Lizobact KOMPLIT spray 30ml, 125 dose

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.

The drug is used topically, by spraying on the mucous membrane of the oropharynx, after meals.

The recommended dose is 5 injections per application 3-6 times / 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 after treatment there is no improvement or the symptoms worsen, or new symptoms appear, the patient should consult a doctor.

The drug should be used only according to the indications, the route of administration and the doses indicated in the instructions.

Patients with impaired renal function do not need to adjust the dosage regimen.

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

Mode of application

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

Before using the drug for the first time, remove the plastic cover from the dispenser. After that, it is necessary to put the nebulizer on the dispenser with light pressure.

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

The sprayer must be turned upward, at a right angle in relation to the bottle.

Before using the spray for the first time, you must press the dispenser several times until a uniform spray is obtained.

You should open your mouth wide, direct the nebulizer towards the affected area and press the dispenser several times in accordance with the recommendations for dosing the drug. You must hold your breath while spraying the drug. Do not swallow the drug.

After applying the drug, the nebulizer should be turned downward, which leads to a blockage of the nebulization.

Spray for topical application dosed in the form of a clear, colorless to slightly yellowish solution with a weak characteristic odor.

1 dose

lidocaine hydrochloride monohydrate 0.1066 mg,

in terms of lidocaine hydrochloride 0.1 mg

lysozyme hydrochloride in terms of anhydrous substance 4 mg (160,000 FIP UNITS *)

cetylpyridinium chloride monohydrate 0.315 mg,

in terms of cetylpyridinium chloride 0.3 mg *

1 mg of lysozyme hydrochloride corresponds to 40,000 FIP units.

Excipients: glycerol - 40 mg, propylene glycol - 4 mg, methyl parahydroxybenzoate - 0.096 mg, propyl parahydroxybenzoate - 0.024 mg, peppermint flavor - 0.02 mg, sodium hydroxide - qs, purified water - up to 0.2 ml.

• 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 chicken egg white;

• open wounds of the mouth;

• age up to 18 years (efficacy and safety have not been studied);

• pregnancy;

• period of breastfeeding.

  With care: epilepsy; cardiac conduction disorders; the simultaneous use of drugs containing analogs of lidocaine; porphyria; violation of the integrity of the mucous membrane of the oral cavity, pharynx and larynx; impaired liver function; history of allergic reactions.

pharmachologic effect

Combined drug, the action of which is due to its constituent components.

Lidocaine hydrochloride

Lidocaine hydrochloride is a local anesthetic of the amide type that 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 an 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 (pain sensation) and small myelinated (pain sensation, temperature), faster than large myelinated fibers (touch sensation, pressure).

Effective for all types of local anesthesia. Expands blood vessels. Does not irritate fabrics.

Lysozyme hydrochloride

Lysozyme hydrochloride is a mucopolysaccharide that destroys (lyses) the 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 disinfectant effect on the mucous membrane.

Pharmacokinetics

Lizobakt KomplitЃ is applied topically and has an effect on the oropharynx area. 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 damaged skin. About 65% of lidocaine binds to blood plasma proteins. After absorption, lidocaine is rapidly distributed in all tissues of the body, penetrates the placental and blood-brain barriers, and is excreted in breast milk.

Lidocaine is extensively metabolized in the liver, bioavailability after oral administration is 35%. About 90% of the administered dose is dealkylated to form monoethylglycinexylidide (MEGX) and glycinexylidide (GX), which provide the therapeutic and toxic effects of lidocaine. GX has a longer T1 / 2 than lidocaine (about 10 hours) and can accumulate with repeated administration. Subsequently, additional biotransformation occurs, and metabolites are excreted by the kidneys, incl. about 10% in the form of unchanged lidocaine. Inhibition of isoenzymes CYP1A2 and CYP3A4 of cytochrome P450 can increase the concentration of lidocaine.

T1 / 2 of lidocaine from plasma is approximately 1.6 hours.

Pharmacokinetics in special patient groups. Due to its rapid metabolism, the pharmacokinetics of lidocaine can be influenced by conditions that impair liver function. In patients with impaired liver function, T1 / 2 of lidocaine may increase by 2 or more times. Impaired renal function does not affect the pharmacokinetics of lidocaine, but can lead to the accumulation of its metabolites.

Lysozyme hydrochloride

Lysozyme hydrochloride is practically not absorbed through the oral mucosa.

Cetylpyridium chloride

Cetylpyridinium chloride is poorly absorbed through the oral mucosa.

Application during pregnancy and lactation

The use of the drug during pregnancy and during breastfeeding is contraindicated.

Application for violations of liver function

The drug should be used with caution in case of impaired liver function.

Application for impaired renal function

Patients with impaired renal function do not need to adjust the dosage regimen.

Application in children

The use of the drug under the age of 18 is contraindicated.

special instructions

Lidocaine hydrochloride

Lidocaine has porphyrogenic potential and should only be used for life-threatening emergencies in patients with acute porphyria. Porphyria precautions should be taken in all patients.

