SUMMARY CMI

XYLOCAINE with ADRENALINE injection

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using XYLOCAINE with ADRENALINE injection?

XYLOCAINE with ADRENALINE injection contains the active ingredient lidocaine hydrochloride and adrenaline (epinephrine) (as acid tartrate). XYLOCAINE with ADRENALINE injection is used to prevent or relieve pain, but it will not put you to sleep. XYLOCAINE with ADRENALINE is also used after surgery to relieve pain. It can also be used to make childbirth less painful.

For more information, see Section 1. Why am I using XYLOCAINE with ADRENALINE injection? in the full CMI.

2. What should I know before I use XYLOCAINE with ADRENALINE injection?

Do not use if you have ever had an allergic reaction to XYLOCAINE with ADRENALINE injection or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, are pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use XYLOCAINE with ADRENALINE injection? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with XYLOCAINE with ADRENALINE injection and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How XYLOCAINE with ADRENALINE injection is given?

Xylocaine will be injected by your doctor into the skin, near a single nerve, or into an area which contains a large number of nerves. The dosage you will be given will depend on your body size, age and the type of pain relief required.

More instructions can be found in Section 4. How XYLOCAINE with ADRENALINE injection is given? in the full CMI.

5. What should I know while receiving XYLOCAINE with ADRENALINE injection?

For more information, see Section 5. What should I know while receiving XYLOCAINE with ADRENALINE injection? in the full CMI.

6. Are there any side effects?

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given XYLOCAINE with ADRENALINE injection.

Some of these mild side effects include tremors, nervousness, dizziness, blurred vision, drowsiness, ringing in the ears, numbness, feeling strange (disoriented), nausea (feeling sick), vomiting.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

XYLOCAINE with ADRENALINE injection

Active ingredients: lidocaine hydrochloride and adrenaline (epinephrine) (as acid tartrate)

Consumer Medicine Information (CMI)

This leaflet provides important information about using XYLOCAINE with ADRENALINE injection.

You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using XYLOCAINE with ADRENALINE injection.

Where to find information in this leaflet:

1. Why am I using XYLOCAINE with ADRENALINE injection?
2. What should I know before I use XYLOCAINE with ADRENALINE injection?
3. What if I am taking other medicines?
4. How XYLOCAINE with ADRENALINE injection is given?
5. What should I know while being given XYLOCAINE with ADRENALINE injection?
6. Are there any side effects?
7. Product details

1. Why am I using XYLOCAINE with ADRENALINE injection?

XYLOCAINE with ADRENALINE contains the active ingredients lidocaine hydrochloride and adrenaline (epinephrine) (as acid tartrate).

This medicine is used to prevent or relieve pain, but it will not put you to sleep. XYLOCAINE with ADRENALINE is also used after surgery to relieve pain. It can also be used to make childbirth less painful.

When injected, it makes the nerves unable to pass messages to the brain. Depending on the amount used, it will either totally stop pain or will cause a partial loss of feeling.

XYLOCAINE (a local anaesthetic) is combined with adrenaline (epinephrine) to make it last longer. Adrenaline (epinephrine) makes the blood vessels at the site of injection narrower, which keeps the XYLOCAINE where it is needed for a longer time.

Your doctor will have explained why you are being treated with XYLOCAINE with ADRENALINE 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.

Ask your doctor if you have any questions about why this medicine has been given to you.

Your doctor may have prescribed it for another use.

XYLOCAINE with ADRENALINE is not addictive.

2. What should I know before I use XYLOCAINE with ADRENALINE injection?

Warnings

You must not be given XYLOCAINE with ADRENALINE if:

• you are allergic to lidocaine hydrochloride, adrenaline (epinephrine) or any of the ingredients listed at the end of this leaflet
• you are allergic to other local anaesthetics e.g. bupivacaine
• you are allergic to other substances
• the expiry date printed on the pack has passed.
• the solution is not clear, or the packaging is torn or shows signs of tampering.

If you have an allergic reaction, you may get a skin rash, hay fever or an asthma attack.

