Consumer medicine information

XYLOCAINE VISCOUS

Lidocaine (lignocaine) hydrochloride

BRAND INFORMATION

Brand name

Xylocaine Viscous

Active ingredient

Lidocaine (lignocaine) hydrochloride

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using XYLOCAINE VISCOUS.

What is in this leaflet

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

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

All medicines have risks and benefits.

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

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

What Xylocaine Viscous is for

Xylocaine Viscous is used to prevent pain and discomfort during medical tests and procedures. Your doctor will explain the tests which will be carried out and the reason for them. It can also be used to relieve pain following operations or in certain diseases.

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

Your doctor will have explained why you are being treated with Xylocaine Viscous and told you what dose you should use.

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

Your doctor or pharmacist may recommend this medicine for another use. Ask them if you want more information.

Xylocaine Viscous is not addictive.

Before you use Xylocaine Viscous

When you must not use it

Do not use Xylocaine Viscous if you are pregnant or breastfeeding unless your doctor says it is safe. Ask your doctor about the risks and benefits involved. Xylocaine has been widely used during pregnancy and there have been no reports of any ill effects on the baby.

When used correctly, it is unlikely that any Xylocaine Viscous will get into your breast milk if you are breastfeeding.

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

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

Do not give this medicine to anyone else.

Before you start to use it

You must tell your doctor if:

  1. you have any allergies to:
  • other local anaesthetics
  • ingredients listed at the end of this leaflet
  • any other substances
    If you have an allergic reaction, you may get a skin rash, hayfever, breathing difficulties or feel faint.
  1. you have any of these medical conditions:
  • epilepsy
  • heart problems
  • liver problems
  • kidney problems
  • open wounds or infection where the solution will be used

It may not be safe for you to take Xylocaine Viscous 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
  • any medicines that you buy at the chemist, supermarket or health food shop.

These medicines may affect the way Xylocaine Viscous 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 or pharmacist about any of these things, tell them before you use any Xylocaine Viscous.

Using Xylocaine Viscous

How to use it

Shake the bottle well before use.

Adults
The dose is 15 mL, not more often than every three hours. For use in the mouth, the solution should be swished around the mouth for 30 seconds and spat out. For use in the throat, the solution should be gargled and may be swallowed.

This dose may be reduced for elderly patients.

Children over 3 years
No more than 4 mg/kg (1 mL for every 5 kg of bodyweight) or 5mL, whichever is lower, should be used as above, not more often than every three hours, as required. No more than 4 doses should be given in a 24 hour period. Excess Xylocaine Viscous should be spat out.

Children under 3 years
No more than 4 mg/kg (1 mL for every 5 kg of bodyweight) or 1.25 mL, whichever is lower, should be applied with a cotton swab to the area, not more often than every three hours, as required. No more than 4 doses should be given in a 24 hour period.

Overdose

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

The lignocaine in Xylocaine Viscous can be absorbed into the blood, therefore it is important to use the correct amount of this medicine to avoid an overdose.

The first signs of overdose are dizziness, blurred vision, tremor or nervousness. In the rare case of problems occurring, you will be watched closely by medical staff.

While you are using it

Things to be careful of

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

You should not exceed the recommended dose unless your doctor tells you to. This may cause serious side effects if too much Xylocaine Viscous is taken.

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

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

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Xylocaine Viscous. Xylocaine Viscous will help to 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 or pharmacist to answer any questions you may have.

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

  • skin rash or irritation
  • drowsiness

These are all mild side effects of Xylocaine Viscous.

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
  • numbness

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

Serious side effects are rare.

Xylocaine from Xylocaine Viscous can pass into the bloodstream, and in high doses can rarely cause more serious side effects. These may include:

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

These are very serious side effects. You will need urgent medical attention or hospitalisation.

All of these side effects are very rare.

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

Storage

Keep your Xylocaine Viscous in the bottle until it is time to use it.

Keep it in a cool place where the temperature stays below 25°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 solution you have left over if your doctor tells you to stop using it, or you find that the expiry date has passed.

Product description

Xylocaine Viscous is a clear red viscous liquid in a 200 mL bottle. Each mL of viscous solution contains 21.3 mg Lignocaine hydrochloride monohydrate equivalent to 20 mg of Lignocaine hydrochloride, plus

  • Methyl hydroxybenzoate
  • Propyl hydroxybenzoate
  • Sodium hydroxide
  • Saccharin sodium
  • Cherry Extract (FACHE59130)
  • Carmellose Sodium
  • Purified water

Lignocaine is known as lidocaine in the U.S.A.

