LIDOCAINE ACCORD 2% lidocaine (lignocaine) hydrochloride 40 mg/2 mL injection ampoule

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Active ingredient:
lidocaine (lignocaine) hydrochloride
Available from:
Accord Healthcare Pty Ltd
Authorization status:
Registered
Authorization number:
309533

Version 1.0

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LIDOCAINE ACCORD 1% and 2%

Lidocaine (lignocaine) hydrochloride Solution Injection, 10 mg/mL and 20 mg/mL

Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the

common questions people ask about

Lidocaine Accord. It does not contain

all the information that is known about

Lidocaine Accord.

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 taking Lidocaine Accord

against the benefits they expect it will

have for you.

If you have any concerns about being

given this medicine, ask your doctor

or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Lidocaine Accord

is used for

Lidocaine Accord is used to prevent or

relieve pain, but it will not put you to

sleep.

Lidocaine Accord is also used after

surgery to relieve pain. It can also be

used to make childbirth less painful.

Lidocaine Accord belongs to a group of

medicines called local anaesthetics. It

is injected into the body where it makes

the nerves unable to pass messages to

the brain.

Depending on the amount used,

Lidocaine Accord will either totally

stop pain or will cause a partial loss of

feeling.

Lidocaine Accord is sometimes

combined with adrenaline

(epinephrine) to make it last longer.

Adrenaline (epinephrine) makes the

blood vessels at the site of injection

narrower, which keeps the Lidocaine

Accord where it is needed for a longer

time.

Your doctor will have explained why

you are being treated with Lidocaine

Accord 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.

Lidocaine Accord is not addictive.

Before you are given

Lidocaine Accord

When you must not be

given it

If you are pregnant or breastfeeding

do not use Lidocaine Accord unless

your doctor says so. Ask your doctor

about the risks and benefits of using

this medicine while you are pregnant

or breastfeeding.

Lidocaine Accord 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 Lidocaine Accord from

breast milk if you are breastfeeding, but

it is unlikely that the amount available

to the baby will do any harm.

Lidocaine Accord will only be used if

the solution is clear, the package is

undamaged and the use by (expiry)

date marked on the pack has not

been passed.

Before you are given it

You must tell your doctor if:

1. you have any allergies to

any ingredients listed at the end of

this leaflet

other local anaesthetics e.g.

bupivacaine

other substances

If you have an allergic reaction, you

may get a skin rash, hay fever or an

asthma attack.

2. you have any of these medical

conditions

problems with your blood pressure

or circulation

blood poisoning

problems with the clotting of your

blood

nerve problems, e.g. epilepsy

heart, liver or kidney problems

thyroid problems

malignant hyperthermia

diabetes

skin infections

It may not be safe for you to take

Lidocaine Accord 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

ones for depression

cimetidine

any medicines that you buy at the

Version 1.0

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chemist, supermarket or health food

shop.

These medicines may affect the way

Lidocaine Accord 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 are given any Lidocaine

Accord.

How Lidocaine Accord

is given

Lidocaine Accord 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. The

last will be the case if you are given an

EPIDURAL injection (an injection

around the spinal cord).

Lidocaine Accord should not be

injected directly into the blood.

The dosage you will be given will

depend on your body size, age and the

type of pain relief required. Your

doctor will have had a lot of experience

injecting Lidocaine Accord or other

local anaesthetics and will choose the

best dose for you. They will be willing

to discuss this decision with you.

If you are given too much

(overdose)

The doctor giving you Lidocaine

Accord 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 Lidocaine Accord, 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 Lidocaine

Accord, equipment will be available to

care for you if an overdose happens.

While you are given

Lidocaine Accord

Things to be careful of

Be careful driving or operating

machinery after you have been given

Lidocaine Accord.

You may be drowsy, and your reflexes

may be slow.

Do not drink alcohol while you are

being given Lidocaine Accord.

If you drink alcohol while you are

being given Lidocaine Accord your

blood pressure may drop making you

feel dizzy and faint.

Please talk to your doctor or pharmacist

about these possibilities if you think

they may bother you.

Side Effects

Tell your doctor or nurse as soon as

possible if you do not feel well while

you are being given Lidocaine

Accord.

Lidocaine Accord will help relieve pain

in most people, but it may have

unwanted side-effects. 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, nurse or

pharmacist to answer any questions

you may have.

