Consumer medicine information

Xylocaine Special Adhesive

Lidocaine (lignocaine)

BRAND INFORMATION

Brand name

Xylocaine 10% Special Adhesive

Active ingredient

Lidocaine (lignocaine)

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Xylocaine Special Adhesive.

What is in this leaflet

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

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

All medicines have risks and benefits.

If you have any concerns about using this medicine, ask your doctor, pharmacist or dentist.

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

What XYLOCAINE SPECIAL ADHESIVE is for

Xylocaine Special Adhesive is used in dentistry to prevent pain during scaling or injection and when fitting dentures.

Xylocaine Special Adhesive is also used to relieve pain during the removal of baby teeth.

Xylocaine Special Adhesive belongs to a group of medicines called local anaesthetics. It works by making nerves unable to pass messages to the brain.

Your doctor or dentist will have explained why you are being given Xylocaine Special Adhesive and told you what dose to use.

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

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

Xylocaine Special Adhesive is not addictive.

Before you use XYLOCAINE SPECIAL ADHESIVE

When you must not use it

Do not use Xylocaine Special Adhesive if you are pregnant or breastfeeding unless your doctor or dentist says so. Ask them about the risks and benefits involved. Lidocaine (lignocaine) has been used widely during pregnancy and there have been no reports of any ill effects on the baby.

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

Do not use after the use by (expiry) date printed on the pack. It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.

Do not use Xylocaine Special Adhesive if the packaging is torn or shows signs of tampering.

Do not use it to treat any other complaints unless your doctor or dentist tells you to.

Do not give this medicine to anyone else.

Before you start to use it

You must tell your doctor, pharmacist or dentist if:

  1. you have any allergies to
  • other local anaesthetics e.g. bupivacaine
  • any ingredients listed at the end of this leaflet
  • any other substances

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

  1. you have any of these medical conditions
  • open wounds or infection in the mouth
  • epilepsy
  • heart, liver or kidney problems

It may not be safe for you to use Xylocaine Special Adhesive if you have any of these conditions.

Taking other medicines

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

  • medicines to treat irregular heartbeats.
  • cimetidine
  • phenytoin and other anti-epileptic drugs such as phenobarbitone, primidone and carbamazepine
  • medicines that you buy at the chemist, supermarket or health food shop.

These medicines may affect the way Xylocaine Special Adhesive works.

Your doctor or dentist 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 use Xylocaine Special Adhesive.

Using XYLOCAINE SPECIAL ADHESIVE

How much to use

Your doctor, pharmacist or dentist will tell you how much ointment you should use. The dose depends on the size of the area and should be applied in a thin layer for adequate control of symptoms.

For adults, the maximum single dose is 2.5g. This is roughly equivalent to squeezing a 7.5cm length of ointment from the tube.

Do not use more than 8.5-10g of ointment in any 24 hour period.

For children less than 12 years, do not use more than 0.5g ointment/kg bodyweight as a single dose. Do not apply more than three doses during any 24 hours.

Ask your doctor or dentist if you are unsure about the amount of Xylocaine Special Adhesive to use.

Overdose

Telephone your doctor, the Poisons Information Centre (13 11 26) or go to casualty at your nearest hospital immediately if you think that you or anyone else may have used too much Xylocaine Special Adhesive even if there are no signs of discomfort or poisoning.

If you accidentally swallow Xylocaine Special Adhesive it is unlikely to cause any problems due to the small amount of lidocaine (lignocaine) it contains.

However, you may have a numb tongue and throat. This will wear off without treatment.

Do not eat or drink anything until your tongue feels normal again.

If you use too much Xylocaine Special Adhesive you will probably feel nervous and dizzy, and develop blurred vision and tremor.

While you are using it

Things you must do

See your doctor or dentist if pain and discomfort continue.

Things to be careful of

Be careful driving or operating machinery until you know how Xylocaine Special Adhesive affects you. It may have a very mild effect on alertness and co-ordination. You may become drowsy and your reflexes may be slow.

Things you must not do

Do not eat or drink anything for at least 1 hour after using Xylocaine Special Adhesive in the mouth or throat area. You may swallow your food down the wrong way, or burn or bite your mouth.

Do not use Xylocaine Special Adhesive on open wounds or infected areas.

