Laringotab (Tablets) Instructions for Use

Marketing Authorization Holder

Avva Rus, JSC (Russia)

ATC Code

R02AA20 (Other antiseptics)

Active Substances

Pyridoxine (Rec.INN registered by WHO)

Lysozyme (DCF adopted for use in France)

Dosage Form

Laringotab

Lozenges 20 mg+10 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Lozenges from white to almost white with a brownish tint, round, biconvex; inclusions are allowed.

* lysozyme hydrochloride with a nominal activity of 40000 FIP U/mg

Excipients: hypromellose – 10 mg, povidone K-25 – 7.82 mg, magnesium stearate – 4 mg, sodium saccharin – 0.4 mg, vanilla flavor – 0.1 mg, lactose monohydrate – to obtain a tablet weighing 200 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Drugs for the treatment of throat diseases; antiseptic agents

Pharmacological Action

Combined antiseptic agent.

Lysozyme is an enzyme of protein nature, used as an antiseptic due to its direct effect on gram-positive and gram-negative bacteria, as well as fungi and viruses. It participates in the regulation of local nonspecific immunity.

Pyridoxine has a protective effect on the oral mucosa (exerts an anti-aphthous effect). It does not affect the pharmacodynamic properties of lysozyme.

Indications

Treatment of infectious and inflammatory diseases of the oral mucosa, gums, and larynx: gingivitis; stomatitis; catarrhal phenomena of the upper respiratory tract; aphthous ulcerations; herpetic lesions of the oral mucosa (as part of complex therapy); erosions of the oral mucosa of various etiologies.

ICD codes

Dosage Regimen

Use topically in the oral cavity.

Dissolve one lozenge slowly in the mouth.

Administer 3 to 4 times per day.

Adhere to a standard treatment course of 8 days.

Do not exceed the recommended daily frequency.

Discontinue use if symptoms persist beyond the treatment course.

Consult a physician for use beyond the indicated duration.

Adverse Reactions

Possible allergic reactions.

Contraindications

Children under 3 years of age; hypersensitivity to the components of the combination.

Use in Pregnancy and Lactation

Can be used during pregnancy and lactation (breastfeeding).

Special Precautions

In case of an allergic reaction, use should be discontinued.

Drug Interactions

When used concomitantly, the combination enhances the effect of antibiotics, including penicillin, chloramphenicol, nitrofurantoin, enhances the effect of diuretics, and weakens the activity of levodopa.

Isoniazid, penicillamine, pyrazinamide, immunosuppressants, estrogens, and oral contraceptives may increase the need for pyridoxine (antagonistic action against pyridoxine or increased renal excretion).

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.