Lidocaine Hydrochloride Injection 1% w/v Taj Pharma

Lidocaine Hydrochloride Injection 1% w/v Taj Pharma

Name of the medicinal product

Lidocaine Hydrochloride Injection 1% w/v Taj Pharma.
Lidocaine Hydrochloride Injection 2%w/v Taj Pharma.

Qualitative and quantitative composition

For 1% :-
Each 5 ml solution contains 50mg Lidocaine Hydrochloride
Each 10 ml solution contains 100mg Lidocaine Hydrochloride
Each 20 ml solution contains 200mg Lidocaine Hydrochloride

For 2% :-
Each 5 ml solution contains 100mg Lidocaine Hydrochloride
Each 10 ml solution contains 200mg Lidocaine Hydrochloride
Each 20 ml solution contains 400mg Lidocaine Hydrochloride

For the full list of excipients, see section 6.1

Pharmaceutical form

Solution for Injection.

Clear and colourless solution.

Clinical particulars

4.1 Therapeutic indications

Suppression of ventricular extrasystoles and ventricular tachycardia, especially after an acute myocardial infarction.

Local anaesthesia by surface infiltration, regional, epidural and caudal routes, dental anaesthesia, either alone or in combination with adrenaline.

Lidocaine may also be administered by subcutaneous, intramuscular or intravenous injection.

Not intended for use in the eye.

4.2 Posology and method of administration

In ventricular arrhythmias

The usual adult IV bolus dose is 50-100mg administered at a rate of approximately 25-50mg per minute. If the desired response is not achieved, a second dose may be administered 5 minutes after completion of the first injection. Not more than 200-300mg should be administered during a one hour period. Elderly patients and those with congestive heart failure or cardiogenic shock may require smaller bolus doses.

Maintenance infusion of a 0.2 or 0.4% solution in 5% glucose.

Adults: 20-50 micrograms/kg/minute (1-4mg/minute in an average 70 kg adult).

Slower infusion rates should be used in patients with congestive heart failure or liver disease; no dosing modification appears necessary in patients with renal failure. When arrhythmias reappear during a constant infusion of Lidocaine, a small bolus may be given to rapidly increase plasma concentration of the drug; the infusion rate is increased simultaneously. The infusion should be terminated as soon as the patient’s basic cardiac rhythm appears to be stable or at the earliest sign of toxicity.

Infants and children may be given an initial IV bolus of 0.5-1mg/kg. This dose may be repeated according to the response of the patient, but the total dose should not exceed 3-5mg/kg. A maintenance IV infusion of 10-50 micrograms/kg per minute may be given via an infusion pump.

For advanced cardiac life support in children, the recommended dosage is an initial IV bolus of 1mg/kg. If ventricular tachycardia or ventricular fibrillation is not corrected following defibrillation and an initial bolus, an IV infusion should be started at a rate of 20-50 mcg/kg per minute.

Constant ECG monitoring is recommended during therapy with Lidocaine Hydrochloride, however if this equipment is not available and a ventricular arrhythmia is suspected, a single IM dose may be administered if bradycardia is not present. The deltoid muscle is the preferred site for IM injection.

In Local Anaesthesia

Usual doses should generally be reduced in children and in elderly or debilitated patients. To minimise the possibility of toxic reactions, children should be given Lidocaine Hydrochloride solutions in concentrations of 0.5% or 1%.

Single doses of Lidocaine (for anaesthesia other than spinal) should not exceed 4.5mg/kg (or 200mg) in adults or children 12 – 18 years of age. Lidocaine by local infiltration for children under the age of 12 years should not exceed 3mg/kg, repeated not more often than every 4 hours.

For spinal anaesthesia, up to 100mg of the drug may be given. For continuous epidural or caudal anaesthesia, the maximum dose should not be repeated at intervals of less than 1.5 hours. For paracervical block for obstetric analgesia (including abortion) the maximum recommended dosage (200mg) should not be repeated at intervals of less than 1.5 hours. For IV regional anaesthesia in adults using a 0.5% solution, the dose administered should not exceed 4mg/kg.