Check with your doctor if you:

• have or have had any of these medical conditions:
  - problems with your blood pressure or circulation
  - blood poisoning
  - problems with the clotting of your blood
  - nerve problems, e.g. epilepsy
  - heart, liver or kidney problems
  - thyroid problems
  - malignant hyperthermia
  - diabetes
  - skin infections

It may not be safe for you to take XYLOCAINE with ADRENALINE if you have any of these conditions.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Ask your doctor about the risks and benefits of using this medicine while you are pregnant or breastfeeding.

XYLOCAINE with ADRENALINE 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 with ADRENALINE from breast milk if you are breastfeeding, but it is unlikely that the amount available to the baby will do any harm.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and XYLOCAINE with ADRENALINE may interfere with each other. These include:

• ones to control your heartbeat
• ones for blood pressure (anti-hypertensives)
• ones for epilepsy or fits
• ones for depression
• cimetidine.

If you have not told your doctor about any of these things, tell them before you are given any XYLOCAINE with ADRENALINE.

4. How XYLOCAINE with ADRENALINE injection is given?

How much is given

The dosage you will be given will depend on your body size, age and the type of pain relief required. Your doctor will have had a lot of experience injecting XYLOCAINE with ADRENALINE or other local anaesthetics and will choose the best dose for you.

How XYLOCAINE with ADRENALINE injection is administered

XYLOCAINE with ADRENALINE will be injected by your doctor into the skin, 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 of injection, near the site of injection or in an area that may seem unrelated to the site of injection e.g. an epidural injection (an injection into the epidural space between vertebrae around the spinal cord in the lower back resulting in a feeling of numbness in the lower body. A thin tube will be inserted so a continuous dose can be given over a period of time).

XYLOCAINE with ADRENALINE injection should not be injected directly into the blood.

If you are given too much XYLOCAINE with ADRENALINE injection

The doctor giving you XYLOCAINE with ADRENALINE 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 with ADRENALINE injection, or the dose is accidentally injected directly into your blood, you may develop problems for a short time with your sight or hearing. You may get a numb feeling in or around the mouth, feel dizzy or stiff, or have twitchy muscles.

Whenever you are given XYLOCAINE with ADRENALINE injection, equipment will be available to care for you if an overdose happens.

If any overdose occurs, you should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

5. What should I know while being given XYLOCAINE with ADRENALINE injection?

Things you should do

Remind any doctor, dentist or nurse you visit that you have been given XYLOCAINE with ADRENALINE injection.

Driving or using machines

Depending on the dosage you may experience a very mild effect on your ability to drive a car or operate machinery.

Drinking alcohol

Do not drink alcohol while you are being given XYLOCAINE with ADRENALINE injection.

If you drink alcohol while you are being given XYLOCAINE with ADRENALINE injection your blood pressure may drop making you feel dizzy and faint.

Looking after your medicine

XYLOCAINE with ADRENALINE injection will usually be stored in the hospital ward or in emergency medical kits like in ambulances.

It should be kept in a cool dry place, protected from light where the temperature stays below 25°C.

When to discard your medicine

Any XYLOCAINE with ADRENALINE injection from a single dose preparation which is not used, will be disposed of in a safe manner by your doctor or pharmacist.

6. Are there any side effects?

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given XYLOCAINE with ADRENALINE injection.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

XYLOCAINE with ADRENALINE injection will help relieve pain in most people, but it may have unwanted side effects.

See the information below and, if you need to, ask your doctor or nurse if you have any further questions about side effects.

Less serious side effects

Serious side effects

If you are sensitive to sodium metabisulphite (found in adrenaline (epinephrine) containing preparations), it may cause life-threatening reactions or less severe asthmatic episodes.

After an epidural injection you may develop a headache or backache which is not related to the medicine used. These can, on rare occasions, last for some months after the injection is given.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What XYLOCAINE with ADRENALINE injection contains

XYLOCAINE with ADRENALINE injection does not contain an antimicrobial agent.

Do not take this medicine if you are allergic to any of these ingredients.