Sponsor

AstraZeneca Pty Ltd
ABN 54 009 682 311
Alma Road
NORTH RYDE NSW 2113

This leaflet was prepared in May 2015.

Australian Registration Number:
Xylocaine Viscous 12007

® Trade Marks herein are the property of the AstraZeneca group

Published by MIMS October 2015

BRAND INFORMATION

Brand name

Xylocaine Viscous

Active ingredient

Lidocaine (lignocaine) hydrochloride

Schedule

S2

 

Name of the medicine

Lidocaine (lignocaine) hydrochloride monohydrate.

Excipients.

Methyl hydroxybenzoate, propyl hydroxybenzoate, sodium hydroxide, saccharin sodium, cherry extract FACHE 59130 (PI: 2395), carmellose sodium and purified water.

Description

Molecular formula: C14H22N2O.HCl.H2O, molecular weight: 288.8, CAS: 6108-05-0.
Xylocaine Viscous is an aqueous topical anaesthetic for use on mucous membranes.
Each mL of Xylocaine Viscous contains lidocaine (lignocaine) hydrochloride monohydrate 21.3 mg (equivalent to lidocaine (lignocaine) hydrochloride 20 mg), methyl hydroxybenzoate, propyl hydroxybenzoate, sodium hydroxide, saccharin sodium, cherry extract FACHE 59130 (PI: 2395), carmellose sodium and purified water.

Pharmacology

Lidocaine (lignocaine), the active ingredient of Xylocaine Viscous, stabilises the neuronal membrane and prevents the initiation and conduction of nerve impulses, thereby effecting local anaesthetic action.
The onset of action of Xylocaine Viscous occurs within 3-5 minutes on mucous membranes. Its low surface tension ensures an even film over the surface of the mucous membrane so that the Xylocaine comes into intimate contact with the total surface. High viscosity ensures sufficiently prolonged contact with the mucous membrane. It is ineffective when applied to intact skin.
Lidocaine (lignocaine) 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 (lignocaine) is well absorbed from the gastrointestinal tract but little intact drug appears in the circulation because of biotransformation in the liver. Lidocaine (lignocaine) 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 (lignocaine). Approximately 90% of lidocaine (lignocaine) 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 (lignocaine) is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 microgram of free base/mL, 60 to 80% of lidocaine (lignocaine) is protein bound. Binding is also dependent on the plasma concentrations of the alpha-1-acid glycoprotein.
Lidocaine (lignocaine) crosses the blood brain and placental barriers, presumably by passive diffusion.
Studies of lidocaine (lignocaine) 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 (lignocaine) 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 (lignocaine) required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6.0 microgram free base/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

Xylocaine Viscous is indicated for the relief of pain and discomfort associated with irritated or inflamed mucous membranes of the mouth, pharynx and upper gastrointestinal tract, e.g. post-tonsillectomy sore throat, dumping syndrome; introduction of instruments and catheters into the respiratory and gastrointestinal tracts.

Contraindications

Known history of hypersensitivity to lidocaine (lignocaine) or other local anaesthetics of the amide-type or to other components of the viscous solution.
Hypersensitivity to methyl and/or propyl hydroxybenzoate or to their metabolite para-aminobenzoic acid.

Precautions

Warning.

Excessive dosage, or short intervals between doses, can result in high levels of lidocaine (lignocaine) or its metabolites and serious adverse effects. In order to prevent 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. (See Overdosage.)
Patients should not exceed the recommended dose or use Xylocaine Viscous for prolonged periods except on the advice of their physician.
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.
Excessive dosage or short intervals between doses may result in high plasma levels and serious adverse effects. Following too high or repeated doses, including accidental ingestion of viscous lidocaine (lignocaine) in infants and children under the age of three years, serious side effects have been reported involving the cardiovascular and central nervous systems including fatal outcomes. Patients should be instructed to adhere strictly to the recommended dosage. This is especially important in children where the doses vary with weight.

Paediatric patients.

Xylocaine Viscous should not be administered to infants and children for teething pain.

Dosage reduction.

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

Excessive absorption.

