Lysobact COMPLETE^® (Spray) Instructions for Use

Marketing Authorization Holder

Bosnalijek, JSC (Bosnia And Herzegovina)

ATC Code

R02AA (Antiseptic preparations)

Active Substances

Lidocaine (Rec.INN registered by WHO)

Cetylpyridinium chloride (Rec.INN registered by WHO)

Lysozyme (DCF adopted for use in France)

Dosage Form

Lysobact COMPLETE®

Metered-dose topical spray 0.1 mg+4 mg+0.3 mg/1 dose: 125-dose bottle with dispenser

Dosage Form, Packaging, and Composition

Metered-dose spray for topical application as a clear, colorless to slightly yellowish solution with a faint characteristic odor.

* 1 mg of lysozyme hydrochloride corresponds to 40000 FIP U.

Excipients : glycerol – 40 mg, propylene glycol – 4 mg, methylparaben – 0.096 mg, propylparaben – 0.024 mg, peppermint flavor – 0.02 mg, sodium hydroxide – q.s., purified water – to 0.2 ml.

125 doses – dark glass bottles (1) with a dispenser and a protective cap – cardboard packs.

Clinical-Pharmacological Group

A drug with antibacterial and local anesthetic action for topical use in ENT practice

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

Combined medicinal product

Lidocaine hydrochloride is a local anesthetic of the amide type, exerting a superficial analgesic effect. It 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 a nerve. In general, local anesthetics block autonomic nerves, small unmyelinated (pain sensation) and small myelinated fibers (pain, temperature sensation) faster than large myelinated fibers (touch, pressure sensation).
Effective for all types of local anesthesia. Dilates blood vessels. Does not have an irritating effect on tissues.

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

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, effective against some viruses. Cetylpyridinium chloride has a disinfecting effect on the mucous membrane.

Pharmacokinetics

Lidocaine is rapidly 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 body tissues, crosses the placental barrier and the blood-brain barrier, and is excreted in breast milk; it is intensively metabolized in the liver, its bioavailability after oral administration is 35%. About 90% of the administered dose is dealkylated to form monoethyglycinexylidide (MEGX) and glycinexylidide (GX), which provide the therapeutic and toxic effects of lidocaine. GX has a longer T_1/2 than lidocaine (about 10 h) and can accumulate with repeated administration. Subsequently, additional biotransformation occurs, and metabolites are excreted by the kidneys, including about 10% in the form of unchanged lidocaine. The T_1/2 of lidocaine from plasma is approximately 1.6 h.

Lysozyme is practically not absorbed through the oral mucosa.

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.

ICD codes

Dosage Regimen

Administer topically into the oral cavity and oropharynx.

Use only for adult patients 18 years of age and older.

Apply 2-3 sprays directly to the affected area of the throat.

Repeat administration up to 5 times per day, or as directed by a physician.

Allow a minimum interval of 2-3 hours between applications.

Do not exceed the maximum daily dose of 15 sprays.

Limit the total duration of treatment to 5 consecutive days.

Discontinue use and consult a physician if symptoms persist beyond 5 days or worsen.

Avoid eating, drinking, brushing teeth, or chewing gum for at least one hour after application to prevent aspiration and ensure efficacy.

Do not use on open wounds in the oral cavity.

Do not consume milk immediately before or after use, as it reduces antiseptic activity.

Adverse Reactions

From the immune system anaphylactic shock, angioedema.

From the skin and subcutaneous tissues : local hypersensitivity reactions, skin rash, urticaria, erythema multiforme, Stevens-Johnson syndrome.

From the respiratory system bronchospasm.

From the cardiovascular system cardiovascular complications.

From the CNS loss of sensation.

From the digestive system inflammation of the oral mucosa, dry mouth, tongue discomfort.

General disorders at the administration site asthenia, pharyngeal paresthesia, pharyngeal hypesthesia, throat irritation.

Contraindications

Hypersensitivity, hypersensitivity to chicken egg protein, open wounds of the oral cavity, children under 18 years of age, pregnancy and breastfeeding period.

With caution

Epilepsy, cardiac conduction disorders, simultaneous use of medicinal products containing analogues of lidocaine, porphyria, violation of the integrity of the oral mucosa, pharynx and larynx, impaired liver function, history of allergic reactions.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Use with caution in case of impaired liver function.

Use in Renal Impairment

The drug is approved for use in case of impaired renal function.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Lidocaine has porphyrinogenic potential, and in patients with acute porphyria, it can only be used for emergency indications associated with a threat to life. Precautions regarding porphyria should be observed in all patients.

When applying the drug to the mucous membrane in high doses or during long-term treatment, the risk of developing systemic effects of local anesthetics increases (disorders from the central nervous system with the development of convulsions, depression of the cardiovascular system).

It is necessary to use with caution in patients with epilepsy, cardiac conduction disorders, impaired liver function, history of allergic reactions.

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

Should not be used in patients with a history of allergic reactions.

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

Should not be taken with milk, as it reduces the antimicrobial activity of cetylpyridinium chloride.

It 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.

Not intended for long-term, repeated, and continuous use.

If symptoms persist for more than 5 days and/or in case of other symptoms (severe oropharyngeal pain, nausea, vomiting), or concomitant fever, it is necessary to consult a doctor.

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

When using local anesthetics in the oral cavity and oropharynx, the local anesthetic effect can lead to impaired swallowing, which potentially increases the risk of aspiration. In this regard, patients should be warned not to eat and/or drink for one hour after application of the medicinal product. In addition, it is recommended to avoid brushing teeth and chewing gum during the period while the anesthetic effect in the oral cavity and/or oropharynx persists.

Care should be taken to avoid getting the solution into the eyes. If this happens accidentally, it is necessary to rinse the eyes with clean water or an eye wash solution, and you should also keep your eyes open for at least 15 minutes.

Drug Interactions

Simultaneous use with other drugs that limit hepatic blood flow (for example, with propranolol, cimetidine) can lead to a decrease in the clearance of lidocaine.

With long-term 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 inhibitory effect of lidocaine on the heart is additive to the effects of beta-blockers and other antiarrhythmic drugs).

Cardiac glycosides weaken the cardiotonic effect.

Curare-like drugs enhance muscle relaxation.

Procainamide increases the risk of central nervous system excitation, hallucinations.

When prescribed with antiarrhythmic drugs (amiodarone) , an increase in the negative inotropic effect is possible

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

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

With intravenous administration of sodium thiopental against the background of lidocaine action, 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 prescribed lidocaine parenterally.

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

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

Lysozyme hydrochloride weakens the activity of levodopa.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.