being treated and patient response.

Co-administration with Local Anesthetic: Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can be mixed with 1% or 2% lidocaine HCl. First, withdraw the required suspension dose into the syringe, then add lidocaine and shake briefly. Do not inject lidocaine into the suspension vial.

Betamethasone sodium phosphate + Betamethasone acetate injectable suspension has notable drug-drug interactions that require careful monitoring. Hepatic enzyme inducers such as phenytoin, carbamazepine, rifampin, and barbiturates can accelerate its metabolism and reduce efficacy, while CYP3A4 inhibitors like ketoconazole, itraconazole, ritonavir, or cobicistat can increase corticosteroid exposure and adverse effects. Estrogens, including oral contraceptives, may potentiate its effects. Concurrent use with potassium-depleting agents (e.g., loop diuretics, amphotericin B) heightens hypokalemia risk. NSAIDs and aspirin may increase gastrointestinal ulcer or bleeding risk, and oral anticoagulants (e.g., warfarin) may have variable effects, necessitating coagulation monitoring. Corticosteroids can elevate blood glucose, reducing the efficacy of antidiabetic agents, and co-administration with cyclosporine may enhance drug activity and provoke seizures. Cholestyramine can increase corticosteroid clearance, while some macrolides may decrease clearance, altering exposure. These interactions can be clinically significant, so all concomitant medications should be reviewed before use.

• In patients with diabetes, herpes simplex of the eye, systemic fungal infections, cerebral malaria
• Hypersensitivity to betamethasone or any other component of the formulation
• Intramuscular administration in patients with idiopathic thrombocytopenia purpura

Local: Pain, redness, or infection at the injection site

Systemic (with prolonged use or high dose): Cushingoid features (e.g., moon face, weight gain), Hyperglycemia, Hypertension, Mood or behavioral changes, Osteoporosis, Increased risk of infection, Adrenal suppression

Pregnancy: Category C. Betamethasone Sodium Phosphate and Betamethasone Acetate Injection should be used during pregnancy if the possible benefits of the medication justify the potential hazards to the fetus.

Lactation: Betamethasone Sodium Phosphate and Betamethasone Acetate may appear in human milk and could suppress growth. Caution should be exercised when Betamethasone Sodium Phosphate and Betamethasone Acetate is administered to a nursing mother.

• Use caution in patients with diabetes, hypertension, osteoporosis, or peptic ulcer
• May cause adrenal suppression with prolonged use
• Avoid live vaccines during treatment
• Risk of infection at injection site
• May mask signs of infection
• Not for IV administration
• Shake well before use

Pediatric Use: Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (>2 years of age), and aggressive lymphomas and leukemias (>1 month of age). Other indications for pediatric use of corticosteroids, eg, severe asthma and wheezing, are based on adequate and well controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.

Geriatric Use: No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and young patients, but greater sensitivity of some older individuals cannot be ruled out.

Corticosteroid

Store below 30°C. Protect from light. Do not freeze. Keep out of reach of children. Shake well before use.