Lidocaine B. Braun 20 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lidocaine B. Braun 20 mg/ml injection solution

Hydrochloride lidocaine

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Lidocaine B. Braun is and what it is used for
2. What you need to know before using Lidocaine B. Braun
3. How to use Lidocaine B. Braun
4. Possible adverse effects
5. How to store Lidocaine B. Braun
6. Contents of the pack and other information

1. What Lidocaine B. Braun is and what it is used for

This medicine contains lidocaine hydrochloride and belongs to a group of medicines called amide-type local anaesthetics. It is used to block pain by reducing the transmission of nerve impulses near its site of action.

Lidocaine also belongs to a group of medicines known as antiarrhythmics, so it can also be used to control severe, rapid, or abnormal heartbeats (severe ventricular arrhythmias).

2. What you need to know before using Lidocaine B. Braun

Do not use Lidocaine B. Braun:

• If you are allergic to lidocaine, to other amide-type local anesthetics, or to any of the other ingredients of this medicine (listed in section 6).

• For epidural anesthesia in patients with severe hypotension (very low blood pressure) or cardiogenic shock (the heart pumps blood inadequately) or hypovolemic shock.

Epidural anesthesia must not be used during childbirth.

It should not be used to control rapid or abnormal heartbeats if:

• you have serious heart disorders, particularly when your heart beats irregularly or slowly,
• you have had a heart attack within the last 3 months, or if your heart's ability to pump blood throughout the body is markedly reduced, unless your condition is potentially life-threatening.

Warnings and precautions:

Talk to your doctor, pharmacist, or nurse before using Lidocaine B. Braun.

• if you are elderly or in a generally weakened condition,
• if you have heart problems such as slow or irregular heartbeat or heart failure,
• if you suffer from any lung or respiratory disorders,
• if you have liver disease or kidney problems,
• if you have epileptic seizures,
• if there is inflammation or infection at the injection site,
• if you have porphyria (a rare inherited disease affecting the skin and nervous system),
• if you have blood clotting disorders,
• if you are in the last trimester of pregnancy,
• a specific facial nerve disorder (Melkersson-Rosenthal syndrome),
• if you have low blood pressure or low blood volume,
• if you have a particular severe muscle weakness (myasthenia gravis).

Control of rapid or abnormal heartbeats

Your doctor will administer this medicine for the treatment of heart problems only with special caution if you have increased blood acidity (acidosis).

When you receive this medicine, your:

• electrocardiogram (ECG),
• blood pressure,
• level of consciousness, and
• breathing will be monitored.

If any of the parameters mentioned above worsen, your doctor may need to review your therapy. In addition, your doctor will ensure that standard emergency equipment is available during treatment.

If you receive this medicine for a prolonged period, your doctor will ensure that:

• your fluid balance,
• blood electrolyte levels, and
• your acid-base balance are monitored.

If you receive large doses of this medicine, your doctor will correct:

• any existing low potassium levels in your blood,
• oxygen deficiency, and
• disturbances in your acid-base balance before starting the infusion/injection.

Note:

If you are under anesthesia, your doctor will carefully monitor your condition. This is because side effects affecting your nervous system and heart may go unnoticed and may occur without prior warning symptoms.

Children

The use of lidocaine is not recommended in children under 1 year of age. In children under 4 years of age, it should be used with caution, as data on efficacy and safety are limited.

Use of Lidocaine B. Braun with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor if you are taking any of the following medicines:

• other local anesthetics,
• medicines used in the treatment of gastroduodenal ulcers (e.g., cimetidine),
• medicines used to treat irregular heartbeat (e.g., amiodarone).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will only administer this medicine during pregnancy or breastfeeding if it is considered necessary.

Driving and using machines

Lidocaine B. Braun may temporarily affect your ability to move, concentrate, and coordinate. Your doctor will advise you whether you may drive or operate machinery.

Lidocaine B. Braun contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per ampoule; therefore, it is essentially "sodium-free".

3. How to use Lidocaine B. Braun

Anaesthetic therapy

Lidocaine B. Braun will be administered to you by a doctor. It will be given as an injection into a vein, into a muscle, under the skin, around nerves, or into the epidural space near the spinal cord.

Lidocaine B. Braun is usually administered near the part of the body to be operated on.

