ADRENALINE

What it is

ADRENALINE JR VIATRIS is an adrenaline (epinephrine) injection that contains 150 micrograms (0.15 mg) in 0.3 mL as the active ingredient. It is presented as a clear and colourless liquid. The product contains sulfites as an excipient with known effect.

Approved indications

— Emergency treatment of anaphylaxis (acute severe allergic reactions) due to insect stings, or bites, foods, drugs or other allergens.

Dosing overview

For children weighing 15 to 30 kg, the dose is an intramuscular injection of ADRENALINE JR VIATRIS Auto-Injector containing 0.15 mg adrenaline injection (0.15 mg/0.3 mL). With severe persistent anaphylaxis, repeat injections may be necessary, and the dose may be repeated after 15 minutes if symptoms recur or have not subsided. It is recommended that patients are prescribed two ADRENALINE JR VIATRIS Auto-Injector pens which they should carry at all times.

Key safety warnings

A severe anaphylactic reaction is a life-threatening emergency and administration of ADRENALINE JR VIATRIS is not intended as a substitute for immediate medical care; in conjunction with adrenaline administration, the patient should seek immediate medical or hospital care. Adrenaline should not be injected intravenously as cerebral haemorrhage may occur due to a sharp rise in blood pressure. ADRENALINE JR VIATRIS Auto-Injector contains sodium metabisulfite, a sulfite, which may cause allergic-type reactions including anaphylactic symptoms and bronchospasm in susceptible people, especially those with a history of asthma. The presence of a sulfite in this product should not deter administration for serious allergic reactions even if the patient is sulfite-sensitive. Adrenaline can cause potentially fatal ventricular arrhythmias including fibrillation, especially in patients with organic heart disease or those receiving other drugs that sensitise the heart to arrhythmias. Adrenaline should be administered with caution in patients who have heart disease, including patients with cardiac arrhythmias, coronary artery or organic heart disease or hypertension. To decrease the risk of Clostridium infection, do not inject ADRENALINE JR VIATRIS into the buttock, and advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the adrenaline injection site.

Contraindications

Contraindications are relative as this product is intended for use in life-threatening emergencies. Adrenaline should not be used in patients with certain types of arrhythmia, cerebral arteriosclerosis and where vasopressor drugs are contraindicated, such as thyrotoxicosis. Adrenaline is also contraindicated in shock (other than anaphylactic shock) and in patients during general anaesthesia with halogenated hydrocarbons or cyclopropane.

Regulatory history

ADRENALINE JR VIATRIS was first approved on 1 March 2018. The product is registered on the Australian Register of Therapeutic Goods as ARTG 296843 under licence category RE.