Do not get Xylocaine Special Adhesive in your eyes. If any of the ointment does go in your eye, rinse immediately with lots of water for at least 15 minutes and call your doctor.

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

Side effects

Tell your doctor, pharmacist or dentist as soon as possible if you do not feel well while you are using Xylocaine Special Adhesive.

Xylocaine Special Adhesive will help relieve pain and discomfort in most people, 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 doctor, pharmacist or dentist to answer any questions you may have.

Tell your doctor, pharmacist or dentist if you notice the following and it worries you:

  • skin rash or irritation
  • lightheadness, dizziness, nervousness
  • blurred vision
  • drowsiness

These are all side effects of Xylocaine Special Adhesive.

Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:

  • wheezing or difficulty breathing
  • chest pain
  • severe rash or itching
  • increased sweating

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

Serious side effects are rare.

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

After using it

Storage

Keep your Xylocaine Special Adhesive ointment in a cool place where the temperature stays below 25 degrees C.

Do not store it or any other medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not leave it in the car on hot days.

Disposal

Ask your pharmacist what to do with any ointment you have left over if your doctor or dentist tells you to stop using it, or you find that the expiry date has passed.

Product description

What Xylocaine Special Adhesive looks like

Xylocaine Special Adhesive is a white to slightly yellow ointment.

Ingredients

Each gram of ointment contains 100 mg lidocaine (lignocaine) base as the active ingredients;

plus,

Spearmint Oil
Carmellose
Propylene Glycol
Macrogol 300
Macrogol 400
Macrogol 1500

Lidocaine is known as lignocaine.

Sponsor

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

This leaflet was revised in Feb 2018

Australian Registration Number Xylocaine Special Adhesive 12006

® = Trade Marks herein are the property of the AstraZeneca Group

Published by MIMS May 2019

BRAND INFORMATION

Brand name

Xylocaine 10% Special Adhesive

Active ingredient

Lidocaine (lignocaine)

Schedule

S2

 

Name of the medicine

Lidocaine (lignocaine).

Excipients.

Propylene glycol, macrogol (300, 400 and 1500), carmellose sodium and spearmint oil.

Description

Xylocaine 10% Special Adhesive contains lidocaine (lignocaine) base as the active ingredient.
Xylocaine 10% Special Adhesive is formulated to adhere to moist oral mucosa and provide topical anaesthesia.
Each gram of Special Adhesive contains: lidocaine base 100 mg, propylene glycol, macrogol (300, 400 and 1500), carmellose sodium and spearmint oil.

Pharmacology

Lidocaine, the active ingredient of Xylocaine 10% Special Adhesive, stabilises the neuronal membrane and prevents the initiation and conduction of nerve impulses, thereby effecting local anaesthetic action.
The onset of action of Xylocaine 10% Special Adhesive occurs within 3-5 minutes on mucous membrane and the effect lasts for approximately 15-20 minutes. It is ineffective when applied to intact skin.
Lidocaine may be absorbed following topical administration to mucous membranes, its rate of absorption and amount of dose absorbed depending upon concentration and total dose administered, the specific site of application and duration of exposure. In general, the rate of absorption occurs most rapidly after intratracheal administration. Lidocaine is well absorbed from the gastrointestinal tract, but little intact drug appears in the circulation because of biotransformation in the liver.
Lidocaine is metabolised rapidly by the liver, and metabolites and unchanged drug are excreted by the kidney.
Excessive blood levels may cause changes in cardiac output, total peripheral resistance and mean arterial pressure. These changes may be attributable to a direct depressant effect of the anaesthetic agent on various components of the cardiovascular system.
Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage and conjugation. The pharmacological/ toxicological actions of the metabolites are similar to, but not less potent than, those of lidocaine. Approximately 90% of lidocaine is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline.
The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of free base 1 to 4 microgram/mL, 60 to 80% of lidocaine is protein bound. Binding is also dependent on the plasma concentrations of the α-1-acid glycoprotein.
Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion.
Studies of lidocaine metabolism following IV bolus injection have shown that the elimination half-life is usually 1.5 to 2 hours. The half-life may be prolonged 2-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics, but may increase the accumulation of metabolites.
Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above free base 6.0 microgram/mL. In the rhesus monkey arterial blood levels of 18 to 21 microgram/mL have been shown to be the threshold for convulsive activity.

