Consumer medicine information

What is in this leaflet

Xylocaine and lidocaine (also known as lignocaine), are different names for the same medicine - which is used as to stop pain during dental procedures. It is only called Xylocaine Dental in this leaflet.

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

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

All medicines have risks and benefits. Your dentist will have weighed the risks of you being given Xylocaine Dental against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your dentist or pharmacist.

Keep this leaflet. You may need to read it again.

What XYLOCAINE DENTAL is for

Xylocaine Dental is used to prevent or relieve pain during dental procedures, but it will not put you to sleep.

Xylocaine Dental belongs to a group of medicines called local anaesthetics. It is injected into the mouth where it makes the nerves unable to pass messages to the brain.

Depending on the amount used, Xylocaine Dental will either totally stop pain or will cause a partial loss of feeling.

Xylocaine Dental contains adrenaline (also known as epinephrine) to make it last longer. Adrenaline (epinephrine) makes the blood vessels at the site of injection narrower, which means you bleed less and it is easier for your dentist to see what is happening.

Your dentist will have explained why you are being treated with Xylocaine Dental. Follow all directions given to you by your dentist carefully. They may differ from the information contained in this leaflet. Ask your dentist if you want more information.

Xylocaine Dental is not addictive

Before you are given XYLOCAINE DENTAL

When you must not be given it

Do not use Xylocaine Dental if you are pregnant or breastfeeding unless your doctor and dentist say so. Ask your doctor or dentist about the risks and benefits involved.

Xylocaine Dental has been widely used during pregnancy and there have been no reports of any ill effects on the baby. It can be used during childbirth.

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

Xylocaine Dental 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 dentist if:

1. you have any allergies to

• other local anaesthetics
• any other substances
• ingredients listed at the end of this leaflet

If you have an allergic reaction, you may get a skin rash, hayfever, asthma or feel faint.

2. you have any of these medical conditions

• problems with your blood pressure or circulation
• blood poisoning
• problems with the clotting of your blood
• nerve problems
• heart problems
• liver problems
• kidney problems
• malignant hyperthermia

It may not be safe for you to be given Xylocaine Dental if you have any of these conditions.

Taking other medicines

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

• mexilitene
• medicines that you buy at the chemist, supermarket or health food shop.

These medicines may affect the way Xylocaine Dental works.

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

If you have not told your dentist about any of these things, tell them before you are given any Xylocaine Dental.

How XYLOCAINE DENTAL is given

Xylocaine Dental will be injected by your dentist into the gum inside your mouth near a single nerve, or into an area which contains a large number of nerves.

This will result in an area of numbness at the site or near the site of injection.

Xylocaine Dental should not be injected directly into the blood.

The dosage you will be given will depend on your body size, age and the type of dental work you will be having done.

Your dentist will have had a lot of experience injecting Xylocaine Dental or other local anaesthetics and will choose the best dose for you. They will be willing to discuss this decision with you.

Overdose

The dentist giving you Xylocaine Dental will be experienced in the use of local anaesthetics, so it is unlikely that you will be given an overdose. However, if you are particularly sensitive to Xylocaine Dental, or the dose is accidently injected directly into your blood, you may develop problems for a short time. You may get a numb feeling in or around the mouth, feel dizzy or stiff, or have twitchy muscles. If Xylocaine Dental with adrenaline (epinephrine) is being used and this happens, you will feel alarmed and your heart will beat very rapidly.

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

While you are using it

Things you must not do

Do not eat or drink anything until the feeling has returned to your mouth. You may burn or bite yourself.

Things to be careful of

Be careful driving or operating machinery until you know how Xylocaine Dental affects you. You may be drowsy and your reflexes may be slow.

Do not drink alcohol immediately before or after you are given Xylocaine Dental. If you drink alcohol while you are being given Xylocaine Dental your blood pressure may drop making you feel dizzy and faint.

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

Side effects

Tell your dentist or pharmacist as soon as possible if you do not feel well while you are taking Xylocaine Dental.

Xylocaine Dental helps most people have pain free visits to the dentist, but it may have unwanted side-effects in a few people.

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 dentist or pharmacist to answer any questions you may have.

Tell your dentist if you notice any of the following:

• nervousness
• dizziness
• blurred vision
• drowsiness
• ringing in the ears
• numbness
• feeling strange (disoriented)
• nausea
• vomiting

These are all mild side effects of Xylocaine Dental.

Tell your dentist immediately if you notice any of the following:

• feeling of alarm
• rapid heart beat (palpitations)

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

Serious side effects are rare.

If Xylocaine Dental is given wrongly, or you are very sensitive to it, it sometimes causes

• fits
• unconsciousness
• breathing problems
• low blood pressure
• slow heart beat
• collapse

These are very serious side effects. If you have them, you may have had a serious (allergic) reaction to Xylocaine Dental. You may need urgent medical attention or hospitalisation.

All of these side effects are very rare.

Tell your dentist if you notice anything else that is making you feel unwell. Some people may get other side effects while using Xylocaine Dental.

After using it

Storage

Xylocaine Dental will be stored by your dentist under the recommended conditions.

It should be kept in a fridge where the temperature stays at 2°C to 8°C (Refrigerate. Do not freeze) and it is protected from light.

Once removed from refrigeration for use, it will be stored below 25°C and used within 4 weeks and not returned to the refrigerator.

Excursions outside the recommended storage temperature are permitted during transport.

Disposal

Any Xylocaine Dental from a single dose which is not used, will be disposed of in a safe manner by your dentist.

