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Lidocaine (Solution, Spray, Drops) Instructions for Use

ATC Codes

D04AB01 (Lidocaine)

N01BB02 (Lidocaine)

Active Substance

Lidocaine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Local anesthetic for superficial anesthesia

Pharmacotherapeutic Group

Anesthetics; local anesthetics; amides

Pharmacological Action

Lidocaine is a Class IB antiarrhythmic agent, a local anesthetic, and an acetanilide derivative. It possesses membrane-stabilizing activity. It causes blockade of sodium channels in excitable neuronal membranes and cardiomyocyte membranes.

It reduces the duration of the action potential and the effective refractory period in Purkinje fibers and suppresses their automaticity. In this case, Lidocaine suppresses the electrical activity of depolarized, arrhythmogenic areas but minimally affects the electrical activity of normal tissues. When used in average therapeutic doses, it practically does not change myocardial contractility and does not slow AV conduction. When used as an antiarrhythmic agent, with intravenous administration, the onset of action is within 45-90 seconds, duration is 10-20 minutes; with intramuscular administration, the onset of action is within 5-15 minutes, duration is 60-90 minutes.

It causes all types of local anesthesia: terminal, infiltration, and conduction.

It is a local anesthetic for superficial anesthesia. Its action is due to the blockade of voltage-gated sodium channels, which prevents the generation of impulses in the endings of sensory nerves and the conduction of pain impulses along nerve fibers.

When applied topically, it dilates blood vessels and does not have a local irritant effect. It has an analgesic effect.

The effect develops within 1-5 minutes after application to mucous membranes or skin and lasts for 30-60 minutes.

Pharmacokinetics

After intramuscular administration, absorption is almost complete. Distribution is rapid, Vd is about 1 L/kg (lower in patients with heart failure). Binding to plasma proteins depends on the concentration of the active substance in plasma and is 60-80%. It is metabolized mainly in the liver with the formation of active metabolites, which may contribute to the manifestation of therapeutic and toxic effects, especially after infusion for 24 hours or more.

It is rapidly absorbed from mucous membranes (especially the pharynx and respiratory tract). The degree of absorption is determined by the degree of blood supply to the mucous membrane, the total dose, the location of the site, and the duration of application, and the dosage form used. After application to the mucous membrane of the upper respiratory tract, it is partially swallowed and inactivated in the gastrointestinal tract. The time to reach Cmax when applied to the oral mucosa and upper respiratory tract is 10-20 minutes.

It is metabolized in the liver (90-95%) with the participation of microsomal enzymes by dealkylation of the amino group and cleavage of the amide bond with the formation of metabolites less active than lidocaine (monoethylglycinexylidide and glycinexylidide), whose T1/2 is 2 hours and 10 hours, respectively.

T1/2 tends to be biphasic with a distribution phase of 7-9 minutes. Overall, T1/2 is dose-dependent, is 1-2 hours, and may increase to 3 hours or more during prolonged intravenous infusions (more than 24 hours). It is excreted by the kidneys as metabolites, 10% unchanged.

In liver diseases, the intensity of metabolism decreases and ranges from 50% to 10% of the normal value.

In chronic renal failure, accumulation of metabolites is possible.

Indications

For systemic use

In cardiological practice: treatment and prevention of ventricular arrhythmias (extrasystole, tachycardia, flutter, fibrillation), including in the acute period of myocardial infarction, during implantation of an artificial pacemaker, in glycoside intoxication, and anesthesia.

For anesthesia: terminal, infiltration, conduction, spinal (epidural) anesthesia in surgery, obstetrics and gynecology, urology, ophthalmology, dentistry, otorhinolaryngology; blockade of peripheral nerves and nerve ganglia.

For topical use

For terminal (superficial) anesthesia of mucous membranes: in dentistry, in otorhinolaryngology, in obstetrics and gynecology, during instrumental and endoscopic examinations, in surgery and dermatology.

ICD codes

ICD-10 code Indication
I21 Acute myocardial infarction
I47.2 Ventricular tachycardia
I49.0 Ventricular fibrillation and flutter
I49.4 Other and unspecified premature depolarization
T46.0 Poisoning by cardiac glycosides and drugs of similar action
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
ICD-11 code Indication
BA41.Z Acute myocardial infarction, unspecified
BC65.5 Catecholaminergic polymorphic ventricular tachycardia
BC71.0Z Ventricular tachycardia, unspecified
BC71.1 Ventricular fibrillation
BE2Y Other specified diseases of the circulatory system
NE60 Poisoning by drugs, medicaments or biological substances, not elsewhere classified
QB9A Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Solution

The dosage regimen is set individually, depending on the type of anesthesia and the site of administration, the size of the anesthetized area, and the patient’s age. The agent should be administered in the lowest concentration and the lowest dose that gives the required effect.