Tell your doctor or nurse if you

notice any of the following and they

worry you:

tremors

nervousness

dizziness

blurred vision

drowsiness

ringing in the ears

numbness

feeling strange (disoriented)

nausea (feeling sick)

vomiting

These are all mild side effects of

Lidocaine Accord.

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.

If Lidocaine Accord is given wrongly,

or you are very sensitive to it, it

sometimes causes:

fits

unconsciousness

breathing problems

low blood pressure

slow heart beat

collapse

These are all serious side effects. You

may need urgent medical attention.

Some people may get other side effects

while being given Lidocaine Accord.

Tell your doctor if you notice

anything else that is making you feel

unwell.

Storage

Lidocaine Accord will be stored by

your doctor or pharmacist under the

recommended conditions.

Lidocaine Accord should be stored

below 25

Disposal

Any Lidocaine Accord from a single

dose preparation which is not used, will

be disposed of in a safe manner by your

doctor or pharmacist.

Product Description

What it looks like

Lidocaine Accord containing solutions

Version 1.0

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are clear, colourless and available in

ampoules in packs of 20 and vials in

packs of 1 and 5.

Not all presentations and pack sizes

may be marketed.

Ingredients

Active ingredient:

Lidocaine (lignocaine) hydrochloride

Inactive ingredients:

sodium chloride

sodium hydroxide

hydrochloric acid

water for injections

Name and Address of the

Sponsor

Accord Healthcare Pty Ltd

Level 24, 570 Bourke Street

Melbourne, VIC, 3000

Australia

Australian Registration Numbers

Lidocaine Accord 1%

20 mg/2 mL: AUST R 309534

50 mg/5 mL: AUST R 309529

100 mg/10 mL: AUST R 309530

200 mg/20 mL: AUST R 309525

Lidocaine Accord 2%

40 mg/2 mL: AUST R 309533

100 mg/5 mL: AUST R 309520

200 mg/10 mL: AUST R 309526

400 mg/20 mL: AUST R 309521

Date of Preparation

This leaflet was prepared on 20

September 2019.

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AUSTRALIAN PRODUCT INFORMATION

LIDOCAINE ACCORD (LIDOCAINE HYDROCHLORIDE) SOLUTION FOR

INJECTION

1

NAME OF THE MEDICINE

Lidocaine (lignocaine) hydrochloride

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Lidocaine Accord 1%

1 mL contains 10 mg lidocaine hydrochloride.

1 ampoule of 2 mL solution for injection contains 20 mg lidocaine hydrochloride.

1 ampoule of 5 mL solution for injection contains 50 mg lidocaine hydrochloride.

1 ampoule of 10 mL solution for injection contains 100 mg lidocaine hydrochloride.

1 vial of 20 mL solution for injection contains 200 mg lidocaine hydrochloride.

Lidocaine Accord 2%

1 mL contains 20 mg lidocaine hydrochloride.

1 ampoule of 2 mL solution for injection contains 40 mg lidocaine hydrochloride.

1 ampoule of 5 mL solution for injection contains 100 mg lidocaine hydrochloride.

1 ampoule of 10 mL solution for injection contains 200 mg lidocaine hydrochloride.

1 vial of 20 mL solution for injection contains 400 mg lidocaine hydrochloride.

For the full list of excipients, see

Section 6.1 List of Excipients.

3

PHARMACEUTICAL FORM

Lidocaine Accord is a clear, colourless solution for injection.

4

CLINICAL PARTICULARS

4.1

T

HERAPEUTIC INDICATIONS

Lidocaine Accord solutions are indicated for the production of local or regional anaesthesia by the

following techniques:

infiltration

intravenous regional anaesthesia

peripheral nerve block

epidural block

subarachnoid block.

4.2

D

OSE AND METHOD OF ADMINISTRATION

Lidocaine Accord solutions contain no antimicrobial agent. The product is for single use in one patient

only. Discard any residue.

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.

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.

