Lysobact COMPLETE spray for external application, 125 doses

Composition

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

Pharmacological action

Pharmacotherapeutic group: antiseptic.

ATX code: R02AA.

Pharmacological properties

Pharmacodynamics

A combined drug, the action of which is due to the components included in its composition.

Lidocaine Hydrochloride

Lidocaine hydrochloride is a local anesthetic of the amide type, which has a superficial analgesic effect. Lidocaine blocks the generation and conduction of nerve impulses in sensory, motor, and autonomic nerve fibers. At the molecular level, lidocaine acts primarily on the cell membrane: it specifically blocks sodium ion channels in the inactive state, which prevents the generation of an action potential, preventing the conduction of a nerve impulse when lidocaine is applied topically 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 for all types of local anesthesia. Dilates blood vessels. It has no irritating effect on fabrics.

Lysozyme Hydrochloride

Lysozyme hydrochloride is a mucopolysaccharide that breaks down (lyses) cell walls of bacteria by hydrolysis of its peptidoglycans (in particular, murein). Active against gram-positive and some gram-negative bacteria, viruses and fungi.

Cetylpyridinium chloride

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

Pharmacokinetics

Lysobact COMPLIT® is applied topically and has an effect on the oropharyngeal region. If swallowed, a small amount of the drug may enter the digestive system.

Lidocaine Hydrochloride

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

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

Inhibition of cytochrome P 450 CYP1A2 and CYP3A4 isoenzymes may increase lidocaine concentrations.

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

Special patient groups

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

Impaired renal function does not affect the pharmacokinetics of lidocaine, but it can lead to accumulation of its metabolites.

Lysozyme hydrochloride

Lysozyme hydrochloride is practically not absorbed through the oral mucosa.

Cetylpyridinium chloride

Cetylpyridinium chloride is poorly absorbed through the oral mucosa.

Indications

Symptomatic treatment of sore throat in infectious and inflammatory diseases of the pharynx and larynx (acute and chronic pharyngitis, pharyngolaryngitis, tonsillitis) in adult patients as part of complex therapy.

Use during pregnancy and lactation

Use during pregnancy and lactation is contraindicated.

Contraindications

Hypersensitivity to lidocaine hydrochloride and other local anesthetics of the amide type, lysozyme hydrochloride, cetylpyridinium chloride, as well as to any of the components of the drug.

Hypersensitivity to egg white.

Open wounds of the oral cavity.

Children under 18 years of age (efficacy and safety have not been studied).

Pregnancy and breast-feeding period.

With caution

Epilepsy, cardiac conduction disorders, concomitant use of drugs containing lidocaine analogues, porphyria, violation of the integrity of the oral, pharyngeal and laryngeal mucosa, impaired liver function, a history of allergic reactions.

If you have any of the diseases listed above, you should consult your doctor before using the drug.

Side effects

The estimation of the frequency of undesirable effects is based on the following classification: very common (≥1/10); common (≥1/100 to <1/10); infrequent (≥1/000 to <1/100); rare (≥1/10,000 to <1/1); very rare (

1 In extremely rare cases, the use of local anesthetics may be accompanied by allergic reactions. Hypersensitivity reactions to lidocaine hydrochloride after local injection were manifested in the form of localized edema, minor breathing difficulties, or in the form of a generalized rash.

Lisobact COMPLIT® may cause headaches, stomach problems and diarrhea due to the presence of glycerol in the composition.

Lisobact COMPLIT® may cause alcohol-like symptoms due to the presence of propylene glycol in the formulation.

Lisobact COMPLIT® may cause delayed allergic reactions (e. g. contact dermatitis) or (less often) immediate reactions (urticaria, bronchospasm) due to the presence of methyl – and propylparahydroxybenzoate in the composition.

If you experience any of the side effects listed in the instructions or if they get worse, or if you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Lidocaine Hydrochloride

Despite the potential multiple interactions of lidocaine with other drugs, they are not likely to be clinically relevant in this case, since Lysobact COMPLIT® is used topically.