The maximum dose for adults should not exceed 300 mg.

In adults, children, and adolescents aged 12-18 years, a single dose of lidocaine (except for spinal anesthesia) should not exceed 4.5 mg/kg, with a maximum of 300 mg.

For children, elderly, and debilitated patients, Lidocaine is administered in lower doses corresponding to their age and physical condition.

Spray

As an antiarrhythmic agent for adults when administering a loading dose intravenously – 1-2 mg/kg over 3-4 minutes; the average single dose is 80 mg. Then immediately switch to drip infusion at a rate of 20-55 mcg/kg/min. Drip infusion can be carried out for 24-36 hours. If necessary, against the background of drip infusion, intravenous bolus administration of lidocaine can be repeated at a dose of 40 mg 10 minutes after the first loading dose.

Intramuscularly, administer 2-4 mg/kg, if necessary, repeated administration is possible after 60-90 minutes.

For children with intravenous administration of a loading dose – 1 mg/kg, if necessary, repeated administration is possible after 5 minutes. For continuous intravenous infusion (usually after a loading dose) – 20-30 mcg/kg/min.

For use in surgical and obstetric practice, dentistry, ENT practice, the dosage regimen is set individually, depending on the indications, clinical situation, and the dosage form used.

Maximum doses for adults with intravenous administration: loading dose – 100 mg, with subsequent drip infusion – 2 mg/min; with intramuscular administration – 300 mg (about 4.5 mg/kg) within 1 hour.

For children, in case of repeated administration of a loading dose at 5-minute intervals, the total dose is 3 mg/kg; with continuous intravenous infusion (usually after a loading dose) – 50 mcg/kg/min.

Drops

Topically in the dosage form for use in ophthalmology, by instillation into the conjunctival sac immediately before examination or surgery.

Adverse Reactions

From the nervous system dizziness, headache, weakness, motor restlessness, nystagmus, loss of consciousness, drowsiness, visual and auditory disturbances, tremor, trismus, convulsions (the risk of their development increases against the background of hypercapnia and acidosis), cauda equina syndrome (paralysis of the legs, paresthesia), paralysis of the respiratory muscles, respiratory arrest, motor and sensory block, respiratory paralysis (more often develops with subarachnoid anesthesia), tongue numbness (when used in dentistry).

From the cardiovascular system increase or decrease in blood pressure, tachycardia – when administered with a vasoconstrictor, peripheral vasodilation, collapse, chest pain.

From the digestive system nausea, vomiting, involuntary defecation.

Allergic reactions skin rash, urticaria (on the skin and mucous membranes), skin itching, angioedema, anaphylactic shock.

Local reactions with spinal anesthesia – back pain, with epidural anesthesia – accidental entry into the subarachnoid space; with topical use in urology – urethritis; when applied to the mucous membrane or skin, a sensation of slight tingling may occur, which disappears as the anesthetic effect develops (within 1 minute), transient erythema, edema, and sensitivity disorders.

Other involuntary urination, methemoglobinemia, persistent anesthesia, decreased libido and/or potency, respiratory depression, up to arrest, hypothermia; with anesthesia in dentistry: loss of sensation and paresthesia of the lips and tongue, prolonged anesthesia.

Contraindications

Severe bleeding, shock, arterial hypotension, infection of the intended injection site, severe bradycardia, cardiogenic shock, severe forms of chronic heart failure, sick sinus syndrome in elderly patients, AV block II and III degree (except for cases where a probe for ventricular stimulation is inserted), severe liver dysfunction.

For subarachnoid anesthesia – complete heart block, bleeding, arterial hypotension, shock, infection at the lumbar puncture site, septicemia.

Use of lidocaine in the form of an aerosol for tonsillectomy and adenoidectomy in children under 8 years of age; hypersensitivity to lidocaine.

Hypersensitivity to lidocaine and other local anesthetics of the amide type.