What XYLOCAINE with ADRENALINE injection looks like

XYLOCAINE with ADRENALINE is a clear, colourless, sterile solution for injection available in different strengths and in different presentations.

• XYLOCAINE 0.5% with ADRENALINE 1:200,000 injection

Contains lidocaine hydrochloride 5 mg/mL and adrenaline (epinephrine) (as acid tartrate) 5 microgram/mL.

Available in packs of 5 x 20 mL single dose glass vials.

Australian Registration number: AUST R 12008

• XYLOCAINE 1% with ADRENALINE 1:100,000 injection

Contains lidocaine hydrochloride 10 mg/mL and adrenaline (epinephrine) (as acid tartrate) 10 microgram/mL.

Available in packs of 10 x 5 mL single dose glass ampoules.

Australian Registration number: AUST R 12017

• XYLOCAINE 1% with ADRENALINE 1:200,000 injection

Contains lidocaine hydrochloride 10 mg/mL and adrenaline (epinephrine) (as acid tartrate) 5 microgram/mL.

Available in packs of 5 x 20 mL single dose glass vials.

Australian Registration number: AUST R 12015

• XYLOCAINE 2% with ADRENALINE 1:200,000 injection

Contains lidocaine hydrochloride 20 mg/mL and adrenaline (epinephrine) (as acid tartrate) 5 microgram/mL.

Available in packs of 5 x 20 mL single dose glass vials.

Australian Registration number: AUST R 12021

• XYLOCAINE 2% with ADRENALINE 1:80,000 injection

Contains lidocaine hydrochloride 20 mg/mL and adrenaline (epinephrine) (as acid tartrate) 12.5 microgram/mL.

Available in packs of 10 x 5 mL single dose glass ampoules.

Australian Registration number: AUST R 54520

Who distributes XYLOCAINE with ADRENALINE injection

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

This leaflet was revised in July 2025.

Published by MIMS August 2025

1 Name of Medicine

Xylocaine: lidocaine hydrochloride.
Xylocaine with Adrenaline: lidocaine hydrochloride and adrenaline (epinephrine) acid tartrate.

2 Qualitative and Quantitative Composition

Plain aqueous solutions are sterile, isotonic and contain lidocaine hydrochloride, sodium chloride, sodium hydroxide and/or hydrochloric acid for pH adjustment and water for injections.
Lidocaine hydrochloride with adrenaline (epinephrine) acid tartrate solutions are also sterile and isotonic, and in addition contain adrenaline (epinephrine) acid tartrate and sodium metabisulfite.

Excipients with known effect.

3 Pharmaceutical Form

Clear, colourless solution for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Xylocaine solutions are indicated for the production of local or regional anaesthesia by the following techniques: infiltration; intravenous regional anaesthesia - excluding solutions with adrenaline (epinephrine) acid tartrate; peripheral nerve block such as intercostal block; major plexus block such as brachial plexus block; epidural block; subarachnoid block.

4.2 Dose and Method of Administration

The lowest dosage and volume that results in effective anaesthesia should be used and should be based on the status of the patient and the type of regional anaesthesia intended. Xylocaine solutions contain no antimicrobial agent and should be used only once and any residue discarded.
Lidocaine should be administered with great caution to patients with impaired cardiovascular function as they may be less able to compensate for functional changes associated with the prolongation of AV conduction produced by these drugs.

Adult.

Note: 1. Recommended doses.

2. Hypotension.

3. Test dose.

Use in children.

Use in elderly.

With impaired hepatic function.

With impaired renal function.