The dose your doctor gives you will depend on the type of pain relief you need, as well as your height, age, physical condition, and the site of injection. You will receive the lowest possible dose needed to achieve the desired effect. The dose of lidocaine should be reduced in special populations and in patients with poor general health.

Control of rapid or irregular heartbeats

This medicine will only be administered by healthcare professionals, and your doctor will determine the most appropriate dose for you.

The usual loading dose for adults is 50 to 100 mg, or 1 to 1.5 mg/kg body weight, as a direct intravenous injection, administered at a rate not exceeding 25–50 mg per minute.

To maintain therapeutic plasma concentrations (1.5–5 µg/ml), lidocaine should be infused at a rate of 20 to 50 µg/kg/min (approximately 1–4 mg per minute).

The dose should be adjusted according to individual needs and therapeutic response.

This is especially important if you have heart, liver, or kidney problems.

During pregnancy, the dose should be as low as possible.

Use in children

Anaesthetic therapy

Doses should be reduced in children. Lidocaine should be used with caution in children under four years of age.

The maximum dose should not exceed 5 mg of lidocaine hydrochloride per kilogram of body weight.

Control of rapid or irregular heartbeats

The use of lidocaine is not recommended in newborns. The initial dose of lidocaine in children is 0.5 to 1 mg/kg. This dose may be repeated according to the patient's response, but the total dose must not exceed 3–5 mg/kg body weight. If maintenance is required, an intravenous infusion of 10 to 50 µg/kg/min may be administered using an infusion pump.

If you use more Lidocaine B. Braun than you should

The doctor treating you is prepared to manage serious adverse effects related to an overdose of Lidocaine B. Braun.

The first signs that you may have received too much lidocaine are usually:

• seizures,
• restlessness,
• feeling tired or dizzy,
• nausea,
• numbness or tingling around the lips and mouth,
• vision problems.

If you experience any of these symptoms, or if you think you have received too much lidocaine, inform your doctor or nurse immediately.

More serious adverse effects related to lidocaine overdose may occur, such as disturbances in balance and coordination, hearing changes, euphoria, confusion, speech difficulties, pallor, sweating, tremors, seizures, effects on the heart and blood vessels, loss of consciousness, coma, and transient cessation of breathing (apnea).

If you have any further questions about the use of this medicine, ask your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91.562 04 20, stating the name of the medicine and the amount taken. Bring this leaflet with you.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Immediately inform your doctor or nurse if you experience a severe allergic reaction (angioedema or anaphylactic shock). Signs may include sudden onset of:

• Swelling of the face, lips, tongue, or throat; this may lead to difficulty swallowing.

• Severe or sudden swelling of the hands, feet, and ankles.

• Difficulty breathing.

• Intense skin itching (with hives).

• Fever.

• Decrease in blood pressure.

The possible adverse effects after administration are essentially the same as those produced by other amide-type local anesthetics.

Very common adverse effects (may affect more than 1 in 10 patients):

• Nausea and vomiting.
• Difficulty swallowing.
• Depressed mood.

Common adverse effects (may affect between 1 and 10 in 100 patients):

• Transient neurological symptoms (pain in legs and buttocks).
• Confusion, restlessness, irritability, euphoria, hallucinations, and depression.
• Drowsiness.
• Dizziness.
• Blurred vision.
• Tremors.
• Vertigo.
• Tingling sensation.

Uncommon adverse effects (may affect between 1 and 10 in 1,000 patients):

• Seizures.
• Numbness of the tongue or tingling sensation around the mouth.
• "Ringing" in the ears or noise sensitivity.
• Loss of consciousness.
• Tinnitus.
• Speech difficulties.
• Hypertension (high blood pressure).

Rare adverse effects (may affect between 1 and 10 in 10,000 patients):

• Hypersensitivity reactions, such as urticaria, skin rash, angioedema, bronchospasm, breathing difficulty, and, in severe cases, anaphylactic shock.
• Trauma.
• Chills.
• Irritation (reaction in an area of the body).
• Spinal cord compression.
• Muscle spasms.
• Hypotension (low blood pressure).
• Respiratory depression (slow or interrupted breathing).
• Bradycardia (slow heart rate).

Very rare adverse effects (may affect 1 in 10,000 patients):

• Ventricular tachycardia.

