LIDOCAINE-BAXTER

What it is

Lidocaine-Baxter is a sterile, isotonic solution containing lidocaine (lignocaine) hydrochloride monohydrate. It is a clear, colourless solution for injection. The medicine is available in two concentrations: 1% (10 mg/mL) and 2% (20 mg/mL), supplied in ampoules of 2 mL, 5 mL or 20 mL.

Approved indications

Lidocaine-Baxter solutions are indicated for the production of local or regional anaesthesia by the following techniques: — Infiltration. — Intravenous regional anaesthesia. — Peripheral nerve block. — Epidural block. — Subarachnoid block.

Dosing overview

The dose of lidocaine-Baxter at any one time should not exceed 3 mg/kg. 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. 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 intravenous cannula should be inserted before the local anaesthetic is injected. Delay in proper management of dose-related toxicity, under-ventilation from any cause and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and death. 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 cases involving the shoulder joint. Symptoms such as joint pain, stiffness and loss of motion can begin as early as the second month after surgery. Currently, there is no effective treatment for chondrolysis, and patients have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. Therefore, Lidocaine-Baxter 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. The risk of these events is increased by the use of indwelling epidural catheters, traumatic or repeated epidural/spinal puncture, and the concomitant use of drugs affecting haemostasis such as NSAIDs, platelet inhibitors or other anticoagulants. Patients should be frequently monitored for signs and symptoms of neurological impairment.

Contraindications

Lidocaine-Baxter is contraindicated in patients with allergy or hypersensitivity to amide type local anaesthetics or to any excipients. 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.

PBS listing

No PBS listing information is available in the provided documents.

Regulatory history

Lidocaine-Baxter was first listed on the Australian Register of Therapeutic Goods on 7 April 2015, with six registered variants covering 1% and 2% concentrations in 2 mL, 5 mL and 20 mL ampoules and vials.