Stomatidin^® (Solution) Instructions for Use

Marketing Authorization Holder

Bosnalijek, JSC (Bosnia And Herzegovina)

ATC Code

A01AB12 (Hexetidine)

Active Substance

Hexetidine (Rec.INN registered by WHO)

Dosage Form

Stomatidin®

Topical solution 0.1%: bottle 200 ml

Dosage Form, Packaging, and Composition

Solution for topical application in the form of a clear red liquid.

Excipients: propylene glycol – 100 mg, polysorbate 20 – 10 mg, citric acid monohydrate – 0.4 mg, sodium saccharin – 0.3 mg, racemic menthol – 0.15 mg, methyl salicylate – 0.1 mg, dye azorubine – 0.1 mg, ethanol 96% – 0.1 ml, water – up to 1 ml.

200 ml – dark glass bottles (1) with a plastic cap with first-opening control – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Drugs used in dentistry; antimicrobial drugs and antiseptics for the local treatment of oral diseases

Pharmacological Action

An antiseptic preparation for topical use in ENT practice and dentistry.

The antimicrobial action of hexetidine is associated with the suppression of oxidative reactions of microbial cell metabolism (a thiamine antagonist).

The drug has an antibacterial effect against gram-negative and gram-positive bacteria, Pseudomonas aeruginosa and Proteus spp., and an antifungal effect (including against fungi of the genus Candida). At a concentration of 100 mg/ml, inhibition of growth of most bacterial strains is achieved.

No development of resistance has been observed.

Hexetidine has a weak analgesic effect on the mucous membrane.

Pharmacokinetics

Hexetidine adheres well to the mucous membrane and is practically not absorbed. After a single application, hexetidine is detected on the oral mucosa for 65 hours. In dental plaque, active concentrations persist for 10-14 hours after application.

Indications

• Infectious and inflammatory diseases of the oral cavity and pharynx: tonsillitis (including angina with involvement of the lateral ridges, Plaut-Vincent’s angina), pharyngitis, gingivitis, bleeding gums, periodontopathies, stomatitis, glossitis, aphthous ulcers to prevent superinfection;
• To prevent infection of the alveoli after tooth extraction;
• Fungal infections of the oral cavity and pharynx (especially candidal stomatitis);
• Before and after operations in the oral cavity and pharynx;
• Additional oral hygiene in general diseases;
• To eliminate bad breath, especially in the case of decaying tumors of the oral cavity and pharynx.

ICD codes

Dosage Regimen

Topically.

For rinsing, always use the undiluted drug.

The solution must not be swallowed. It is necessary to spit out the solution after rinsing.

For diseases of the oral cavity in adults and children over 5 years of age, rinse the mouth with 10-15 ml (1 tablespoon) of the undiluted drug solution for 30 seconds.

For diseases of the pharynx (throat) in adults and children over 5 years of age, use rinses with 10-15 ml of the undiluted drug solution for 30 seconds.

When treating diseases of the oral cavity, the drug can be applied with a tampon.

Apply 2 times a day (preferably in the morning and evening), after meals.

The duration of use of the drug is set individually.

If the symptoms of the disease do not disappear after 5 days of using the drug and/or are accompanied by fever, the patient should consult a doctor.

Adverse Reactions

Local reactions burning, irritation and moderate dryness of the oral mucosa.

Other allergic reactions; with prolonged use, a change in taste sensations is possible.

After discontinuation of the drug, the side effects disappear.

Contraindications

• Atrophic pharyngitis;
• Children under 5 years of age;
• First trimester of pregnancy;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Data on the penetration of hexetidine through the placental barrier and excretion in breast milk are insufficient.

The use of the drug in the first trimester of pregnancy is contraindicated. The drug may be used in the second and third trimesters of pregnancy if the potential benefit to the mother outweighs the risk to the fetus.

If it is necessary to use the drug during lactation, the issue of discontinuing breastfeeding should be decided.

Pediatric Use

The drug is contraindicated in children under 4 years of age.

Special Precautions

Do not use the drug in categories of patients who cannot perform this procedure (rinsing) on their own.

Effect on ability to drive vehicles and mechanisms

The drug contains 10% ethanol (ethyl alcohol 96%). The drug should be taken no later than 30 minutes before driving a vehicle.

Overdose

Symptoms if large amounts of the drug are accidentally swallowed, nausea and vomiting may occur.

Treatment gastric lavage, symptomatic therapy.

Drug Interactions

Not described.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F). Do not freeze.

Shelf Life

Shelf life – 2 years.

The shelf life of the drug after opening the bottle is 6 months.

Dispensing Status

The drug is dispensed 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.