Lidocaine Injection

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

Lidocaine Injection contains the active ingredient lidocaine hydrochloride monohydrate.

Lidocaine Injection is as a local anaesthetic to stop pain and feeling in the area around where it is injected. Lidocaine Injection is also used as an antiarrhythmic drug to restore irregular and/or rapid heartbeats to normal.

For more information, see Section 1. Why am I given Lidocaine Injection? in the full CMI.

Do not use if you have ever had an allergic reaction to lidocaine (Lidocaine) hydrochloride or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before receiving Lidocaine Injection? in the full CMI.

Some medicines may interfere with Lidocaine Injection and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

Lidocaine Injection is given by injection into the skin, directly into the blood stream or into an organ. It must only be given by a doctor or nurse.

More instructions can be found in Section 4. How is Lidocaine Injection given? in the full CMI.

For more information, see Section 5. What should I know after receiving Lidocaine Injection? in the full CMI.

Common and serious side effects are weakness, confusion, nervousness, drowsiness, disorientation, nausea, vomiting, headache, dizziness or light-headedness, ringing in the ears, slurred speech, numbness, tremors, twitching, breathing difficulties, blurred or double vision, fits or convulsions, skin rash, hives or itching, slow or rapid heart rate.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Lidocaine hydrochloride monohydrate.

2 Qualitative and Quantitative Composition

Each 1 mL of lidocaine injection contains 10 mg or 20 mg lidocaine hydrochloride monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Lidocaine injection is a clear, colourless, sterile, isotonic, preservative-free solution.

4 Clinical Particulars

4.9 Overdose

In anaesthesia, acute emergencies associated with the use of lidocaine are normally related to high plasma levels, or unintended subarachnoid injection (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).
With accidental intravascular injections, the toxic effect will be obvious within one to three minutes. With overdosage, peak plasma concentrations may not be reached for 20 to 30 minutes depending on the site of injection, and toxic signs will be delayed. Toxic reactions mainly involve the central nervous and cardiovascular systems.
Symptoms. In children, early signs of local anaesthetic toxicity may be difficult to detect in cases where the block is given during general anaesthesia.
Acute toxicity. CNS toxicity is a graded response with symptoms and signs of escalating severity. The first symptoms are circumoral paraesthesia, numbness of the tongue, lightheadedness, hyperacusis and tinnitus. Visual disturbance and muscular tremors are more serious and precede the onset of generalised convulsions. These signs must not be mistaken for neurotic behaviour.
Unconsciousness and grand mal convulsions may follow. These may last from a few seconds to several minutes. Hypoxia and hypercarbia occur rapidly following convulsions due to the increased muscular activity, together with the interference with normal respiration and loss of the airway. In severe cases, apnoea may occur. Acidosis increases the toxic effects of local anaesthetics.
Recovery is due to redistribution of the local anaesthetic drug from the central nervous system and metabolism. Recovery may be rapid unless large amounts of the drug have been injected.
Cardiovascular toxicity. Cardiovascular toxicity indicates a more severe situation. Hypotension, bradycardia, decreased cardiac output, heart block, arrhythmia and even ventricular arrhythmias, ventricular fibrillation and cardiac arrest may occur as a result of huge systemic concentrations of local anaesthetics.
Cardiovascular toxic effects are generally preceded by signs of toxicity in the central nervous system, unless the patient is receiving a general anaesthetic or is heavily sedated with drugs such as a benzodiazepine or a barbiturate. In rare cases, cardiac arrest has occurred without prodromal CNS effects.
Management of adverse effects. Treatment of toxicity should be to discontinue administration of lidocaine. Institute emergency resuscitative procedures and administer the emergency drugs necessary to manage the situation. Adequate ventilation of the patient (including oxygen if necessary) should be ensured and convulsions should be arrested if present. Adequacy of the circulation should then be evaluated, bearing in mind that drugs used to treat convulsions depress the circulation when administered intravenously.
For severe convulsions, small increments of diazepam or a short-acting barbiturate such as thiopentone should be administered. Suxamethonium will stop the muscle convulsions rapidly but will require tracheal intubation and controlled ventilation, and should only be used by those familiar with these procedures. If ventricular fibrillation or cardiac arrest occurs, effective cardiovascular resuscitation treatment must be instituted and maintained for a prolonged period if necessary. Optimal oxygenation and ventilation, and circulatory support as well as treatment of acidosis are of vital importance. If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasopressor, chronotropic and or inotropic agents should be considered. Children should be given doses commensurate with age and weight.
Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. The genotoxic potential of 2,6-xylidine has been studied with mixed results: positive results were reported in assays of gene mutations (weakly positive in the Ames test with metabolic activation and in the mouse lymphoma assay) and chromosomal damage (chromosomal aberrations in Chinese hamster ovary cells at concentrations at which the drug is precipitated from solution). No evidence of genotoxicity was found in in vivo assays for chromosomal damage (micronucleus assay) and DNA damage (unscheduled DNA synthesis). Covalent binding studies of DNA from liver and ethmoid turbinates in rats indicate that 2,6-xylidine may be genotoxic under certain conditions in vivo.
Carcinogenicity. A two year oral toxicity study of 2,6-xylidine, a metabolite of lidocaine, has shown that in both male and female rats, 2,6-xylidine in daily doses of 900 mg/m² (150 mg/kg) resulted in carcinomas and adenomas of the nasal cavity. No nasal tumours were observed in the low dose (15 mg/kg) or control animals. The compound also caused subcutaneous fibromas and/or fibrosarcomas in male and female rats (significant at 150 mg/kg).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLDHYMO.gif Chemical name: 2-diethylamino-2',6'-dimethylacetanilide hydrochloride monohydrate.
Molecular formula: C₁₄H₂₂N₂OHClH₂O.
Molecular weight: 288.8.
CAS number. 6108-05-0.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/BRILIDST.gif