With caution should be used parenterally in conditions accompanied by a decrease in hepatic blood flow (including in chronic heart failure, liver diseases), progressive cardiovascular failure (usually due to the development of heart blocks and shock), in severely ill and debilitated patients, in elderly patients (over 65 years old); for epidural anesthesia – in neurological diseases, septicemia, impossibility of puncture due to spinal deformity; for subarachnoid anesthesia – in back pain, brain infection, benign and malignant brain tumors, in coagulopathies of various origins, migraine, subarachnoid hemorrhage, arterial hypertension, arterial hypotension, paresthesia, psychosis, hysteria, in uncooperative patients, impossibility of puncture due to spinal deformity.

With caution should be used topically during instrumental examinations (rectoscopy) in patients with hemorrhoidal bleeding, local infection in the application area, trauma to the mucous membrane or skin in the application area, severe somatic pathology, epilepsy, bradycardia, impaired cardiac conduction, impaired liver function, severe shock, in young children, elderly patients, during pregnancy and lactation.

Use in Pregnancy and Lactation

Use during pregnancy and lactation only for vital indications. Lidocaine is excreted in breast milk.

In obstetric practice, use with caution paracervically in cases of impaired intrauterine development of the fetus, fetoplacental insufficiency, prematurity, postmaturity, and preeclampsia.

Use in Hepatic Impairment

Contraindicated for parenteral use in severe liver dysfunction.

Use with caution in liver diseases accompanied by a decrease in hepatic blood flow.

Use in Renal Impairment

In chronic renal failure, accumulation of metabolites is possible.

Pediatric Use

Use with caution in the form of an aerosol in children.

Geriatric Use

Use with caution in elderly patients (over 65 years old).

Special Precautions

Solutions of lidocaine should be administered with caution into tissues with abundant vascularization (for example, in the neck area during thyroid surgery); in such cases, Lidocaine is used in lower doses.

With simultaneous use with beta-blockers, with cimetidine, a reduction in the dose of lidocaine is required; with polymyxin B – respiratory function should be monitored.

During treatment with MAO inhibitors, Lidocaine should not be used parenterally.

Injection solutions containing epinephrine and norepinephrine are not intended for intravenous administration.

Lidocaine should not be added to transfused blood.

When used topically, it is important to prevent lidocaine from entering the respiratory tract (risk of aspiration). Application to the buccal mucosa is associated with a risk of dysphagia and subsequent aspiration, especially in children. If the sensitivity of the tongue and buccal mucosa is impaired, the risk of biting them increases. Lidocaine is well absorbed through mucous membranes (especially in the trachea) and damaged skin. This should be taken into account, especially when treating large tissue areas in children.

In cases of use during surgical operations in the pharynx or nasopharynx, it should be taken into account that Lidocaine, by suppressing the pharyngeal reflex, enters the larynx and trachea and suppresses the cough reflex, which can lead to bronchopneumonia. This is especially important in children, as they more often induce the swallowing reflex. In this regard, the spray is not recommended for local anesthesia before tonsillectomy and adenoidectomy in children under 8 years of age.

Caution should be exercised when applying lidocaine to damaged mucous membranes and/or infected areas.

Influence on the ability to drive vehicles and mechanisms

After using lidocaine, it is not recommended to engage in activities requiring high concentration and rapid psychomotor reactions.

Drug Interactions

With simultaneous use with barbiturates (including phenobarbital), an increase in the metabolism of lidocaine in the liver, a decrease in plasma concentration, and, as a result, a decrease in its therapeutic effectiveness are possible.

With simultaneous use with beta-blockers (including propranolol, nadolol), an enhancement of the effects of lidocaine (including toxic ones) is possible, apparently due to a slowdown in its metabolism in the liver.

With simultaneous use with MAO inhibitors, an enhancement of the local anesthetic action of lidocaine is possible.

With simultaneous use with drugs causing neuromuscular blockade (including suxamethonium chloride), an enhancement of the action of drugs causing neuromuscular blockade is possible.

With simultaneous use with hypnotics and sedatives, an enhancement of the depressant effect on the central nervous system is possible; with ajmaline, quinidine – an enhancement of the cardiodepressant action is possible; with amiodarone – cases of convulsions and sick sinus syndrome have been described.

With simultaneous use with hexenal, sodium thiopental (intravenously), respiratory depression is possible.

With simultaneous use with mexiletine, the toxicity of lidocaine increases; with midazolam – a moderate decrease in the plasma concentration of lidocaine; with morphine – an enhancement of the analgesic effect of morphine.

