LIDOCAINE B. BRAUN 20 mg/ml injectable solution

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

Do not useLidocaine B. Braunif:

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

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

Epidural anesthesia should not be used during labor.

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

• You have severe heart disorders, particularly when your heart beats irregularly or slowly,
• You have had a heart attack in the last 3 months or if your heart's ability to pump blood to the whole body is significantly reduced, unless your condition is potentially life-threatening.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to use Lidocaine B. Braun.

• If you are elderly or in a debilitated general state,
• If you have heart problems such as a slow or irregular heartbeat or heart failure,
• If you have any lung or respiratory disorder,
• If you have any liver or kidney disease,
• If you have a history of epileptic seizures,
• If you have inflammation or infection at the injection site,
• If you have porphyria (a rare inherited disease that affects the skin and nervous system),
• If you have blood coagulation problems,
• 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 severe muscle weakness (myasthenia gravis).

Control of rapid or abnormal heartbeats

Your doctor will administer this medicine to treat heart problems only with special caution if you have high blood acidity (acidosis).

If you receive this medicine, your:

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

If any of the mentioned parameters worsen, your doctor may need to review your therapy. Additionally, they will ensure that the usual emergency equipment is available during therapy.

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

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

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

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

Note:

If you are under anesthesia, your doctor will examine your condition with great care. This will be done because side effects that affect your nervous system and heart can go unnoticed and can occur without previous warning symptoms.

Children

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

Using Lidocaine B. Braun with other medicines:

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• other local anesthetics.
• medicines used to treat stomach 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Your doctor will only administer this medicine during your pregnancy or breastfeeding if they consider it necessary.

Driving and using machines

Lidocaine B. Braun may temporarily affect your ability to move, attention, and coordination. Your doctor will tell you if you can drive or use machines.

Lidocaine B. Braun contains sodium

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

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3. How to use Lidocaine B. Braun

Anesthetic 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 the nerves, or into the epidural space near the spinal cord.

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

The dose that your doctor administers will depend on the type of pain relief you need. It will also depend on your height, age, and physical condition, as well as the part of the body where the medicine is injected. You will receive the lowest possible dose to produce the desired effect. The dose of lidocaine should be reduced in special populations and in patients in poor general condition.

Control of rapid or abnormal heartbeats

This medicine will be administered only by healthcare personnel, and your doctor will determine the most suitable 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, at a rate that should not exceed 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 (about 1-4 mg per minute).

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

This applies especially when there are heart, liver, or kidney problems.

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

Use in children

Anesthetic therapy

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

The usual maximum dose is 400 mg or approximately 20 ml of Lidocaine B. Braun.

Control of rapid or abnormal 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 should not exceed 3-5 mg/kg body weight. If maintenance is necessary, an intravenous infusion of 10 to 50 µg/kg/min can be administered using an infusion pump.

If you use more Lidocaine B. Braun than you should

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

The first signs that you are using more lidocaine than you should are usually the following:

• seizures,
• restlessness,
• feeling of tiredness or dizziness,
• nausea,
• numbness or tingling sensation of the lips and around the mouth,
• vision problems.

If you experience any of these signs or if you think you have received more lidocaine than you should, tell your doctor or nurse immediately.

More serious side effects related to an overdose of lidocaine may occur, such as balance and coordination disorders, auditory changes, euphoria, confusion, speech problems, paleness, sweating, tremors, seizures, effects on the heart and blood vessels, loss of consciousness, coma, and short-term interruption of breathing (apnea).

If you have any further questions on the use of this product, ask your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service phone: 91.562 04 20, indicating the medicine and the amount used. Carry this leaflet with you.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately if you experience a severe allergic reaction (angioedema or anaphylactic shock). The signs may include:

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

• Severe or sudden swelling of the hands, feet, and ankles.
• Difficulty breathing.
• Severe itching of the skin (with hives).
• Fever.
• Low blood pressure.

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

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

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

Common side effects (may affect up to 1 in 10 patients):

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

Uncommon side effects (may affect up to 1 in 100 patients):

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

Rare side effects (may affect up to 1 in 1,000 patients):

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

Very rare side effects (may affect up to 1 in 10,000 patients)

• Ventricular tachycardia.

Side effects with unknown frequency (cannot be estimated from the available data)

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

Control of rapid or abnormal heartbeats

The following side effects can be serious. If you experience any of the following side effects, tell your doctor immediately. You may need immediate treatment.

Rare side effects (may affect up to 1 in 10,000 patients):

• Allergic reactions ranging from rashes and swelling to severe allergic reactions such as low blood pressure, difficulty breathing, constriction of the airways, and anaphylactic shock.
• Muscle contractions up to generalized seizures and convulsions.
• Depression of the level of consciousness up to coma.
• Slow heartbeats, heart block, and up to cardiac arrest.
• Low blood pressure.
• Difficulty breathing up to interruption of breathing.

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

• Rapid heartbeats.

