Consumer medicine information

Xylocaine Jelly

Lidocaine (lignocaine) hydrochloride

BRAND INFORMATION

Brand name

Xylocaine 2% Jelly

Active ingredient

Lidocaine (lignocaine) hydrochloride

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Xylocaine Jelly.

What is in this leaflet

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

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 using Xylocaine Jelly against the benefits they expect it will have for you.

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 Jelly is for

Xylocaine Jelly is used to prevent pain and discomfort during medical tests and procedures. Your doctor will explain fully the tests which will be carried out and the reason for them.

Xylocaine Jelly belongs to a group of medicines called local anaesthetics. It works by making the nerves unable to pass messages to the brain. The jelly also acts as a lubricant.

Your doctor will have explained why you are being treated with Xylocaine Jelly 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.

Xylocaine Jelly is not addictive.

Before you use it

When you must not use it

Do not use Xylocaine Jelly if you are pregnant or breastfeeding unless your doctor says to do so. Ask your doctor about the risks and benefits involved.

There is no evidence available at the moment to show that being given Xylocaine Jelly under your doctor's instructions is harmful to unborn babies.

Your baby can take in very small amounts of Xylocaine Jelly 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 Jelly if the packaging is torn or shows signs of tampering.

Do not use it to treat any other complaints unless your doctor 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
  • ingredients listed at the end of this leaflet
  • other local anaesthetics
  • any other substances.
If you have an allergic reaction, you may get a skin rash, hayfever, asthma or feel faint.
  1. you have any of these medical conditions
  • epilepsy
  • heart problems
  • liver problems
  • kidney problems
  • open wounds or infection where the jelly will be used.
It may not be safe for you to use Xylocaine Jelly if you have any of these conditions.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy at the chemist, supermarket or health food shop. These medicines may affect the way Xylocaine Jelly 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 use any Xylocaine Jelly.

Using Xylocaine Jelly

How to use it

Xylocaine Jelly will be given to you by your doctor or nurse. Your doctor or pharmacist may also suggest that you buy it without prescription.

Xylocaine Jelly is given before a procedure to prevent discomfort, or applied to the end of medical instruments for lubrication as well.

The maximum dose of jelly is 30 mL (600 mg) in a 12 hour period.

Overdose

Telephone your doctor or go to casualty at your nearest hospital immediately if you think that you or anyone else may have used too much Xylocaine Jelly even if there are no signs of discomfort or poisoning.

Xylocaine Jelly can be absorbed into the blood, but very large amounts of it are needed to give an overdose.

Signs of overdose include dizziness, blurred vision, tremor or nervousness.

While you are using it

Things to be careful of

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

Do not eat or drink anything for at least 1 hour after using Xylocaine Jelly 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 using Xylocaine Jelly.

Xylocaine Jelly 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:

  • sore throat following use in the mouth or throat
  • skin rash or irritation
  • drowsiness.

These are all mild side effects of Xylocaine Jelly.

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
  • dizziness
  • confusion
  • numbness
  • blurred vision
  • vomiting
  • drowsiness
  • sensations of heat or cold.

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

Serious side effects are rare.

Xylocaine Jelly can pass into the bloodstream, although this is extremely unlikely to happen in high enough amounts from Xylocaine Jelly to cause any problems. In high doses serious side effects occur. These may include:

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

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

These serious 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 using Xylocaine Jelly.

Storage

Keep your Xylocaine Jelly in the pack until it is time to use it. If you take it out of the pack it will not keep well.

Keep it in a cool dry 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 medicine 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 Jelly is a clear to almost clear, slightly coloured, highly viscous liquid, packed in a 30 g aluminium tube. The tube is enclosed in a clear blister and includes one single use disposable nozzle.

It is supplied for single use only.

Xylocaine Jelly is sterile, until opened.

Each gram of Xylocaine Jelly contains lidocaine (lignocaine) hydrochloride 20 mg as the active ingredient.

Excipients include:

  • hypromellose
  • methyl hydroxybenzoate
  • propyl hydroxybenzoate
  • sodium hydroxide
  • purified water
  • hydrochloric acid (for pH adjustment).

Sponsor

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

Australian Registration Number: AUST R 12026

This leaflet was revised in January 2018.

Published by MIMS May 2019

BRAND INFORMATION

Brand name

Xylocaine 2% Jelly

Active ingredient

Lidocaine (lignocaine) hydrochloride

Schedule

S2

 

Name of the medicine

Lidocaine (lignocaine) hydrochloride.

Excipients.

Hypromellose, methyl hydroxybenzoate, propyl hydroxybenzoate, sodium hydroxide, water for injections and hydrochloric acid or sodium hydroxide for pH adjustment.

Description

Xylocaine 2% Jelly is a topical, sterile, anaesthetic for urological and endoscopic procedures and lubrication of endotracheal tubes and endoscopes.
Each gram of Xylocaine Jelly contains lidocaine (lignocaine) hydrochloride 21.3 mg (equivalent to lidocaine (lignocaine) hydrochloride anhydrous 20 mg), hypromellose, methyl hydroxybenzoate, propyl hydroxybenzoate, sodium hydroxide, water for injections and hydrochloric acid or sodium hydroxide for pH adjustment.

Pharmacology

Lidocaine (lignocaine), the active ingredient of Xylocaine Jelly, stabilises the neuronal membrane and prevents the initiation and conduction of nerve impulses, thereby effecting local anaesthetic action.
Xylocaine 2% Jelly provides prompt anaesthesia of mucous membranes and lubrication which reduces friction. Lidocaine (lignocaine) is absorbed following application to mucous membranes, with anaesthesia usually occurring rapidly (within 3 to 5 minutes, depending upon the area of application).
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 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 in urine. 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 free base 1 to 4 microgram/mL, 60 to 80% of lidocaine (lignocaine) is protein bound. Binding is also dependent on the plasma concentrations of the α1-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 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.
Xylocaine Jelly is ineffective when applied to intact skin.
Its water miscible base, characterised by high viscosity and low surface tension, brings the anaesthetic into intimate and prolonged contact with the tissue giving effective anaesthesia of short duration (approximately 20-30 minutes).
Blood concentrations of lidocaine (lignocaine) after instillation in the urethra of doses up to 800 mg are low and well below toxic levels.

Indications

Surface anaesthesia and lubrication:
of the male and female urethra during cystoscopy, catheterisation, exploration by sound and other endourethral operations;
of nasal and pharyngeal cavities in endoscopic procedures, e.g. gastroscopy and bronchoscopy;
during proctoscopy and rectoscopy;
during intubation.
For the relief of pain after circumcision in children.

Contraindications

Known history of hypersensitivity to local anaesthetics of the amide type or other components of the jelly.
Hypersensitivity to methyl and/or propyl hydroxybenzoate or to their metabolite ρ-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. 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).
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.

Dose 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 wound surfaces and mucous membranes is relatively high, especially in the bronchial tree. Because of the possibility of significant systemic absorption, Xylocaine Jelly 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 (lignocaine), in common with other local anaesthetics, should be used with caution in patients with epilepsy, impaired cardiac conduction, bradycardia, impaired hepatic function, severe shock and patients with severe renal dysfunction.

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.

Endotracheal tube lubrication.

When used for endotracheal tube lubrication, care should be taken to avoid introduction of the jelly into the lumen of the tube. The jelly may dry on the inner surface leaving a residue which tends to clump with flexion, narrowing the lumen. It has been reported rarely that this residue has caused the lumen to occlude.

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.

Porphyric patients.

Xylocaine 2% Jelly 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 up to 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 childbearing age have used lidocaine (lignocaine). No specific disturbances to the reproduction process have so far been reported.

Use in lactation.

Lidocaine (lignocaine) 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.

Interactions

Antiarrhythmic drugs.

Lidocaine (lignocaine) should be used with caution in patients receiving antiarrhythmic drugs, e.g. 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.

Drugs that reduce the clearance of lidocaine (lignocaine) (e.g. cimetidine or β-blockers) may cause potentially toxic plasma concentrations when lidocaine (lignocaine) is given in repeated high doses over a long time period. Caution should be taken if administered concurrently with lidocaine (lignocaine). However, such interactions should be of no clinical importance following short-term treatment with Xylocaine 2% Jelly at recommended doses.
Phenytoin and other antiepileptic drugs, e.g. 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 due to excessive dosage or rapid absorption, or may result from 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, sensation 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 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. 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.

Local reactions.

An increased incidence of postoperative 'sore throat' has been reported following endotracheal tube lubrication with Xylocaine Jelly.
There have been rare reports of endotracheal tube occlusion associated with the presence of dried jelly residue in the inner lumen of the tube (see Precautions).

Dosage and Administration

As with any local anaesthetic, reactions and complications are best averted by employing the minimum effective dosage. Debilitated or elderly patients and children should be given doses commensurate with their age and physical condition.
The dose of topical lidocaine (lignocaine) should be taken into consideration in estimating the total dose of lidocaine (lignocaine) if parenteral lidocaine (lignocaine) 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. 1 mL of Xylocaine Jelly is approximately equal to 1 g of Xylocaine Jelly.

Urethral anaesthesia.

Surface anaesthesia of the male adult urethra.

The usual dose required for adequate analgesia in males is 20 mL jelly (= 400 mg lidocaine (lignocaine) hydrochloride).
The jelly is instilled slowly into the urethra until it reaches the external sphincter, proximal to the prostate, where a certain resistance is felt. A penile clamp is then applied for several minutes at the corona. The remaining jelly is administered, filling the length of the urethra.
For procedures, e.g. sounding or cystoscopy, a larger quantity of jelly (up to 40 mL) may be required. This amount should be instilled in 3 to 4 portions and anaesthesia allowed to take effect for 5 to 10 minutes before insertion of the instrument.

Surface anaesthesia of the female adult urethra.

Instill 5 to 10 mL in small portions to fill the whole urethra. In order to obtain adequate anaesthesia, 3 to 5 minutes should be allowed prior to performing urological procedures.

Endoscopy (upper and lower airways and rectal).

Instillation of 10-20 mL into the appropriate body cavity is recommended for adequate analgesia, and a small amount should be applied to lubricate the endoscope. When combined with other lidocaine (lignocaine) products, the total dose should not exceed 400 mg.

Lubrication for endotracheal intubation.

About 2 mL applied to the surface of the tube just prior to insertion. Care should be taken to avoid introducing the product into the lumen of the tube (see Precautions).

Children.

In children under the age of 12 years, up to 6 mg/kg can be used.

Overdosage

In the event of an overdose, contact the Poisons Information Centre on 13 11 26.

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 ultrashort acting barbiturate or a benzodiazepine, 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 (lignocaine).

Presentation

Xylocaine 2% Jelly is supplied for single use as a 15 g or 30 g aluminium tube.
(Note: Not all pack sizes are marketed).

Storage

Store below 25°C.

Poison Schedule

S2.