Hexoral^® (Solution, Aerosol) Instructions for Use

ATC Code

A01AB12 (Hexetidine)

Active Substance

Hexetidine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

The antimicrobial action of the drug Hexoral^® is associated with the suppression of oxidative reactions of bacterial metabolism (thiamine antagonist). The drug has a broad spectrum of antibacterial and antifungal action, in particular against gram-positive bacteria and fungi of the genus Candida.

Hexetidine has a weak anesthetic effect on the mucous membrane.

The drug has an antiviral effect against influenza A viruses, respiratory syncytial virus (RS virus), and herpes simplex virus type 1 that affect the respiratory tract.

Pharmacokinetics

Hexetidine adheres very well to the mucous membrane and is practically not absorbed.

After a single application of the drug, traces of the active substance are detected on the mucous membrane of the gums for 65 hours. In dental plaque, active concentrations persist for 10-14 hours after application.

Indications

As a symptomatic agent.

• Symptomatic treatment for infectious and inflammatory diseases of the oral cavity and larynx:
  • Tonsillitis, angina (including Plaut-Vincent’s angina, angina of the lateral folds), pharyngitis, gingivitis, stomatitis, glossitis, periodontitis;
  • Fungal diseases.
• Prevention of infectious complications before and after surgical interventions in the oral cavity and larynx, as well as in case of injuries (including prevention of alveolus infection after tooth extraction);
• Oral hygiene (including to eliminate bad breath).

ICD codes

Dosage Regimen

Solution

The drug is used topically. Hexetidine adheres to the mucous membrane and thus gives a lasting effect. In this regard, the drug should be used after meals.

Children from 3 to 6 years old can use the drug after consultation with a healthcare professional. Children can use the drug from an age when there is no danger of uncontrolled swallowing when using the solution.

Adults and children over 6 years old fill the measuring cup to the 15 ml mark and rinse the oral cavity and larynx with 15 ml of undiluted solution for at least 30 seconds 2-3 times a day.

Hexoral^® solution for topical application can only be used for rinsing the oral cavity and larynx. The solution should not be swallowed; after application, the solution should be spit out.

It is always necessary to use the undiluted solution.

When treating diseases of the oral cavity, the drug can also be applied with a tampon for 2-3 minutes.

The duration of treatment is determined by the doctor.

Aerosol

Topically. Hexetidine adheres to the mucous membrane and thus gives a lasting effect. In this regard, the drug should be used after meals.

Children from 3 to 6 years old can use the drug after consultation with a healthcare professional.

Adults and children over 6 years old treat the affected areas while holding their breath. 1 spray for 1-2 seconds 2 times/day.

During the administration of the drug, it is necessary to hold the breath, because inhalation of the drug can provoke laryngospasm.

The duration of treatment is determined by the doctor.

General recommendations for use

The drug is sprayed into the oral cavity or pharynx. With the help of an aerosol, the affected areas can be treated easily and quickly. It is necessary to perform the following actions:

1. Put the spray nozzle on the aerosol can;

2. Direct the end of the spray nozzle to the affected area of the oral cavity or pharynx;

3. During the administration of the drug, the bottle should be held constantly in a vertical position, as shown in the figure;

4. Administer the required amount of the drug by pressing the head of the spray nozzle for 1-2 seconds, do not breathe when administering the aerosol.

Adverse Reactions

Adverse reactions identified during post-registration use of the drug are classified as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), frequency unknown (frequency cannot be estimated from the available data).

Immune system disorders very rare – hypersensitivity reactions (including urticaria), angioedema.

Nervous system disorders very rare – ageusia, dysgeusia.

Respiratory system disorders very rare – cough, shortness of breath due to the occurrence of a hypersensitivity reaction, laryngospasm.

Gastrointestinal disorders very rare – dry mouth, dysphagia, nausea, salivary gland enlargement, vomiting.

General disorders and administration site conditions: very rare – reactions at the application site (including irritation of the oral and pharyngeal mucosa, burning sensation, oral paresthesia, tongue discoloration, tooth discoloration, inflammation, blistering and ulceration).

If any of the specified side effects worsen or other side effects are noted, the patient should consult a doctor.

Contraindications

• Hypersensitivity to the components of the drug;
• Erosive-squamous lesions of the oral mucosa;
• Children under 3 years of age.

With caution in case of hypersensitivity to acetylsalicylic acid.

Use in Pregnancy and Lactation

There is no information about any adverse effects when using the drug Hexoral^® during pregnancy and breastfeeding. However, before prescribing Hexoral^® to pregnant or breastfeeding women, the expected benefit and risk of treatment should be carefully weighed, taking into account the lack of sufficient data on the penetration of the drug through the placental barrier and excretion in breast milk.

Pediatric Use

Contraindicated for use in children under 3 years of age.

Special Precautions

There are no special instructions.

During the administration of the drug, it is necessary to hold the breath.

Children can use the drug from an age when there is no danger of uncontrolled swallowing or when they do not resist a foreign object (spray nozzle) in the mouth when using the aerosol and are able to hold their breath when spraying the drug.

The ethanol content in the drug is 5.15%. One dose of the drug contains 20.3 mg of ethanol (in terms of absolute alcohol).

The contents of the aerosol can are under pressure. The can should not be opened, punctured, or burned, even if the can is empty.

If the medicinal product is spoiled or the expiration date has expired, it should not be poured into sewers or thrown out on the street. It is necessary to place the medicinal product in a bag and put it in a trash container. These measures will help protect the environment.

Influence on the ability to drive vehicles and mechanisms

Hexoral^® aerosol for topical application does not affect the ability to drive vehicles and engage in other potentially hazardous activities.

Overdose

It is unlikely that Hexetidine can have a toxic effect when used in accordance with the recommended dosage regimen.

Symptoms swallowing a large amount of the drug containing ethanol can lead to the appearance of signs/symptoms of alcohol intoxication.

Treatment symptomatic therapy, as in alcohol intoxication. Gastric lavage is necessary within 2 hours after swallowing an excessive dose. In any case of overdose, the patient should immediately consult a doctor.

Drug Interactions

No data available.

Storage Conditions

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

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the package.

The contents of the aerosol can should be used within 6 months after the first use.

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.