One ampoule of the solution contains:

• active substance: lidocaine hydrochloride 40 mg in 2 ml or 35 mg in 3.5 ml and 50 mg in 5 ml;
• excipients: sodium chloride, 1 M sodium hydroxide solution (up to pH 5.0-7.0), water for injection.

Solution for injection 10 mg/ml and 20 mg/ml.

Anesthetics. Local anesthetics. Amides. Lidocaine.

АТC code N01BВ02

• local anesthesia (terminal, infiltration, conduction) in surgery, ophthalmology, dentistry, otolaryngology;
• blockade of peripheral nerves and neural ganglia.

• history of hypersensitivity to any of the components of the medicine or other amide local anesthetics;
• sick sinus syndrome (especially in elderly patients), significant depression of left ventricular function;
• Wolff-Parkinson-White syndrome
• heart block: atrioventricular II - III degree (except when a probe is inserted to stimulate the ventricles), intraventricular; sinus-atrial;
• intraventricular conduction abnormalities;
• cardiogenic shock;
• retrobulbar administration (especially in glaucoma patients);
• porphyria;
• Adams-Stokes syndrome;
• for anesthesia in obstetric practice - embryofoetal development disorders, fetoplacental insufficiency, prematurity, postmaturity, gestosis;
• for epidural anesthesia - severe hypotension, cardiogenic shock and hypovolemic shock, neurological diseases, septicemia, inability to perform puncture due to spinal deformity;
• for subarachnoid anesthesia - back pain, brain infections, benign and malignant brain tumors, coagulopathies of various genesis, migraine, subarachnoid hemorrhage, arterial hypertension and hypotension, paresthesias, psychosis, hysteria, noncontact patients, inability to perform puncture due to spinal deformity;
• epileptiform seizures with previous use of Lidocaine (history);
• children or adolescents under 18 years of age

With caution: severe heart failure, severe hepatic and/or renal failure, in immunocompromised patients, hypovolemia, AV block, sinus bradycardia, arterial hypotension, myasthenia gravis, pregnancy and lactation.

Before using lidocaine it is necessary to conduct a skin test for hypersensitivity to the product, which is evidenced by swelling and erythema of the injection site.

For anesthesia the amount of medicine and the total dose depends on the type of anesthesia and the nature of the surgical intervention.

For infiltration anesthesia: up to 30 ml of a solution with a concentration of 10 mg/ml (1%).

For conduction anesthesia: solutions with a concentration of 10 mg/ml (1%) and 20 mg/ml (2%); the maximum total dose is up to 400 mg (40 ml of 1% solution and 20 ml of 2% lidocaine solution).

In dental practice: 1-5 ml (20-100 mg) of 2% solution; for intercostal nerve block - 3-5 ml (30-50 mg) of 1% solution; for paracervical anesthesia - 10 ml (100 mg) of 1% solution in each side (repeated administration after at least 1.5 hours is possible); for Oberst-Lukashevich block - 2-3 ml of 2% solution.

For vagosympathetic block: cervical - 5 ml (50 mg) 1% solution, lumbar - 5-10 ml (50-100 mg) 1% solution.

For epidural anesthesia: 200-300 mg (10-15 ml) of 2% lidocaine solution. Continuous administration of the anesthetic with a catheter is not recommended; the maximum dose should not be repeated more often than 90 minutes.

For mucosal anesthesia (tracheal intubation, bronchoesophagoscopy, fibrogastroduodenoscopy, polypectomy, maxillary sinus puncture, etc.): 2% solution in a volume not exceeding 20 ml. The duration of anesthesia is 15-30 minutes.

In ophthalmology: Instill 2 drops of 2% solution to the conjunctival sac 2-3 times at 30-60 second intervals just before surgery or examination.

Maximum dose for adults is no more than 4.5 mg/kg or 300 mg.

To prolong the effect of lidocaine, it is possible to add ex tempore  0.1% adrenaline solution (1 drop per 5-10 ml of lidocaine solution, but no more than 5 drops). In this case, the maximum permissible dose of lidocaine is increased to 500 mg.

Note: after intravenous administration, lidocaine has a short duration of action (lasting 15-20 minutes). If intravenous administration by drip infusion is not available, 50-100 mg may be repeated as needed once or twice at intervals of at least 10 minutes after the immediate initial intravenous infusion.

For preparation of an infusion solution, add 1 g or 2 g of lidocaine to 1 liter of 5% dextrose solution for injection to obtain a lidocaine solution at a concentration of 1 mg/ml or 2 mg/ml.

In elderly patients, a dose reduction is recommended, especially for prolonged intravenous infusions. No dose adjustment is required in chronic renal failure. In liver diseases (cirrhosis, hepatitis) and in patients with reduced hepatic blood flow (e.g., against a background of chronic heart failure), the dose should be reduced by 40-50%.

Attention!