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Adult

Table

1:

Recommended

Dosages

for

Lidocaine

Accord

Solutions

for

Various

Anaesthetic

Procedures in the Average, Healthy, 70 kg Adult Patient

PROCEDURE

CONCENTRATION

DOSE

INFILTRATION

IV REGIONAL

ANAESTHESIA*

Bier’s Block

NERVE BLOCKS

Paravertebral

3 - 5

30 - 50

Pudendal (each side)

Paracervical

STELLATE

GANGLION

BLOCK

Cervical

Lumbar

EPIDURAL

ANAESTHESIA**

Thoracic

10 - 20

100 - 200

Lumbar

5 - 10

100 - 200

EPIDURAL

ANALGESIA

Lumbar

10 - 20

100 - 200

Caudal

10 - 20

100 - 200

* IV administration of lidocaine may provoke a hypotensive response and in an overdosage may be precipitous. Therefore,

when administering an IV regional dose of 200 mg per single injection, slowly releasing the tourniquet in Bier’s block is

advocated.

** Dose determined by number of segments to be anaesthetised (2 - 3 mL per segment).

Note:

1. Recommended doses

The above suggested concentrations and volumes serve only as a guide. Toxic doses vary widely

between patients and toxic effects may occur after any local anaesthetic procedure.

Careful observation of the patient must therefore be maintained. It is recommended that the dose

of lidocaine at any one time should not exceed 3 mg/kg. However, the dose administered must be

tailored to the individual patient and procedure, and the maximum doses here quoted should be

used as a guide only.

2. Hypotension

During thoracic and lumbar epidural anaesthesia, a marked fall in blood pressure and/or

intercostal paralysis may be seen, possibly due to the use of excessive doses, improper positioning

Page 3 of 12

of the patient or accidental disposition of the anaesthetic within the subarachnoid space.

Hypotension and bradycardia may occur as a result of sympathetic blockade.

3. Test dose

For epidural anaesthesia, a 3 - 5 mL test dose of a local anaesthetic solution preferably containing

up to 15 micrograms of adrenaline (lidocaine with adrenaline is available from other brands)

should be administered.

Verbal contact and repeated monitoring of heart rate and blood pressure should be maintained for

5 minutes after the test dose after which, in the absence of signs of subarachnoid or intravascular

injection, the main dose may be administered.

Use of a test dose containing adrenaline may have further advantages in that an intravascular

injection of adrenaline will be quickly recognised by an increase in heart rate, usually within

about 40 seconds. To detect this, the heart rate and rhythm should be monitored with an

electrocardiogram.

Prior to administration of the total dose, aspiration should be repeated. The main dose should be

injected slowly, with continual assessment of the patient. If toxic symptoms or signs occur, the

injection should be stopped immediately.

Use in children

(See

Section 4.4 Special Warnings and Precautions for Use

For children, a reduced dosage based on body weight or surface area should be used. The dosage should

be calculated for each patient individually and modified in accordance with the physician's experience

and knowledge of the patient.

In order to minimise the possibility of toxic effects, the use of lidocaine 0.5% or 1% solutions is

recommended for most anaesthetic procedures involving paediatric patients.

In children, early signs of local anaesthetic toxicity may be difficult to detect in cases where the block is

given during general anaesthesia.

Use in elderly

(See

Section 4.4 Special Warnings and Precautions for Use

A reduction in dosage may be necessary for elderly patients especially those with compromised

cardiovascular and/or hepatic function.

In epidural anaesthesia, a smaller dose may provide adequate anaesthesia.

With impaired hepatic function

(See

Section 4.4 Special Warnings and Precautions for Use

Although lidocaine is metabolised by the liver, dosage reduction for local anaesthesia is probably not

warranted. However, caution should be exercised with repeated doses.

With impaired renal function

(See

Section 4.4 Special Warnings and Precautions for Use

Impairment of renal function is unlikely to affect lidocaine clearance in the short term (24 hours).

However, toxicity due to accumulation may develop with prolonged or repeated administration.

4.3

C

ONTRAINDICATIONS

Allergy or hypersensitivity to amide type local anaesthetics or to any excipients. Detection of suspected

hypersensitivity by skin testing is of limited value.

Local anaesthetics are contraindicated for epidural and spinal anaesthesia in patients with uncorrected

hypotension or coagulation disorders or in patients receiving anti coagulation treatment.

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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.

General contraindications related to epidural anaesthesia, regardless of the local anaesthetic used, should

be taken into account.

4.4

S

PECIAL WARNINGS AND PRECAUTIONS FOR USE

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

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, UNDER-VENTILATION FROM ANY

CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS,

CARDIAC ARREST AND DEATH.