Product description

Xylocaine Dental is a clear colourless solution and is available under the following name:

2% XYLOCAINE Dental with adrenaline (epinephrine) 1:80,000
The active ingredients are lidocaine (lignocaine) hydrochloride 20 mg/mL and adrenaline (epinephrine) 12.5 microgram/mL.

These are available as 2.2 mL dental cartridges in packs of 50 and 100 cartridges.

Not all pack sizes/presentations are being distributed.

Supplier/Sponsor

Xylocaine Dental is supplied in Australia by:

Dentsply Sirona Pty Ltd
11 – 21 Gilby Road
Mount Waverley, VIC 3149
Australia

Tel: 1300 55 29 29

Name and address of New Zealand Sponsor:

Dentsply Sirona (N.Z.) Limited
c/o- Lowndes Jordan
Level 15, PWC Tower
188 Quay Street
Auckland 1010
New Zealand

Tel: 0800 33 68 77

This leaflet was prepared in February 2022.

Australian Registration Number
12024

® Trade Mark herein is the property of the AstraZeneca group

Published by MIMS May 2022

1 Name of Medicine

Lidocaine (lignocaine) hydrochloride monohydrate.
Adrenaline (epinephrine) acid tartrate.

2 Qualitative and Quantitative Composition

2% Xylocaine Dental with Adrenaline (epinephrine) 1:80,000 contains: lidocaine (lignocaine) hydrochloride monohydrate 46.9 milligram/2.2 mL, equivalent to lidocaine (lignocaine) base 38.1 milligram/2.2 mL; adrenaline (epinephrine) acid tartrate 49.9 microgram/2.2 mL, equivalent to adrenaline (epinephrine) base 27.5 microgram 2.2 mL.
Lidocaine (lignocaine) is classed as a membrane stabilising agent, and is a local anaesthetic of the amide type. Adrenaline (epinephrine) is a potent sympathomimetic.
Excipient with known effect. Sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

2% Xylocaine Dental with Adrenaline (epinephrine) 1:80,000 is a clear, colourless solution, practically free of visible particles, and is available in 2.2 mL standard and self-aspirating cartridges.
Note. 1. Adrenaline (epinephrine)-containing solutions contain the antioxidant sodium metabisulphite, 1.1 mg/2.2 mL.
2. All Dentsply Sirona Xylocaine dental cartridges (with adrenaline (epinephrine)) are paraben free and for single use in a single patient only. Remaining unused contents should be discarded.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia) and 0800 764 766 (New Zealand).
Systemic toxicity to amide type local anaesthetics 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.
Toxic cardiovascular reactions to local anaesthetics are usually depressant in nature, may occur rapidly and with little warning and can lead to peripheral vasodilation, hypotension, myocardial depression, bradycardia and possibly cardiac arrest.
Treatment of a patient with toxic symptoms consists of ensuring a patent airway and supporting ventilation with oxygen and assisted or controlled respiration as required. This usually will be sufficient in the management of most reactions.
Further treatment depends on diagnosis. Medical assistance should be summoned.
If convulsions occur, intravenous diazepam should be administered incrementally. Sodium thiopentone (5 mg/kg) may be used if diazepam is unavailable or ineffective. If convulsions interfere with breathing and/or are not rapidly controlled by specific anticonvulsant medication, suxamethonium (1-2 mg/kg) may be used to paralyse the patient. Artificial ventilation must then be instituted.
If ventricular fibrillation or cardiac arrest occurs, effective cardiovascular resuscitation treatment must be instituted and maintained for a prolonged period if necessary.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. The genotoxic potential of 2,6-xylidine, a metabolite of lidocaine (lignocaine), 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, has shown that in both male and female rats, 2,6xylidine 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

Chemical structure. The chemical structure of lidocaine (lignocaine) hydrochloride monohydrate is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLIHYMO.gif The chemical name for lidocaine (lignocaine) hydrochloride monohydrate is 2-(diethylamino)-N(2,6-dimethylphenyl)acetamide hydrate hydrochloride. International Non-proprietary Name (INN) for lignocaine is also known as lidocaine.
The Australian Approved Name (AAN) is lidocaine (lignocaine) hydrochloride monohydrate.
Lidocaine (lignocaine) base has a pKa of 7.85 (25°C) and a molecular weight of 234.3.
Lidocaine (lignocaine) hydrochloride monohydrate is a white crystalline powder with a molecular weight of 288.8. It is very soluble in water and freely soluble in alcohol and chloroform. It must be protected from light.
The chemical structure of adrenaline (epinephrine) acid tartrate is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSADRATE.gif The chemical name for adrenaline (epinephrine) is (1R)-1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanol hydrogen (2R,3R)-2,3-dihydroxybutanedioate. Adrenaline is also known as epinephrine.
The Australian Approved Name is adrenaline (epinephrine) acid tartrate.
Adrenaline (epinephrine) acid tartrate is a white to greyish-white crystalline powder with a molecular weight of 333.3. It is freely soluble in water and slightly soluble in alcohol.
CAS number. The CAS number for lidocaine (lignocaine) hydrochloride monohydrate is 6108-05-0.
The CAS number for adrenaline (epinephrine) acid tartrate is 51-42-3.

7 Medicine Schedule (Poisons Standard)

Australian Poisons Schedule: S4 - Prescription Only Medicine.
New Zealand Medicine Classification: Prescription Medicine.

Summary Table of Changes

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