Concomitant use of Lysobact COMPLIT with other drugs that restrict hepatic blood flow (for example, propranolol, cimetidine) may lead to a decrease in lidocaine clearance. With prolonged use in combination with other drugs that induce microsomal enzymes (for example, phenytoin, barbiturates), due to which the drug is metabolized, an increase in the dose of lidocaine may be required. Inhibition of cytochrome P 450 CYP1A2 (fluvoxamine) and CYP3A4 (itraconazole, erythromycin) isoenzymes may increase lidocaine concentrations.

The depressing effect of lidocaine on the heart is additive to the effects of beta-blockers and other antiarrhythmic drugs 1. Cardiac glycosides weaken the cardiotonic effect, curare-like drugs enhance muscle

relaxation. Procainamide increases the risk of central nervous system arousal and hallucinations. When prescribed with antiarrhythmic drugs (amiodarone), the negative inotropic effect may increase

Hypokalemia caused by acetazolamide, loop diuretics, and thiazides may counteract the effect of lidocaine.

When lidocaine is administered simultaneously with sleeping pills and sedatives, it is possible to increase their depressing effect on the central nervous system.

With intravenous use of sodium thiopental against the background of lidocaine, respiratory depression is possible. 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 be given lidocaine parenterally.

With the simultaneous use of lidocaine and polymyxin, it is possible to increase the depressing effect on neuromuscular transmission, so in this case it is necessary to monitor the patient’s respiratory function.

Lysozyme hydrochloride

Lysozyme hydrochloride enhances the action of antibiotics, including penicillin, chloramphenicol, nitrofurantoin, diuretics, weakens the activity of levodopa.

Cetylpyridinium chloride

The drug should not be taken simultaneously with milk, as it reduces the antimicrobial activity of cetylpyridinium chloride. When using Lysobact COMPLIT®, patients should not simultaneously use other local anesthetics to disinfect the oral cavity and / or pharynx.

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

How to take, course of use and dosage

Topically, by spraying on the oropharyngeal mucosa. It is applied 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.

When the dispenser is pressed once,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 is released. If there is no improvement after treatment, or if the symptoms worsen or new symptoms appear, you should consult your doctor.

Use the drug only according to the indications, the method of use and in the doses indicated in the instructions.

Patients with impaired renal function

No dosage adjustment is required.

Patients with impaired liver function

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

Method of application

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

Remove the plastic cover from the dispenser before first using Lysobact COMPLIT®.

After that, it is necessary to put the spray gun on the dispenser with light pressure.

The sprayer can be shifted to the side, which ensures an adequate distribution of the spray throughout the oral mucosa.

The sprayer must be turned up, at the right angle in relation to the bottle. Before applying the spray for the first time, it is necessary to press the dispenser several times until a uniform spray is obtained.

Open your mouth wide, point the nebulizer towards the affected area, and press the dispenser several times in accordance with the dosage recommendations.

Hold your breath as you spray the product. Do not swallow the drug.

After applying the drug, the sprayer should be turned down, which leads to blocking its spraying.

Overdose

Symptoms

Applying local anesthetics to the oral mucosa can lead to difficulty swallowing, which increases the risk of aspiration in the respiratory tract. Therefore, an overdose of Lisobact COMPLIT® may lead to a slight increase in the risk of excessive local analgesic effect in the glottis, which may subsequently lead to a weakening of control over the swallowing reflex.

Lidocaine Hydrochloride

Very high concentrations of lidocaine in the blood can provoke effects on the central nervous system (CNS) and/or on the cardiovascular system. Initial CNS symptoms may include nervousness, dizziness, tinnitus, nystagmus, psychomotor agitation, agitation, paresthesia, blurred vision, nausea, vomiting, and tremor, which may progress to spinal cord depression, as well as tonic and clonic seizures. Reactions from the cardiovascular system are characterized by its depression and are manifested by hypotension, myocardial depression, bradycardia and a potential risk of cardiac arrest.

