NORADRENALINE KABI

What it is

Noradrenaline BNM is a sterile, clear colourless concentrated solution for injection containing noradrenaline (norepinephrine) as acid tartrate monohydrate, available in ampoules. It is a concentrated solution for injection which must be diluted in glucose containing solutions prior to infusion.

Approved indications

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

Dosing overview

The average dilution is 1 mL of Noradrenaline BNM (1:1000) added to 250 mL of 5% glucose solution, or 4 mL of Noradrenaline BNM (1:1000) added to 1 litre of 5% glucose solution, with each 1 mL of dilution containing 4 micrograms of noradrenaline. After observing the response to an initial dose of 2 to 3 mL (8 to 12 micrograms of base) per minute, the rate of flow is adjusted to establish and maintain a low normal blood pressure (usually 80 to 100 mm Hg systolic) sufficient to maintain the circulation to vital organs. The average maintenance dose ranges from 0.5 to 1 mL per minute (2 to 4 micrograms of base). In all cases, dosage of Noradrenaline BNM should be titrated according to the response of the patient.

Key safety warnings

Noradrenaline BNM should be used with extreme caution in patients receiving monoamine oxidase (MAO) inhibitors or antidepressants of the triptyline or imipramine types because severe, prolonged hypertension may result. Noradrenaline BNM should be given into a large vein, particularly an antecubital vein, because the risk of necrosis of the overlying skin from prolonged vasoconstriction is apparently very slight when administered into this vein; the femoral vein is also an acceptable route of administration. Gangrene has been reported in a lower extremity when infusions of noradrenaline (norepinephrine) were given in an ankle vein. Noradrenaline BNM infusion solutions should not be administered into the veins in the leg in elderly patients. Care should be taken to avoid extravasation of Noradrenaline BNM into the tissues as local necrosis might ensue due to the vasoconstrictive action of the drug. The antidote for extravasation ischaemia is phentolamine; to prevent sloughing and necrosis, 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. Noradrenaline (norepinephrine) should be used only in conjunction with appropriate blood volume replacement. Prolonged administration of any potent vasopressor may result in plasma volume depletion; 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 with subsequent tissue hypoxia and lactic acidosis.

Contraindications

Noradrenaline BNM 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 therapy can be completed. Noradrenaline BNM 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, in the opinion of the attending physician, the administration of Noradrenaline BNM is necessary as a lifesaving procedure. Hypersensitivity to noradrenaline (norepinephrine) or any of the excipients.

Regulatory history

Noradrenaline BNM was first approved on 20 July 2016. Multiple variants of Noradrenaline were first listed on the ARTG on 2022-03-01, including NORADRENALINE MEDSURGE and NORADRENALINE MEDICIANZ in strengths of 1 mg/1 mL, 2 mg/2 mL, 4 mg/4 mL, 5 mg/5 mL, 8 mg/8 mL and 10 mg/10 mL concentrated injection ampoules.