With simultaneous use with prenylamine, there is a risk of developing torsades de pointes ventricular arrhythmia.

Cases of agitation, hallucinations with simultaneous use with procainamide have been described.

With simultaneous use with propafenone, an increase in the duration and severity of side effects from the central nervous system is possible.

It is believed that under the influence of rifampicin, a decrease in the plasma concentration of lidocaine is possible.

With simultaneous intravenous infusion of lidocaine and phenytoin, an enhancement of side effects of central origin is possible; a case of sinoatrial block due to the additive cardiodepressant action of lidocaine and phenytoin has been described.

In patients receiving phenytoin as an anticonvulsant, a decrease in the plasma concentration of lidocaine is possible, which is due to the induction of liver microsomal enzymes under the influence of phenytoin.

With simultaneous use with cimetidine, the clearance of lidocaine is moderately reduced and its plasma concentration is increased, there is a risk of increased side effects of lidocaine.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Egis Pharmaceuticals PLC (Hungary)

Dosage Form

Bottle Rx Icon Lidocaine Solution for intravenous administration 200 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration aqueous, transparent, colorless or almost colorless, aqueous, odorless.

1 ml 1 amp.
Lidocaine hydrochloride (as lidocaine hydrochloride monohydrate 213.31 mg) 100 mg 200 mg

Excipients : water for injections – up to 2 ml.

2 ml – ampoules of colorless glass of hydrolytic class I with two code rings (red and green) and a white break line (5) – contour cell packaging (2) – cardboard packs.

Marketing Authorization Holder

Egis Pharmaceuticals PLC (Hungary)

Dosage Form

Bottle Rx Icon Lidocaine Topical and external use spray 4.6 mg/1 dose: 38 g (650 doses) bottle with dosing pump and spray head

Dosage Form, Packaging, and Composition

Metered spray for topical and external use in the form of an almost colorless alcoholic solution with a characteristic menthol odor.

1 dose 1 bottle
Lidocaine 4.6 mg 38 g

Excipients: peppermint leaf oil, propylene glycol, ethanol (96%).

38 g (650 doses) – dark glass bottles with a capacity of 50 ml (1) with a dosing pump and spray head – cardboard packs.

Marketing Authorization Holder

Egis Pharmaceuticals PLC (Hungary)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 40 mg/2 ml: amp. 100 pcs.

Dosage Form, Packaging, and Composition

Solution for injection clear, colorless or almost colorless, odorless.

1 ml 1 amp.
Lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate 43 mg) 20 mg 40 mg

Excipients: sodium chloride for parenteral forms – 12 mg, water for injections – up to 2 ml.

2 ml – ampoules with a break point and with a green code ring (5) – contour cell packs (20) – cardboard boxes.

Marketing Authorization Holder

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 200 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml 1 amp.
Lidocaine hydrochloride 100 mg 200 mg

2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 40 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml 1 amp.
Lidocaine hydrochloride 20 mg 40 mg

2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 200 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml 1 amp.
Lidocaine hydrochloride 100 mg 200 mg

2 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 40 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml 1 amp.
Lidocaine hydrochloride 20 mg 40 mg

2 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Belmedpreparaty, JSC (Republic of Belarus)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 20 mg/1 ml: amp. 2 ml 5 or 10 pcs., fl. 10 ml 1 pc.

Dosage Form, Packaging, and Composition

Solution for injection clear, colorless or slightly yellowish.

1 ml
Lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate) 20 mg

Excipients: sodium chloride, sodium hydroxide solution 1M, water for injections.

2 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – ampoules (10) – cardboard boxes.
10 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 100 mg/1 ml: amp. 2 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a clear, colorless or yellowish liquid.

1 ml 1 amp.
Lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate) 100 mg 200 mg

Excipients: 1M sodium hydroxide solution, water for injections.

2 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – ampoules (10) – cardboard boxes with partitions.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 20 mg/1 ml: amp. 2 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a clear, colorless or yellowish liquid.

1 ml 1 amp.
Lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate) 20 mg 40 mg

Excipients: sodium chloride, 1M sodium hydroxide solution, water for injections.

2 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – ampoules (10) – cardboard boxes with partitions.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 10 mg/1 ml: amp. 10 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a clear, colorless or yellowish liquid.

1 ml 1 amp.
Lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate) 10 mg 100 ml

Excipients: sodium chloride, 1M sodium hydroxide solution, water for injections.

