LORANGINE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LORANGIN

Composition:

Active substances: hexetidine, choline salicylate, chlorobutanol hemihydrate;

50 ml of solution contain hexetidine 0.05 g, choline salicylate 0.25 g, chlorobutanol hemihydrate 0.125 g;

Excipients: propionic acid, sodium saccharinate, polysorbate 20, lemon oil, anise oil, peppermint oil, cineole, 96% ethanol, menthol, methyl salicylate, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear liquid with a characteristic aromatic, alcoholic-lemon odor. Opalescence may be present.

Pharmacotherapeutic group. Preparations used in throat diseases. 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 hexetidine generally exerts a bacteriostatic effect on aerobic strains, with weak bactericidal activity. Against anaerobic strains, hexetidine has a pronounced bactericidal effect. The mechanism of action involves competitive inhibition with thiamine: the structure of hexetidine is similar to that of thiamine, which is essential for microbial growth.

Anti-inflammatory activity.

Choline salicylate provides analgesic, antipyretic, and anti-inflammatory effects.

Analgesic activity.

Chlorobutanol hemihydrate exerts an analgesic effect.

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.

• Children under 6 years of age;
• hypersensitivity to any component of the drug;
• atrophic pharyngitis;
• bronchial asthma or any other respiratory tract diseases associated with existing airway 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 the product contains ethanol.

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

Use with caution in patients with a predisposition to allergic reactions, including bronchial asthma, particularly in patients with hypersensitivity to acetylsalicylic acid.

If signs of hypersensitivity to the product occur, its use should be discontinued immediately.

Since the product contains ethanol, it should be used with caution in patients with liver disease.

Prolonged use is not recommended, as 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 considered.

If symptoms persist for more than 5 days and/or body temperature is elevated, the treatment strategy should be reevaluated.

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

Use during pregnancy or breastfeeding.

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

Ability to affect reaction speed when driving or operating machinery.

The product contains ethanol. Drivers are advised not to operate a motor vehicle for at least thirty minutes after using the product.

Dosage and Administration

Apply 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

Contraindicated in children under 6 years of age.

Overdose

No reports of overdose have been reported.

Alcohol intoxication due to the ethanol content may occur following absorption of a sufficient amount of oral spray.

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

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

No cases of hexetidine overdose leading to hypersensitivity reactions have been observed.

Treatment of overdose is symptomatic and rarely required. If a child has ingested the contents of the bottle, seek medical advice immediately. Gastric lavage should be considered within 2 hours after ingestion, and measures to counteract signs of alcohol intoxication should be initiated.

Side effects.

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

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

Respiratory, thoracic and mediastinal disorders: cough, dyspnea.

Gastrointestinal disorders: dry mouth, dysphagia, salivary gland enlargement, pain on swallowing. In case of accidental ingestion, gastrointestinal disturbances may occur, primarily nausea and vomiting.

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

General disorders and administration site conditions: local reactions – reversible discoloration of teeth and tongue; mucosal sensitivity, namely 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 mucosa, throat irritation, swelling at the site of contact, dryness of nasal/throat mucosa.

If any adverse reactions occur, treatment should be discontinued and medical advice should be sought.

Shelf life.

2 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Packaging.

50 ml in a dark glass bottle with a screw neck and an attached spray pump that screws onto the bottle. One bottle per cardboard box.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

MICROFARM LLC.

Manufacturer’s address and place of business.

20 Shevchenka St., Kharkiv, 61013, Ukraine.