Kameton-zdorovya forte

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KAMETON-ZDOROVYE FORTE (CAMETON-ZDOROVYE FORTE)

Composition:

Active substances: 1 g of the preparation contains chlorobutanol hemihydrate (calculated as chlorobutanol) 0.01 g, racemic camphor 0.01 g, menthol (levomenthol) 0.01 g, eucalyptus oil 0.01 g, hexetidine 0.001 g;

Excipient: isopropyl myristate.

Pharmaceutical form. Oromucosal spray.

Main physicochemical properties: clear, colorless or slightly yellowish, oily liquid with a characteristic aromatic odor.

Pharmacotherapeutic group. Agents acting on the respiratory system. Preparations used in throat disorders. Antiseptics. ATC code R02A A20.

Pharmacological Properties

Pharmacodynamics. A combination drug whose effects are due to its constituent components. Chlorobutanol hemihydrate and eucalyptus oil provide antimicrobial action; chlorobutanol hemihydrate and camphor exert a mild local anesthetic effect. Menthol constricts blood vessels and induces a local sensation of cold, which also contributes to local anesthetic effect, reducing blood flow and swelling in the affected area. Hexetidine provides antibacterial, antifungal, hemostatic, analgesic, and coating actions.

The antibacterial activity of hexetidine is effective against both gram-positive and gram-negative microbial strains, as well as against both aerobic and anaerobic organisms. Hexetidine binds to the oral mucosa, from where it is gradually released. When applied locally, the drug demonstrates antimicrobial, anti-inflammatory, and mild local anesthetic effects and promotes normalization of respiration. The drug also provides a deodorizing effect. The drug base exerts a moisturizing effect on the mucous membrane due to the occlusive effect provided by the hydrophobic solvent isopropyl myristate. The combination of these pharmacological properties ensures comprehensive pathogenetic therapy of inflammatory diseases of the upper respiratory tract.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications. Local treatment of acute and chronic (mainly in the stage of exacerbation) infectious-inflammatory diseases of the throat: tonsillitis, pharyngitis, laryngitis, candidiasis of the oral cavity and pharynx; prevention and treatment of infectious-inflammatory complications before and after surgical interventions in dentistry and otorhinolaryngology; in injuries of the pharyngeal cavity.

Contraindications. Hypersensitivity to any component of the drug. Contraindicated in patients with atrophic pharyngitis, bronchial asthma, or any other respiratory tract diseases associated with existing airway hyperreactivity. Inhalation may cause bronchoconstriction.

Interaction with other medicinal products and other forms of interaction. Not described.

Possible interaction with other antiseptic medicinal products. Hexetidine may be inactivated by alkaline solutions.

If simultaneous use of any medicinal products is necessary, consult a physician.

Special precautions for use

It is not recommended that several individuals use the same canister/bottle to avoid the spread of infection. During spraying of the medicinal product, care should be taken to avoid contact with the eyes. Patients who are prone to allergies should consult a physician before using the product. After application, the protective cap should be placed back on the spray nozzle.

Use with caution in patients with allergic reactions, including asthma, especially in patients with allergy to acetylsalicylic acid.

The product should be used with caution in patients with epilepsy. The product may lower the epileptic threshold and provoke seizures in children.

Do not disassemble the canister with the product and do not give it to children; protect from impacts.

The product should be used with caution in children, as bronchospasm may develop.

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

Treatment of children should be carried out under medical supervision.

When treating mucous membranes of the throat, the product should be applied after eating; the oral cavity should be rinsed with warm boiled water before application. In case of burns, remove necrotic deposits from affected areas with a sterile swab.

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

Use during pregnancy or breastfeeding. There are no data from studies on the ability of hexetidine to cross the placenta or be excreted in human breast milk; therefore, the product should not be used during pregnancy or breastfeeding.

Ability to influence reaction rate when driving vehicles or operating machinery. Data are lacking.

Method of Administration and Dosage

For use in adults and children aged 6 years and older.

Apply the preparation locally to the mucous membranes and affected areas of the throat cavity. The single dose for adults and patients aged 15 years and older is 2–3 sprays into the throat cavity; for children aged 6 to 12 years – 1–2 sprays into the throat cavity; for children aged 12 to 15 years – 2 sprays into the throat cavity. Each spray corresponds to approximately 0.12 g of the preparation.

The preparation should be used 3–4 times daily. The duration of treatment is determined individually by a physician and depends on the intensity of therapy (usually 3–10 days). The preparation should not be used for longer than 2 weeks.

Instructions for Using the Aerosol Can/Bottle

1. Remove the protective cap from the aerosol can/bottle and, ensuring the spray nozzle is clean, attach it to the valve stem.
2. Shake the aerosol can/bottle for 1 minute and perform no more than 5 actuations of the spray nozzle until a fine mist appears. If no spray appears, the procedure may be repeated.
3. Direct the free end of the spray nozzle toward the affected area of the throat and press the spray nozzle. Do not use the aerosol can/bottle in an inverted position.
4. After completing the application, cover the aerosol can/bottle with the protective cap to prevent contamination.
5. Keep the spray nozzle clean; after use, it is recommended to rinse it under warm running water and then dry it in a warm place.

Children. The preparation should not be used in children under 6 years of age.

Overdose. Overdose may lead to an increase in adverse effects and allergic reactions. Treatment: discontinue use of the preparation and provide symptomatic therapy.

Adverse reactions.

The medicinal product is generally well tolerated, but reactions due to increased individual sensitivity to the components of the drug may occasionally occur.

Skin and subcutaneous tissue disorders: development of ulcers on mucous membranes, allergic contact dermatitis.

General disorders and administration site conditions: ageusia, dysgeusia, burning sensation/irritation in the throat, swelling at the site of contact, dryness of the nasal/throat mucosa, altered taste sensations for up to 48 hours (sweet taste may change twice to a bitter taste), mucosal sensitivity (including numbness), mucosal paresthesia, inflammation, blisters, irritation (pain, burning sensation, itching) of the tongue and/or oral mucosa, decreased sensitivity, hypersensitivity reactions (including laryngospasm, bronchospasm, itching, angioedema, urticaria, skin rashes).

Respiratory, thoracic and mediastinal disorders: cough, dyspnea.

Gastrointestinal disorders: pain on swallowing, enlargement of salivary glands, dysphagia, reversible discoloration of teeth and tongue; gastrointestinal disturbances, primarily nausea and vomiting, may occur if the drug is accidentally swallowed.

If any adverse reactions occur, discontinue use of the drug immediately and consult a physician without delay.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze. Keep out of reach of children.

Packaging. 25 g in a bottle with spray nozzle and protective cap in a box; 40 g in a bottle with oral spray device and protective cap in a box.

Supply category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business. Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenko Street, building 22.