10 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
10 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
10 ml – ampoules (10) – cardboard boxes.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 10 mg/1 ml: amp. 5 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a clear, colorless or yellowish liquid.

1 ml 1 amp.
Lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate) 10 mg 50 mg

Excipients: sodium chloride, 1M sodium hydroxide solution, water for injections.

5 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
5 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 20 mg/1 ml: amp. 10 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a clear, colorless or yellowish liquid.

1 ml 1 amp.
Lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate) 20 mg 200 mg

Excipients: sodium chloride, 1M sodium hydroxide solution, water for injections.

10 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
10 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
10 ml – ampoules (10) – cardboard boxes.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 20 mg/1 ml: amp. 5 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a clear, colorless or yellowish liquid.

1 ml 1 amp.
Lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate) 20 mg 100 mg

Excipients: sodium chloride, 1M sodium hydroxide solution, water for injections.

5 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
5 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 20 mg/ml: amp. 2 ml 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml 1 amp.
Lidocaine hydrochloride 10 mg 100 mg

10 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard packs.
10 ml – ampoules of colorless glass (5) – contour cell packs (2) – cardboard packs.
10 ml – ampoules of colorless glass (10) – cardboard boxes.

Marketing Authorization Holder

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 2% (40 mg/2 ml): amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 2% 1 ml 1 amp.
Lidocaine hydrochloride 20 mg 40 mg

2 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Bright Way, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 20 mg/ml: 2 ml, 5 ml or 10 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection clear, colorless or slightly yellowish.

1 ml
Lidocaine hydrochloride monohydrate 21.34 mg,
   Equivalent to the content of lidocaine hydrochloride 20 mg

Excipients: sodium chloride – 6 mg, sodium hydroxide solution 1M – to pH 5.0-7.0, water for injections – up to 1 ml.

2 ml – ampoules (5) – cardboard packs.
2 ml – ampoules (10) – cardboard packs.
2 ml – ampoules (100) – cardboard containers for hospitals.
2 ml – ampoules (240) – cardboard containers for hospitals.
2 ml – ampoules (250) – cardboard containers for hospitals.
2 ml – ampoules (480) – cardboard containers for hospitals.
2 ml – ampoules (500) – cardboard containers for hospitals.
5 ml – ampoules (5) – cardboard packs.
5 ml – ampoules (10) – cardboard packs.
5 ml – ampoules (100) – cardboard containers for hospitals.
5 ml – ampoules (240) – cardboard containers for hospitals.
5 ml – ampoules (250) – cardboard containers for hospitals.
5 ml – ampoules (480) – cardboard containers for hospitals.
5 ml – ampoules (500) – cardboard containers for hospitals.
10 ml – ampoules (5) – cardboard packs.
10 ml – ampoules (10) – cardboard packs.
10 ml – ampoules (100) – cardboard containers for hospitals.
10 ml – ampoules (240) – cardboard containers for hospitals.
10 ml – ampoules (250) – cardboard containers for hospitals.
10 ml – ampoules (480) – cardboard containers for hospitals.
10 ml – ampoules (500) – cardboard containers for hospitals.

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 20 mg/1 ml: 2 ml or 10 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection clear, colorless or slightly yellowish in color.

1 ml
Lidocaine hydrochloride monohydrate (calculated as lidocaine hydrochloride) 20 mg

Excipients: sodium chloride – 6 mg, water for injections – up to 1 ml, sodium hydroxide solution 1M – to pH 5.0-7.0.

2 ml – polyethylene ampoules (10) – cardboard packs.
10 ml – polyethylene ampoules (10) – cardboard packs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 100 mg/1 ml: amp. 2 ml 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection transparent, colorless or slightly colored.

1 ml
Lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate) 100 mg

Excipients: sodium hydroxide solution 1M – to pH 5.0-7.0, water for injections – up to 1 ml.

2 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – glass ampoules (10) – cardboard boxes.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 20 mg/1 ml: amp. 2 ml, 5 ml, or 10 ml 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection transparent, colorless or slightly colored.

1 ml
Lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate) 20 mg

Excipients: sodium chloride – 6 mg, sodium hydroxide solution 1M – to pH 5.0-7.0, water for injections – up to 1 ml.