Rapid intravenous administration may cause a sharp drop in blood pressure and lead to collapse. In these cases, phenylephrine, ephedrine and other vasoconstrictors are used.

1% lidocaine solution is used as a solvent for preparation of injection solutions for intramuscular administration of b-lactam antibiotics of cephalosporin group at the rate of 3 ml lidocaine per bottle containing 1.0 g of antibiotic.

Nervous system disorders:

• common - paresthesias, dizziness;
• uncommon - signs of systemic neurotoxicity (seizures, paresthesia around the mouth, tongue numbness, tremor, delirium, drowsiness, dysarthria, loss of consciousness);
• rare - neuropathy, peripheral nerve injury, arachnoiditis.

Eye disorders:

• rare - diplopia (double vision).

Cardiac disorders:

• common - bradycardia;
• rare - arrhythmia, cardiac arrest.

Vascular disorders:

• very common - hypotension;
• common - hypertension.

Respiratory, thoracic and mediastinal disorders:

• rare - respiratory failure, depression and respiratory arrest.

Immune system disorders:

• rare - allergic reactions (urticaria, skin rashes, Quincke's edema, in more severe cases - anaphylactic shock).

Gastrointestinal disorders:

• very common - nausea;
• common - vomiting.

Symptoms: initial signs of intoxication - dizziness, nausea, vomiting, euphoria, asthenia, decreased blood pressure; then - convulsions of facial mimic muscles, tonic-clonic convulsions of skeletal muscles, psychomotor agitation, bradycardia, collapse; when used in a newborn - bradycardia, respiratory center suppression, respiratory arrest.

Treatment: when the first signs of intoxication appear, stop the injection, put the patient is transferred to a horizontal position; conduct oxygen inhalation. Intravenous administration of diazepam is indicated for seizures, m-cholinoblockers (atropine), vasoconstrictors (norepinephrine, phenylephrine) - for bradycardia. If necessary, intubation, artificial lung ventilation, resuscitation measures are conducted. Dialysis is not effective.

Lidocaine penetrates the placental barrier and therefore is not recommended during pregnancy (especially in the first trimester), but only after a careful benefit/risk analysis. A small amount of lidocaine may be excreted into breast milk, so breastfeeding should be discontinued when lidocaine is prescribed.

There is no data on the use of the product in pediatric practice, therefore, its use in children is not recommended.

Before using lidocaine it is necessary to conduct a skin test for individual sensitivity to the product, which is evidenced by swelling and erythema of the injection site. Only healthcare professionals may administer lidocaine.

Regional and local anesthesia should be administered by experienced professionals in an appropriately equipped room with equipment and products readily available for immediate use for cardiac monitoring and resuscitation. Personnel performing anesthesia must be qualified and trained in anesthesia techniques and must be familiar with the diagnosis and treatment of systemic toxic reactions, adverse events and reactions, and other complications.

In patients with acute myocardial infarction, lidocaine administration may increase the risk of death by increasing the incidence of asystoles. Intramuscular injections of lidocaine may increase creatinine phosphokinase activity, which may complicate the diagnosis of myocardial infarction. Lidocaine is not recommended for supraventricular arrhythmias (due to ineffectiveness and risk of increased ventricular contractions - for flutter-fibrillation).

When administering lidocaine, special caution and dose reduction are required in cases of circulatory insufficiency, hypotension, hypovolemia, hypokalemia, hepatic and/or renal dysfunction. Before using Lidocaine, plasma potassium levels should be normalized.

Epidural anesthesia can lead to hypotension and bradycardia; this risk can be reduced by preadministration of colloid and crystalloid solutions. Paracervical block may cause fetal bradycardia or tachycardia, so monitoring of fetal heart activity is necessary.

Particular caution should be exercised when administering the product to elderly patients.

Patients predisposed to malignant hypertension require special attention because they may be resistant to amide local anesthetics.

When administered retrobulbarly, lidocaine rarely reaches the subarachnoid space, causing serious adverse reactions including cardiovascular failure, apnea, seizures, and temporary blindness. Lidocaine solutions should not be injected retrobulbarly in glaucoma patients.

10 mg/ml solution for injection: in 5 ml and 3.5 ml ampoules made of low-density polyethylene.

20 mg/ml solution for injection: in 2 ml ampoules made of low-density high-pressure polyethylene.

Labels from label paper are stuck on polymer ampoules.

5 or 10 ampoules with instruction for use in the state and Russian languages are placed a carton pack.

In a place protected from light, at a temperature below 25˚C.

Keep out of the reach of children.

2 years.

Do not use after expiration date.

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan, tel.: (727) 253-03-88.

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan.

Name, address, contact information of the organization accepting claims (proposals) against quality of products from consumers in the territory of the Republic of Kazakhstan, which is responsible for post-authorization safety surveillance of the medicine:

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan,

Tel./Fax: (727) 253-07-07, 253-03-88, e-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра.