METARAMINOL GH PHARMA

What it is

Metaraminol GH Pharma is metaraminol tartrate available as a solution for injection or infusion containing 10 mg in 1 mL. Additional formulations contain 5 mg in 10 mL and 2.5 mg in 5 mL. It is a clear colourless sterile solution for intravenous administration, visibly free from particles.

Approved indications —

Prevention and treatment of the acute hypotensive state occurring with spinal anaesthesia. — Adjunctive treatment of hypotension due to haemorrhage. — Adjunctive treatment of hypotension due to reactions to medications. — Adjunctive treatment of hypotension due to surgical complications. — Adjunctive treatment of shock associated with brain damage due to tumour or trauma. — Adjunctive treatment of hypotension due to cardiogenic shock. — Adjunctive treatment of hypotension due to septicaemia.

Dosing overview

Metaraminol GH Pharma is for intravenous administration only, delivered by injection or infusion. In severe shock when time is critical, direct intravenous injection of 0.5 to 5 mg may be used, followed by an infusion of 15 to 100 mg in a diluent made up to a total volume of 500 mL. For intravenous infusion in adjunctive treatment of hypotension, the recommended dose is 15 to 100 mg in 0.9% sodium chloride injection or glucose injection 5% to make up a total volume of 500 mL infusion, adjusting the rate of infusion to maintain blood pressure at the desired level.

Key safety warnings

Because the maximum effect is not immediately apparent, at least ten minutes should elapse before increasing the dosage. The effect tapers off when the vasopressor is discontinued, and the patient should be carefully observed so that therapy can be reinitiated promptly if blood pressure falls too rapidly. Patients with coexistent shock and acidosis may show poor response to vasopressors. Established methods of shock management, such as blood or fluid replacement when indicated, and other measures directed to the specific cause of the shock should also be used. Metaraminol GH Pharma should be used in one patient on one occasion only, contains no antimicrobial preservative, and unused solution should be discarded.

Regulatory history

The 10 mg per 1 mL injection ampoule formulation (ARTG 99402) was first listed on 3 September 2004. Two additional formulations—the 3 mg per 6 mL and 5 mg per 10 mL solution for injection vials (ARTG 300197 and ARTG 304084)—were first listed on 7 June 2019.