XYLOCAINE

What it is

XYLOCAINE is lidocaine hydrochloride, or XYLOCAINE with ADRENALINE is lidocaine hydrochloride and adrenaline (epinephrine) acid tartrate, provided as injection solutions for the production of local or regional anaesthesia. The product is a clear, colourless solution for injection. Plain aqueous solutions are sterile, isotonic and contain lidocaine hydrochloride, sodium chloride, sodium hydroxide and/or hydrochloric acid for pH adjustment and water for injections. Lidocaine hydrochloride with adrenaline (epinephrine) acid tartrate solutions are also sterile and isotonic, and in addition contain adrenaline (epinephrine) acid tartrate and sodium metabisulfite.

Approved indications

XYLOCAINE solutions are indicated for the production of local or regional anaesthesia by the following techniques: — Infiltration — Intravenous regional anaesthesia (excluding solutions with adrenaline (epinephrine) acid tartrate) — Peripheral nerve block such as intercostal block — Major plexus block such as brachial plexus block — Epidural block — Subarachnoid block

Dosing overview

The lowest dosage and volume that results in effective anaesthesia should be used and should be based on the status of the patient and the type of regional anaesthesia intended. It is recommended that the dose of lidocaine at any one time should not exceed 3 mg/kg (plain solutions) or 7 mg/kg (solutions with adrenaline (epinephrine) acid tartrate). For children, a reduced dosage based on body weight or surface area should be used, and the dosage should be calculated for each patient individually and modified in accordance with the physician's experience and knowledge of the patient. A reduction in dosage may be necessary for elderly patients especially those with compromised cardiovascular and/or hepatic function, and in epidural anaesthesia, a smaller dose may provide adequate anaesthesia.

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. Because of the possibility of hypotension and bradycardia following major blocks, an IV cannula should be inserted before the local anaesthetic is injected. Injection should always be made slowly with frequent aspirations to avoid inadvertent intravascular injection which can produce cerebral symptoms even at low doses. Although intra-articular continuous infusions of local anaesthetics following arthroscopic and other surgical procedures is an unapproved use, there have been post-marketing reports of chondrolysis in patients receiving such infusions, with the majority of reported cases involving the shoulder joint. XYLOCAINE and XYLOCAINE with ADRENALINE should not be used for post-operative intra-articular continuous infusion. When neuraxial anaesthesia (epidural/spinal anaesthesia) is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis, with risk increased by indwelling epidural catheters, traumatic or repeated puncture, and concomitant use of drugs affecting haemostasis. Solutions containing adrenaline (epinephrine) acid tartrate also contain sodium metabisulfite which may cause allergic type reactions including anaphylactic type 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.

Contraindications

Allergy or hypersensitivity to amide type local anaesthetics or to any excipients is a contraindication. Allergy or hypersensitivity to sodium metabisulfite in solutions with adrenaline (epinephrine) acid tartrate is a contraindication. Local anaesthetics are contraindicated for epidural and spinal anaesthesia in patients with uncorrected hypotension or coagulation disorders or in patients receiving anti coagulation treatment. Local anaesthetic techniques must not be used when there is inflammation and/or sepsis in the region of the proposed injection and/or in the presence of septicaemia. Adrenaline (epinephrine) acid tartrate is contraindicated in conditions where the production or exacerbation of tachycardia may prove fatal, such as thyrotoxicosis or severe heart disease, or in obstetrics when maternal blood pressure exceeds 130/80 mm Hg. Solutions with adrenaline (epinephrine) acid tartrate must not be used for local analgesia in parts of the body with compromised blood supply or supplied by end arteries, such as fingers, toes, nose, ears or penis, due to the possibility of producing arterial vasoconstriction and subsequent ischaemic gangrene distal to the site of injection. Solutions with adrenaline (epinephrine) acid tartrate must not be used for intravenous regional techniques.

PBS listing

XYLOCAINE solution containing lidocaine hydrochloride 20 mg per mL (2%), 200 mL is listed on the PBS as one item with unrestricted access at an ex-manufacturer price of A$85.68.

Regulatory history

Multiple XYLOCAINE formulations were first listed on the ARTG on 13 August 1991, including XYLOCAINE 0.5%, 0.5% with adrenaline 1:200,000, 1%, 1% with adrenaline 1:200,000, 1.5% with adrenaline 1:200,000, and 2%. Additional strengths including XYLOCAINE 1% with adrenaline 1:100,000 and 2% with adrenaline 1:80,000 were listed in 1996. The medicine was first approved on 10 October 2008.