Solutions of 1% Lidocaine Hydrochloride (without preservative) are used for epidural or caudal anaesthesia. To prevent intravascular or subarachnoid injection of a large epidural dose of Lidocaine, a test dose of 2-5 mls should be injected at least 5 minutes prior to administering the total dose.

In epidural anaesthesia 2-3 mls of 1% solution is usually required for each dermatome to be anaesthetised.

In caudal block for production of obstetric analgesia or in epidural thoracic block, 20-30 mls of a 1% solution (200-300mg) of the drug may be used. For epidural lumbar anaesthesia, the dose is 25-30 mls (250-300mg) of a 1% solution.

For intercostal nerve block: 3 mls of a 1% solution (30mg).

For paravertebral nerve block: 3-5 mls of a 1% solution (30-50mg).

For pudendal nerve block (each side): 10 mls of a 1% solution (100mg).

For paracervical nerve block (each side) for obstetric analgesia: 10 mls of a 1% solution (100mg).

For sympathetic nerve blocks: Cervical (stellate ganglion) nerve block: 5 mls of a 1% solution (50mg).

Lumbar nerve block: 5-10 mls of a 1% solution (50-100mg).

For percutaneous infiltration anaesthesia: 1-60 mls of a 0.5% solution or 0.5 to 30ml of a 1% solution (5-300mg).

For IV regional anaesthesia: 10-60 mls of 0.5% solution (50-300mg).

4.3 Contraindications

Known hypersensitivity to lidocaine or other anaesthetics of the amide type.

In ventricular arrhythmia

Sino-atrial disorders
All grades of atrioventricular block
Severe myocardial depression
Porphyria (use with caution in local anaesthesia)

Local anaesthesia

Complete heart block
Hypovolaemia

4.4 Special warnings and precautions for use

As with other local anaesthetics, Lidocaine should be used with caution in patients with epilepsy, myasthenia gravis, cardiac conduction disturbances, (see also section 4.3), congestive heart failure, bradycardia, severe shock, impaired respiratory function or impaired renal function with a creatinine clearance of less than 10mL/minute. Lidocaine is metabolised in the liver and it should be used with caution in patients with impaired hepatic function. Lower doses should be used in congestive cardiac failure and following cardiac surgery (See 4.2 Posology).

Hypokalaemia, hypoxia and disorders of acid-base balance should be corrected before treatment with intravenous lidocaine begins.

Facilities for resuscitation should be available when administering local anaesthetics.

The effect of local anaesthetics may be reduced if the injection is made into an inflamed or infected area.

Intra-articular administration of lidocaine may cause chondrotoxicity.

Certain local anaesthetic procedures may be associated with serious adverse reactions, regardless of the local anaesthetic drug used.

Central nerve blocks may cause cardiovascular depression, especially in the presence of hypovolaemia, and therefore epidural anaesthesia should be used with caution in patients with impaired cardiovascular function.
Blood pressure should be monitored during spinal anaesthesia. Epidural anaesthesia may lead to hypotension and bradycardia. This risk can be reduced by preloading the circulation with crystalloidal or colloidal solutions. Hypotension should be treated promptly.
Paracervical block can sometimes cause foetal bradycardia or tachycardia, and careful monitoring of the foetal heart rate is necessary
Injections in the head and neck regions may be made inadvertently into an artery, causing cerebral symptoms even at low doses.
Retrobulbar injections may rarely reach the cranial subarachnoid space, causing serious/severe reactions, including cardiovascular collapse, apnoea, convulsions and temporary blindness
Retro- and peribulbar injections of local anaesthetics carry a low risk of persistent ocular motor dysfunction. The primary causes include trauma and/or local toxic effects on muscles and/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.

Intramuscular Lidocaine may increase creatinine phosphokinase concentrations which can interfere with the diagnosis of acute myocardial infarction. Lidocaine has been shown to be porphyrinogenic in animals and should be avoided in persons suffering from porphyria.