Adverse effects with unknown frequency (cannot be estimated from available data):

• Horner's syndrome (associated with epidural anesthesia or applications in the head and neck region).

Monitoring of rapid or irregular heartbeats

The following adverse effects may be serious. If any of these side effects occur, inform your doctor immediately. Immediate treatment may be required.

Rare adverse effects (may affect between 1 and 10 in 10,000 patients):

• Allergic reactions ranging from skin rashes and swelling to severe allergic reactions such as low blood pressure, difficulty breathing, airway constriction, and anaphylactic shock.
• Muscle contractions progressing to generalized seizures.
• Decreased level of consciousness up to coma.
• Slow heartbeats, heart block, and even cardiac arrest.
• Low blood pressure.
• Breathing difficulties up to respiratory arrest.

Very rare (may affect 1 in 10,000 patients):

• Rapid heartbeats.

Other adverse effects include:

Very common (may affect more than 1 in 10 patients):

• Feeling unwell, vomiting.
• Anxiety, difficulty swallowing.

Common adverse effects (may affect between 1 and 10 in 100 patients):

• Confusion, restlessness, irritability, euphoria, hallucinations, depression.
• Drowsiness, dizziness, sensation of spinning, difficulty speaking, tinnitus, blurred vision.
• Sensation of prickling, tingling, burning, stinging, or numbness of the skin.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Medicines Pharmacovigilance System for Human Use: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lidocaine B. Braun

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

For single use only. The contents of the ampoules must be used immediately after opening. After opening, any unused portion of the solution must be discarded.

The solution should only be used if it is clear, colourless, and the container is undamaged.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the container and other information

Composition of Lidocaine B. Braun

The active substance is lidocaine hydrochloride.

One ml of the injectable solution contains 20 mg of lidocaine hydrochloride.

Each 5 ml vial of solution contains 100 mg of lidocaine hydrochloride.

Each 10 ml vial of solution contains 200 mg of lidocaine hydrochloride.

The other components are: sodium chloride, sodium hydroxide (for pH adjustment), and water for injections.

Appearance of the product and contents of the container

Lidocaine B. Braun is a clear, colourless injectable solution.

It is supplied in polyethylene ampoules (Mini-Plasco) of 5 ml and 10 ml. Pack sizes of 1, 20 and 100 ampoules are available.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

• Braun Melsungen AG

Carl-Braun-Strasse 1 Postal address:

34212 Melsungen, Germany 34209 Melsungen, Germany

Date of the most recent revision of the summary of product characteristics: June 2021.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products: http://www.aemps.gob.es/

---

This information is intended exclusively for physicians or healthcare professionals:

Dosage and administration

Lidocaine B. Braun must only be used by physicians experienced in regional anesthesia and resuscitation techniques, or under their supervision. Resuscitation equipment must be readily available when administering local anesthetics. The lowest effective dose required to achieve the desired effect should be administered. The dose must be individually adjusted according to the specific characteristics of each case.

Anesthetic treatment

Adults

When injected into tissues with high systemic absorption, the single dose of lidocaine hydrochloride should not exceed 400 mg. The table below may serve as a guide for adults with a body weight of approximately 70 kilograms. The dose should be adjusted according to age, body weight, and the patient's condition:

Route of administration or procedure	Recommended doses of lidocaine hydrochloride
Concentration (mg/ml)	Volume (ml)	Total dose (mg)
Infiltration anesthesia
Minor procedures	10 mg/ml	2–10 ml	20–100 mg
Major procedures	10 mg/ml 20 mg/ml	10–20 ml 5–10 ml	100–200 mg 100–200 mg
Intravenous regional anesthesia:
Arm	10 mg/ml 20 mg/ml	10–20 ml 5–10 ml	100–200 mg 100–200 mg
Leg	10 mg/ml 20 mg/ml	20 ml 10 ml	200 mg 200 mg
Nerve blocks	10 mg/ml 20 mg/ml	2–20 ml 1–10 ml	20–200 mg 20–200 mg
Epidural anesthesia:
Lumbar analgesia	10 mg/ml 20 mg/ml	25–40 ml 12.5–20 ml	250–400 mg 250–400 mg
Thoracic anesthesia	10 mg/ml 20 mg/ml	20–30 ml 10–15 ml	200–300 mg 200–300 mg
Sacral surgical analgesia	10 mg/ml 20 mg/ml	40 ml 20 ml	400 mg 400 mg
Obstetric sacral analgesia	10 mg/ml 20 mg/ml	20–30 ml 10–15 ml	200–300 mg 200–300 mg

To prolong anesthesia, lidocaine may be combined with a vasoconstrictor such as adrenaline. The addition of adrenaline at a concentration of 1/100,000 to 1/200,000 has proven effective.

