Instructions for Oralor oral solution bottle 200 ml
Composition
active ingredients: hexetidine, choline salicylate, chlorobutanol hemihydrate;
100 ml of solution contain:
- hexetidine in terms of 100% substance 0.1 g,
- choline salicylate in terms of 100% substance 0.5 g,
- chlorobutanol hemihydrate calculated as 100% anhydrous substance 0.25 g;
Excipients: sodium saccharin, polysorbate 20, sorbic acid, ethanol 96%, eucalyptol, methyl salicylate, lime oil, sage oil, glycerin, purified water.
Dosage form
Oral solution.
Main physicochemical properties: transparent slightly colored solution with a specific pleasant odor.
Pharmacotherapeutic group
Antiseptics. ATX code R02A A20.
Pharmacological properties
Pharmacodynamics
The effect of the drug is due to three active components.
Antibacterial and antifungal activity
Hexetidine has an antibacterial effect on both gram-positive and gram-negative strains of microorganisms, both aerobes and anaerobes.
Hexetidine has a generally bacteriostatic effect on aerobic strains, and a weak bactericidal effect. Hexetidine has a pronounced bactericidal effect on anaerobic strains. The mechanism of action is a competitive action with thiamine: the structure of hexetidine is similar to the structure of thiamine, which is necessary for the growth of microorganisms.
Anti-inflammatory activity
Choline salicylate has analgesic, antipyretic, and anti-inflammatory effects. It is used to treat oral diseases.
Analgesic activity
Chlorobutanol has an analgesic effect. It can be used, in particular, in otolaryngology (nasal drops, rinsing) and in dental practice (applications and irrigation). Classically it is used as an anesthetic.
The active substances are fixed on the mucous membrane of the oral cavity, from where they are gradually released.
Indication
Use for local treatment of oral infections; for postoperative care in dentistry.
Contraindication
- Hypersensitivity to any component of the drug;
- atrophic pharyngitis;
- bronchial asthma or any other respiratory diseases associated with hypersensitivity of the respiratory tract.
Interaction with other medicinal products and other types of interactions
Do not use together with preparations containing antiseptics.
Hexetidine can be inactivated by alkaline solutions.
Application features
When using the medicine, do not swallow it and avoid contact with the eyes, as it contains ethanol.
Use with caution in patients with epilepsy. The drug may lower the epileptic threshold and cause seizures in children.
Use with caution in patients with a tendency to allergic reactions, including bronchial asthma, especially in patients with allergy to acetylsalicylic acid. If signs of hypersensitivity appear, use of the drug should be discontinued immediately.
Due to the ethanol content, the drug should be administered with caution to patients with liver disease.
Long-term use is not recommended, as it may alter the natural microbial balance of the mouth and throat, where there is a risk of bacterial and fungal spread.
If general clinical signs of bacterial infection appear, general antibacterial therapy should be prescribed.
If symptoms persist for longer than 5 days and/or body temperature increases, the treatment regimen should be reviewed.
If inflammation increases, treatment with the drug should be discontinued.
Use during pregnancy or breastfeeding
There are no human studies on the possibility of hexetidine crossing the placenta and being excreted in breast milk, so the drug should not be used during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The medicine contains ethanol. Drivers are not recommended to drive a car for 30 minutes after using the medicine.
Method of administration and doses
Apply topically to rinse the mouth.
For one mouthwash for adults and children over 6 years of age: dissolve 10 ml, or 2 teaspoons, of the medicine in ¼ cup of warm water.
From 2 to 4 rinses per day.
Do not swallow.
The course of treatment is 5 days.
Children: Do not use in children under 6 years of age.
Overdose
There have been no reports of overdose of the drug.
If a sufficient amount of the solution is absorbed into the oral cavity, alcohol intoxication may occur due to the ethyl alcohol content.
The concentration of hexetidine in the drug is not toxic if used as directed.
Acute alcohol intoxication is unlikely. If a child swallows a significant dose of the drug, alcohol intoxication may occur due to the ethyl alcohol content.
Treatment of overdose is symptomatic, but rarely necessary. If a child swallows the contents of the bottle, seek medical attention immediately. Gastric lavage should be considered within 2 hours of ingestion and measures should be taken to eliminate signs of alcohol intoxication.
Adverse reactions
Immune system disorders: hypersensitivity reactions, including urticaria, angioedema, laryngospasm, bronchospasm.
From the nervous system: ageusia, dysgeusia, change in taste sensations within 48 hours (the sensation of sweet may change to the sensation of bitter).
Respiratory, thoracic and mediastinal disorders: cough, shortness of breath.
On the part of the digestive system: dry mouth, dysphagia, salivary gland enlargement, pain when swallowing. In case of accidental ingestion of the drug, gastrointestinal disorders 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 (burning, numbness); irritation (pain, heat, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paresthesia; inflammation; blisters; mucosal ulceration, throat irritation, contact site swelling, dryness of the nasal/throat mucosa.
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
120 ml or 200 ml in a glass or polymer bottle in a cardboard pack with a measuring cup.
Vacation category
Without a prescription.
Producer
Private Joint-Stock Company Pharmaceutical Factory "Viola".
Location of the manufacturer and address of the place of its activity. Ukraine, 69063, Zaporizhia region, Zaporizhia city, Akademika Amosova street, building 75.
