1 NAME OF THE MEDICINAL PRODUCT F- Corten 8 mg/2ml ampoule. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule (2ml) contains: Active ingredient: Dexamethasone sodium phosphate 8.74 mg (Equivalent to Dexamethasone phosphate 8 mg) Excipients with known effect: Each 2 millimetre (2ml) of solution contains 2 milligrams (2mg) of sodium bisulfite. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Clear colorless solution free from visible particular matter in ampoule for I.V., I.M., intra-articular & intra-lesional injection. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications In the management of acute adrenocortical insufficiency, pre and post operative support, shock and in the active management of corticosteroid responsive conditions. In the management of inflammatory diseases of joints and soft tissue such as rheumatoid arthritis. In the short term management of acute self-limited allergic conditions such as angioneurotic oedema or acute exacerbations of chronic allergic disorders such as bronchial asthma or serum sickness. 4.2 Posology and method of administration Route of Administration: Intravenous Intramuscular Intra-articular and intralesional Recommended Dosage: N.B. All doses are expressed as mg dexamethasone phosphate. The usual dosage is 0.5-24 mg daily depending on the individual patient's condition and response. In Shock: Usually a dose of 2 to 6 mg/kg body weight is given intravenously as a single dose. This may be repeated if required, in 2 to 6 hours, or followed by the same dose as an intravenous infusion. High-dose therapy should be continued only until the patient's condition has stabilised and usually for no longer than 48-72 hours. This bolus injection can then be followed by continuous IV infusion of 3 mg/kg bodyweight per 24 hours. Dexamethasone Injection can be diluted with Sodium Chloride Injection B.P. or Glucose Injection B.P.
