Lidocaine hydrochloride S.A.L.F.

Package leaflet: Information for the user

LIDOCAINE HYDROCHLORIDE S.A.L.F. 10 mg/ml injection solution, 20 mg/ml injection solution

Lidocaine hydrochloride
Generic medicine
Read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What LIDOCAINE HYDROCHLORIDE S.A.L.F. is and what it is used for
2. What you need to know before using LIDOCAINE HYDROCHLORIDE S.A.L.F.
3. How to use LIDOCAINE HYDROCHLORIDE S.A.L.F.
4. Possible side effects
5. How to store LIDOCAINE HYDROCHLORIDE S.A.L.F.
6. Contents of the pack and other information

1. What LIDOCAINA CLORIDRATO S.A.L.F. is and what it is used for

LIDOCAINA CLORIDRATO S.A.L.F. contains the active substance lidocaine hydrochloride, which belongs both to the group of medicines called local anaesthetics, which act by blocking pain at the site where they are applied, and to the group of medicines known as antiarrhythmics, which act by regulating the heartbeat.
LIDOCAINA CLORIDRATO S.A.L.F. is indicated:

• as a local anaesthetic, to eliminate the sensation of pain during dental procedures (extractions, tooth smoothing for crowns and bridges, cavity preparation, vital pulpectomies, abscess incisions, apicectomies), minor skin procedures (e.g. removal of cysts), and procedures on the jaw.
• for the treatment of irregular heartbeats (ventricular arrhythmias) that may occur particularly in cases of heart tissue death due to inadequate supply of oxygen and nutrients (myocardial infarction), or during heart procedures (e.g. cardiac catheterization or cardiac surgery); in these cases, this medicine is administered by intravenous injection.

2. What you should know before using LIDOCAINE HYDROCHLORIDE S.A.L.F.

Do not use LIDOCAINE HYDROCHLORIDE S.A.L.F.

• if you are allergic to lidocaine, to other similar medicines (amide-type local anesthetics), or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or suspect you may be pregnant;
• if the patient is a child under 4 years of age.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using LIDOCAINE HYDROCHLORIDE S.A.L.F.
This medicine will be administered to you by a doctor or nurse in a medical facility equipped with the necessary equipment and medicines to manage emergencies. Serious, sometimes fatal, reactions have rarely occurred after using this medicine, even if you have not previously experienced allergic reactions when using this medicine or other similar medicines.
Before using this medicine, check that the solution is clear, colorless, and free from visible particles.

If LIDOCAINE HYDROCHLORIDE S.A.L.F. is used as a local anesthetic:
Before administering this medicine, your doctor will assess your circulation. Also, inform your doctor if you are taking other medicines or if you have previously experienced allergic reactions.
Your doctor will administer this medicine at the lowest possible dose that achieves the desired effect, using slow injections and avoiding direct injection into a vein.
During treatment with this medicine, your doctor will closely monitor you.
Use LIDOCAINE HYDROCHLORIDE S.A.L.F. with caution and inform your doctor if you have been treated with an anesthetic less than 24 hours ago, as two maximum doses of this medicine should never be administered unless at least 24 hours have passed between administrations.
Administration of this medicine must be immediately stopped if you experience changes in sensation (altered sensorium) or drowsiness.
If this medicine is administered during dental procedures, keep in mind that you will temporarily lose sensation in your mouth; therefore, avoid chewing until sensation returns to normal.
Do not administer this medicine in infected or inflamed areas.

If LIDOCAINE HYDROCHLORIDE S.A.L.F. is used as an antiarrhythmic:
Your doctor will administer this medicine via direct intravenous injection and will monitor your heart (electrocardiogram) during administration.
During treatment, serious heart and blood vessel problems (cardiovascular reactions), breathing difficulties, or central nervous system problems may occur; therefore, the doctor must have emergency resuscitation equipment readily available.
In case of severe reactions, lidocaine administration will be discontinued.
When this medicine is administered via direct intravenous injection for the treatment of irregular heartbeats (ventricular arrhythmias), your doctor will adjust the dose and exercise particular caution if:

• you have severe liver or kidney problems;
• you have heart problems (congestive heart failure, heart block, or other conduction disorders);
• you have reduced blood volume (hypovolemia);
• you have low oxygen levels (hypoxia) or severe breathing problems (respiratory depression);
• you are predisposed to abnormally high body temperature (malignant hyperthermia).