INJECTION SHOULD ALWAYS BE MADE SLOWLY WITH FREQUENT ASPIRATIONS TO

AVOID INADVERTENT INTRAVASCULAR INJECTION WHICH CAN PRODUCE CEREBRAL

SYMPTOMS EVEN AT LOW DOSES.

ALTHOUGH INTRA-ARTICULAR CONTINUOUS INFUSIONS OF LOCAL ANAESTHETICS

FOLLOWING ARTHROSCOPIC AND OTHER SURGICAL PROCEDURES IS AN UNAPPROVED

USE, THERE HAVE BEEN POST-MARKETING REPORTS OF CHONDROLYSIS IN PATIENTS

RECEIVING SUCH INFUSIONS. THE MAJORITY OF REPORTED CASES OF CHONDROLYSIS

HAVE INVOLVED THE SHOULDER JOINT; CASES OF GLENO-HUMERAL CHONDROLYSIS

HAVE BEEN DESCRIBED IN PAEDIATRIC AND ADULT PATIENTS FOLLOWING INTRA-

ARTICULAR CONTINUOUS INFUSIONS OF LOCAL ANAESTHETICS WITH AND WITHOUT

ADRENALINE 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

EXPERIENCED

CHONDROLYSIS

HAVE

REQUIRED

ADDITIONAL DIAGNOSTIC AND THERAPEUTIC PROCEDURES AND SOME REQUIRED

ARTHROPLASTY

SHOULDER

REPLACEMENT.

THEREFORE,

LIDOCAINE

ACCORD

SHOULD

USED

POST-OPERATIVE

INTRA-ARTICULAR

CONTINUOUS

INFUSION.

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.

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 NSAID, platelet

inhibitors or other anticoagulants. Patients should be frequently monitored for signs and symptoms of

neurological impairment.

The safety and effectiveness of Lidocaine Accord depends on proper dosage, correct technique and

adequate precautions. Standard textbooks should be consulted regarding specific techniques and

precautions for various regional anaesthetic procedures.

The lowest dosage that results in effective anaesthesia should be used (see

Section 4.2 Dose and Method

Page 5 of 12

of Administration

). Repeated injection of Lidocaine Accord 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.

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.

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.

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.

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.

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.

Lidocaine should be used with caution in patients with known drug sensitivities.

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.

Lidocaine Accord 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

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

Page 6 of 12

Dose and Method of Administration

Use in renal impairment

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

Use in the elderly

Section 4.2 Dose and Method of Administration, Use in elderly.

Paediatric use

Section 4.2 Dose and Method of Administration, Use in children

Effects on laboratory tests

Creatinine

Creatinine measurements in patients with therapeutic plasma levels of lidocaine are about 15 - 35%

higher when measured by an enzymatic method versus the Jaffé method. This appears to be due to assay

interference from N-ethylglycine, a metabolite of lidocaine.

Creatine kinase

The intramuscular injection of lidocaine may result in an increase in creatine kinase levels for up to

48 hrs. This may interfere with the diagnosis of myocardial infarction.

4.5

I

NTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS

Anti-arrhythmic drugs

Local anaesthetics of the amide type, such as lidocaine, should be used with caution in patients receiving

other local anaesthetics or agents structurally related to amide-type local anaesthetics e.g. certain anti

arrhythmic drugs such as disopyramide, procainamide, mexilitene since potentiation of cardiac effects

occur.

Specific

interaction

studies

with

lidocaine

anti-arrhythmic

drugs

class

(e.g.

amiodarone) have not been performed, but caution should be advised (see

Section 4.4 Special Warnings

and Precautions for Use

Amiodarone

Amiodarone has been reported to reduce the clearance of lidocaine in two case reports, although a small

prospective study of combined therapy on lidocaine pharmacokinetics found no change in clearance or

other pharmacokinetic factor. This combination has been reported to precipitate seizures and to lead to

severe sinus bradycardia and a long sinoatrial arrest. Until more experience with concurrent use of

lidocaine and amiodarone becomes available, patients receiving the combination should be monitored

carefully.

Beta adrenoreceptor antagonists

Propranolol and metoprolol reduce the metabolism of IV administered lidocaine and the possibility of

this effect with other beta adrenergic blockers should be kept in mind. If these drugs are administered

concurrently, the patient should be closely observed for signs of lidocaine toxicity.