Special populations

In patients with renal impairment or hepatic impairment and in elderly patients, the dose should be reduced according to the patient's age and physical condition (see section 4.4 and section 5.2 of the summary of product characteristics).

Paediatric population

Doses should be individually calculated based on the patient's age, body weight, and the nature of the procedure. The anesthetic technique should be carefully selected, and techniques that are painful should be avoided. The child's behavior should be closely monitored during treatment. The average dose to be administered ranges from 20 mg to 30 mg of lidocaine hydrochloride per session. The dose of lidocaine hydrochloride that may be administered to children can also be calculated using the following expression: child's weight (in kilograms) × 1.33.

The equivalent of 5 mg of lidocaine hydrochloride per kilogram of body weight must not be exceeded.

To prevent systemic toxicity in children, the lowest effective concentration should always be used.

Lidocaine is indicated in adults and children. However, it should be used with caution in children under four years of age, as there is limited data to support the safety and efficacy of this product in this patient population at this time.

Injectable lidocaine is not recommended for use in newborns (see section 5.2 of the summary of product characteristics). In this age group, the optimal serum concentration of lidocaine required to avoid toxic effects such as seizures and cardiac arrhythmias is unknown.

Treatment of severe ventricular arrhythmias

Lidocaine is generally administered in cases of severe ventricular arrhythmias unresponsive to other antiarrhythmics such as beta-blockers or amiodarone, or when amiodarone is contraindicated.

The dose should be individually adjusted according to each patient's needs and clinical response.

Adults

Loading dose (intravenous bolus):

The usual loading dose is 50 to 100 mg or 1 to 1.5 mg/kg body weight as an intravenous injection, corresponding to 2.5–5 ml or 0.05–0.075 ml/kg of Lidocaine B. Braun 20 mg/ml.

The injection rate should not exceed 25–50 mg/min, corresponding to 1.25–2.5 ml/min of Lidocaine B. Braun 20 mg/ml.

If the therapeutic effect after the first dose is insufficient within the first 5–10 minutes, a second dose of 0.5 to 0.75 mg/kg should be administered one or two times, up to a maximum of 200–300 mg within one hour.

Maintenance dose (intravenous infusion):

To maintain therapeutic plasma concentrations (1.5–5 µg/ml), lidocaine should be infused at a rate of 20–50 µg/kg/min (approximately 1–4 mg/min), corresponding to 0.001–0.0025 ml/kg/min of Lidocaine B. Braun 20 mg/ml.

The infusion should be stopped as soon as the patient's cardiac rhythm appears stable or at the first signs of toxicity. Continuing the infusion beyond 24 hours is rarely necessary. A dose reduction may be required during prolonged intravenous infusions (lasting more than 24 hours) due to the risk of accumulation. As soon as possible, patients should be switched from this therapy to an oral antiarrhythmic maintenance treatment.

Special populations

Use in elderly patients

In elderly patients, the dose should be individually calculated according to the patient's age and body weight. Dose reduction may be necessary in this population, as cardiac output and hepatic blood flow decrease with advancing age, resulting in reduced lidocaine clearance (see section 5.2 of the summary of product characteristics).

Cardiac failure and hepatic impairment

The dose should be reduced in patients with cardiac failure and hepatic impairment due to decreased lidocaine clearance (see section 5.2 of the summary of product characteristics).

Renal impairment

Renal impairment generally does not require special dose adjustment. However, these patients should be monitored for toxic effects caused by metabolite accumulation. In cases of severe renal impairment, dose adjustment may be necessary (see section 5.2 of the summary of product characteristics).

Paediatric population

The safety and efficacy of lidocaine use in children has not yet been fully established. Lidocaine is not recommended for use in newborns (see section 5.2 of the summary of product characteristics).

