Dorithricin^® (Tablets) Instructions for Use

Marketing Authorization Holder

Medice Pharma, GmbH & Co. KG (Germany)

Manufactured By

Medice Arzneimittel Putter, GmbH & Co. KG (Germany)

ATC Code

R02AA20 (Other antiseptics)

Active Substances

Benzalkonium chloride (Rec.INN registered by WHO)

Benzocaine (Rec.INN registered by WHO)

Tyrothricin (Rec.INN registered by WHO)

Dosage Form

Dorithricin®

Lozenges 1.5 mg+1 mg+0.5 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Lozenges white, round, flat-cylindrical, with a bevel, engraved with “DORITHRICIN” on one side, with a minty odor.

Excipients: sorbitol – 871 mg, talc – 80 mg, povidone-25 thousand – 10 mg, carmellose sodium – 10 mg, sucrose stearate – 20 mg, peppermint leaf oil – 5 mg, sodium saccharin – 1 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Drug with antimicrobial and local anesthetic action for topical use in ENT practice and dentistry

Pharmacotherapeutic Group

Drugs for the treatment of throat diseases; antibiotics

Pharmacological Action

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

Benzocaine is a local anesthetic that reduces pain when swallowing, which often accompanies infectious and inflammatory processes of the oral cavity and throat.

Benzalkonium chloride is a quaternary ammonium compound, belongs to cationic surfactants, interacts with lipoproteins and disrupts the permeability of cell membranes. It has antiseptic properties, is active against gram-positive bacteria, and has a fungicidal effect on Candida albicans and some lipophilic viruses.

Tyrothricin is a topical antibiotic, a mixture of antimicrobial linear and cyclic polypeptides isolated at the fermentation stage of Brevibacillus brevis Dudos, consisting mainly of gramicidin and tyrocidine. Tyrothricin acts bactericidally, causing a breakdown in phosphorylation processes in the respiratory chain and destroying bacterial cell membranes. Due to the special mechanism of action of tyrothricin, which is absent in systemic antibiotics, cross-resistance to the drug does not occur.

Pharmacokinetics

Benzocaine is poorly soluble in water, which causes its slow absorption. Like all ester derivatives of para-aminobenzoic acid, it is broken down by esterase in blood plasma and the liver. As a result, para-aminobenzoic acid and ethyl alcohol are formed, which is metabolized to acetyl coenzyme A.

Para-aminobenzoic acid undergoes conjugation with glycine or is excreted by the kidneys unchanged.

Benzalkonium chloride is practically not absorbed, does not have a resorptive effect, and is excreted by the kidneys. No accumulation of the substance in body tissues has been detected.

Tyrothricin – due to low systemic absorption, pharmacokinetic data are not available. Does not affect intestinal microflora.

Indications

Infectious and inflammatory diseases of the oral cavity and pharynx, accompanied by pain syndrome

• Pharyngitis, laryngitis, initial stage of tonsillitis;
• Inflammation of the gums and oral mucosa (gingivitis, stomatitis).

ICD codes

Dosage Regimen

Administer orally. Slowly dissolve one lozenge in the mouth.

Initiate treatment every three hours. Adhere strictly to the dosing interval.

The maximum daily dose is six lozenges. Do not exceed this limit.

The standard treatment course is seven days. Extend therapy only on physician recommendation.

This regimen applies to adults and children over six years of age.

Discontinue use if symptoms persist beyond the treatment period.

Adverse Reactions

Allergic reactions are possible, rarely – gastrointestinal disorders (nausea, diarrhea).

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

Contraindications

• Increased individual sensitivity to any of the components of the drug;
• Hereditary fructose intolerance and glucose/galactose malabsorption syndrome or sucrase/isomaltase deficiency;
• Children under 6 years of age.

Use in Pregnancy and Lactation

The use of the drug Dorithricin^® during pregnancy and lactation is possible if the expected benefit to the mother outweighs the potential risk to the fetus.

Pediatric Use

Contraindicated in children under 6 years of age.

Special Precautions

Information for patients with diabetes: 1 lozenge of the drug contains approximately 0.07 bread units (BU).

Effect on ability to drive vehicles and machinery

No effect.

Overdose

No cases of overdose have been described at recommended doses. Accidental intake of large doses of Dorithricin^® may cause disturbances in the digestive system (nausea, vomiting, diarrhea). In this case, it is necessary to perform gastric lavage, take activated charcoal and consult a doctor.

Drug Interactions

No cases of clinically significant interaction of the drug Dorithricin^® with other drugs have been described.

Storage Conditions

The drug should be stored out of the reach of children at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is available without a prescription.

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.