Other side effects include:

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

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

Common side effects (may affect up to 1 in 100 patients):

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that the side effects are not listed in this leaflet. You can also report side effects directly through the Medicines Surveillance System www.notificaRAM.es. By reporting side 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 which is stated on the packaging. The expiry date is the last day of the month stated.

No special storage conditions are required.

For single use only. The contents of the ampoules should be used immediately after opening. Once the packaging is opened, discard the unused portion of the solution.

The solution should only be used if it is clear and colorless and the packaging is not damaged.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lidocaine B. Braun

The active substance is lidocaine hydrochloride.

1 ml of the solution for injection contains 20 mg of lidocaine hydrochloride.

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

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

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

Appearance of the product and packaging contents

Lidocaine B. Braun is a clear and colorless solution for injection.

It is presented in polyethylene (Mini-Plasco) ampoules of 5 and 10 ml. It is presented in packs of 1, 20, and 100 ampoules.

Not all 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 last revision of this leaflet: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/

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This information is intended only for healthcare professionals:

Dosage and Administration

Lidocaína B. Braun should only be used by physicians with experience in regional anesthesia and resuscitation techniques or under their supervision. Resuscitation equipment should be available when administering local anesthetics. The lowest possible dose that produces the desired effect should be administered. The dose must be adjusted individually 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 described below can serve as a guide for adults with a body weight of approximately 70 kilograms. The dose should be adjusted based on age, weight, and patient condition:

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 been effective.

Special Populations

In patients with renal or hepatic insufficiency and in elderly patients, the dose should be reduced according to the patient's age and physical condition (see sections 4.4 and 5.2 of the technical sheet).

Pediatric Population

The doses are calculated individually according to the patient's age and body weight and the nature of the procedure. The anesthesia technique should be carefully selected, and those techniques that are painful should be avoided. The child's behavior should be closely monitored during treatment. The average dose to be administered is in the range of 20 mg to 30 mg of lidocaine hydrochloride per session. The dose of lidocaine hydrochloride that can be administered to children can also be calculated using the expression: child's weight (in kilograms) x 1.33.

The equivalent of 5 mg of lidocaine hydrochloride per kilogram of body weight should 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.

Lidocaine injectable is not recommended for use in newborns (see section 5.2 of the technical sheet). In this age group, the optimal concentration of lidocaine in serum necessary to avoid toxic effects such as convulsions and cardiac arrhythmias is unknown.

Treatment of Severe Ventricular Arrhythmias

Lidocaine is generally administered in cases of severe ventricular arrhythmias that do not respond to other antiarrhythmics such as beta blockers or amiodarone or in cases of contraindications for amiodarone.

The dose should be adjusted individually according to the needs of each patient and the clinical response obtained.

Adults

Loading dose (intravenous bolus):

The usual loading dose is 50 to 100 mg or 1 to 1.5 mg/kg of body weight as a direct 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 during the first 5-10 minutes, a second dose of 0.5 to 0.75 mg/kg should be administered once or twice, up to a maximum of 200-300 mg in 1 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 (over 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 heart rate is apparently stable or at the first signs of toxicity. It is rarely necessary to continue the infusion after 24 hours. A reduction in dose may be necessary in prolonged intravenous infusions (over 24 hours) due to the risk of accumulation. As soon as possible, patients should be switched to oral antiarrhythmic maintenance therapy.

Special Populations

Use in Elderly Patients

In elderly patients, the dose should be calculated individually according to the patient's age and body weight. A reduction in dose may be necessary in this population, as cardiac output and hepatic blood flow decrease with age, resulting in a decrease in lidocaine elimination (see section 5.2 of the technical sheet).

Cardiac and Hepatic Insufficiency

The dose should be reduced in patients with cardiac and hepatic insufficiency due to a reduction in lidocaine clearance (see section 5.2 of the technical sheet).

Renal Insufficiency

Renal insufficiency generally does not require special dose adjustment. However, these patients should be monitored for toxic effects caused by the accumulation of metabolites. In cases of severe renal insufficiency, dose adjustment may be necessary (see section 5.2 of the technical sheet).

Pediatric Population

The safety and efficacy of lidocaine use in children have not been fully established. Lidocaine is not recommended for use in newborns (see section 5.2 of the technical sheet).

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 of body weight. If maintenance is necessary, an intravenous infusion of 10 - 50 µg/kg/min can be administered using an infusion pump.

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

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 at a rate of 20-50 µg/kg of body weight per minute should be administered.

Administration

Anesthetic Therapy

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

Lidocaine B. Braun can be administered intramuscularly, subcutaneously, intradermally, perineurally, epidurally, or intravenously (in local intravenous anesthesia or Bier block).

Treatment of Severe Ventricular Arrhythmias

Intravenously. Intraosseously.

Administer as a slow intravenous injection or as an intravenous infusion after dilution with a suitable solution (see sections 6.2 and 6.6 of the technical sheet).