The initial dose of lidocaine in children is 0.5–1 mg/kg. This dose may be repeated according to the patient's response, but the total dose should not exceed 3–5 mg/kg body weight. If maintenance is required, an intravenous infusion of 10–50 µg/kg/min may be administered using an infusion pump.

For advanced cardiovascular life support in children, a rapid initial intravenous or intraosseous (bolus) dose of 1 mg/kg body weight is recommended, up to a maximum dose of 100 mg.

If ventricular tachycardia or ventricular fibrillation is not corrected by defibrillation (or cardioversion) and the recommended initial dose of lidocaine, an intravenous or intraosseous infusion should be administered at a rate of 20–50 µg/kg body weight per minute.

Administration Route

Anesthetic Therapy

The route of administration of lidocaine varies depending on the type of anesthetic procedure used (infiltration anesthesia, intravenous regional anesthesia, nerve block, or epidural anesthesia).

Lidocaine B. Braun can be administered by intramuscular, subcutaneous, intradermal, perineural, epidural, or intravenous route (in local intravenous anesthesia or Bier block).

Treatment of Severe Ventricular Arrhythmias

Intravenous route. Intraosseous route.

Administer as a slow intravenous injection or as an intravenous infusion after dilution with an appropriate solution (see sections 6.2 and 6.6 of the summary of product characteristics).

Due to the relatively short duration of action of lidocaine, a continuous infusion should follow the injection, if possible, using an infusion pump. Continuous ECG, blood pressure, level of consciousness, and respiratory monitoring are recommended during lidocaine administration (see section 4.4 of the summary of product characteristics).

The infusion solution can be prepared by adding 1000 mg of lidocaine hydrochloride, corresponding to 50 ml of Lidocaine B. Braun 20 mg/ml, to a volume of 500 ml of glucose solution or physiological saline solution, resulting in a concentration of 2 mg/ml.

Interaction with other medicinal products and other forms of interaction

Drugs that inhibit the metabolism of lidocaine (e.g., cimetidine) may cause potentially toxic plasma concentrations when lidocaine is administered repeatedly at high doses over prolonged periods of time. Such interactions are not clinically relevant during short-term treatment with lidocaine at recommended doses.

Lidocaine should be used with caution in patients receiving other local anaesthetics or class Ib antiarrhythmic drugs, as toxic effects are cumulative.

Specific interaction studies between lidocaine and class III antiarrhythmic drugs (e.g., amiodarone) have not been conducted, but caution is recommended (see section 4.4 of the Summary of Product Characteristics).

If lidocaine is administered as an antiarrhythmic agent, additional administration of epinephrine or norepinephrine may potentiate adverse cardiac effects.

Class I Antiarrhythmic Agents

Concomitant administration of lidocaine with other class I antiarrhythmic agents should be avoided due to the risk of serious cardiac adverse effects.

Other Antiarrhythmic Agents

If lidocaine is used in combination with other antiarrhythmic agents such as beta-blockers or calcium channel blockers, the inhibitory effects on atrioventricular and intraventricular conduction and on contractility may be increased.

Medicinal products that may lower the seizure threshold

Since lidocaine itself lowers the seizure threshold, co-administration with other medicinal products that lower the seizure threshold (e.g., tramadol or bupropion) may increase the risk of seizures.

Warnings and special precautions for use

In general, before injecting lidocaine, it must be ensured that emergency resuscitation equipment and medications for the treatment of toxic reactions are immediately available. For major blocks, an intravenous cannula should be inserted before injecting the local anaesthetic. Like all local anaesthetic agents, lidocaine may cause acute toxic effects on the cardiovascular system and central nervous system when high blood concentrations are achieved, particularly after extensive intravascular administration.

Caution should be exercised in treating the following categories of patients:

• Elderly and generally debilitated patients.
• Patients with second- or third-degree atrioventricular (AV) block, as the local anaesthetic may reduce myocardial conductivity.
• Patients with congestive heart failure, bradycardia, or impaired respiratory function.
• Patients with severe hepatic disease or renal insufficiency.
• Patients with epilepsy. These patients should be closely monitored for signs of central nervous system toxicity. An increased tendency to seizures may occur even with doses below the maximum recommended.
• Patients with coagulopathy. Treatment with anticoagulants (e.g., heparin), NSAIDs, or plasma substitutes increases the tendency to bleeding. Accidental injury to blood vessels may lead to severe hemorrhage. If necessary, bleeding time, activated partial thromboplastin time (aPTT), prothrombin time (PT), and platelet count should be checked.
• Third trimester of pregnancy.
• In children under 4 years of age, as safety and efficacy data are limited.
• In newborns, special caution is required (see section 5.2 of the Summary of Product Characteristics).