Hameln Lidocaine Injection is not recommended for use in neonates. The optimum serum concentration of lidocaine required to avoid toxicity, such as convulsions and cardiac arrhythmias, in this age group is not known.

4.5 Interaction with other medicinal products and other forms of interaction

Effects of Lidocaine on other medicinal products

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

There may be an increased risk of enhanced and prolonged neuromuscular blockade in patients treated concurrently with muscle relaxants (e.g. suxamethonium).

Effects of other medicinal products on Lidocaine

The clearance of Lidocaine may be reduced by beta-adrenoceptor blocking agents (e.g. propranolol) and by cimetidine, requiring a reduction in the dosage of lidocaine. Increase in serum levels of lidocaine may also occur with anti-viral agents (e.g. amprenavir, atazanavir, darunavir, lopinavir).

There may be an increased risk of ventricular arrhythmia in patients treated concurrently with antipsychotics which prolong or may prolong the QT interval (e.g. pimozide, sertindole, olanzapine, quetiapine, zotepine), or 5HT₃ antagonists (e.g. tropisetron, dolasetron).

While adrenaline (epinephrine) when used in conjunction with lidocaine might decrease vascular absorption, it greatly increases the danger of ventricular tachycardia and fibrillation if accidentally injected intravenously.

Cardiovascular collapse has been reported following the use of bupivacaine in patients on treatment with verapamil and timolol; Lidocaine is closely related to bupivacaine.

Concomitant use of quinupristin/dalfopristin should be avoided.

Hypokalaemia produced by acetazolamide, loop diuretics and thiazides may antagonize the effect of lidocaine if administered concomitantly (see section 4.4).

Inhibition of CYP1A2 by fluvoxamine considerably reduces elimination of lidocaine and increases the risk of lidocaine toxicity. Concomitant use of both fluvoxamine and a CYP3A4 inhibitor such as erythromycin can further increase lidocaine concentrations. Because lidocaine possesses a narrow therapeutic window, doses of lidocaine may need to be adjusted accordingly. Conversely, reduced serum lidocaine concentrations may result from drugs that may stimulate the hepatic metabolism of lidocaine (e.g. phenytoin, oral HRT).

Narcotics are probably proconvulsants and this would support the evidence that lidocaine reduces the seizure threshold to fentanyl in man.

Opioid-antiemetic combination sometimes used for sedation in children could reduce the convulsant threshold to lidocaine and increase the CNS depressant effect.

Lidocaine is markedly bound to α-l-acid glycoprotein (AAG). AAG concentrations may be reduced by oestrogens leading to a higher free fraction of lidocaine in women than in men and the free fraction is further increased during pregnancy and in women taking oral contraceptives or HRT.

4.6 Fertility, pregnancy and lactation

Pregnancy

Although animal studies have revealed no evidence of harm to the foetus, Lidocaine crosses the placenta and should not be administered during early pregnancy unless the benefits are considered to outweigh the risks.

Lidocaine given by epidural or paracervical block, especially in large doses, or by local perineal infiltration prior to delivery crosses rapidly into the foetal circulation. Elevated lidocaine levels may persist in the newborn for at least 48 hours after delivery. Foetal bradycardia or neonatal bradycardia, hypotonia or respiratory depression may occur.

Lactation

Small amounts of Lidocaine are secreted into breast milk and the possibility of an allergic reaction in the infant, albeit remote, should be borne in mind when using Lidocaine in nursing mothers.

4.7 Effects on ability to drive and use machines

When outpatient anaesthesia affects areas of the body involved in driving or operating machinery, patients should be advised to avoid these activities until normal function is fully restored.

4.8 Undesirable effects

In common with other local anaesthetics, adverse reactions to Lidocaine are rare and are usually the result of raised plasma concentrations due to accidental intravascular injection, excessive dosage or rapid absorption from highly vascular areas, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Systemic toxicity mainly involves the central nervous system and/or the cardiovascular system (see also 4.9 Overdose).