2 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
5 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
10 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – glass ampoules (10) – cardboard boxes.
5 ml – glass ampoules (10) – cardboard boxes.
10 ml – glass ampoules (10) – cardboard boxes.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 10 mg/1 ml: amp. 3.5 ml, 5 ml, or 10 ml 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection transparent, colorless or slightly colored.

1 ml
Lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate) 10 mg

Excipients: sodium chloride – 6 mg, sodium hydroxide solution 1M – to pH 5.0-7.0, water for injections – up to 1 ml.

3.5 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
5 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
10 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
3.5 ml – glass ampoules (10) – cardboard boxes.
5 ml – glass ampoules (10) – cardboard boxes.
10 ml – glass ampoules (10) – cardboard boxes.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Eye drops 2%: 5 ml or 10 ml bottle or dropper bottle

Dosage Form, Packaging, and Composition

Eye drops in the form of a transparent, colorless or from light yellow to light yellow with a brownish tint color.

1 ml
Lidocaine hydrochloride monohydrate 21.3 mg,
   Which corresponds to the content of lidocaine hydrochloride 20 mg

Excipients: sodium chloride – 6 mg, benzethonium chloride – 0.04 mg, water for injections – up to 1 ml.

5 ml – bottles – cardboard packs.
5 ml – dropper bottles – cardboard packs.
10 ml – bottles – cardboard packs.
10 ml – dropper bottles – cardboard packs.

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Eye drops 2% (20 mg/ml): dropper tube 1.3 ml 5 or 10 pcs., 1.5 ml 5 pcs.

Dosage Form, Packaging, and Composition

Eye drops 2% 1 ml
Lidocaine hydrochloride 20 mg

Excipients: benzethonium chloride, sodium chloride, water for injections.

1.3 ml – dropper tubes (5) – cardboard packs.
1.3 ml – dropper tubes (10) – cardboard packs.
1.5 ml – dropper tubes (5) – cardboard packs.

Marketing Authorization Holder

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 100 mg/ml: 2 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml
Lidocaine hydrochloride 100 mg

2 ml – ampoules (5) – plastic contour packs (2) – cardboard packs.

Marketing Authorization Holder

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 40 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml 1 amp.
Lidocaine hydrochloride 20 mg 40 mg

2 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 200 mg/10 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml 1 amp.
Lidocaine hydrochloride 20 mg 200 mg

10 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 20 mg/ml: 2 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 2% 1 ml 1 amp.
Lidocaine hydrochloride 20 mg 40 mg

2 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Manufactured By

Virion NPO (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 2% (40 mg/2 ml): amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 2% 1 ml 1 amp.
Lidocaine hydrochloride 20 mg 40 mg

2 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Pharmazashchita SPC, FSUE FMBA of Russia (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 20 mg/ml: 2 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection transparent, colorless or slightly colored.

1 ml
Lidocaine hydrochloride (calculated on the anhydrous substance) 20 mg

Excipients: sodium chloride – 6 mg, sodium hydroxide 1M solution – to pH 5.0-7.0, water for injections – up to 1 ml.

1 pc. – syringes – contour cell packs (1) – cardboard packs.

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 200 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml 1 amp.
Lidocaine hydrochloride 100 mg 200 mg

2 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 40 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml 1 amp.
Lidocaine hydrochloride 20 mg 40 mg

2 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 2% (100 mg/5 ml): amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 2% 1 ml 1 amp.
Lidocaine hydrochloride 20 mg 100 mg

5 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 2% (200 mg/10 ml): amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 2% 1 ml 1 amp.
Lidocaine hydrochloride 20 mg 200 mg

10 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 1% (50 mg/5 ml): amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1% 1 ml 1 amp.
Lidocaine hydrochloride 10 mg 50 mg

5 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 1% (100 mg/10 ml): amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1% 1 ml 1 amp.
Lidocaine hydrochloride 10 mg 100 mg

10 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 10% (200 mg/2 ml): amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 10% 1 ml 1 amp.
Lidocaine hydrochloride 100 mg 200 mg

2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 2% (40 mg/2 ml): amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 2% 1 ml 1 amp.
Lidocaine hydrochloride 20 mg 40 mg

2 ml – ampoules (10) – carton packs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 10 mg/ml: 3.5 ml or 5 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution from colorless to light yellow, transparent.

1 ml
Lidocaine hydrochloride 10 mg

Excipients: sodium chloride – 6 mg, sodium hydroxide solution 1M – to pH 5.0-7.0, water for injection – to 1 ml.

