NORALIN

What it is

NORALIN is noradrenaline (norepinephrine) as acid tartrate monohydrate, supplied as a concentrate for intravenous injection. It is a sterile, clear colourless concentrated solution for injection available in ampoules. NORALIN is registered on the ARTG in four strengths: 3 mg/50 mL, 5 mg/50 mL, 6 mg/50 mL, and 10 mg/50 mL solutions for intravenous infusion.

Approved indications

— Restoration of blood pressure in acute hypotensive states including phaeochromocytomectomy, sympathectomy, poliomyelitis, spinal anaesthesia, myocardial infarction, septicaemia, blood transfusion and drug reactions. — Adjunctive treatment in cardiac arrest, to restore and maintain adequate blood pressure after an effective heartbeat and ventilation have been established by other means.

Dosing overview

NORALIN is a concentrated solution that must be diluted in glucose-containing solutions (5% glucose in distilled water or 5% glucose in saline solution) prior to infusion and must not be administered in saline solution alone. It should be given into a large vein. For acute hypotensive states, add 1 mL of the concentrate to 250 mL of 5% glucose solution, or 4 mL to 1 litre, yielding a dilution where each 1 mL contains 4 micrograms of noradrenaline base. Following an initial dose of 2 to 3 mL (8 to 12 micrograms of base) per minute, adjust the rate to maintain a low normal blood pressure (usually 80 to 100 mm Hg systolic). The average maintenance dose ranges from 0.5 to 1 mL per minute (2 to 4 micrograms of base). Dosage should be titrated according to patient response. The infusion rate should be reduced gradually, avoiding abrupt withdrawal. For cardiac arrest, NORALIN infusions are administered intravenously to maintain systemic blood pressure, using the same dosing approach as for acute hypotensive states.

Key safety warnings

NORALIN should be used with extreme caution in patients receiving monoamine oxidase inhibitors or antidepressants of the triptyline or imipramine types because severe, prolonged hypertension may result. NORALIN should be given into a large vein, particularly an antecubital vein, because the risk of skin necrosis from prolonged vasoconstriction is slight at this site. The femoral vein is also acceptable. Gangrene has been reported in a lower extremity when infusions were given in an ankle vein. Care should be taken to avoid extravasation into tissues as local necrosis might ensue due to the vasoconstrictive action. If extravasation occurs, the antidote is phentolamine; the area should be infiltrated as soon as possible with 10 mL to 15 mL of saline solution containing 5 mg to 10 mg of phentolamine. Because of varying responses to NORALIN, hypertension may be produced with overdoses; blood pressure should be recorded every two minutes from administration start until the desired pressure is obtained, then every five minutes if administration continues. The rate of flow must be watched constantly and the patient should not be left unattended whilst receiving NORALIN. Prolonged administration of NORALIN may result in plasma volume depletion which should be continuously corrected by appropriate fluid and electrolyte replacement; if plasma volumes are not corrected, hypotension may recur when the infusion is discontinued or blood pressure may be maintained at the risk of severe peripheral and visceral vasoconstriction with reduced blood flow and tissue perfusion.

Contraindications

NORALIN should not be given to patients who are hypotensive from hypovolaemia except as an emergency measure to maintain coronary and cerebral artery perfusion until blood volume replacement can be completed. NORALIN should not be given to patients with mesenteric or peripheral vascular thrombosis because of the risk of increasing ischaemia and extending the area of infarction, unless the attending physician considers it necessary as a lifesaving procedure. NORALIN is contraindicated in patients with hypersensitivity to noradrenaline or any of the excipients.

Regulatory history

NORALIN was first registered on the ARTG on 17 April 2020 in four strengths: 3 mg/50 mL, 5 mg/50 mL, 6 mg/50 mL, and 10 mg/50 mL solutions for intravenous infusion.