Cimetidine

Cimetidine reduces the clearance of IV administered lidocaine and toxic effects due to high serum

lidocaine levels have been reported when these two drugs have been administered concurrently.

Anticonvulsive agents

Phenytoin and other antiepileptic drugs such as 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.

Page 7 of 12

Inhalational anaesthetics

Lidocaine decreases the minimum effective concentration of inhalational anaesthetics, e.g. nitrous oxide.

Skeletal muscle relaxants

Lidocaine and skeletal muscle relaxants, e.g. suxamethonium, lead to excessive neuromuscular blockade;

therefore, this combination must be used with caution.

Structurally related local anaesthetics

Lidocaine should be used with caution in patients receiving agents structurally related to local

anaesthetics.

Alkaline solutions

The solubility of lidocaine is limited at pH values above 7.0. This must be taken into consideration if

adding an alkaline solution since precipitation might occur at higher pH values.

4.6

F

ERTILITY

,

PREGNANCY AND LACTATION

Effects on fertility

No data available.

Use in pregnancy (Category A)

The safe use of lidocaine during pregnancy has not been established. Although lidocaine has been used

extensively for surgical procedures during pregnancy with no reports of ill effects to mother or foetus,

there are no adequate or well-controlled studies in pregnant women of the effect of lidocaine on the

developing foetus.

Lidocaine has been effectively used for obstetrical analgesia and adverse effects on the course of labour

or delivery are rare. After epidural administration of lidocaine to women in labour, lidocaine crosses the

placental barrier. However, concentrations in umbilical veins are lower than those found in the maternal

circulation. It has been suggested that blood glucose levels should be checked in newborns after obstetric

regional anaesthesia.

Note:

Paracervical blocks may be associated with foetal bradycardia (see

Section 4.4 Special Warnings

and Precautions for Use

Use in lactation

Lidocaine passes into breast milk. The amount of lidocaine appearing in breast milk from a nursing

mother receiving parenteral lidocaine is unlikely to lead to a significant accumulation of the parent drug

in the breast fed infant. The remote possibility of an idiosyncratic or allergic reaction in the breast fed

infant from lidocaine remains to be determined.

4.7

E

FFECTS 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

A

DVERSE EFFECTS

(U

NDESIRABLE 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

CNS manifestations are excitatory and/or depressant and may be characterised by light-headedness,

nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, hyperacusis, blurred

Page 8 of 12

vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness,

respiratory depression and/or arrest, agitation, difficulty swallowing, paraesthesia circumoral, numbness

of the tongue and slurred speech.

The excitatory manifestations may be very brief or may not occur at all, in which case the first

manifestation of toxicity may be drowsiness merging into 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. In unconscious patients, circulatory collapse should

be watched for as CNS effects may not be apparent, as an early manifestation of toxicity may in some

cases progress to frank convulsions and ultimately lead to respiratory depression and/or arrest. It is crucial

to have resuscitative equipment and anticonvulsant drugs available to manage such patients. (See

Section

4.9 Overdose

Treatment of Overdosage

Cardiovascular

Cardiovascular manifestations are usually depressant and are characterised by bradycardia, hypotension,

and cardiovascular collapse, which may lead to cardiac arrest.

Cardiac arrhythmias and hypertension have also been observed.

Methaemoglobinaemia can occur following IV administration.

Cardiovascular toxic effects are generally preceded by signs of toxicity in the central nervous system,

unless the patient is receiving a general anaesthetic or is heavily sedated with drugs such as a

benzodiazepine or a barbiturate. In rare cases, cardiac arrest has occurred without prodromal CNS effects.

In children, early signs of local anaesthetic toxicity may be difficult to detect in cases where the block is

given during general anaesthesia.

Haemodynamic

Regional anaesthesia may lead to maternal hypotension.

Allergic

Allergic

reactions

characterised

cutaneous

lesions,

urticaria,

oedema

anaphylactoid

reactions/shock.

Allergy to amide type local anaesthetics is rare.

The detection of sensitivity by skin testing is of doubtful value.

Neurologic

The incidences of adverse reactions associated with the use of local anaesthetics may be related to the

total dose of local anaesthetic administered and are also dependent on the particular drug used, the route

of administration and the physical status of the patient.