3.5 ml – ampoules (5) – contour cell packaging (1) – carton packs.
3.5 ml – ampoules (5) – contour cell packaging (2) – carton packs.
5 ml – ampoules (5) – contour cell packaging (1) – carton packs.
5 ml – ampoules (5) – contour cell packaging (2) – carton packs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Contact Information

SINTEZ OJSC Kurgan Joint Stock Company of Medicines and Products (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Eye drops 2%: dropper bottle 5 ml

Dosage Form, Packaging, and Composition

Eye drops 2% transparent, colorless or slightly colored.

1 ml
Lidocaine hydrochloride 20 mg

Excipients: benzethonium chloride, sodium chloride, water for injection.

5 ml – polyethylene dropper bottles (1) – carton packs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Eye drops 4% (40 mg/1 ml): bottle 5 ml

Dosage Form, Packaging, and Composition

Eye drops 4% 1 ml
Lidocaine hydrochloride 40 mg

5 ml – bottles (1) – carton packs.

Marketing Authorization Holder

Slavic Pharmacy, LLC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 20 mg/ml: amp. 100 pcs.

Dosage Form, Packaging, and Composition

Solution for injection transparent, colorless or slightly colored.

1 ml
Lidocaine hydrochloride (as monohydrate) 20 mg

Excipients: sodium chloride – 6 mg, sodium hydroxide solution 1 M to pH 5.0-7.0, water for injection – to 1 ml.

2 ml – polymer ampoules (5) – carton packs.
2 ml – polymer ampoules (10) – carton packs.
5 ml – polymer ampoules (5) – carton packs.
5 ml – polymer ampoules (10) – carton packs.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Lidocaine Dosed topical and external use spray 4.6 mg/1 dose: 50 ml (650 doses) bottle with dose-dispenser nozzle/spray nozzle

Dosage Form, Packaging, and Composition

Dosed spray for topical and external use in the form of a transparent, colorless or yellowish liquid with a characteristic odor of ethanol and menthol.

1 dose 1 bottle
Lidocaine hydrochloride (calculated as the anhydrous substance) 4.6 mg 3.8 g

Excipients: ethanol (ethyl alcohol 95%) – 15.36 g, propylene glycol – 3.8 g, menthol – 0.076 g, sodium hydroxide – 0.19 g, purified water – 14.774 g.

50 ml (650 doses) – bottles (1) with dose-dispenser nozzle/spray nozzle – carton packs.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Dosed spray for topical and external use 4.6 mg/dose: 38 g bottle.

Dosage Form, Packaging, and Composition

Spray for topical and external use in the form of an almost colorless solution with a characteristic odor of menthol.

1 bottle
Lidocaine 3.8 g

Excipients: peppermint leaf oil – 0.08 g, propylene glycol – 6.82 g, ethanol (ethyl alcohol) 96% – 27.3 g.

Total mass 38 g.

38 g (650 doses) – bottles – carton packs.

Marketing Authorization Holder

Pharmasintez, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 20 mg/1 ml: 2 ml, 5 ml or 10 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a transparent, colorless or slightly colored liquid.

1 ml
Lidocaine hydrochloride monohydrate (calculated as lidocaine hydrochloride) 20 mg

Excipients: sodium chloride – 6 mg, sodium hydroxide solution 1M – to pH 5.0-7.0, water for injection – to 1 ml.

2 ml – polyethylene ampoules, connected in cassettes (10) – carton packs.
5 ml – polyethylene ampoules, connected in cassettes (10) – carton packs.
10 ml – polyethylene ampoules, connected in cassettes (10) – carton packs.

Marketing Authorization Holder

Pharmsintez OJSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Solution for injection 20 mg/1 ml: 2 ml, 5 ml or 10 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection transparent, colorless or almost colorless.

1 ml
Lidocaine hydrochloride monohydrate (calculated as lidocaine hydrochloride) 20 mg

Excipients: sodium chloride – 6 mg, sodium hydroxide solution 1M – to pH 5.0-7.0, water for injection – to 1 ml.

2 ml – polyethylene ampoules (10) – carton packs.
5 ml – polyethylene ampoules (10) – carton packs.
10 ml – polyethylene ampoules (10) – carton packs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Dosed topical spray 4.6 mg/1 dose: 38 g (650 doses) bottle with sprayer

Dosage Form, Packaging, and Composition

Dosed spray for topical use in the form of a transparent, colorless or yellowish liquid, with a characteristic odor of ethyl alcohol and menthol.