Following regional blockade as when lidocaine is injected intrathecally or extradurally, hypotension, hypoventilation, Horners Syndrome and hypoglycaemia may be seen. The degree of these effects will depend on the dose and the height of the block. Urinary retention may occur following sacral or lumbar epidural block. It should not outlast the duration of the block. Apnoea and hemiparesis may occur following stellate ganglion block. The probable cause is a direct injection of lidocaine into the vertebral or carotid arteries.

Immune system disorders

Hypersensitivity reactions (allergic or anaphylactoid reactions, anaphylactic shock) – see also Skin & subcutaneous tissue disorders

Skin testing for allergy to Lidocaine is not considered to be reliable.

Nervous & Psychiatric disorders

Neurological signs of systemic toxicity include dizziness or light-headedness, nervousness, tremor, circumoral paraesthesia, tongue numbness, drowsiness, convulsions, coma.

Nervous system reactions may be excitatory and or depressant. Signs of CNS stimulation may be brief, or may not occur at all, so that the first signs of toxicity may be confusion and drowsiness, followed by coma and respiratory failure.

Neurological complications of spinal anaesthesia include transient neurological symptoms such as pain of the lower back, buttock and legs. These symptoms usually develop within twenty-four hours of anaesthesia and resolve within a few days. Isolated cases of arachnoiditis or cauda equina syndrome, with persistent paraesthesia, bowel and urinary dysfunction, or lower limb paralysis have been reported following spinal anaesthesia with lidocaine and other similar agents. The majority of cases have been associated with hyperbaric concentrations of lidocaine or prolonged spinal infusion.

Eye disorders

Blurred vision, diplopia and transient amaurosis may be signs of lidocaine toxicity.

Bilateral amaurosis may also be a consequence of accidental injection of the optic nerve sheath during ocular procedures. Orbital inflammation and diplopia have been reported following retro- or peribulbar anaesthesia (see section 4.4 Special warnings and precautions for use).

Ear and labyrinth disorders

Tinnitus, hyperacusis

Cardiac and vascular disorders

Cardiovascular reactions are depressant and may manifest as hypotension, bradycardia, myocardial depression, cardiac arrhythmias and possibly cardiac arrest or circulatory collapse.

Hypotension may accompany spinal and epidural anaesthesia. Isolated cases of bradycardia and cardiac arrest have also been reported.

Respiratory, thoracic or mediastinal disorders

Dyspnoea, bronchospasm, respiratory depression, respiratory arrest

Gastrointestinal disorders

Nausea, vomiting

Skin & subcutaneous tissue disorders

Rash, urticaria, oedema (including angioedema, face oedema)

Blood and the lymphatic system disorders

Methaemoglobinaemia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Symptoms of acute systemic toxicity

Central nervous system toxicity presents with symptoms of increasing severity. Patients may present initially with circumoral paraesthesia, numbness of the tongue, light-headedness, hyperacusis and tinnitus. Visual disturbance and muscular tremors or muscle twitching 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, which may last from a few seconds to several minutes. Hypoxia and hypercapnia occur rapidly following convulsions due to 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.

Effects on the cardiovascular system may be seen in severe cases. Hypotension, bradycardia, arrhythmia and cardiac arrest may occur as a result of high systemic concentrations, with potentially fatal outcome.

Recovery occurs as a consequence of redistribution of the local anaesthetic drug from the central nervous system, and metabolism and may be rapid unless large amounts of the drug have been injected.

Treatment of acute toxicity

If signs of acute systemic toxicity appear, injection of the anaesthetic should be stopped immediately.

