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.

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.

4 Clinical Particulars

4.1 Therapeutic Indications

Lidocaine (lignocaine) solutions are indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques.
Lidocaine (lignocaine) solutions with adrenaline (epinephrine) are recommended for oral surgery requiring prolonged duration of anaesthesia and haemostasis.

4.2 Dose and Method of Administration

The lowest dosage that results in effective anaesthesia for the planned treatment should be used. The dosage will also depend on the area of the oral cavity to be anaesthetised, the vascularity of the oral tissues and the technique of anaesthesia.

Adults.

1. Recommended doses.

2. Safe dose.

Paediatric.

4.3 Contraindications

1. Allergy or hypersensitivity to amide type local anaesthetics or other components of the injection solution which may be present e.g. sodium metabisulfite (see Section 3 Pharmaceutical Form, Note).
2. Local anaesthetic techniques must not be used when there is inflammation and/or sepsis in the region of the proposed injection.
The following are additional contraindications for solutions with adrenaline (epinephrine).
3. Solutions with adrenaline (epinephrine) should not be used in patients with a known sensitivity to sympathomimetic amines.
4. Solutions with adrenaline (epinephrine) should not be used in most patients with cerebral arteriosclerosis.
Also see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

4.4 Special Warnings and Precautions for Use

1. When any local anaesthetic agent is used, 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.
2. Injection should always be made slowly with frequent aspirations to avoid inadvertent intravascular injection which can produce toxic effects. Multiple injections should be administered at spaced intervals.
3. The safety and effectiveness of lidocaine (lignocaine) depend on proper dosage, correct technique and adequate precautions. Standard textbooks should be consulted regarding specific techniques and precautions for various anaesthetic procedures.
4. Lidocaine (lignocaine) should be given with great caution to patients with severe bradycardia, cardiac conduction disturbances or severe digitalis intoxication.
5. Lidocaine (lignocaine) and/or its metabolites may accumulate during prolonged or repeated administration in patients with hepatic, renal or cardiac diseases. However, this is unlikely to occur at the doses normally used in dentistry.
6. Adrenaline (epinephrine)-containing solutions should be used with extreme caution in patients with severe or untreated hypertension, arteriosclerotic heart disease, heart block, cerebral vascular insufficiency, thyrotoxicosis, advanced diabetes or any other pathological condition that might be aggravated by the effects of adrenaline (epinephrine). Adrenaline (epinephrine) may induce anginal pain in patients suffering from ischaemic heart disease. The use of Citanest Octapressin solutions may be preferable in these conditions.
7. Lidocaine (lignocaine) should be used with caution in patients with known drug sensitivities. Patients allergic to ester derivatives of para-aminobenzoic acid (procaine, tetracaine, benzocaine etc.) have not shown cross sensitivity to agents of the amide type.
8. Lidocaine (lignocaine) should be used with caution in patients with genetic predisposition to malignant hyperthermia as the safety of amide local anaesthetic agents in these patients has not been fully established.
9. The patient should be advised to exert caution to avoid inadvertent trauma to the lips, tongue, cheek mucosa or soft palate when these structures are anaesthetised. Eating and drinking hot liquids should therefore be postponed until normal function returns.
10. Lidocaine (lignocaine) with adrenaline (epinephrine) solutions contain sodium metabisulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than non-asthmatic people.
11. Local anaesthetics react with certain metals and cause the release of their respective ions which, if injected, may cause severe local irritation. Adequate precautions should be taken to avoid prolonged contact between lidocaine (lignocaine) solutions and metal surfaces e.g. cartridges should not be preloaded and connected to needles until just prior to use.
12. Cartridges showing discolouration or cracks should be discarded. Adrenaline (epinephrine)containing solutions should not be autoclaved. Surface sterilisation using pure, undiluted isopropyl alcohol (91%) or 70% ethyl alcohol (USP) may be carried out if desired.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

1. Antiarrhythmic drugs.

2. Amiodarone.

3. Anticonvulsive agents.

4. Inhalational anaesthetics.

5. CNS acting drugs.

6. Oxytocic drugs of the ergot type.

7. Adrenergic neuron blocking agents.

8. Inhalation anaesthetics.

9. Cardiac glycosides.

10. Quinidine.

11. Hypoglycaemics.

12. Beta-blockers.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Depending on dosage, local anaesthetics may have a very mild effect on mental function and may temporarily impair locomotion and coordination.

4.8 Adverse Effects (Undesirable Effects)

Reactions to lidocaine (lignocaine) are very rare in the doses used in dental procedures. If adverse reactions occur, they are similar in character to those observed with other local anaesthetics of the amide type.
Adverse reactions may be due to high plasma levels as a result of excessive dosage, rapid absorption, delayed elimination or metabolism, or inadvertent intravascular injection. Such reactions are systemic in nature and involve the central nervous system and/or the cardiovascular system (see Section 4.9 Overdose). Pronounced acidosis or hypoxia may increase the risk and severity of toxic reactions.
The following adverse events have been observed during use of lidocaine (lignocaine) medical injections and have not necessarily been associated with the dental use of lidocaine (lignocaine).

More common reactions.

Less common reactions.

Allergy.

Neurological reactions.

Reporting suspected adverse effects.

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

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

2% Xylocaine Dental with Adrenaline (epinephrine) 1:80,000 contains sodium chloride, sodium metabisulfite, water for injections, and may contain sodium hydroxide and/or hydrochloric acid for pH adjustment.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

2% Xylocaine Dental with Adrenaline (epinephrine) 1:80,000 should be stored at 2°C to 8°C (Refrigerate. Do not freeze) and protected from light. Once removed from refrigeration for use, store below 25°C and use within 4 weeks. Do not return to refrigerator.
Excursions outside the recommended storage temperature are permitted during transport.

6.5 Nature and Contents of Container

See Table 2.
Not all pack sizes/presentations are being distributed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

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

Summary Table of Changes