Neurological reactions following regional nerve blocks have included persistent numbness, paraesthesia

and other sensory disturbances.

In a prospective review of 10,440 patients who received lidocaine for spinal anaesthesia, the incidences

were reported to be about 3% each for positional headaches, hypotension and backache; 2% for shivering;

and less than 1% each for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision.

Many of these observations may be related to local anaesthetic techniques, with or without a contribution

from the local anaesthetic.

In the practice of

caudal or lumbar epidural

block, occasional unintentional penetration of the

subarachnoid space by the catheter may occur. Subsequent adverse effects may depend partially on the

amount of drug administered subdurally.

These may include spinal block of varying magnitude (including total spinal block), hypotension

secondary to spinal block, loss of bladder and bowel control and loss of perineal sensation and sexual

function. Persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal

Page 9 of 12

segments with slow recovery (several months) or incomplete recovery have been reported in rare

instances when caudal or lumbar epidural block has been attempted. Backache and headache have also

been noted following use of these anaesthetic procedures.

Peripheral nerve injury and arachnoiditis have been observed.

Reporting suspected adverse effects

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows

continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are

asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9

O

VERDOSE

Symptoms

Acute emergencies associated with the use of local anaesthetics are generally related to high plasma

levels or to unintended subarachnoid injection of the local anaesthetic solution (see

Section 4.4 Special

Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)

With accidental intravascular injections, the toxic effect will be obvious within 1-3 min. With

overdosage, peak plasma concentrations may not be reached for 20-30 min depending on the site of

injection and toxic signs will be delayed. Toxic reactions mainly involve the central nervous and

cardiovascular systems.

In children, early signs of local anaesthetic toxicity may be difficult to detect in cases where the block is

given during general anaesthesia.

Symptoms of acute toxicity

Central nervous system toxicity is a graded response with symptoms and signs of escalating severity.

The first symptoms are circumoral paraesthesia, numbness of the tongue, light-headedness, hyperacusis

and tinnitus. Visual disturbance and muscular tremors are more serious and precede the onset of

generalised convulsions. These signs must not be mistaken for neurotic behaviour.

Unconsciousness and grand mal convulsions may follow. These may last from a few seconds to several

minutes. Hypoxia and hypercarbia occur rapidly following convulsions due to the increased muscular

activity, together with the interference with normal respiration and loss of the airway. In severe cases,

apnoea may occur. Acidosis increases the toxic effects of local anaesthetics.

Recovery is due to redistribution of the local anaesthetic drug from the central nervous system and

metabolism. Recovery may be rapid unless large amounts of the drug have been injected.

Cardiovascular toxicity

indicates a more severe situation. Hypotension, bradycardia, decreased cardiac

output, heart block, arrhythmia and even ventricular arrhythmias, ventricular fibrillation and cardiac

arrest may occur as a result of huge systemic concentrations of local anaesthetics.

Cardiovascular toxic effects are generally preceded by signs of toxicity in the central nervous system,

unless the patient is receiving a general anaesthetic or is heavily sedated with drugs such as a

benzodiazepine or a barbiturate. In rare cases, cardiac arrest has occurred without prodromal CNS effects.

Treatment of overdosage

If signs of acute systemic toxicity appear injection of the local anaesthetic should be stopped

immediately. 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 intravenously.

Should convulsions persist despite adequate respiratory support, and if the status of the circulation

permits, appropriate anticonvulsant medication such as an ultra-short acting barbiturate (e.g. thiopentone)

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.

Page 10 of 12

Suxamethonium will stop the muscle convulsions rapidly but will require tracheal intubation and

controlled ventilation, and should only be used by those familiar with these procedures.

If ventricular fibrillation or cardiac arrest occurs, effective cardiovascular resuscitation treatment must

be instituted and maintained for a prolonged period if necessary. Optimal oxygenation and ventilation,

and circulatory support as well as treatment of acidosis are of vital importance.

If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with intravenous

fluids, vasopressor, chronotropic and or inotropic agents should be considered. Children should be given

doses commensurate with age and weight.

Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26

(Australia).

5

PHARMACOLOGICAL PROPERTIES

5.1

P

HARMACODYNAMIC PROPERTIES

Mechanism of action

Lidocaine is classed as a membrane stabilising agent and is a local anaesthetic of the amide type.

