Lisobact COMPLETE, spray 0.1 mg+4, 0.0 mg+0.3 mg/dose 125 doses

Pharmacotherapeutic group: antiseptic.

ATX code: R02AA.

Pharmacological properties

Pharmacodynamics

A combination drug whose action is due to its constituent components.

Lidocaine hydrochloride

Lidocaine hydrochloride is an amide-type local anesthetic with a superficial analgesic effect. Lidocaine blocks the generation and conduction of nerve impulses in the sensitive, motor and autonomic nerve fibers. At the molecular level, lidocaine affects mainly the cell membrane: it specifically blocks the sodium ion channels in the inactive state, which prevents the generation of the action potential, preventing the nerve impulse conduction when lidocaine is applied locally near the nerve. In general, local anesthetics block autonomic nerves, small unmyelinated (sensation of pain) and small myelinated (sensation of pain, temperature) faster than large myelinated fibers (sensation of touch, pressure).

It is effective in all types of local pain relief. It dilates the blood vessels. Does not have an irritating effect on the tissue.

Lysocym hydrochloride

Lysocym hydrochloride is a mucopolysaccharide that destroys (lyses) the cell walls of bacteria by hydrolyzing its peptidoglycans (in particular, murein). It is active against Gram-positive and some Gram-negative bacteria, viruses and fungi.

Cetylpyridinium chloride

Cetylpyridinium chloride is an antiseptic of the group of quaternary ammonium bases, has variable antifungal activity, bactericidal action against Gram-positive and Gram-negative bacteria, effective against some viruses. Cetylpyridinium chloride has a disinfectant effect on mucous membranes.

Pharmacokinetics

Lysobact COMPLETE^® is used topically and has an effect on the oropharyngeal area. If swallowed, a small amount of the drug may enter the digestive system.

Lidocaine hydrochloride

Lidocaine is quickly absorbed through the oral mucosa, the digestive tract or through damaged skin. About 65% of lidocaine binds to plasma proteins. After absorption, lidocaine is rapidly distributed to all tissues of the body, penetrates through the placental and blood-brain barrier, and is excreted into breast milk.

Lidocaine is extensively metabolized in the liver, its bioavailability after oral administration is 35%. About 90% of the administered dose is dealkylated to form monoethylglycinkylidide (MEGX) and glycinkylidide (GX), which provide therapeutic and toxic effects of lidocaine. GX has a longer half-life than lidocaine (about 10 h) and can cumulate with repeated administration. Subsequently, additional biotransformation occurs, and metabolites are excreted by the kidneys, including about 10% in the form of unchanged lidocaine.

Inhibition of cytochrome P450 isoenzymes CYP1A2 and CYP3A4 may increase lidocaine concentrations.

The elimination half-life of lidocaine from plasma is approximately 1.6 hours.

Special patient groups

Due to rapid metabolism, the pharmacokinetics of lidocaine may be affected by conditions that impair hepatic function. In patients with impaired liver function the half-life of lidocaine may be increased by a factor of 2 or more.

Disordered renal function does not affect the pharmacokinetics of lidocaine, but may lead to cumulation of its metabolites.

Lisocime hydrochloride

Lisocime hydrochloride is practically not absorbed through the oral mucosa.

Cetylpyridinium chloride

Cetylpyridinium chloride is poorly absorbed through the oral mucosa.

Indications

Active ingredient

Composition

Substances

Lidocaine hydrochloride monohydrate in terms of

lidocaine hydrochloride

0.1066 mg

0.10 mg

0.533 mg

0.50 mg

Lysocim hydrochloride

calculated in anhydrous substance

4.00 mg

/p>

(160,000 FIP IU*)

20.00 mg

(800,000 FIP units*)

Cetylpyridinium chloride monohydrate

calculated to cetylpyridinium chloride

0.315 mg

0.30 mg

1.575 mg

1.50 mg

Auxiliary Ingredients

Glycerol

40.00 mg

200.00 mg

Propylene glycol

4.00 mg

20.00 mg

Methyl parahydroxybenzoate

0.096 mg

0.48 mg

Propyl parahydroxybenzoate

0.024 mg

0.12 mg

Peppermint flavoring

0.02 mg

0.10 mg

Sodium hydroxide

q.s.

q.s.

Water purified

up to 0.20 ML

up to 1.00 ML

* – 1.0 mg of lysozyme hydrochloride corresponds to 40,000 FIP units.

How to take, the dosage

Topically, by spraying on the oropharyngeal mucosa. It is administered after meals. 5 injections per application 3-6 times a day with a minimum interval of 2 hours.

The course of treatment is 5 days.

A single press of the pipette releases 0.20 ml of a solution containing 4 mg of lysozyme hydrochloride, 0.3 mg of cetylpyridinium chloride and 0.1 mg of lidocaine hydrochloride. If after treatment there is no improvement or if symptoms worsen or new symptoms develop, you should consult a physician.

Please only use according to the indication, route of administration, and dosage listed in the directions.

Patients with impaired renal function

There is no need for dosing adjustment.