Due to the relatively short duration of action of lidocaine, the injection should be followed by a continuous infusion, if possible, using an infusion pump. Continuous monitoring of the ECG, blood pressure, level of consciousness, and respiration (see section 4.4 of the technical sheet) is recommended during the administration of lidocaine.

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 or saline solution, resulting in a concentration of 2 mg/ml.

Interactions 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 in high doses over prolonged periods. Such interactions are of no clinical relevance during short-term treatment with lidocaine at the recommended doses.

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

No specific interaction studies have been conducted with lidocaine and antiarrhythmic drugs of class III (e.g., amiodarone), but caution is recommended (see section 4.4 of the technical sheet).

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

Class I Antiarrhythmic Agents

The simultaneous administration of lidocaine with other class I antiarrhythmic agents should be avoided, as there is a risk of severe 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 effect on atrioventricular and intraventricular conduction and contractility may be increased.

Drugs that May Decrease the Seizure Threshold

Since lidocaine itself decreases the seizure threshold, co-administration with other drugs that decrease the seizure threshold (e.g., tramadol or bupropion) may increase the risk of seizures.

Special Warnings and Precautions for Use

In general, before injecting lidocaine, it should be ensured that all emergency resuscitation equipment and medications for the treatment of toxic reactions are available. In cases of major blocks, an intravenous cannula should be inserted before injecting the local anesthetic. Like all local anesthetics, lidocaine can cause acute toxic effects on the cardiovascular and central nervous systems when high blood concentrations occur, especially after extensive intravascular administration.

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

• Elderly and debilitated patients in general.
• Patients with AV block II or III, as the local anesthetic can reduce myocardial conductivity.
• Patients with congestive heart failure, bradycardia, or impaired respiratory function.
• Patients with severe hepatic or renal disease.
• Patients with epilepsy. These patients should be carefully monitored for the appearance of central nervous system symptoms. An increase in the tendency to seizures should be considered even with doses below the maximum.
• Patients with coagulopathy. Treatment with anticoagulants (e.g., heparin), NSAIDs, or plasma substitutes increases the tendency to bleeding. Accidental injury to blood vessels can cause severe bleeding. If necessary, bleeding time and partial thromboplastin time (PTT) should be checked, as well as platelet count.
• Third trimester of pregnancy
• In children under four years of age, as safety and efficacy data are limited
• In newborns, special caution should be exercised (see section 5.2 of the technical sheet)

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 antiarrhythmic drugs may be cumulative (see section 4.5 of the technical sheet).

There have been post-marketing reports of cases of chondrolysis in patients who received continuous postoperative intra-articular infusion of local anesthetics. In most of the reported cases of chondrolysis, the shoulder joint was involved. Due to the multiple contributing factors and the inconsistency in the scientific literature regarding the mechanism of action, causality has not been established. Continuous intra-articular infusion is not an approved indication for lidocaine (see section 4.8 of the technical sheet).

Epidural anesthesia can 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 anesthesia can cause hypotension and bradycardia. This risk can be reduced by administering intravenous crystalloid or colloid solutions. Hypotension should be treated immediately with, for example, ephedrine 5-10 mg intravenously; repeat as necessary.

Paracervical block can occasionally cause fetal bradycardia or tachycardia, and close monitoring of fetal heart rate is necessary (see section 4.6 of the technical sheet).

Neurological trauma and/or local toxic effects on muscles and nerves are mainly caused by the injection of local anesthetics. The extent of these tissue lesions depends on the magnitude of the trauma, the concentration of the local anesthetic, and the duration of tissue exposure to the local anesthetic. For this reason, the minimum effective dose should be used.

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

After removing the tourniquet after intravenous regional anesthesia, there is a greater risk of adverse reactions. Therefore, the local anesthetic should be eliminated in several fractions.

During anesthetic procedures in the neck and head region, patients are exposed to a higher risk of toxic effects of the drug on the central nervous system even at low doses (see section 4.8 of the technical sheet).

Rarely, retro-ocular injections can reach the subarachnoid cranial space, causing intense/severe reactions, including cardiovascular collapse, apnea, convulsions, and transient blindness.

Retro- and periocular injections of local anesthetics carry a low risk of persistent ocular motor dysfunction. The main causes include trauma and/or local toxic effects on muscles and/or nerves.

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

Lidocaine injectable is not recommended for use in newborns (see section 5.2 of the technical sheet).

Lidocaine has been shown to be porphyrinogenic in animals and should not be administered to patients with acute porphyria unless absolutely unavoidable. Precautions should be taken in all patients with porphyria.

Antiarrhythmic Therapy

In acidosis, the binding of lidocaine to plasma proteins is reduced, and therefore, the concentration of free lidocaine is increased. Therefore, the effect of lidocaine may be intensified in cases of acidosis.

Hypokalemia, hypoxia, and acid-base balance disorders should be corrected before using lidocaine in patients who require large doses of antiarrhythmic agents.

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

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

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