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

The drug should be used with caution in patients with epilepsy, cardiac conduction disorders, liver dysfunction, 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

Lizobact KomplitЃ 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 the drug and consult a doctor in cases of rash, itching or redness of the skin, swelling of the face, lips, tongue or throat, respiratory system and / or difficulty in swallowing, as these may be signs of an allergic reaction to the drug Lizobact KomplitЃ ...

Cetylpyridinium chloride

With prolonged use, the appearance of local irritation is potentially possible due to the cetylpyridinium chloride, which is part of the drug.

Lizobact KomplitЃ 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 disruption of the normal microflora of the oral cavity with the risk of developing a 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 pain in the oropharynx, nausea, vomiting), or a concomitant increase in body temperature, you should consult your doctor.

If the patient has difficulty swallowing, this drug should not be used; the patient needs to see a doctor.

When local anesthetics are used in the mouth and oropharynx, the local anesthetic 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 1 hour after using the drug Lizobakt KomplitЃ. In addition, it is recommended that you avoid brushing your teeth and chewing gum for as long as the oral and / or oropharyngeal pain relief effect lasts.

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

Lizobakt KomplitЃ does not contain sugar and is suitable for use in persons suffering from diabetes mellitus.

Influence on the ability to drive vehicles and mechanisms

Lizobakt KomplitЃ does not affect the ability to drive vehicles and work with mechanisms.

Overdose

Symptoms

Applying local anesthetics to the oral mucosa can make it difficult to swallow, resulting in an increased risk of airway aspiration. Therefore, an overdose of Lizobact KomplitЃ may lead to a slight increase in the risk of an excessive local anesthetic effect in the glottis region, which may subsequently lead to a weakening of the control of the swallowing reflex.

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

Despite the fact that the bioavailability of lidocaine is quite low, it may be sufficient to lead to significant intoxication if the drug is swallowed. Cases of toxic effects on the central nervous system, seizures and death after ingestion of drugs intended for topical use have been reported. However, in the case of Lizobact ComplitЃ, more than 1 liter of spray must be swallowed in order for the amount of lidocaine (0.5 g or more) to be sufficient to form a clinically significant toxic effect.

Lysozyme hydrochloride. Overdose cases were not observed.

Cetylpyridinium chloride. Signs and symptoms of intoxication when ingestion of significant amounts of cetylpyridinium chloride: nausea, vomiting, edema, cyanosis, asphyxia followed by paralysis of the respiratory muscles, CNS depression, arterial hypotension and coma.

Treatment

Treatment of a lidocaine overdose includes providing adequate ventilation and relieving seizures. Artificial ventilation with oxygen supply by breathing support or controlled breathing is carried out as needed. To eliminate epileptic seizures, sodium thiopental, diazepam can be used. In the event of ventricular fibrillation or cardiac arrest, adequate cardiovascular resuscitation is necessary. Multiple doses of epinephrine and sodium bicarbonate should be given as soon as possible.

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

Drug interactions

Lidocaine hydrochloride

Despite the potentially possible numerous interactions of lidocaine with other drugs, in this case, most likely, they will not have clinical significance due to the fact that Lizobact KomplitЃ is used topically.

The simultaneous use of the drug Lizobact KomplitЃ with other drugs that limit hepatic blood flow (for example, with propranolol, cimetidine) can lead to a decrease in the clearance of lidocaine. 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 isoenzymes CYP1A2 (fluvoxamine) and CYP3A4 (itraconazole, erythromycin) of cytochrome P450 may increase the concentration of lidocaine.

The depressing effect of lidocaine on the heart is additive in relation to the effects of beta-blockers and other antiarrhythmic drugs. Cardiac glycosides weaken the cardiotonic effect, curariform drugs enhance muscle relaxation. Procainamide increases the risk of developing arousal of the central nervous system, hallucinations. When prescribed with antiarrhythmic drugs (amiodarone), an increase in the negative inotropic effect is possible.

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

With the simultaneous appointment of lidocaine and hypnotics or sedatives, their inhibitory effect on the central nervous system may be enhanced.

With the on / in the introduction of sodium thiopental against the background of the action of lidocaine, respiratory depression is possible.

Under the influence of MAO inhibitors (furazolidone, procarbazine, selegiline), the local anesthetic effect of lidocaine may be enhanced. Patients taking MAO inhibitors should not be given parenteral lidocaine.

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

Lysozyme hydrochloride

Lysozyme hydrochloride enhances the effect of antibiotics, incl. penicillin, chloramphenicol, nitrofurantoin, diuretics, weakens the activity of levodopa.

Cetylpyridinium chloride

The drug should not be taken simultaneously with milk, since the antimicrobial activity of cetylpyridinium chloride decreases.

During the use of Lizobact KomplitЃ, patients should not simultaneously use other local anesthetics to disinfect the oral cavity and / or pharynx.

If the patient is using the above or other drugs (including over-the-counter), consult a doctor before using Lizobact KomplitЃ.