Instructions for medical use

medicinal product (package insert)

Trade name

Lidocaine-DF

International nonproprietary name

Lidocaine

Dosage form, dosage

Spray for external and local use, 10%

Pharmacotherapeutic group

Nervous system. Anesthetics. Local anesthetics. Amides. Lidocaine

ATX code N01BV02

Indications for use

Lidocaine- DF spray is used in adults and children aged 2 years and older in all cases requiring rapid and effective anesthesia of the mucous membranes, especially in anesthesiology (e.g. intubation), otolaryngology, obstetrics, oral surgery and traumatology.

List of information required before use

Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

- Known hypersensitivity to local anesthetics of the amide type.

- Shock state or conduction block for Lidocaine- DF .

- Avoid contact of Lidocaine- DF with eyes . In case of accidental spray, rinse eyes immediately and thoroughly with water.

Necessary precautions for use

As with all local anesthetics, it is advisable to have emergency equipment and medications on hand in case of an emergency.

It is recommended to administer the lowest dose that allows for sufficient anesthesia to be achieved in order to avoid excessively high plasma concentrations and the risk of adverse effects (e.g., seizures).

Children over 12 years of age with a body weight of less than 25 kg should receive doses appropriate to their weight and physiological condition.

Excessive doses or short intervals between doses may cause high plasma levels and serious adverse effects. Absorption through mucous membranes is variable but is particularly high in the bronchial tree. Therefore, application at this level may result in a rapid increase in plasma concentrations or excessive plasma concentrations with an increased risk of toxic symptoms such as seizures. Lidocaine- DF spray should be used with caution in patients with mucosal trauma or injury in the intended application area. Application to damaged mucosa leads to greater systemic absorption. Treatment of serious adverse reactions may require the use of resuscitation equipment, oxygen therapy, and other resuscitative agents. During general anesthesia, paralyzed patients experience higher plasma concentrations than spontaneously breathing patients. Non-paralyzed patients have a greater ability to swallow a larger portion of the dose, resulting in higher first-pass metabolism after absorption from the intestine.

Contact of Lidocaine- DF with eyes should be avoided .

Using local anesthetics oropharyngeally can interfere with swallowing and may lead to aspiration. Numbing the tongue or oral mucosa can increase the risk of a bite.

If the dose administered may cause elevated blood levels, certain patients should be monitored for potential adverse effects:

• patients with cardiovascular diseases and heart failure;

• patients with partial or complete heart block;

• elderly people and patients in poor general condition;

• patients with severe renal impairment;

• patients with advanced liver disease.

Lidocaine- DF spray should not be used on plastic endotracheal tube balloons. Lidocaine base contacting both PVC and non-PVC endotracheal tube balloons can cause damage to the balloon. These can result in small pinhead-sized holes, which can cause leaks and lead to a loss of balloon pressure.

Lidocaine- DF spray is likely porphyrinogenic and should be prescribed to patients with acute porphyria only for serious and urgent indications. Appropriate precautions should be observed for all patients with porphyritis.

Patients receiving class III antiarrhythmic drugs (eg, amiodarone) should be monitored closely and have ECG monitoring, as the effects on the heart may be additive.

Caution should be exercised when applying Lidocaine- DF spray to severely damaged or infected areas.

Lidocaine- DF spray should be used with particular caution in patients with cardiovascular diseases, epilepsy and liver diseases.

Interactions with other drugs

At high doses of Lidocaine- DF, the risk of additional systemic toxicity should be considered in patients receiving other local anesthetics or substances structurally related to local anesthetics, such as antiarrhythmic agents such as mexiletine and tocainide.

Specific interaction studies of lidocaine and class III antiarrhythmic agents (eg, amiodarone) have not been conducted, but caution is recommended when using this combination.

Drugs that reduce lidocaine clearance (e.g., cimetidine, propranolol, and nadolol) can cause major toxic plasma concentrations when lidocaine is administered in high, repeated doses over a prolonged period. Therefore, such interactions are not clinically significant during short-term lidocaine treatment at recommended doses.

Special warnings

During pregnancy or lactation

Lidocaine crosses the placenta.

Animal studies have shown no teratogenic potential for lidocaine. Extensive data on pregnant women indicate that no malformations or toxicity to the fetus or neonate have been observed. Lidocaine may be used during pregnancy if clinically necessary.

Lidocaine is excreted in breast milk. However, since lidocaine is metabolized relatively rapidly and almost entirely in the liver, it can be assumed that only very low levels of lidocaine are excreted in breast milk, and at therapeutic doses of lidocaine, no effects on the newborn or breastfed infant are expected. Lidocaine can be used during breastfeeding.

There are no data on fertility in men or women. Studies have shown that lidocaine has no effect on fertility in males or females in animals.

Peculiarities of the drug's influence on the ability to drive a vehicle or potentially dangerous machinery

Depending on the dose administered, local anesthetics may have minor effects on mental function and temporarily impair locomotion and coordination.

Recommendations for use

Dosage regimen

Lidocaine - DF spray produces rapid and profound anesthesia of mucous membranes lasting approximately 10-15 minutes. Anesthesia onset occurs within 1-3 minutes, depending on the area of application. As with any local anesthetic, the safety and effectiveness of lidocaine depend on the correct dose, administration technique, adequate precautions, and timely emergency measures. The dosages listed in the table below are for reference only. The physician's experience and knowledge of the patient's condition are crucial when choosing the correct dose.

Lidocaine- DF spray should not be used on plastic endotracheal tube cuffs.