Although the bioavailability of lidocaine is quite low, it may be sufficient to cause significant intoxication if the drug is swallowed. Cases of toxic effects on the central nervous system, seizures, and death have been reported after ingestion of topical medications. However, in the case of Lysobact COMPLIT®, more than one liter of the spray is required to be swallowed so that the amount of lidocaine (0.5 g or more) is sufficient to form a clinically significant toxic effect.

Lysozyme Hydrochloride

No cases of overdose were observed.

Cetylpyridinium chloride

Signs and symptoms of intoxication with ingestion of significant amounts of cetylpyridinium chloride: nausea, vomiting, edema, cyanosis, asphyxia followed by paralysis of the respiratory muscles, central nervous system depression, hypotension and coma.

Treatment

Treatment of lidocaine overdose includes ensuring adequate ventilation of the lungs and stopping epileptic seizures. Artificial ventilation with oxygen supply by maintaining respiration or controlled breathing is carried out as needed. To eliminate epileptic seizures, thiopental sodium, diazepam can be used. In case of ventricular fibrillation or cardiac arrest, adequate cardiovascular resuscitation is necessary. Several doses of epinephrine and sodium bicarbonate should be administered as soon as possible.

In case of overdose, stop using the drug and consult a doctor.

Special instructions

Lidocaine Hydrochloride

Lidocaine has porphyrogenic potential, and in patients with acute porphyria, it can only be used for life-threatening emergency indications. All patients should take precautions against porphyria.

When the drug is applied to the mucous membrane in high doses or with prolonged treatment, the risk of developing systemic effects of local anesthetics increases (central nervous system disorders with the development of convulsions, depression of the cardiovascular system).

The drug should be used with caution in patients with epilepsy, cardiac conduction disorders, impaired liver function, and a history of allergic reactions.

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

Lysozyme Hydrochloride

Lisobact COMPLIT® 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 doctor in cases of rash, itching or redness of the skin, swelling of the face, lips, tongue or throat, breathing and / or difficulty swallowing, as these may be signs of an allergic reaction to Lisobact COMPLIT®.

Cetylpyridinium chloride

With prolonged use, local irritation may potentially occur due to the cetylpyridinium chloride included in the preparation.

Lysobact COMPLIT® should not be taken with milk, as it reduces the antimicrobial activity of cetylpyridinium chloride.

The drug is not recommended for use in the presence of open wounds in the oral cavity, because cetylpyridinium hydrochloride slows down wound healing.

Long-term use of cetylpyridinium hydrochloride can lead to a violation of the normal microflora of the oral cavity with the risk of bacterial or fungal infection.

The drug is not intended for long-term, repeated and continuous use. If symptoms persist for more than 5 days and/or if other symptoms appear (severe oropharyngeal pain, nausea, vomiting), or a concomitant rise in temperature, consult your doctor.

If patients have difficulty swallowing, they should not use this medicine; they should consult a doctor.

When local anesthetics are used in the oral cavity and in the oropharynx, the local analgesic effect can lead to impaired swallowing, potentially increasing the risk of aspiration. In this regard, patients should be warned not to eat and/or drink within one hour after applying Lysobact COMPLIT®. In addition, it is recommended to avoid brushing your teeth and chewing gum during the period when the pain relief effect in the oral cavity and/or in the oropharynx area persists.

Care should be taken not to allow the solution to get into the eyes. If this happens accidentally, you should flush your eyes with clean water or an eye wash solution, and keep your eyes open for at least 15 minutes.

Lysobact COMPLIT® does not contain sugar and is suitable for use in people suffering from diabetes mellitus.

Influence on the ability to drive vehicles and mechanisms

The drug Lysobact COMPLIT® does not affect the ability to drive vehicles and work with mechanisms.

Form of production

Spray for topical application dosed 0.1 mg + 4.0 mg +0.3 mg / dose. 125 doses in dark glass bottles with dispenser and protective cap. One bottle of u together with the instructions for use in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 °C. Do not freeze it. Keep out of reach of children!

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Lidocaine, Lysozyme, Cetylpyridinium chloride

Dosage Form

Oral spray