Treatment will be required if convulsions and CNS depression occurs. The objectives of treatment are to maintain oxygenation, stop the convulsions and support the circulation. A patent airway should be established and oxygen should be administered, together with assisted ventilation (mask and bag) if necessary. The circulation should be maintained with infusions of plasma or intravenous fluids. Where further supportive treatment of circulatory depression is required, use of a vasopressor agent may be considered although this involves a risk of central nervous system excitation. If the convulsions do not stop spontaneously in 15-20 seconds, they may be controlled by the intravenous administration of Diazepam or Thiopentone Sodium, bearing in mind that anti-convulsant drugs may also depress respiration and the circulation. Prolonged convulsions may jeopardise the patient’s ventilation and oxygenation and early endotracheal intubation should be considered. If cardiac arrest should occur, standard cardiopulmonary resuscitation procedures should be instituted. Continual optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance.

Dialysis is of negligible value in the treatment of acute overdosage with Lidocaine

Pharmacological properties

5.1 Pharmacodynamic properties

Lidocaine is a local anaesthetic of the amide type. It is used to provide local anaesthesia by nerve blockade at various sites in the body and in the ionic control of dysrhythmias. It acts by inhibiting the ionic refluxes required for the initiation and conduction of impulses, thereby stabilising the neuronal membrane. In addition to blocking conduction in nerve axons in the peripheral nervous system, Lidocaine has important effects on the central nervous system and cardiovascular system. After absorption Lidocaine may cause stimulation of the CNS followed by depression and in the cardiovascular system, it acts primarily on the myocardium where it may produce decreases in electrical excitability, conduction rate and force of contraction. It has a rapid onset of action (about one minute following intravenous injection and fifteen minutes following intramuscular injection) and rapidly spreads through the surrounding tissues. The effect lasts about ten to twenty minutes and about sixty to ninety minutes following intravenous and intramuscular injection respectively.

5.2 Pharmacokinetic properties

Lidocaine is absorbed from injection sites including muscle and its rate of absorption is determined by factors such as the site of administration and the tissue vascularity. Except for intravascular administration, the highest blood levels occur following intercostal nerve block and the lowest after subcutaneous administration. Lidocaine is bound to plasma proteins, including alpha-1-acid-glycoprotein. The drug crosses the blood brain and placental barriers.

Lidocaine is metabolised in the liver and about 90% of a given dose undergoes N-dealkylation to form monoethylglycinexylidide and glycinexylidide, both of which may contribute to the therapeutic and toxic effects of Lidocaine. Further metabolism occurs and metabolites are excreted in the urine with less than 10% of unchanged Lidocaine. The elimination half life of Lidocaine following an intravenous bolus injection is one to two hours, but this may be prolonged in patients with hepatic dysfunction.

5.3 Preclinical safety data

Not applicable.

Pharmaceutical particulars

6.1 List of excipients

Water for Injections E.P.

1N Hydrochloric Acid QS

1N Sodium Hydroxide QS (the maximum allowed is 1% )

6.2 Incompatibilities

Lidocaine caused precipitation of Amphotericin, Methohexitone Sodium and Sulfadiazine Sodium in Glucose Injection. It is recommended that admixtures of Lidocaine & Glyceryl trinitrate should be avoided.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Store at less than 25°C.

Protect from light.

6.5 Nature and contents of container

Clear glass ampoule, glass type 1, E.P.

Pack sizes 2,5,10 and 20ml ampoules. Batch size 10 ampoules per carton.

6.6 Special precautions for disposal and other handling

Not applicable.

Manufactured By:
Taj Pharmaceuticals Ltd.
at: Plot. No. 220, Mahagujarat
Industrial Estate, At & Post-Moraiya,
Tal-Sanand, Dist- Ahmedabad Gujarat (India)

Lidocaine Hydrochloride Injection 1.0% w/v and 2.0% w/v

Package leaflet: Information for the patient

Lidocaine Hydrochloride 1% w/v Solution for Injection
Lidocaine Hydrochloride 2% w/v Solution for Injection

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leafleat. See section 4.

The product is referred as above but for ease it has been mentioned as Lidocaine hydrochloride throughout the leaflet.

What is in this leaflet

What Lidocaine Hydrochloride is and what it is used for
2. What you need to know before you are given Lidocaine Hydrochloride
3. How Lidocaine Hydrochloride is given to you
4. Possible side effects
5. How to store Lidocaine Hydrochloride
6. Contents of the pack and other information
WHAT LIDOCAINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR

Lidocaine Hydrochloride is a local anaesthetic and belongs to a class of drugs called amide type local anaesthetics. It produces loss of feeling or sensation confined to one part of the body.

Lidocaine Hydrochloride Injection may be used to produce local numbness (anaesthesia) by injection of the solution into or around the area of operation. It may also be used to produce local anaesthesia by injection of the solution close to the nerves whose conduction is to be cut off, or into the epidural space near the spinal cord, or by administering the solution into a vein in a limb that has been isolated from the circulation by means of a tourniquet (bandage that stops the flow of blood from vessel by applying pressure).

WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LIDOCAINE HYDROCHLORIDE

You should not be given this medicine:

if you know you are allergic to lidocaine hydrochloride, to any of the other ingredients of this medicine (listed in section 6) or to other similar amide type anaesthetics
if you suffer from state of decreased blood volume (hypovolaemia)
if you suffer from abnormality of impulse propagation in the heart causing decreased blood pressure, slow heart rate (complete heart block)
If the solution also contains adrenaline, lidocaine hydrochloride should not be injected into a vein or used in areas such as fingers, toes, ears, nose or penis, as the blood supply to these areas might become inadequate

Speak to your doctor if one of these applies to you before you are given this medicine.

Warnings and precautions

Talk to your doctor or nurse before you are given Lidocaine Hydrochloride if:

you suffer from any heart problem, particularly if it affects the heart rate
you suffer from fits (epilepsy)
you have low concentration of potassium in the blood causing muscle cramps, constipation (hypokalaemia)
you ever had an allergic reaction to local anaesthetic e.g. a skin rash or breathlessness or collapse
you have had recent vomiting, diarrhoea or bleeding, or if you have not been drinking normal amounts of fluid
you are feeling ill and run down
you have been told that you have too much acid in your blood and tissues, or not enough oxygen
you suffer from any liver disease or kidney problems
you have porphyria (a rare inherited disease that affects the skin and nervous system)
you have an infection of the skin with pus at or near the site to be injected
you have problems with your breathing
you are pregnant, likely to become pregnant or breast-feeding
you suffer from loss of muscle function and weakness (myasthenia gravis).

Use in children

Lidocaine injection is not recommended for use in neonates (less than a month old).

Other medicines and Lidocaine Hydrochloride

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

A large number of drugs can interact with Lidocaine Hydrochloride which can significantly alter their effects. These drugs include:

medicines used to treat high blood pressure such as diuretics (water tablets) betablockers, e.g. timolol and propranolol and calcium channel blockers, e.g. verapamil, prenylamine
medicines used in the treatment of stomach ulcers (e.g. ranitidine, cimetidine)
dopamine used to stimulate the heart and to treat shock
strong pain relieving medicines such as codeine and pethidine (Narcotics or opioid drugs)
medicines used to treat certain types of muscle jerking (e.g. Serotonin or 5- hydroxytryptamine)
medicines used to treat viral infection (e.g. amprenavir, atazanavir, darunavir and lopinavir)
medicines used to treat irregular heart beat (mexiletine, amiodarone)
medicines used to treat infections (quinupristin/dalfopristin)
medicines used to treat mental disorders (pimozide, sertindole, olanzapine, quetiapine, zotepine)
medicines used to treat nausea and vomiting (tropisetron, dolasetron).

If adrenaline (epinephrine) is to be added to your lidocaine injection, you should also tell your doctor if you suffer from high blood pressure, shortage of blood supply to the brain, an overactive thyroid gland or if you are taking antidepressant drugs.

If you are already taking one of these medicines, speak to your doctor before you receive Lidocaine Hydrochloride.

Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Lidocaine Hydrochloride should only be used during pregnancy and breast feeding if absolutely necessary.

Driving and using machines:

Certain areas of your body will be numb for about 2-4 hours after having this medicine. If this is likely to affect your ability to drive or use machinery you should wait for the effect to wear off.