Absorption from wound surfaces and mucous membranes is relatively high, especially in the bronchial tree. Because of the possibility of significant systemic absorption, Xylocaine Viscous should be used with caution in patients with traumatised mucosa and/or sepsis in the region of the proposed application.
In order to prevent serious adverse effects, if the dose or site of administration is likely to result in high blood levels, lidocaine (lignocaine), in common with other local anaesthetics, should be used with caution in patients with epilepsy, impaired cardiac conduction, bradycardia, impaired hepatic function, in severe shock, the elderly, patients in poor general health and patients with severe renal dysfunction.
Patients treated with anti-arrhythmic 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 hypothermia patients is generally safe, but cases of malignant hyperthermia have occasionally documented after use.

Endotracheal tube lubrication.

When used for endotracheal tube lubrication care should be taken to avoid introduction of the viscous solution into the lumen of the tube. The solution may dry on the inner surface leaving residue which tend to clump with flexion, narrowing the lumen. There have been rare reports in which this residue has caused the lumen to occlude.

Porphyric patients.

Xylocaine Viscous is probably porphyrinogenic and should only be used on patients with acute porphyria where there are strong or urgent indications. Appropriate precautions should be taken for all porphyric patients.

Carcinogenic and mutagenic potential.

Genotoxicity tests with lidocaine (lignocaine) are inconclusive. In genotoxicity studies, a metabolite of lidocaine (lignocaine), 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 (lignocaine) crosses the placental barrier and may be taken up by foetal tissues. When used for surface anaesthesia, lidocaine (lignocaine) 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 (lignocaine).
It is reasonable to assume that a large number of pregnant women and women of child-bearing age have used lidocaine (lignocaine). No specific disturbances to the reproduction process have so far been reported.

Labour and delivery.

Lidocaine (lignocaine) is not contraindicated in labour and delivery.

Use in lactation.

Lidocaine (lignocaine) enters the 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.

Interactions

Antiarrhythmic drugs.

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

Enzyme inducing drugs.

Cimetidine and beta-blockers have been shown to cause potentially toxic plasma concentrations when lidocaine (lignocaine) is given in repeated high doses over a long period of time. Therefore, caution should be taken if lidocaine (lignocaine) was administered at higher than recommended doses over an extended period of time.
Phenytoin and other antiepileptic drugs, such as phenobarbitone, primidone and carbamazepine, appear to enhance the metabolism of lidocaine (lignocaine) but the significance of this effect is not known. Phenytoin and lidocaine (lignocaine) 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 (lignocaine) 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 (lignocaine) 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. Several cases of contact dermatitis have been reported with the use of lidocaine (lignocaine).

Dosage and Administration

As with any local anaesthetic, reactions and complications are best averted by employing the minimal effective dosage. Debilitated, acutely ill or elderly patients and children should be given doses commensurate with their age, weight and physical condition.
Shake the bottle well before use.
For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is 15 mL undiluted. For use in the mouth, the solution should be swished around the mouth for approximately 30 seconds and spat out. For use on the pharynx, the solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours.

Maximum dosage.

Although the incidence of adverse effects with lidocaine (lignocaine) is quite low, caution should be exercised when using large amounts.

Adults.

No more than 15 mL (300 mg lidocaine (lignocaine) HCl) every 3 hours or 120 mL in a 24 hour period.

Children over 3 years of age.

No more than 4 mg/kg (0.2 mL/kg) of bodyweight or 5 mL (100 mg lidocaine (lignocaine) HCl), whichever is lower. No more than 4 doses should be given in a 24 hour period. The dose should not be administered at intervals of less than three hours. It is recommended that excess solution is spat out.

Children under 3 years of age.

No more than 4 mg/kg (0.2 mL/kg) of bodyweight or 1.25 mL (25 mg lidocaine (lignocaine) HCl) whichever is lower, accurately measured and applied only to the affected area with a cotton swab. No more than 4 doses should be given in a 24 hour period. This dose should not be administered at intervals of less than three hours.
At the present time there is not enough documentation to allow recommendations for a more prolonged use of Xylocaine Viscous in children under the age of 3 years.
The solution should not be administered to sooth teething pain in infants and children because of safety concerns.

Overdosage

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

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.

Should symptoms of systemic toxicity occur, the signs are anticipated to be similar in nature to those following the administration of local anaesthetics by other routes. Local anaesthetic toxicity is manifested by symptoms of nervous system excitation and, in severe cases, central nervous and cardiovascular depression.
Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsive drugs.
If circulatory arrest should occur, immediate cardiopulmonary resuscitation should be instituted. Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance.

Presentation

Xylocaine Viscous is a red viscous liquid packed in a 200 mL bottle.

Storage

Store below 25°C.

Poison Schedule

S2.