Lidocaine, like other local anaesthetics, causes a reversible blockade of impulse propagation along nerve

fibres by preventing the inward movement of sodium ions through the nerve membrane. Local

anaesthetics of the amide type are thought to act within the sodium channels of the nerve membrane.

Local anaesthetic drugs may have similar effects on excitable membranes in the brain and myocardium.

If excessive amounts of drug reach the systemic circulation rapidly, symptoms and signs of toxicity will

appear, emanating mainly from the central nervous system and cardiovascular systems.

Central nervous system toxicity usually precedes the cardiovascular effects as it occurs at lower plasma

concentrations. Direct effects of local anaesthetics on the heart include slow conduction, negative

inotropism and eventually cardiac arrest.

Indirect cardiovascular effects, e.g. hypotension and bradycardia, may occur after epidural or spinal

administration depending on the extent of the concomitant sympathetic block.

Clinical trials

No data available.

5.2

P

HARMACOKINETIC PROPERTIES

Absorption

Lidocaine has a rapid onset and a medium duration of action. The onset of action is 1-5 minutes following

infiltration and 5-15 minutes following other types of administration.

The rate of absorption depends upon the dose, the route of administration and the vascularity of the

injection site. Intercostal blocks give the highest peak plasma concentrations (approximately 1.5 μg/mL

for every 100 mg injected), while abdominal subcutaneous injections give the lowest (approx. 0.5 μg/mL

per 100 mg injected). Epidural and major nerve block produce peak plasma levels intermediate between

these.

The addition of adrenaline considerably slows the absorption of lidocaine, although the rate also depends

on the site of injection. Peak plasma concentrations are reduced by 50% following subcutaneous

injection, by 30% following epidural injection and by 20% following intercostal block if adrenaline

5 μg/mL is added.

Absorption of lidocaine from the epidural space occurs in 2 phases; the first phase is in the order of

9 minutes and the second is approximately 82 minutes. The slow absorption is the rate-limiting step in

the elimination of lidocaine, which also explains why the apparent elimination half-life following

epidural injection is longer than after intravenous administration.

Page 11 of 12

Distribution

The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases

with increasing concentration. At concentrations of 1 to 4 μg of free base/mL, 60 - 80% of lidocaine is

protein bound. Binding is also dependent on the plasma concentration of the α

-acid glycoprotein.

Lidocaine crosses the blood-brain and placental barriers by passive diffusion. Since the degree of plasma

protein binding in the foetus is less than in the mother, although free lidocaine concentrations will be the

same, the total plasma concentration will be greater in the mother.

Metabolism

Approximately 90% of a parenteral dose of lidocaine is rapidly metabolised in the liver by de-ethylation

to form monoethylglycinexylidide (MEGX) and glycinexylidide (GX) followed by cleavage of the amide

bond to form xylidine and 4-hydroxyxylidine which are excreted in the urine. Less than 10% of a dose

is excreted unchanged in the urine.

The principal metabolites, MEGX and GX also possess pharmacological activity. The rate of metabolism

of lidocaine appears to be limited by liver blood flow which may be reduced in patients after acute

myocardial infarction and/or congestive heart failure. The rate of lidocaine metabolism may also be

reduced in patients with liver or hepatic tissue necrosis, possibly because of altered perfusion.

Excretion

Lidocaine has a total plasma clearance of 0.95 L/min, a volume of distribution at steady state of 91 L, an

elimination half-life of 1.6 hr and an estimated hepatic extraction ratio of 0.65.

The duration of action depends upon the concentration used, the dose given, the nerves to be blocked and

the status of the patient. The 2% solution will produce an effect for 1½ - 2 hrs when given epidurally,

and up to 5 hrs when given as a peripheral nerve block. When used in a 1% concentration there is less

effect on motor nerve fibres and the duration of effect is shorter.

5.3

P

RECLINICAL SAFETY DATA

Genotoxicity

The genotoxic potential of 2,6-xylidine has been studied with mixed results: Positive results were

reported in assays for gene mutations (weakly positive in the Ames test with metabolic activation and in

the mouse lymphoma assay) and chromosomal damage (chromosomal aberrations in Chinese hamster

ovary cells at concentrations at which the drug precipitated from solution). No evidence of genotoxicity

was found in in vivo assays for chromosomal damage (micronucleus assay) and DNA damage

(unscheduled DNA synthesis). Covalent binding studies of DNA from liver and ethmoid turbinates in

rats indicate that 2,6-xylidine may be genotoxic under certain conditions in vivo.