1 bottle 1 dose
Lidocaine hydrochloride (calculated as the anhydrous substance) 3.8 g 4.6 mg

Excipients per 1 bottle/1 dose: ethanol (ethyl alcohol 95%) – 15.36 g/18.594 mg, propylene glycol – 3.8 g/4.6 mg, levomenthol – 0.076 g/0.092 mg, sodium hydroxide – 0.19 g/0.23 mg, purified water – to 38 g/to 46 mg.

38 g (650 doses) – bottles with a dosing pump (1) with an oral sprayer – carton packs.

Marketing Authorization Holder

Pharmstandard-UfaVITA OJSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 1%: 2 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution transparent, colorless or with a slight yellowish tint.

1 ml
Lidocaine hydrochloride 10 mg

Excipients: sodium chloride – 6 mg, sodium hydroxide solution 1M – to pH 5.0-7.0, water for injection – to 1 ml.

2 ml – ampoules (10) – carton packs.

Marketing Authorization Holder

Formula-FR, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Lidocaine Dosed spray for topical and external use 4.6 mg/dose: 38 g bottle (650 doses).

Dosage Form, Packaging, and Composition

Spray for topical and external use a transparent, colorless or yellowish liquid with a characteristic odor of ethanol and menthol.

1 dose 1 bottle
Lidocaine hydrochloride monohydrate (calculated as lidocaine hydrochloride) 3.8 g 4.6 mg

Excipients: ethanol (ethyl alcohol 95%) – 18.594 mg (15.36 g), propylene glycol – 4.6 mg (3.8 g), menthol – 0.092 mg (0.076 g), sodium hydroxide – 0.23 mg (0.19 g), purified water – 17.884 mg (14.774 g).

38 g (650 doses) – bottles (1) – carton packs (complete with a dose-dispenser nozzle or spray nozzle).

Marketing Authorization Holder

Ellara, LLC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 100 mg/ml: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a transparent colorless or slightly colored liquid.

1 ml 1 amp.
Lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate) 100 mg 200 mg

Excipients: sodium hydroxide – to pH 5.0-7.0, water for injection – to 1 ml.

2 ml – ampoules (5) marked with paint – carton packs.
2 ml – ampoules (5) with a label – carton packs.
2 ml – ampoules (10) marked with paint – carton packs.
2 ml – ampoules (10) with a label – carton packs.
2 ml – ampoules (5) marked with paint – contour cell packaging (1) – carton packs.
2 ml – ampoules (5) with a label – contour cell packaging (1) – carton packs.
2 ml – ampoules (5) marked with paint – contour cell packaging (2) – carton packs.
2 ml – ampoules (5) with a label – contour cell packaging (2) – carton packs.

Marketing Authorization Holder

Ellara, LLC (Russia)

Manufactured By

MC Ellara, LLC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Injection solution 20 mg/ml: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a transparent colorless or slightly colored liquid.

1 ml 1 amp.
Lidocaine hydrochloride 20 mg 40 mg

Excipients: sodium hydroxide to pH 5.0-7.0, water for injection to 1 ml.

2 ml – ampoules (5) marked with paint – carton packs.
2 ml – ampoules (5) with a label – carton packs.
2 ml – ampoules (10) marked with paint – carton packs.
2 ml – ampoules (10) with a label – carton packs.
2 ml – ampoules (5) marked with paint – contour cell packaging (1) – carton packs.
2 ml – ampoules (5) with a label – contour cell packaging (1) – carton packs.
2 ml – ampoules (5) marked with paint – contour cell packaging (2) – carton packs.
2 ml – ampoules (5) with a label – contour cell packaging (2) – carton packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine Bufus Solution for injection 200 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml 1 amp.
Lidocaine hydrochloride 100 mg 200 mg

2 ml – ampoules (10) – carton packs.

Marketing Authorization Holder

Pharmstandard-Ufimsky Vitaminny Zavod OJSC (Russia)

Dosage Form

Bottle Rx Icon Lidocaine hydrochloride Solution for injection 10% (200 mg/2 ml): amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 10% 1 ml 1 amp.
Lidocaine hydrochloride 100 mg 200 mg

2 ml – ampoules (10) – carton packs.

Table of Contents

TABLE OF CONTENTS