Indications

Surface anaesthesia of the gums prior to injection, before scaling and in conjunction with the fitting of new dentures or orthodontic appliances.
Temporary relief of pain associated with removal of deciduous teeth.

Contraindications

Known history of hypersensitivity to lidocaine or other local anaesthetics of the amide type or to other components of the ointment.

Precautions

Warning.

Excessive dosage, or short intervals between doses, can result in high levels of lidocaine or its metabolites and serious adverse effects. Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen and other resuscitative drugs. Patients should not exceed the recommended dose or use Xylocaine 10% Special Adhesive for prolonged periods except on the advice of their physician or dentist.
The lowest dose that results in effective anaesthesia should be used to avoid high plasma levels and serious adverse effects. Tolerance to elevated blood levels varies with the status of the patient.

Dosage reduction.

Debilitated, elderly and/or acutely ill patients and children should be given reduced doses commensurate with their age and physical status.

Excessive absorption.

Absorption from mucous membranes is relatively high, especially in the bronchial tree. This should be taken into consideration when the Special Adhesive is used in children for treatment of large areas. Because of the possibility of significant systemic absorption, Xylocaine Special Adhesive should be used with caution in patients with traumatised mucosa and/or sepsis in the region of the proposed application.
If the dose or site of administration is likely to result in high blood levels, lidocaine, in common with other local anaesthetics, should be used with caution in patients with epilepsy, impaired cardiac conduction, bradycardia, impaired hepatic function and in severe shock.

Antiarrhythmic drugs class III.

Patients treated with antiarrhythmic drugs class III (e.g. amiodarone) should be kept under close surveillance and ECG monitoring considered, since cardiac effects may be additive.

Eating and drinking.

The use of topical anaesthetic agents in the oral cavity may interfere with swallowing and thus enhance the danger of aspiration of food or drink. For this reason, food or drink should not be ingested within 60 minutes of using local anaesthetics in the mouth or throat area. Numbness of the tongue or buccal mucosa may increase the danger of biting or heat trauma. Food, chewing gum or hot drinks should not be taken while the mouth or throat area is anaesthetised.

Malignant hyperthermia.

Many drugs used during the conduct of anaesthesia are considered potential triggering agents for familial malignant hyperthermia. It has been shown that the use of amide local anaesthetics in malignant hyperthermia patients is generally safe, but cases of malignant hyperthermia have occasionally been documented after use.

Sterile instruments.

Xylocaine Special Adhesive is not intended for use with sterile instruments.

Carcinogenic and mutagenic potential.

Genotoxicity tests with lidocaine are inconclusive. In genotoxicity studies, a metabolite of lidocaine, 2,6-xylidine, showed evidence of activity in some tests but not in other tests. This metabolite has been shown to have carcinogenic potential (nasal and subcutaneous tumours) in preclinical toxicological studies evaluating chronic exposure.

Use in pregnancy.

(Category A)
Lidocaine crosses the placental barrier and may be taken up by foetal tissues. When used for surface anaesthesia, lidocaine blood levels after normal doses are low so little drug is available for placental transfer.
There are, however, no adequate and well controlled studies in pregnant women. Reproduction studies have been performed in rats at doses of 500 mg/kg/day and have revealed no evidence of harm to the foetus caused by lidocaine.
It is reasonable to assume that a large number of pregnant women and women of childbearing age have used lidocaine. No specific disturbances to the reproduction process have so far been reported.

Labour and delivery.

Lidocaine is not contraindicated in labour and delivery.

Use in lactation.

Lidocaine enters breast milk, but in such small quantities that there is generally no risk of affecting the child at therapeutic dose levels.

Effects on ability to drive and operate machines.

Depending on the dose, local anaesthetics may have a very mild effect on mental function and may temporarily impair locomotion and coordination. With the recommended doses of lidocaine ointment, adverse effects on the CNS are unlikely.
Xylocaine 10% Special Adhesive is probably porphyrinogenic and should only be prescribed to patients with acute porphyria on strong or urgent indications. Appropriate precautions should be taken for all porphyric patients.

Interactions

Antiarrhythmic drugs.

Lidocaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to local anaesthetics, e.g. antiarrhythmic drugs such as mexiletine, since the toxic effects are additive.
Specific interaction studies with lidocaine and antiarrhythmic drugs class III (e.g. amiodarone) have not been performed, but caution is advised.

Enzyme inducing drugs.

Cimetidine has been shown to reduce clearance of IV administered lidocaine. Caution should be taken if administered concurrently with lidocaine.
Phenytoin and other antiepileptic drugs, e.g. phenobarbitone, primidone and carbamazepine, appear to enhance the metabolism of lidocaine but the significance of this effect is not known. Phenytoin and lidocaine have additive cardiac depressant effects.

Adverse Effects

Systemic adverse reactions are rare and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or reduced tolerance on the part of the patient. Such reactions are systemic in nature and involve the central nervous system and/or the cardiovascular system.

Central nervous system.

CNS reactions are excitatory and/or depressant and may be characterised by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness and, possibly, respiratory arrest. The excitatory reactions may be brief or may not occur at all, in which case the first manifestations of toxicity may be drowsiness, progressing to unconsciousness and respiratory arrest.
Drowsiness following administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a result of rapid absorption.

Cardiovascular.

Cardiovascular reactions are usually depressant and may be characterised by hypotension, myocardial depression, bradycardia and, possibly, cardiac arrest.

Allergic reactions.

Allergic reactions may occur as a result of sensitivity either to the local anaesthetic agent or to other ingredients in the formulation. Allergic reactions as a result of sensitivity to lidocaine are rare (< 0.1%). The detection of sensitivity by skin testing is of doubtful value.
The extremely rare cases of allergy to local anaesthetic preparations have included bronchospasm, chest pain, dyspnoea, pruritus, rash, rhinitis, increased sweating, urticaria, sleepiness, dizziness, paraesthesia, oedema and, in the most severe instances, anaphylactic shock.

Dosage and Administration

As with any local anaesthetic, reactions and complications are best averted by employing the minimal effective dosage. Debilitated or elderly patients and children should be given doses commensurate with their age and physical condition.
The dose of topical lidocaine should be taken into consideration in estimating the total dose of lidocaine if parenteral lidocaine is to be administered concomitantly.
The following dosage recommendations should be regarded as a guide. The clinician's experience and knowledge of the patient's physical status are of importance in calculating the required dose.

Adults.

The maximum single recommended dose of Xylocaine 10% Special Adhesive is 2.5 g, containing lidocaine base 250 mg (approximately equivalent to lidocaine hydrochloride 300 mg). This is roughly equivalent to squeezing a 7.5 cm length of Special Adhesive from the tube. Not more than 8.5 to 10 g of the Special Adhesive should be administered in any 24 hour period.

Children.

In children less than 12 years of age, the maximum single recommended dose should not exceed 0.05 g ointment/kg bodyweight (corresponding to lidocaine 5 mg/kg bodyweight). Not more than three doses should be administered in a 24 hour period.
The Special Adhesive should be applied in a thin layer for adequate control of symptoms.
In dentistry, apply to previously dried oral mucosa, allow at least 3-5 minutes for anaesthesia to become effective. When inserting new dentures, apply to all denture surfaces contacting mucosa.

Overdosage

Contact the Poisons Information Centre on 13 11 26 for advice on management of overdose.

Management of local anaesthetic emergencies.

The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anaesthetic administration. At the first sign of change, oxygen should be administered.

Treatment.

If convulsions occur then immediate attention is required for the maintenance of a patent airway and assisted or controlled ventilation with oxygen, via a positive airway pressure delivery system mask. Adequacy of the circulation should then be evaluated, bearing in mind that drugs used to treat convulsions depress the circulation when administered IV. Should convulsions persist despite adequate respiratory support and if the status of the circulation permits, appropriate anticonvulsant medication, e.g. an ultra short acting barbiturate (e.g. thiopental) or a benzodiazepine (e.g. diazepam), may be administered IV. The clinician should be familiar with these anticonvulsant drugs prior to use of local anaesthetics.
Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.

Presentation

Xylocaine 10% Special Adhesive is supplied as an ointment in a 15 g tube.

Storage

Store below 25°C.

Poison Schedule

S2.