Adults

Table 1: Dosage recommendations

Anesthesia surface

Recommended dose (mg)

Maximum dose for short

interventions (mg) (a)

Maximum dose for long-term intervention (mg) (b)

Nasal interventions

(puncture of the maxillary sinus)

20-60

500

600

Oral and dental procedures

before injection

20-200

500

600

Interventions at the level of the oropharynx

(gastrointestinal endoscopy)

20-200

500

600

Airway interventions

(insertion of tubes and instruments)

50-400

400

600

Interventions at the level of the larynx,

trachea and bronchi

50-200

200 (c)

400

Obstetric and gynecological interventions (vaginal delivery, mucosal suture, cervical biopsy)

50-200

400

600

(a) For short interventions, the administration lasts less than one minute.

( b ) for long interventions, administration is carried out for more than 5 minutes.

( c ) During ventilation testing, the dose is reduced.

Due to the variability in absorption, recommended maximum doses depend on the area being anesthetized.

Children

Children over 12 years of age weighing less than 25 kg should be given doses appropriate to their weight and physiological condition.

For children under 12 years of age, doses should not exceed 3 mg/kg for laryngotracheal administration and 4-5 mg for the nose, mouth, and oropharynx. Lower concentrations are recommended for newborns and infants.

Measures to take in case of overdose

Acute systemic toxicity

The risk of overdose is believed to manifest itself primarily in the central nervous system and cardiovascular system.

At the level of the central nervous system, symptoms appear gradually: their severity increases, initially with perioral paresthesia and numbness of the tongue, dizziness, hyperacusis, and tinnitus, followed by visual disturbances and more severe muscle tremors, preceding the onset of seizures. Unconsciousness and major seizures can last from a few seconds to several minutes. Hypoxia and hypercapnia appear quickly after attacks due to intense muscle activity and disruption of normal breathing.

In severe cases, apnea may occur. Acidosis enhances the toxic effects of the local anesthetic. Healing occurs through the redistribution and metabolism of the local anesthetic from the central nervous system. This can be rapid if large quantities of anesthetic were not administered.

Cardiovascular effects will only be observed at high systemic concentrations: severe hypotension, bradycardia, arrhythmia, and cardiovascular collapse. These symptoms are usually preceded by signs of central nervous system toxicity, unless the patient has received general anesthesia and is heavily sedated with drugs such as benzodiazepines or barbiturates.

Treatment of acute poisoning

If symptoms of systemic toxicity occur, they are expected to be similar in nature to those seen after local anesthetics are administered by other routes. Local anesthetic toxicity manifests itself as symptoms of nervous system excitation and, in severe cases, nervous system depression and cardiovascular depression.

Severe neurological symptoms (seizures, CNS depression) should be treated symptomatically with respiratory support and anticonvulsant medications.

In the event of circulatory arrest, cardiopulmonary resuscitation (CPR) must be initiated immediately. Optimal oxygenation and ventilation, circulatory support, and treatment of acidosis are vital.

Recommendations for seeking advice from a healthcare professional to clarify how to use the drug

If you have any doubts about how to use the drug, consult your doctor.

Description of adverse reactions that occur with standard use of the drug and measures that should be taken in this case

Adverse reactions to Lidocaine- DF spray are rare and in most cases result from excessive dosing or too rapid absorption, resulting in too high plasma concentrations, these effects are systemic in nature and affect the central nervous system and/or cardiovascular system.

A small number of side effects are observed as a result of hypersensitivity, idiosyncrasy or decreased tolerance on the part of the patient.

At the level of the central nervous system, reactions of excitation and/or depression are observed, characterized by: nervousness, dizziness, visual disturbances and tremors, followed by drowsiness, convulsions, loss of consciousness, and in some cases respiratory arrest.

Toxic effects on the cardiovascular system are manifested by: hypotension, myocardial depression, bradycardia and, in some cases, cardiac arrest.

The most important risk groups are hypersensitive individuals, patients with reduced liver function, acidosis and epilepsy.

In rare cases (<0.1%), local anesthetics have caused allergic reactions, such as skin reactions, urticaria, and swelling (in the most severe cases, anaphylactic shock). These reactions are primarily local hypersensitivity, and in rare cases, systemic hypersensitivity.

No serious allergic reactions have been reported with the use of Lidocaine – DF spray.

Local irritation at the application site has been reported with Lidocaine- DF spray. Reversible symptoms, such as throat irritation, hoarseness, and voice suppression, have been reported after application to the laryngeal mucosa prior to endotracheal intubation. Lidocaine- DF spray is used to provide topical anesthesia during the procedure, but it does not prevent irritation after intubation.

If adverse drug reactions occur, contact your healthcare professional, pharmacist, or directly contact the adverse drug reaction (action) information database, including reports of drug ineffectiveness.

State Enterprise on the Right of Economic Management "National Center for Expertise of Medicines and Medical Devices" Committee for Medical and Pharmaceutical Control of the Ministry of Health

Republic of Kazakhstan

http://www.ndda.kz

Additional information

Composition of the medicinal product

One bottle contains:

active substance - lidocaine 3.8 g (4.8 mg in one dose);

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

Description of appearance, smell, taste

A transparent, colourless or yellowish solution with a characteristic odor of ethanol and menthol.

Release form and packaging

38 grams of the medication are packaged in dark glass bottles with a spray cap and protective cap. Each bottle is labeled. Each bottle, along with the spray cap and instructions for medical use in Kazakh and Russian, is placed in a cardboard box.

Shelf life

4 years

Do not use after expiration date.

Storage conditions

Store in a place protected from light, at a temperature of 15°C to 25°C.

Keep out of reach of children!

3600 ₸/unit

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