If you have abnormal potassium levels (hyperkalemia or hypokalemia), low oxygen levels (hypoxia) in the blood, or disturbances in fluid and electrolyte balance (acid-base imbalance), your doctor will treat these conditions before administering this medicine.

Children and adolescents
LIDOCAINE HYDROCHLORIDE S.A.L.F. must not be used in children under 4 years of age.

Other medicines and LIDOCAINE HYDROCHLORIDE S.A.L.F.
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Use LIDOCAINE HYDROCHLORIDE S.A.L.F. with caution and inform your doctor if you are taking the following medicines:

• cimetidine, a medicine used to treat stomach acidity and gastrointestinal ulcers;
• medicines used to treat high blood pressure or heart problems (beta-blockers and antiarrhythmics);
• medicines used to treat heart conditions (digitalis), as this increases the risk of slow heart rate and other disturbances in heart contraction (atrioventricular conduction disturbances);
• medicines used to treat psychiatric disorders (antipsychotics and antidepressants) or medicines used to treat nausea and vomiting (5HT__3 antagonists), as they may increase the risk of serious heart rhythm disturbances (QT interval prolongation and ventricular arrhythmias);
• medicines that reduce lidocaine elimination (amiodarone, antiviral medicines, medicines that inhibit the liver's ability to metabolize lidocaine);
• medicines known as neuromuscular blockers, as lidocaine may prolong their effect.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use this medicine if you are pregnant or suspect you may be pregnant.

Driving and using machines
This medicine may affect your ability to drive or operate machinery. Consult your doctor to determine whether you can drive or use machinery after the procedure.

LIDOCAINE HYDROCHLORIDE S.A.L.F. injectable solution contains sodium
The 5 ml vials contain less than 1 mmol (23 mg) of sodium per dose, i.e., they are practically 'sodium-free'.
The 10 ml vials contain approximately 1 mmol (23.6 mg) of sodium. This should be taken into consideration in patients with impaired renal function or those on a low-sodium diet.
The 50 ml vials contain approximately 5 mmol (118 mg) of sodium. This should be taken into consideration in patients with impaired renal function or those on a low-sodium diet.

3. How to use LIDOCAINE HYDROCHLORIDE S.A.L.F. injectable solution

This medicine will be administered to you by a doctor or trained medical personnel under close supervision.

Use as an anaesthetic
The doctor will administer this medicine through small subcutaneous injections (infiltration) or by injection near nerves (peripheral nerve block).
The recommended dose is 10–40 mg; the doctor will adjust the rate of administration.
If you have not taken other sedative medicines, the maximum dose is 300 mg, either as a single dose or divided into repeated doses within a 2-hour period.

Use in the treatment of heart rhythm disorders (arrhythmias)
This medicine may be administered by direct intravenous injection, with controlled rate (bolus administration or continuous intravenous infusion).

Rapid administration (bolus)
This method is used for the initial treatment of heart rhythm disorders (ventricular arrhythmias).
The recommended dose is 50–100 mg (0.7–1.4 mg per kilogram of body weight). During administration, the doctor will monitor your heart activity (electrocardiogram) and control the injection rate (25–50 mg per minute; 0.35–0.7 mg/kg/min). If the desired response is not achieved with this dose, a second dose may be administered after 5–10 minutes.
The maximum dose is 200–300 mg within one hour.

Slow administration (continuous intravenous infusion)
This method is used for maintenance treatment of heart rhythm disorders and is usually performed after the initial bolus dose.
If necessary, the doctor may dilute the LIDOCAINE HYDROCHLORIDE S.A.L.F. solution with 5% glucose.
The recommended dose is 0.01–0.05 mg per kilogram of body weight per minute (1–4 mg per minute for a 70 kg adult).
As soon as possible, maintenance therapy should be continued with an antiarrhythmic medicine taken by mouth.
During administration, the doctor will monitor your heart activity (electrocardiogram) and will stop the infusion if signs of toxicity appear or once your heart rhythm has stabilized.

Use in children
When LIDOCAINE HYDROCHLORIDE S.A.L.F. is used as an anaesthetic, the doctor will reduce the dose according to the child's weight and age.
For the treatment of heart rhythm disorders (arrhythmias), the safety and efficacy of LIDOCAINE HYDROCHLORIDE S.A.L.F. have not been established. An initial bolus dose of 0.5–1 mg per kilogram of body weight has been suggested, repeated if necessary up to a total of 3–5 mg per kilogram. The suggested maintenance dose (infusion administration) is 10–50 micrograms per kilogram of body weight per minute.

Use in elderly patients
The doctor will adjust the dose according to age and your overall health condition.

Use in patients with heart, liver or kidney problems
The doctor may reduce the dose and rate of infusion, if necessary.

If you use more LIDOCAINE HYDROCHLORIDE S.A.L.F. than you should
This medicine will be administered by a doctor or trained medical personnel, so it is unlikely that you will receive an excessive dose. However, if you think that you have been given too much, inform your doctor or another healthcare professional immediately.
In case of overdose, certain adverse effects may occur (see section 4 “Possible side effects”).

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are more likely to occur if an excessive dose is administered, if the medicine is absorbed too rapidly by the body, due to inadequate administration, or due to allergic-type problems (hypersensitivity, idiosyncrasy, reduced tolerance).

The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

• skin irritation (rashes, urticaria), itching, severe allergic reactions (anaphylactic shock, anaphylactoid reaction), breathing difficulties (bronchospasm), swelling of the throat due to fluid accumulation (laryngeal edema), cardiac and respiratory arrest (cardiorespiratory collapse) due to anaphylactic shock;
• excitation or depression associated with dizziness, vertigo, drowsiness, light-headedness, tingling in the limbs, reduced muscle tone (in neonates), difficulty speaking, hearing disturbances, tremors followed by changes in consciousness, convulsions, difficulty opening the mouth due to muscle contraction (trismus), muscle contractions, lack of coordination of voluntary muscle movements (ataxia), rhythmic and involuntary eye movements (nystagmus), and coma;
• anxiety, disorientation, mental confusion, agitation, nervousness, excitation, hallucinations, and psychosis;
• increased heart rate (tachycardia), slowed heart rate (bradycardia), heart rhythm disturbances (arrhythmias, myocardial depression) up to cardiac arrest. In cases of severe myocardial dysfunction, worsening of heart failure may occur;
• pupil dilation (mydriasis), visual disturbances;
• nausea, vomiting;
• increased respiratory rate (tachypnea), labored breathing (dyspnea), bronchial dilation (bronchodilation), respiratory depression or respiratory arrest;
• sweating;
• blood vessel dilation (vasodilation), decreased or increased blood pressure (hypotension, hypertension);
• changes in blood haemoglobin leading to reduced ability to bind and transport oxygen (methaemoglobinaemia);
• increased metabolism and body temperature.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LIDOCAINE HYDROCHLORIDE S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month, provided the product has remained in its original sealed packaging and has been correctly stored.
Store in the original packaging to protect the medicine from light. Do not freeze.
Use this medicine immediately after opening the container; after use, dispose of the container (and any remaining medicine), even if partially used.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What LIDOCAINA CLORIDRATO S.A.L.F. 10 mg/ml injectable solution contains

• The active substance is lidocaine hydrochloride. Each 5 ml vial contains 50 mg of lidocaine hydrochloride; each 10 ml vial contains 100 mg of lidocaine hydrochloride.
• The other components are: sodium chloride, water for injections.

What LIDOCAINA CLORIDRATO S.A.L.F. 20 mg/ml injectable solution contains

• The active substance is lidocaine hydrochloride. Each 5 ml vial contains 100 mg of lidocaine hydrochloride; each 10 ml vial contains 200 mg of lidocaine hydrochloride; each 50 ml bottle contains 1000 mg of lidocaine hydrochloride.
• The other components are: sodium chloride, water for injections.

Description of the appearance of LIDOCAINA CLORIDRATO S.A.L.F. and contents of the pack
LIDOCAINA CLORIDRATO S.A.L.F. 10 mg/ml injectable solution
Pack containing 5 vials of 5 ml or 10 ml.
LIDOCAINA CLORIDRATO S.A.L.F. 20 mg/ml injectable solution
Pack containing 5 vials of 5 ml or 10 ml, or 4 bottles of 50 ml.
Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 - Cenate Sotto (BG) - Tel. 035 - 940097

The following information is intended exclusively for doctors or healthcare professionals

Dosage and administration
As a local anaesthetic
Administer 10–40 mg or more, depending on the requirements of the procedure, by infiltration or peripheral nerve block. The anaesthetic solution must be injected in small doses at a rate of approximately 1 mL/minute, with prior adequate aspiration.