Carcinogenicity

A two-year oral toxicity study of 2,6-xylidine, a metabolite of lidocaine, has shown that in both male and

female rats, 2-6-xylidine in daily doses of 900 mg/m

(150 mg/kg) resulted in carcinomas and adenomas

of the nasal cavity. No nasal tumours were observed in the low dose (15 mg/kg or control animals). In

addition, the compound also caused subcutaneous fibromas and or fibrosarcomas in male and female rats

(significant at 150 mg/kg).

6

PHARMACEUTICAL PARTICULARS

6.1

L

IST OF EXCIPIENTS

Sodium chloride

Sodium hydroxide

Hydrochloric acid

Water for injections

6.2

I

NCOMPATIBILITIES

Local anaesthetics react with certain metals and cause the release of their respective ions which, if

Page 12 of 12

injected, may cause severe local irritation. Adequate precautions should be taken to avoid prolonged

contact between Lidocaine Accord solutions and metal surfaces such as metal bowls, cannulae and

syringes with metal parts.

6.3

S

HELF 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

S

PECIAL PRECAUTIONS FOR STORAGE

Store below 25

Solutions showing discolouration and unused portions of solutions from ampoules and single dose vials

should be discarded.

Surface sterilisation using pure, undiluted isopropyl alcohol (91%) or 70% ethyl alcohol (USP) may be

carried out if desired.

6.5

N

ATURE AND CONTENTS OF CONTAINER

Lidocaine Accord 1%

Lidocaine Accord 1% is available in four strengths: 20 mg/2 mL, 50 mg/5 mL and 100 mg/10 mL in

Type I glass ampoules in packs of 20. The 200 mg/20 mL is in Type I glass vials in packs of 1 or 5.

Lidocaine Accord 2%

Lidocaine Accord 2% is available in four strengths: 40 mg/2 mL, 100 mg/5 mL and 200 mg/10 mL in

Type I glass ampoules in packs of 20. The 400 mg/20 mL is in Type I glass vials in packs of 1 or 5.

Not all presentations and pack sizes may be marketed.

6.6

S

PECIAL PRECAUTIONS FOR DISPOSAL

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

requirements.

6.7

P

HYSICOCHEMICAL PROPERTIES

Chemical structure

CAS number

number

lidocaine

hydrochloride

monohydrate

(AAN)

6108-05-0

lidocaine

hydrochloride is 73-78-9.

7

MEDICINE SCHEDULE (POISONS STANDARD)

S4 – Prescription Only Medicine

8

SPONSOR

Accord Healthcare Pty Limited

Level 24, 570 Bourke Street

Melbourne, VIC, 3000

Australia

9

DATE OF FIRST APPROVAL

20 September 2019

Version 1.0

NHCOCH

Public Summary

Summary for ARTG Entry:

309533

LIDOCAINE ACCORD 2% lidocaine (lignocaine) hydrochloride 40 mg/2 mL injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

562 Heidelberg Road,ALPHINGTON, VIC, 3078

Australia

ARTG Start Date

20/09/2019

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. LIDOCAINE ACCORD 2% lidocaine (lignocaine) hydrochloride 40 mg/2 mL injection ampoule

Product Type

Single Medicine Product

Effective date

20/09/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Lidocaine Accord solutions are indicated for the production of local or regional anaesthesia by the following techniques:

? infiltration

? intravenous regional anaesthesia

? peripheral nerve block

? epidural block

? subarachnoid block

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

36 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. LIDOCAINE ACCORD 2% lidocaine (lignocaine) hydrochloride 40 mg/2 mL injection ampoule

Dosage Form

Injection, solution

Route of Administration

Epidural

Infiltration

Intrathecal

Intravenous

Visual Identification

A clear, colourless solution.

Active Ingredients

lidocaine (lignocaine) hydrochloride

40 mg

Public Summary

Page 1 of

Produced at 30.09.2019 at 11:10:16 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 30.09.2019 at 11:10:16 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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