Patients with impaired liver function

In patients with impaired liver function it is recommended to use Lizobakt COMPLETE® with caution, in the lowest effective doses.

Lisobact®

It is recommended that the bottle of the drug be used by only one patient.

Please remove the plastic cap from the dispenser before the first use of Lizobact COMPLETE®.

The sprayer should then be placed on the dispenser with light pressure.

The sprayer can be moved to the side, which ensures adequate distribution of the spray over the entire oral mucosa.

The sprayer should be turned up, at a right angle to the bottle. Before using the spray for the first time, squeeze the dispenser several times until an even spray pattern is achieved.

Please open your mouth wide, point the sprayer toward the affected area and press the dispenser several times according to the dosing recommendations.

Stop breathing while spraying. Do not swallow the product.

After applying the product, the sprayer should be turned downward resulting in blockage of the spray.

Interaction

Lidocaine hydrochloride

. Although there are potentially numerous possible interactions between lidocaine and other drugs, these are likely to be of no clinical significance in this case due to the fact that Lizobakt COMPLETE® is used topically.

The concomitant use of Lizobact COMPLETE® with other drugs that restrict hepatic blood flow (e.g., propranololol, cimetidine) may result in decreased lidocaine clearance. When long-term use in combination with other drugs that induce microsomal enzymes (e.g., phenytoin, barbiturates), due to which the drug is metabolized, it may be necessary to increase the dose of lidocaine. Inhibition of cytochrome P450 isoenzymes CYP1A2 (fluvoxamine) and CYP3A4 (itraconazole, erythromycin) may increase lidocaine concentrations.

The cardiac suppressive effect of lidocaine is additive to the effects of beta-adrenoblockers and other antiarrhythmic drugs1. Cardiac glycosides attenuate the cardiotonic effect; curare-like drugs increase muscle

relaxation. Procainamide increases the risk of central nervous system agitation, hallucinations. When prescribed with antiarrhythmic drugs (amiodarone), negative inotropic effects may be increased

Hypokalemia provoked by acetazolamide, “loop” diuretics and thiazides may counteract the effects of lidocaine.

The simultaneous administration of lidocaine and hypnotics and sedatives may increase their depressant effect on the central nervous system.

In intravenous administration of sodium thiopental against the effect of lidocaine, respiratory depression may occur. Under the influence of monoamine oxidase inhibitors (furazolidone, procarbazine, selegiline) the local anesthetic effect of lidocaine may be enhanced.

Patients taking monoamine oxidase inhibitors should not administer lidocaine parenterally.

The concomitant use of lidocaine and polymyxine may increase the inhibitory effect on neuromuscular transmission, in which case the patient’s respiratory function should be monitored.

Lisocime hydrochloride

Lisocime hydrochloride increases the effect of antibiotics, including penicillin.including penicillin, chloramphenicol, nitrofurantoin, diuretics, weakens the activity of levodopa.

Cetylpyridinium chloride

The drug should not be taken simultaneously with milk because it reduces the antimicrobial activity of cetylpyridinium chloride. While using Lizobakt COMPLETE® patients should not use other local anesthetics for disinfection of the oral cavity and/or pharynx at the same time.

If you are using the above or other medications (including over-the-counter medications), please consult your physician before using this medication.

Special Instructions

Lidocaine hydrochloride

Lidocaine has porphyrogenic potential, and in patients with acute porphyria it should only be used in life-threatening emergencies. Precautions for porphyria should be observed in all patients.

When the drug is applied to the mucous membranes in high doses or with long-term treatment, the risk of systemic effects of local anesthetics (central nervous system disorders with the development of seizures, depressed cardiovascular system) increases.

The drug should be used with caution in patients with epilepsy, cardiac conduction disorders, hepatic impairment, history of allergic reactions.

The use of the drug is contraindicated in patients with hypersensitivity to other amide-type local anesthetic agents (such as bupivacaine, levobupivacaine, mepivacaine, prilocaine, ropivacaine).

Lisocim hydrochloride

Lisobact COMPLETE

sup>® should not be used in patients with a history of allergic reactions.

Cases of allergic reactions (hypersensitivity) have been reported in connection with the use of lysozyme. Therefore the patient should stop using this medicine and consult a physician in case of rash, itching or reddening of the skin, swelling of the face, lips, tongue or throat, breathing and/or difficulty in swallowing as these may be signs of an allergic reaction to the drug Lysobakt COMPLETE®.

Long-term use may potentially cause local irritation due to the cetylpyridinium chloride in the drug.

Lisobact COMPLETE® should not be taken with milk because this reduces the antimicrobial activity of cetylpyridinium chloride.

The drug is not recommended if there are open wounds in the mouth because cetylpyridinium hydrochloride slows wound healing.

Long-term use of cetylpyridinium hydrochloride may disrupt the normal oral microflora with the risk of bacterial or fungal infection.

The drug is not intended for long-term, repeated and continuous use. If symptoms last longer than 5 days and/or if other symptoms occur (pronounced oropharyngeal pain, nausea, vomiting), or if there is a concomitant rise in temperature, a physician should be consulted.

If patients have difficulty swallowing, they should not use this medication; they should see a physician.