In healthy adults not pre-treated with sedatives, the maximum doses—either as a single administration or repeated administrations within less than 120 minutes—are a total of 300 mg of lidocaine hydrochloride. In paediatric patients, doses should be reduced proportionally according to weight and age.

As an antiarrhythmic
Adults
Intravenous bolus administration for initial treatment of ventricular arrhythmias
The usual dose of lidocaine is 50–100 mg (0.7–1.4 mg/kg), administered under ECG monitoring at an injection rate of 25–50 mg/minute (0.35–0.7 mg/kg/minute). If the desired response is not achieved with this dose, a second dose may be administered after 5–10 minutes.

No more than 200–300 mg of lidocaine should be administered within one hour.

Continuous intravenous infusion
After bolus administration, a maintenance infusion may be given at a rate of 0.01–0.05 mg/kg/minute (1–4 mg/minute for a 70 kg adult), possibly diluted appropriately with 5% glucose.

Continuing the infusion beyond 24 hours is rarely necessary; however, if prolonged administration is required, dose reduction should be considered to avoid risks of toxicity.

As soon as possible, maintenance therapy should be continued with an orally administered antiarrhythmic agent.

The infusion must be administered under continuous ECG monitoring to prevent overdose and toxic effects. The infusion should be discontinued once the patient's cardiac rhythm has stabilized or at the first sign of toxicity.

Children
The safety and efficacy of lidocaine use in children have not been established. An initial bolus dose of 0.5–1 mg/kg has been suggested, repeated if necessary up to a total of 3–5 mg/kg, followed by a continuous infusion of 10–50 mcg/kg/minute.

Elderly
Dosage should be adjusted according to the patient's age and physical condition. Dose reduction and slower infusion rates may be necessary.

Patients with cardiac, hepatic, or renal impairment
These patients may require reduced doses and slower infusion rates.

Special warnings and precautions for use
As a local anaesthetic
The efficacy and safety of lidocaine use in dentistry depend on appropriate dosing, correct administration technique, and adequate precautions.

The anaesthetic solution must be injected cautiously in small amounts after approximately 10 seconds of prior aspiration.

When infiltrating highly vascularized areas, it is advisable to wait approximately 2 minutes before proceeding with the actual locoregional block.

Direct intravenous administration must be absolutely avoided.

Local anaesthesia should be avoided in infected areas and sites of inflammation.

As an antiarrhythmic
Continuous electrocardiographic monitoring is essential for safe administration.

Severe adverse reactions affecting the cardiovascular, respiratory, and central nervous systems may occur; therefore, appropriate resuscitation equipment must be immediately available.

In case of severe reactions, lidocaine administration must be discontinued.

Lidocaine should be used with caution when administered intravenously for the treatment of ventricular arrhythmias in patients with severe hepatic or renal disease, congestive heart failure, cardiac block or other conduction disorders, hypovolemia, marked hypoxia, severe respiratory depression, or in patients with genetic predisposition to malignant hyperthermia. Conditions such as hypokalaemia, hyperkalaemia, hypoxia, or acid-base imbalances should be corrected prior to initiating lidocaine administration.

Overdose
At the first sign of warning, administration must be stopped immediately. The patient should be placed in a horizontal position, airway patency ensured, and oxygen administered in case of severe dyspnoea, or artificial ventilation performed if necessary.

The use of bulbar analeptics should be avoided, as they may worsen the condition by increasing oxygen consumption. Seizures, if they occur, may be controlled with intravenous diazepam 10–20 mg. Barbiturates are not recommended, as they may exacerbate bulbar depression.

Circulation may be supported by intravenous administration of appropriate doses of corticosteroids. Diluted solutions of vasoconstrictive alpha- and beta-stimulants (e.g., methoxamine, metaraminol, and others) or atropine sulfate may be added as needed.

Sodium bicarbonate, in appropriate concentrations, may be used intravenously as an acidosis corrective.

Incompatibilities
Lidocaine is incompatible with amphotericin, sodium metexithone, sodium sulfadiazine, methoxamine hydrochloride, alkalis, heavy metals, oxidizing agents, tannin, air, and light.

For further information, consult the Summary of Product Characteristics