In general, it is wise to ask your doctor whether it is safe to drive.

Lidocaine Hydrochloride contain sodium

This medicinal product contains less than 1mmol sodium (23mg) per dose, i.e. essentially ‘sodium-free’.

HOW LIDOCAINE HYDROCHLORIDE IS GIVEN TO YOU

The site of injection will depend on the area to be numbed. It will be administered by a trained healthcare professional. The maximum dose for a healthy adult is 200mg. Your doctor will decide the most suitable dosage for your particular case according to your age and physical circumstances as well as the site of injection, the method used and your response to the injection. If you have any concerns or questions about how much of this medicine you have received, speak to your doctor immediately.

POSSIBLE SIDE EFFECTS

Like all medicines, Lidocaine Hydrochloride can cause side effects, although not everyone gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare.

Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately. Lidocaine may result in abnormal amount of methemoglobin (a form of hemoglobin in blood) which may cause bluish discoloration of skin, headache, shortness of breath, malaise and fatigue.

Other serious side effects are also rare, but may occur if too much Lidocaine Hydrochloride is given or if the drug is unintentionally injected into a blood vessel.

Such side effects may occur with certain frequency, which is defined as follows:

Not known: frequency cannot be estimated from the available data

changes in the rhythm and speed of the heart
low blood pressure
slow heart rate (less than 60 beats/minute)
cessation of normal circulation of blood due to failure of the heart
pain at the injection site, or numbness or loss of power after the effects of the injection should have worn off
temporary pain sensation at the lower back, buttocks, legs which resolves within a few days
numbness or tingling/paralysis of legs after administration of lidocaine in the spine
difficulty in passing water, problems with the frequency, consistency and/or ability to control your bowel movements (bowel dysfunction)
loss of balance, pins and needles around the mouth, numbness of the tongue, difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus), dizziness or lightheadedness, confusion, nervousness, restless or twitching, changes in your normal mood or behaviour, involuntary rhythmic muscular contractions, fits or seizures, profound state of unconsciousness (coma)
allergic reaction to local anaesthetic e.g. a skin rash or breathlessness or collapse
feelings of anxiety or fear
blurred vision, double vision or transient visual loss
feeling sick (nausea) or being sick (vomiting)
breathlessness
cessation of breathing (respiratory arrest)
feeling drowsy or faint.

Note : If you are having a blood test, tell your doctor, as injection of lidocaine into a muscle can increase the blood levels of an enzyme marker for muscle damage.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE LIDOCAINE HYDROCHLORIDE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and ampoule label after ‘Exp’. The expiry date refers to the last day of that month.

Do not store above 25°C.

Keep the container in the outer carton in order to protect from light.

The solution should not be used if it is discoloured in any way.

This medicine should not be mixed with any other drugs.

If only part of an ampoule is used, the remaining solution should be discarded.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Lidocaine Hydrochloride Contains

The active substance is lidocaine hydrochloride.

Lidocaine Hydrochloride Injection BP 1% w/v, each 1ml of which contains 10mg of active ingredient.

Lidocaine Hydrochloride Injection BP 2% w/v, each 1ml of which contains 20mg of active ingredient.

The other ingredients are sodium chloride, sodium hydroxide or hydrochloric acid and water for injections.

What Lidocaine Hydrochloride looks like and contents of the pack

Lidocaine Hydrochloride is a clear colourless, sterile solution for injection.

Lidocaine Hydrochloride Injection BP 1% w/v is available in 2ml, 5ml, 10ml and 20ml clear glass ampoules, packed in boxes of 10 ampoules.

Lidocaine Hydrochloride Injection BP 2% w/v is available in 2ml, 5ml, 10ml and 20ml clear glass ampoules, packed in boxes of 10 ampoules.

Manufactured By:
Taj Pharmaceuticals Ltd.
at: Plot. No. 220, Mahagujarat
Industrial Estate, At & Post-Moraiya,
Tal-Sanand, Dist- Ahmedabad Gujarat (India)