When local anesthetics are used in the oral and oropharyngeal regions, the local anesthetic effect may lead to impaired swallowing, potentially increasing the risk of aspiration. Therefore, patients should be warned not to eat and/or drink for one hour after application of Lizobact COMPLETE®. In addition, brushing teeth and chewing gum should be avoided for as long as the oral and/or oropharyngeal analgesic effect persists.

Caution should be taken to avoid getting the solution in the eyes. If this happens by accident, the eyes should be rinsed with clean water or an eye wash and the eyes should be kept open for at least 15 minutes.

Lisobact COMPLETE® is sugar-free and suitable for use in diabetics.

Influence on driving and operating machinery

Lisobact COMPLETE® does not affect the ability to drive vehicles and operate machinery.

Contraindications

Hypersensitivity to lidocaine hydrochloride and other amide-type local anesthetic agents, lysozyme hydrochloride, cetylpyridinium chloride as well as to any of the ingredients of the drug.

Hypersensitivity to chicken egg protein.

Open wounds of the oral cavity.

Children under 18 years of age (effectiveness and safety not studied).

Pregnancy and period of breastfeeding.

Cautions

Epilepsy, cardiac conduction disorders, concomitant use of drugs containing lidocaine analogues, porphyria, disruption of the integrity of the oral mucosa, pharynx and larynx, liver function disorders, allergic reactions in the history.

If you have any of the above conditions, you should consult a physician before using the drug.

Side effects

Evaluation of the incidence of adverse effects is based on the following classification: very common (≥1/10); common (≥1/100 to < 1/10); infrequent (≥1/1000 to < 1/100); rare (≥1/10 000 to < 1/1); very rare (< 1/10 000), unknown (frequency cannot be estimated from available data).

System-organ class

Unwanted response

Lysobact COMPLETE®

Lidocaine hydrochloride

Lysocim

Cetipyridinium chloride

Immune system disorders

Allergic reactions

sup>1 (anaphylactic shock, Quincke’s edema, and local hypersensitivity reactions)

Rarely

Unknown

–

–

Allergic reactions, including allergic edema, skin rash, urticaria, Bronchospasm, and cardiovascular complications

Unknown

Unknown

Very rarely

Very rarely

Nervous system disorders

Loss of sensation

Often

/td>

Rarely

–

Infrequent

Gastrointestinal tract disorders

Inflammation of the oral mucosa (when using the drug in doses higher than recommended)

Inflammation of the oral mucosa (when using the drug in doses higher than recommended)/p>

Rarely

–

–

Rarely

Mouth dryness

Often

Infrequently

–

–

Tongue discomfort

Often

Infrequent

Skin and subcutaneous tissue disorders

Erythema multiforme

Unknown

Unknown

Unknown

Unknown

Stevens-Johnson syndrome.

Unknown

Unknown

Unknown

Unknown

General disorders and disorders together

Asthenia

Infrequent

Infrequent

Overdose

Symptoms

Application of local anesthetics to the oral mucosa may result in difficulty swallowing, resulting in an increased risk of aspiration into the airway. Therefore, an overdose of Lizobakt COMPLETE® may result in a slight increase in the risk of excessive local anesthetic in the vocal cleft area, which may subsequently lead to impaired control of the swallowing reflex.

Lidocaine hydrochloride

Very high concentrations of lidocaine in the blood may provoke effects on the central nervous system (CNS) and/or the cardiovascular system. Initial CNS manifestations may include nervousness, dizziness, tinnitus, nystagmus, psychomotor agitation, agitation, paresthesias, blurred vision, nausea, vomiting and tremors, which may progress to spinal cord depression and tonic and clonic seizures. Cardiovascular reactions are characterized by cardiovascular depression and are manifested by arterial hypotension, myocardial depression, bradycardia and potential risk of cardiac arrest.

While the bioavailability of lidocaine is quite low, it may be sufficient to cause significant intoxication if the drug is swallowed. Cases of CNS toxicity, seizures, and death after swallowing topical preparations have been reported. However, in the case of Lysobakt COMPLETE®, more than one liter of spray must be swallowed for the amount of lidocaine (0.5 g or greater) to be sufficient to produce a clinically significant toxic effect.

Lisocim hydrochloride

Incidents of overdose have not been observed.

Cetylpyridinium chloride

The signs and symptoms of intoxication when ingesting significant amounts of cetylpyridinium chloride: nausea, vomiting, edema, cyanosis, asphyxia followed by respiratory muscle paralysis, CNS depression, arterial hypotension, and coma.

Treatment of lidocaine overdose includes ensuring adequate ventilation of the lungs and control of epileptic seizures. Artificial ventilation with oxygen supply through maintenance breathing or controlled breathing is performed as needed. Sodium thiopental, diazepam may be used for elimination of epileptic seizures. If ventricular fibrillation or cardiac arrest occurs, adequate cardiovascular resuscitation should be performed. Several doses of adrenaline and sodium bicarbonate should be administered as soon as possible.

In case of overdose, discontinue the drug and seek medical attention.

Pregnancy use