4.3 Contraindications

1. Allergy or hypersensitivity to amide type local anaesthetics or to any excipients. Allergy or hypersensitivity to sodium metabisulfite in solutions with adrenaline (epinephrine) acid tartrate. Detection of suspected hypersensitivity by skin testing is of limited value.
2. Local anaesthetics are contraindicated for epidural and spinal anaesthesia in patients with uncorrected hypotension or coagulation disorders or in patients receiving anticoagulation treatment.
3. Local anaesthetic techniques must not be used when there is inflammation and/or sepsis in the region of the proposed injection and/or in the presence of septicaemia.
4. General contraindications related to epidural anaesthesia, regardless of the local anaesthetic used, should be taken into account.
The following are additional contraindications for solutions with adrenaline (epinephrine) acid tartrate:
5. Adrenaline (epinephrine) acid tartrate is contraindicated in conditions where the production or exacerbation of tachycardia may prove fatal, such as thyrotoxicosis or severe heart disease, or in obstetrics when maternal blood pressure exceeds 130/80 mmHg.
6. Solutions with adrenaline (epinephrine) acid tartrate must not be used for local analgesia in parts of the body with compromised blood supply or supplied by end arteries, such as fingers, toes, nose, ears or penis. There is a possibility of producing arterial vasoconstriction and subsequent ischaemic gangrene distal to the site of injection.
7. Solutions with adrenaline (epinephrine) acid tartrate must not be used for intravenous regional techniques.
8. Solutions with adrenaline (epinephrine) acid tartrate should not be used in patients with a known sensitivity to sympathomimetic amines.
9. Solutions with adrenaline (epinephrine) acid tartrate should not be used in most patients with cerebral arteriosclerosis.

