Hexoral

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEXORAL® (HEXORAL®)

Composition:

Active substance: hexetidine;

1 ml of solution contains 2 mg of hexetidine;

Excipients: polysorbate 80, citric acid monohydrate, sodium saccharin, levomenthol, eucalyptus oil, calcium disodium edetate, ethanol 96%, sodium hydroxide, purified water, nitrogen.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear, colorless liquid with a mint flavor.

Pharmacotherapeutic group.

Agents for use in dentistry. Antimicrobial and antiseptic agents for local application. ATC code A01AB12.

Pharmacological properties.

Pharmacodynamics.

Hexetidine is an active substance with rapid and prolonged effect, belonging to the group of local antiseptics used gingivodentally and oropharyngeally.

It exhibits antibacterial and antifungal activity against a broad spectrum of pathogenic microorganisms responsible for oropharyngeal infections. Upon application, it demonstrates wound-healing, hemostatic, and local analgesic properties in the oral cavity and pharynx.

Hexetidine is a broad-spectrum antimicrobial agent. It is effective both in vivo and in vitro against Gram-positive and Gram-negative bacteria, as well as yeasts (Candida albicans) and fungi.

Specific pharmacokinetic studies on the use of Hexoral® spray in humans have not been conducted.

After administration, dental plaque and residual concentrations of hexetidine on mucous membranes may be observed. Studies using radiolabeled hexetidine have shown that hexetidine can be detected in oral tissues from 8 to 10 hours after a single application, and in some cases, it may still be detected in oral tissues up to 65 hours after treatment.

Pharmacokinetics.

There are no clinical data on the pharmacokinetics of hexetidine in humans.

The drug acts locally on the oral mucosa; therefore, only minimal systemic absorption is expected.

The high affinity of hexetidine for proteins and polymers with electronegative sites explains its binding to bacteria and directly contributes to its action on the oral mucosa due to residual concentrations of hexetidine. This affinity also accounts for the binding to dental plaque and thus its antiplaque effect. The antibacterial effect may persist for 10–14 hours after administration.

Studies on absorption following topical administration of Hexoral® spray or hexetidine in humans have not been performed.

No specific studies with Hexoral® spray or hexetidine have been conducted in patients with impaired liver and/or kidney function or in elderly patients.

Clinical characteristics.

Indications.

Tonsillitis, pharyngitis, laryngitis, glossitis, as an adjunctive medicinal agent in throat inflammation, pre- and postoperative treatment in tonsillectomy, injuries of the oral cavity and pharynx, gingivitis, gum bleeding, stomatitis, oral ulcers, inflammation of dental sockets, bad breath, oral hygiene in severe diseases.

Contraindications.

Hexoral® spray is contraindicated:

• in patients with hypersensitivity to hexetidine, eucalyptus oil, levomenthol, or to any other component of the medicinal product;
• in patients with bronchial asthma or any other respiratory tract diseases associated with existing airway hypersensitivity. Inhalation may cause bronchoconstriction;
• in atrophic pharyngitis.

Interaction with other medicinal products and other forms of interaction.

Interaction may occur with other antiseptic medicinal products. Hexetidine may be inactivated by alkaline solutions.

Special precautions for use.

The drug should be used with caution in patients with epilepsy. The drug may lower the epileptic threshold and cause seizures in children. The drug should be used with caution in patients with allergic reactions, including bronchial asthma, especially in patients with allergy to acetylsalicylic acid.

The drug contains ethanol; therefore, it should be prescribed with caution to patients with liver diseases.

Inhalation of the drug should be avoided during use, as the spray may enter the respiratory tract and cause laryngospasm.

There is a risk of laryngospasm in children due to the presence of levomenthol in the formulation.

If inflammation worsens, treatment with the drug should be discontinued.

Prolonged use is not recommended (do not use for more than 10 days without medical advice).

Use during pregnancy or breastfeeding.

Adequate and well-controlled clinical studies on the use of hexetidine in pregnant or breastfeeding women have not been conducted. It is unknown whether hexetidine or its metabolites are excreted in breast milk. A negligible amount of hexetidine is systemically absorbed. It is unlikely that the use of hexetidine during pregnancy or breastfeeding poses a risk to the fetus or infant.

However, hexetidine should not be used during pregnancy or breastfeeding, except when the potential benefit of treatment to the mother outweighs the possible risks to fetal development or the infant.

Ability to affect reaction rate while driving or operating machinery.

The drug contains ethanol. Drivers are advised not to operate a vehicle or machinery within 30 minutes after administration of the drug.

Method of Administration and Dosage.

Adults and children aged 6 years and older.

Hexoral® spray is a topical oral medication.

Technique for administration:

• Attach the flexible tube into the appropriate opening on the spray head by gently pressing it in place. Direct the end of the flexible tube away from yourself.
• While holding the flexible tube in the mouth, direct its tip toward the affected area of the oral cavity or throat. Keep the bottle in an upright position throughout the procedure.
• Hold your breath and administer Hexoral® spray by pressing the spray nozzle for 1–2 seconds.

Apply no more than 3 times daily (depending on the severity of the condition or physician's recommendations).

The duration of treatment is determined individually by a physician, depending on the severity and clinical course of the disease.

Do not use for the treatment of prolonged symptoms.

Do not inhale, as it may provoke laryngospasm.

Consult a physician before starting use of the medication.

Children.

Do not use Hexoral® spray in children under 6 years of age.

Overdose.

Swallowing a large amount of the spray may cause nausea; however, significant systemic absorption is unlikely.

Due to the ethanol content, alcohol intoxication may occur if a sufficient amount of Hexoral® oral spray is absorbed systemically.

The concentration of hexetidine contained in Hexoral® oral spray is not toxic when the product is used as directed.

There have been no reported cases of hexetidine overdose leading to hypersensitivity reactions.

Keep out of reach of children. In case of overdose, seek immediate medical attention.

Adverse reactions.

Immune system disorders: hypersensitivity reactions, including urticaria, angioneurotic edema; allergic reactions, including laryngospasm, bronchospasm.

Nervous system disorders: ageusia, dysgeusia, altered taste sensations for up to 48 hours (sweet taste sensation may change twice to bitter taste sensation).

Respiratory, thoracic and mediastinal disorders: cough, dyspnea, laryngospasm.

Gastrointestinal disorders: dry mouth, dysphagia, increased salivary glands, pain on swallowing. Accidental ingestion of the product may cause gastrointestinal disturbances, primarily nausea and vomiting.

Skin and subcutaneous tissue disorders: allergic contact dermatitis, angioedema.

General disorders and administration site conditions: local reactions, including reversible discoloration of teeth and tongue; mucosal sensitivity, such as burning sensation, numbness; irritation (pain, sensation of warmth, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paresthesia; inflammation; blisters; development of ulcers on the mucous membrane.

Shelf life. 3 years.

Storage conditions.

Store at temperatures not exceeding 30 °C, protected from light in the original packaging, in a place inaccessible to children.

Not recommended for use more than 6 months after first opening.

Packaging.

40 ml in an aluminum can with valve and actuator, 1 can per cardboard box.

Availability category. Over-the-counter.

Manufacturer.

DELPHARM ORLEANS / DELPHARM ORLEANS

Manufacturer's address.

5 avenue de Concyr, ORLEANS CEDEX 2, 45071, France / 5 avenue de Concyr, ORLEANS CEDEX 2, 45071, France.

Applicant's representative.

LLC "Johnson & Johnson Ukraine"

Representative's address.

1V Pavla Tychyny Ave., Kyiv, 02152, Ukraine

+38 (044) 498 0888

+38 (044) 498 7392