Gripocitron lor

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT GRIPOCITRON LOR (GRIPOCITRON LOR)

Composition:

Active substances: 1 ml of the preparation contains 1 mg of hexetidine, 5 mg of choline salicylate, 2.5 mg of chlorobutanol hemihydrate calculated as chlorobutanol;

Excipients: sodium saccharin, polysorbate, propionic acid, 96% ethanol, lemon oil, anise oil, menthol, peppermint oil, eucalyptol, methyl salicylate, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical characteristics: clear, slightly colored solution with a characteristic aromatic odor.

Pharmacotherapeutic group. Preparations used for throat disorders. Antiseptics. ATC code R02A A20.

Pharmacological Properties

Pharmacodynamics.

The action of the drug is due to its three active ingredients.

Antibacterial and antifungal activity. Hexetidine exerts antibacterial effects against both Gram-positive and Gram-negative microbial strains, as well as against both aerobic and anaerobic organisms.

It should be noted that against aerobic strains, hexetidine primarily has a bacteriostatic effect, with weak bactericidal activity. Against anaerobic strains, hexetidine exhibits pronounced bactericidal activity. The mechanism of action involves competitive interaction with thiamine: the structure of hexetidine resembles that of thiamine, which is essential for microbial growth.

Anti-inflammatory activity. Choline salicylate provides analgesic, antipyretic, and anti-inflammatory effects. Used in the treatment of oral cavity diseases.

Analgesic activity is provided by chlorobutanol. Used in otorhinolaryngology (nasal drops, mouthwashes) and in dental practice (applications and sprays) as a local anesthetic.

Pharmacokinetics.

The active substances bind to the oral mucosa, from where they are gradually released.

Clinical characteristics.

Indications.

Antibacterial and analgesic agent for local treatment of diseases of the oral mucosa and oropharynx.

Contraindications.

Hypersensitivity to the components of the drug. Contraindicated in patients with atrophic pharyngitis, bronchial asthma, or any other respiratory tract diseases associated with existing respiratory tract hypersensitivity.

Interaction with other medicinal products and other forms of interaction.

Do not use together with products containing antiseptics. Hexetidine may be inactivated by alkaline solutions.

Special precautions for use.

The preparation should not be swallowed, and contact with the eyes should be avoided, as it contains ethanol. Prolonged use is not recommended, since it may alter the natural microbial balance of the oral cavity and pharynx, with a risk of bacterial and fungal overgrowth. If general clinical signs of bacterial infection appear, systemic antibacterial therapy should be initiated. If symptoms persist for more than 5 days and/or body temperature remains elevated, the treatment strategy should be reevaluated.

The preparation should be used with caution in patients with epilepsy, as it may lower the epileptic threshold and provoke seizures in children. Caution is also advised in patients with a predisposition to allergic reactions, including bronchial asthma, particularly in those with hypersensitivity to acetylsalicylic acid. If signs of hypersensitivity to the drug occur, its use should be discontinued immediately. Since the preparation contains ethanol, it should be administered with caution to patients with liver disease. There is a risk of laryngospasm in children due to the presence of menthol.

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

Use during pregnancy or breastfeeding.

There are no human data available on the ability of hexetidine to cross the placenta or its excretion in breast milk. Therefore, the drug should not be used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.
The preparation contains ethanol. Drivers are advised not to operate a vehicle or machinery for at least 30 minutes after using the drug.

Method of Administration and Dosage

Use as a topical agent for oral and oropharyngeal irrigation.

Adults and children aged 15 years and older: 1 spray 4–6 times daily.

Children aged 6 to 15 years: 1 spray 2–3 times daily.

Treatment duration – no longer than 5 days.

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

Overdose.

There have been no reports of overdose with this medicinal product.

Alcohol intoxication due to the ethyl alcohol content may occur if a sufficient amount of the solution is absorbed in the oral cavity.

The concentration of hexetidine in the product is not toxic when used as directed.

Acute alcohol intoxication is unlikely. However, if a child ingests a large dose of the product, alcohol intoxication may occur due to the ethyl alcohol content.

No cases of excessive hexetidine use leading to hypersensitivity reactions have been reported.

Treatment of overdose is symptomatic and rarely required. In the event that a child ingests the contents of the bottle, seek immediate medical attention. Consider gastric lavage within 2 hours after ingestion and take measures to counteract signs of alcohol intoxication.

Adverse reactions.

Immune system disorders: hypersensitivity reactions, including urticaria, angioedema, allergic reactions, including laryngospasm, bronchospasm.

Nervous system disorders: taste disturbances (including ageusia, dysgeusia), altered taste sensations within 48 hours (sweet taste may be replaced twice by bitter taste).

Respiratory, thoracic and mediastinal disorders: cough, dyspnea.

Gastrointestinal disorders: dry mouth, dysphagia, salivary gland enlargement, pain on swallowing. Accidental ingestion of the product may lead to gastrointestinal disturbances, primarily nausea and vomiting.

Skin and subcutaneous tissue disorders: allergic contact dermatitis, skin reactions (rash).

General disorders and administration site conditions: local reactions, including reversible discoloration of teeth and tongue; mucosal sensitivity, namely burning, numbness; irritation (pain, sensation of warmth, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paraesthesia; inflammation; blisters; ulceration of the mucosa; throat irritation, swelling at the site of contact, dryness of nasal/oral mucosa.

Shelf life. 3 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. 30 ml in a bottle with spray nozzle and protective cap, in a cardboard box.

Availability. Over-the-counter.

Manufacturer. Limited Liability Company "Pharmaceutical Company "Zdorovya".

Manufacturer's address and location of business activity. 22, Shevchenko Street, Kharkiv, Kharkiv Region, 61013, Ukraine.