Product Dossier

XYLOCAINE

Product Dossier for XYLOCAINE (Lidocaine (lignocaine) hydrochloride, Adrenaline (epinephrine) acid tartrate, Dentsply Sirona). ARTG record, PBS listing,…

What it is

Xylocaine is a local anaesthetic containing lidocaine hydrochloride monohydrate and adrenaline (epinephrine) acid tartrate. Lidocaine is a membrane stabilising agent and a local anaesthetic of the amide type. Adrenaline (epinephrine) is a potent sympathomimetic. The 2% formulation with adrenaline (epinephrine) 1:80,000 is available in 2.2 mL standard and self-aspirating cartridges. All Dentsply Sirona Xylocaine dental cartridges with adrenaline (epinephrine) are paraben free and for single use in a single patient only.

Approved indications

— Lidocaine solutions are indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques. — Lidocaine solutions with adrenaline (epinephrine) are recommended for oral surgery requiring prolonged duration of anaesthesia and haemostasis.

Dosing overview

The lowest dosage that results in effective anaesthesia for the planned treatment should be used. For adults receiving Xylocaine 2% with adrenaline (epinephrine) 1:80,000, infiltration typically requires 1–2 mL with onset of action at approximately 1.5 minutes and pulp anaesthesia duration of 60 minutes, whilst nerve block techniques typically require 1.5–5 mL with onset at approximately 4 minutes and pulp anaesthesia duration of 90 minutes. It is recommended that the dose of lidocaine at any one time should not exceed 7 mg/kg for adrenaline (epinephrine) containing solutions. For children, the dose may have to be reduced commensurate with body weight.

Key safety warnings

Resuscitative equipment and drugs, including oxygen, should be immediately available in order to manage possible adverse reactions involving the cardiovascular, respiratory or central nervous systems when any local anaesthetic agent is used. Injection should always be made slowly with frequent aspirations to avoid inadvertent intravascular injection which can produce toxic effects, and multiple injections should be administered at spaced intervals. Lidocaine should be given with great caution to patients with severe bradycardia, cardiac conduction disturbances or severe digitalis intoxication. Adrenaline (epinephrine)-containing solutions should be used with extreme caution in patients with severe or untreated hypertension, arteriosclerotic heart disease, heart block, cerebral vascular insufficiency, thyrotoxicosis, advanced diabetes or any other pathological condition that might be aggravated by the effects of adrenaline (epinephrine), as adrenaline (epinephrine) may induce anginal pain in patients suffering from ischaemic heart disease. Lidocaine with adrenaline (epinephrine) solutions contain sodium metabisulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people, with sulfite sensitivity seen more frequently in asthmatic than non-asthmatic people. The patient should be advised to exert caution to avoid inadvertent trauma to the lips, tongue, cheek mucosa or soft palate when these structures are anaesthetised, and eating and drinking hot liquids should be postponed until normal function returns.

Contraindications

Xylocaine is contraindicated in patients with allergy or hypersensitivity to amide type local anaesthetics or other components of the injection solution which may be present, such as sodium metabisulfite. Local anaesthetic techniques must not be used when there is inflammation and/or sepsis in the region of the proposed injection. Solutions with adrenaline (epinephrine) should not be used in patients with a known sensitivity to sympathomimetic amines. Solutions with adrenaline (epinephrine) should not be used in most patients with cerebral arteriosclerosis.

Regulatory history

Xylocaine was first approved on 13 August 1991.