Patients treated with class III antiarrhythmic drugs (e.g., amiodarone) should be closely monitored, and ECG monitoring should be considered, as the cardiac effects of lidocaine and class III antiarrhythmics may be cumulative (see section 4.5 of the Summary of Product Characteristics).

Post-marketing reports have described cases of chondrolysis in patients who received continuous postoperative intra-articular infusion of local anaesthetics. In most reported cases of chondrolysis, the shoulder joint was involved. Due to multiple contributing factors and inconsistencies in the scientific literature regarding the mechanism of action, a causal relationship has not been established. Continuous intra-articular infusion is not an approved indication for lidocaine (see section 4.8 of the Summary of Product Characteristics).

Epidural anaesthesia may cause serious adverse effects such as cardiovascular depression, especially in cases of concomitant hypovolemia. Caution should always be exercised in patients with reduced cardiovascular function.

Epidural anaesthesia may cause hypotension and bradycardia. This risk can be reduced by intravenous administration of crystalloid or colloid solutions. Hypotension should be treated immediately, e.g., with intravenous ephedrine 5–10 mg; repeat as necessary.

Paracervical block may occasionally cause fetal bradycardia or tachycardia, and close monitoring of fetal heart rate is required (see section 4.6 of the Summary of Product Characteristics).

Traumatic nerve injuries and/or local toxic effects on muscles and nerves are primarily caused by the injection of local anaesthetics. The extent of these tissue injuries depends on the degree of trauma, the concentration of the local anaesthetic, and the duration of tissue exposure to the local anaesthetic. Therefore, the lowest effective dose should be used.

Special caution should also be exercised when injecting local anaesthetic into inflamed (infected) tissue due to increased systemic absorption caused by increased blood flow and reduced efficacy due to the lower pH of infected tissue.

After release of the tourniquet following intravenous regional anaesthesia, there is an increased risk of adverse reactions. Therefore, the local anaesthetic should be eliminated in several fractions.

During anaesthetic procedures in the neck and head region, patients are at increased risk of central nervous system toxic effects even at low doses (see section 4.8 of the Summary of Product Characteristics).

Rarely, retrobulbar injections may reach the cranial subarachnoid space, causing severe reactions including cardiovascular collapse, apnea, seizures, and transient blindness.

Retrobulbar and peribulbar injections of local anaesthetics carry a low risk of persistent ocular motor dysfunction. Main causes include trauma and/or local toxic effects on muscles and/or nerves.

Intramuscular lidocaine may increase creatine phosphokinase concentrations, which may interfere with the diagnosis of acute myocardial infarction.

Lidocaine for injection is not recommended for use in newborns (see section 5.2 of the Summary of Product Characteristics).

Lidocaine has been shown to be porphyrinogenic in animals and should not be administered to patients with acute porphyria unless absolutely necessary. Extreme caution should be exercised in all patients with porphyria.

Antiarrhythmic Therapy

In acidosis, the plasma protein binding of lidocaine is reduced, and therefore the concentration of free lidocaine increases. Thus, the effect of lidocaine may be intensified in the presence of acidosis.

Hypokalemia, hypoxia, and acid-base imbalances should be corrected before using lidocaine in patients requiring high doses of antiarrhythmic agents.

During prolonged parenteral therapy with lidocaine, fluid balance, serum electrolytes, and acid-base balance should be monitored regularly.

Administration of lidocaine should be accompanied by continuous monitoring of ECG, blood pressure, level of consciousness, and respiration. In particular, dose adjustment of antiarrhythmic drugs requires careful monitoring. Cardiac emergency equipment must be readily available. If one or more parameters indicate worsening cardiac function, a therapeutic review should be performed, which may include discontinuation of lidocaine if necessary.

Note: In sedated patients, central nervous system disturbances may go unnoticed, and cardiac adverse effects may occur without prior warning symptoms.