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. Because of the possibility of hypotension and bradycardia following major blocks, an IV cannula should be inserted before the local anaesthetic is injected. Delay in proper management of dose related toxicity, underventilation from any cause and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and death.
2. Injection should always be made slowly with frequent aspirations to avoid inadvertent intravascular injection which can produce cerebral symptoms even at low doses.
3. Although intra-articular continuous infusions of local anaesthetics following arthroscopic and other surgical procedures is an unapproved use, there have been postmarketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of glenohumeral chondrolysis have been described in paediatric and adult patients following intra-articular continuous infusions of local anaesthetics with and without adrenaline (epinephrine) acid tartrate for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. Therefore, Xylocaine and Xylocaine with adrenaline (epinephrine) acid tartrate should not be used for postoperative intra-articular continuous infusion.
4. Careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness should be accomplished after each local anaesthetic injection. It should be kept in mind that at such times restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression or drowsiness may be early warning signs of CNS toxicity.
5. Low molecular weight heparins and heparinoids (spinal/ epidural haematomas) - When neuraxial anaesthesia (epidural/ spinal anaesthesia) is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis. The risk of these events is increased by the use of indwelling epidural catheters, traumatic or repeated epidural/ spinal puncture, and the concomitant use of drugs affecting haemostasis, such as NSAIDs, platelet inhibitors or other anticoagulants. Patients should be frequently monitored for signs and symptoms of neurological impairment.
6. The safety and effectiveness of Xylocaine depend on proper dosage, correct technique and adequate precautions. Standard textbooks should be consulted regarding specific techniques and precautions for various regional anaesthetic procedures.
7. The lowest dosage that results in effective anaesthesia should be used (see Section 4.2 Dose and Method of Administration). Repeated injection of Xylocaine may cause accumulation of lidocaine or its metabolites and result in toxic effects.
Tolerance to elevated blood levels varies with the status of the patient. Elderly, young or debilitated patients, including those with advanced liver disease or severe renal dysfunction, should be given reduced doses commensurate with their age and physical condition.
8. Lidocaine should be given with great caution to patients with epilepsy, impaired cardiac conduction, bradycardia, severe shock or digitalis intoxication. Lidocaine should also be administered with great caution to patients with impaired cardiovascular function as they may be less able to compensate for functional changes associated with the prolongation of AV conduction produced by these drugs. In patients with Stokes-Adams syndrome or Wolff-Parkinson-White syndrome extreme care should be taken to avoid accidental arterio-venous injection.
9. Central nerve blocks may cause cardiovascular depression, especially in the presence of hypovolaemia. Epidural anaesthesia should be used with caution in patients with impaired cardiovascular function. Epidural anaesthesia may lead to hypotension and bradycardia. Hypotension should be treated promptly with a sympathomimetic intravenously and repeated as necessary.
10. Local anaesthetics should be given with great caution (if at all) to patients with pre-existing abnormal neurological pathology, e.g. myasthenia gravis. Use with extreme caution in epidural, caudal and spinal anaesthesia when there are serious diseases of the CNS or of the spinal cord, e.g. meningitis, spinal fluid block, cranial or spinal haemorrhage, tumours, poliomyelitis, syphilis, tuberculosis or metastatic lesions of the spinal cord.
11. Since lidocaine is metabolised in the liver and excreted via the kidneys, the possibility of drug accumulation should be considered in patients with hepatic and/or renal impairment (see Section 4.2 Dose and Method of Administration).
12. Inadvertent intravascular or subarachnoid injection of small doses of local anaesthetics injected into the head and neck area, including retrobulbar, dental and stellate ganglion blocks, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses.
Clinicians who perform retrobulbar blocks should be aware that there have been reports of cardiovascular collapse and apnoea following the use of local anaesthetic injections for retrobulbar block. Prior to retrobulbar block, necessary equipment, drugs and personnel should be immediately available, as with all other regional procedures. Retrobulbar injections may very occasionally reach the subarachnoid space, causing temporary blindness, cardiovascular collapse, apnoea, convulsions, etc. These must be diagnosed and treated promptly.
Retro- and peribulbar injections of local anaesthetics carry a low risk of persistent ocular muscle dysfunction. The primary causes include trauma and/or local toxic effects on muscles or nerves. The severity of such tissue reactions is related to the degree of trauma, the concentration of the local anaesthetic and the duration of exposure of the tissue to the local anaesthetic. For this reason, as with all local anaesthetics, the lowest effective concentration and dose of local anaesthetic should be used. Vasoconstrictors may aggravate tissue reactions and should be used only when indicated.
13. Foetal bradycardia/ tachycardia frequently follows paracervical block and may be associated with foetal acidosis and hypoxia. Occasional cases of perinatal morbidity and mortality have been reported. When the recommended dose is exceeded the risk of foetal bradycardia increases. Careful monitoring of the foetal heart rate is necessary.
14. Lidocaine should be used with caution in patients with known drug sensitivities.
15. There have been reports of lidocaine-induced hypersensitivity reactions leading to Kounis syndrome.
16. Patients being treated with anti-arrhythmic drugs class III (e.g. amiodarone) should be under close surveillance and ECG monitoring since cardiac effects may be additive.
17. Solutions with adrenaline (epinephrine) acid tartrate should be used with extreme caution in patients with severe or untreated hypertension, arteriosclerotic heart disease, cerebral vascular insufficiency, heart block, advanced diabetes, poorly controlled thyrotoxicosis or any other pathological conditions that might be aggravated by the effects of adrenaline (epinephrine) acid tartrate. Adrenaline (epinephrine) acid tartrate may induce anginal pain in patients suffering from ischaemic heart disease.
18. Solutions containing adrenaline (epinephrine) acid tartrate should be used with caution in patients with ventricular fibrillation, prefibrillatory rhythm, tachycardia, myocardial infarction, phenothiazine induced circulatory collapse and prostatic hypertrophy. (See Section 4.3 Contraindications; Section 4.8 Adverse Effects (Undesirable Effects); Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.)
19. Solutions containing adrenaline (epinephrine) acid tartrate also contain sodium metabisulfite which may cause allergic type reactions including anaphylactic type 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.
20. Xylocaine Plain and Xylocaine with Adrenaline solutions for injection are 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.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

1. Creatinine.

2. Creatine kinase.

4.5 Interactions with Other Medicines and Other Forms of Interactions

1. Anti-arrhythmic drugs.

2. Amiodarone.

3. Beta-adrenoreceptor antagonists.

4. Cimetidine.

5. Anticonvulsive agents.

6. Inhalational anaesthetics.

7. Skeletal muscle relaxants.

8. Structurally related local anaesthetics.

9. CNS acting drugs.

10. Oxytocic drugs of the ergot type.

11. Adrenergic neuron blocking agents.

12. Inhalation anaesthetics.

13. Cardiac glycosides.

14. Beta-blockers.

15. Quinidine.

16. Hypoglycaemics.

17. Alkaline solutions.

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)

Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anaesthetic agents. These adverse experiences are, in general, dose related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.
Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported.

