Finished product reference
Betamethasone La (Betamethasone as Disodium Phosphate / Betamethasone Acetate)
Injection, Suspension, Extended Release · Parenteral · 3 mg/3 mg/1mL
- List code
- 153
- Pharmacologic class
- Corticosteroid (glucocorticoid); injectable soluble and depot combination
What it is and how it works
The combination contains betamethasone sodium phosphate, a soluble ester with rapid onset, and betamethasone acetate, a sparingly soluble ester providing prolonged (depot) activity. Betamethasone is a potent glucocorticoid with negligible mineralocorticoid activity that suppresses inflammatory and immune responses.
Indications
Corticosteroid-responsive conditions requiring parenteral therapy, including allergic, rheumatic, dermatological and inflammatory disorders; intra-articular or soft-tissue injection for arthritis, bursitis and tendinitis; promotion of fetal lung maturation in threatened preterm delivery.
Dosage and administration (summary)
Individualised according to condition and site: by intramuscular, intra-articular, intralesional or soft-tissue injection (not for intravenous use). For fetal lung maturation, typically 12 mg intramuscularly, repeated after 24 hours.
Contraindications
Systemic fungal infections; hypersensitivity to betamethasone; intramuscular use in idiopathic thrombocytopenic purpura; injection into infected joints or unstable joints.
Warnings and precautions
Prolonged or repeated use may cause adrenal suppression, Cushingoid features, hyperglycaemia, hypertension, osteoporosis, peptic ulceration, mood changes and increased susceptibility to infection; live vaccines should be avoided during immunosuppressive doses. Do not inject intravenously or subcutaneously; inadvertent subcutaneous injection may cause tissue atrophy. Withdraw gradually after prolonged therapy.
Pregnancy
Used deliberately for fetal lung maturation; otherwise use in pregnancy only when benefit outweighs risk, with monitoring of the neonate for adrenal suppression after prolonged use.
Storage and supply
Store below 25 °C, protected from light; do not freeze; shake well before use.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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