Consumer medicine information

What is in this leaflet

This leaflet answers some of the common questions people ask about XYLOCARD. It does not contain all the information that is known about XYLOCARD.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you taking XYLOCARD against the benefits they expect it will have for you.

Keep this leaflet with the medicine. You may need to read it again.

What XYLOCARD is for

XYLOCARD is used to change an abnormal beat in the heart back to normal. It works by slowing nerve impulses and reducing the excitability of the heart.

XYLOCARD belongs to a group of medicines known as antiarrhythmics.

Your doctor will have explained why you are being treated with XYLOCARD and told you what dose you will be given.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.

XYLOCARD is not addictive.

Before you are given XYLOCARD

When you must not use it

If you are pregnant or breastfeeding do not use XYLOCARD unless your doctor says so. Ask your doctor about the risks and benefits of using this medicine while you are pregnant or breastfeeding. XYLOCARD has been widely used during pregnancy and there have been no reports of any ill effects on the baby.

Your baby can take in very small amounts of XYLOCARD from breast milk if you are breastfeeding, but it is unlikely that the amount available to the baby will do any harm.

XYLOCARD will only be used if the solution is clear, the package is undamaged and the use by (expiry) date marked on the pack has not been passed.

Before you are given it

You must tell your doctor if:

1. you have any allergies to

• ingredients listed at the end of this leaflet
• other antiarrhythmic medicines
• local anaesthetics eg. bupivacaine
• other substances

If you have an allergic reaction, you may get a skin rash, hay fever, difficulty breathing or feel faint.

2. you have any of these medical conditions

• a pace maker
• any other heart problems
• liver problems
• kidney problems
• malignant hyperthermia

It may not be safe for you to take XYLOCARD if you have any of these conditions.

Taking other medicines

Tell your doctor if you are taking any other medicines, including

• ones to control your heart beat
• ones for blood pressure (anti-hypertensives)
• ones for epilepsy or fits
• cimetidine
• alcohol
• any medicines that you buy at the chemist, supermarket or health food shop.

These medicines may affect the way XYLOCARD works.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

If you have not told your doctor about any of these things, tell them before you are given any XYLOCARD.

How XYLOCARD is given

XYLOCARD will be injected by your doctor directly into the bloodstream or will be added to fluids given into the vein. This allows XYLOCARD to reach the heart quickly, where it will reduce the excitability of the heart and help return the heart beat to normal.

The dosage you will be given will depend on your body size, age and medical condition. Your doctor will have had a lot of experience injecting XYLOCARD or other antiarrhythmics, and will choose the best dose for you. They will be willing to discuss this decision with you.

Overdose

The doctor giving you XYLOCARD will be experienced in the use of antiarrhythmic drugs, so it is unlikely that you will be given an overdose. However, if you are particularly sensitive to XYLOCARD, you may develop problems such as nervousness, dizziness, blurred vision, tremor or drowsiness.

Whenever you are given XYLOCARD, equipment will be available to care for you if an overdose happens.

While you are being given it

Things to be careful of

Be careful driving or operating machinery after you have been given XYLOCARD. You may be drowsy and your reflexes may be slow.

Do not drink alcohol while you are being given XYLOCARD. If you drink alcohol while you are being given XYLOCARD your blood pressure may drop making you feel dizzy and faint.

Please talk to your doctor or pharmacist about these possibilities if you think they may bother you.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given XYLOCARD. XYLOCARD will return abnormal heart beats back to normal in most people, but it may have unwanted side-effects. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor, nurse or pharmacist to answer any questions you may have.

Tell your doctor or nurse if you notice any of the following and they worry you:

• drowsiness
• lightheadedness
• nervousness
• dizziness
• feeling strange (disoriented)
• blurred vision
• ringing in the ears
• vomiting
• twitching
• tremors
• feeling hot, cold or numb
• difficulty swallowing
• slurred speech

These are all mild side effects of XYLOCARD.

If XYLOCARD is given wrongly, or you are very sensitive to it, it sometimes causes:

• fits
• unconsciousness
• breathing problems
• low blood pressure
• slow heart beat
• collapse
• a problem with your blood called methaemoglobinaemia

These are all serious side effects. You may need urgent medical attention.

Some people may get other side effects while taking XYLOCARD.

Tell your doctor if you notice anything else that is making you feel unwell.

After using it

Storage

XYLOCARD will be stored by your doctor or pharmacist under the recommended conditions.

It should be kept in a cool dry place where the temperature stays below 25 degrees C.

Disposal

Any XYLOCARD from a single dose which is not used , will be disposed of in a safe manner by your doctor or pharmacist.

Product description

All XYLOCARD solutions are clear and colourless.

XYLOCARD 100* solution contains lidocaine (lignocaine) hydrochloride 2% as the active ingredient;
plus,
Sodium chloride
Sodium hydroxide
Water for Injections

XYLOCARD 500 and XYLOCARD 1000* solutions contain lidocaine (lignocaine) hydrochloride 10% as the active ingredient;
plus,
Sodium hydroxide
Water for Injections

Lidocaine is the new name for lignocaine.

Sponsor

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australia

This leaflet was revised in August 2017

Australian Registration Numbers

Xylocard 100* 12032

Xylocard 500 12036

Xylocard 1000* 12035

* Not currently marketed.

^®Trade Marks herein are the property of the AstraZeneca group

Published by MIMS November 2020

1 Name of Medicine

Lidocaine hydrochloride.

2 Qualitative and Quantitative Composition

The active ingredient in Xylocard is lidocaine hydrochloride.
Plain aqueous solutions are sterile, isotonic and contain lidocaine hydrochloride, sodium hydroxide for pH adjustment and water for injections.

3 Pharmaceutical Form

All Xylocard solutions are clear and colourless.

4 Clinical Particulars

4.9 Overdose

Toxicity is initially manifested as CNS excitation and may result in a slow onset of nervousness, dizziness, blurred vision and tremors followed by drowsiness, convulsions, unconsciousness and possibly respiratory arrest.
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 medicines such as a benzodiazepine or a barbiturate. Toxic cardiovascular reactions are usually depressant in nature, may occur rapidly and with little warning and can lead to peripheral vasodilation, hypotension, myocardial depression and bradycardia. In rare cases, cardiac arrest has occurred without prodromal CNS effects.
Treatment of overdosage. Discontinue administration of Xylocard. Maintain a patent airway and support ventilation with oxygen and assisted or controlled respiration as required.
Should a convulsion persist despite ventilation therapy, small increments of a benzodiazepine (e.g. diazepam) or an ultra short acting barbiturate (e.g. thiopentone) may be given intravenously.
Cardiovascular depression may require circulatory assistance in the form of elevation of legs, intravenous fluids and/or vasopressor agents, volume expanders and, if necessary, cardiac massage.
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 for 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 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). In addition, 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

The chemical name for lidocaine hydrochloride is 2 Diethylaminoaceto 2',6' xylidide hydrochloride.
White crystalline powder which, at 20°C, is soluble in 0.7 parts water; 1.5 parts ethanol (96%); practically insoluble in ether.
Plain aqueous solutions of lidocaine hydrochloride have a pH of 5.0 - 7.0. Lidocaine base has a pKa of 7.85 (25°C) and a molecular weight of 234.3.
Chemical structure. The chemical structure of lidocaine is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLIDHYD.gif CAS number. The CAS number for lidocaine hydrochloride is 73-78-9.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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