Central nervous system.

Cardiovascular.

Haemodynamic.

Allergic.

Neurologic.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms.

Symptoms of acute toxicity.

Cardiovascular toxicity.

Treatment of overdosage.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption and distribution.

Metabolism and excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Xylocaine.

Xylocaine with Adrenaline.

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 mL and 5 mL Polyamp presentations should be stored below 25°C.
20 mL Polyamp presentations should be stored below 30°C.
Xylocaine solutions in glass ampoules should be stored below 30°C.
Xylocaine with Adrenaline in glass ampoules should be stored below 25°C.
Xylocaine with Adrenaline in single dose vials should be stored below 25°C.
Solutions with adrenaline (epinephrine) acid tartrate should be protected from light.
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 Xylocaine solutions and metal surfaces such as metal bowls, cannulae and syringes with metal parts.
Solutions showing discolouration and unused portions of solutions from ampoules and single dose vials should be discarded. Solutions with adrenaline (epinephrine) acid tartrate should not be reautoclaved. Surface sterilisation using pure, undiluted isopropyl alcohol (91%) or 70% ethyl alcohol (USP) may be carried out if desired.

6.5 Nature and Contents of Container

Xylocaine 0.5% [lidocaine hydrochloride] 5 mg/mL.

Xylocaine 0.5% with Adrenaline 1:200,000 [lidocaine hydrochloride 5 mg/mL with adrenaline (epinephrine) 5 microgram/mL (as acid tartrate)].

Xylocaine 1.0% [lidocaine hydrochloride 10 mg/mL].

Xylocaine 1.0% with Adrenaline 1:100,000 [lidocaine hydrochloride 10 mg/mL with adrenaline (epinephrine) 10 microgram/mL (as acid tartrate)].

Xylocaine 1.0% with Adrenaline 1:200,000 [lidocaine hydrochloride 10 mg/mL with adrenaline (epinephrine) 5 microgram/mL (as acid tartrate)].

Xylocaine 1.5% with Adrenaline 1:200,000 [lidocaine hydrochloride 15 mg/mL with adrenaline (epinephrine) 5 microgram/mL (as acid tartrate)].

Xylocaine 2.0% [lidocaine hydrochloride 20 mg/mL].

Xylocaine 2.0% with Adrenaline 1:80,000 [lidocaine hydrochloride 20 mg/mL with adrenaline (epinephrine) 12.5 micrograms/mL)].

Xylocaine 2.0% with Adrenaline 1:200,000 [lidocaine hydrochloride 20 mg/mL with adrenaline (epinephrine) 5 micrograms/mL (as acid tartrate)].

Note.

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

The chemical name for lidocaine hydrochloride is 2-Diethylaminoaceto-2'6'- xylidide hydrochloride. The Australian Approved Name is lidocaine hydrochloride.
The chemical name for adrenaline (epinephrine) acid tartrate is (R)-1-(3,4-Dihydroxyphenyl)- 2-methylaminoethanol. The Australian Approved Name is adrenaline (epinephrine).
Lidocaine is classed as a membrane stabilising agent and is a local anaesthetic of the amide type. It is extremely stable and plain solutions can be sterilised by autoclaving, repeated a maximum of two times if necessary. Xylocaine solutions are available with or without adrenaline (epinephrine) acid tartrate.
Plain aqueous solutions of lidocaine hydrochloride have a pH of 5.0 - 7.0 (approx.); lidocaine hydrochloride with adrenaline (epinephrine) acid tartrate solutions have a pH of 3.3 - 5.5 (approx.). Lidocaine base has a pKa of 7.85 (25°C), an oil/water coefficient of 2.9 and a molecular weight of 234.3.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription only medicine).

Summary Table of Changes