Instructions Stomatidine oral solution 0.1% bottle 200 ml
Composition
active ingredient: hexetidine;
1 ml of solution contains 1 mg of hexetidine;
Excipients: propylene glycol, polysorbate 20, citric acid monohydrate, sodium saccharin, menthol, methyl salicylate, azorubine (E 122), ethanol 96%, purified water.
Dosage form
Oral solution.
Main physicochemical properties: transparent red solution.
Pharmacotherapeutic group
Antimicrobial and antiseptic preparations for topical use in dentistry. ATC code A01A B12.
Pharmacological properties
Pharmacodynamics
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. The antibacterial efficacy of hexetidine is due to its antimetabolic effect on the amino acid thiamine, which is essential for the growth of bacteria and fungi.
Pharmacokinetics
After a single rinse, hexetidine remains in the mucous membrane of the oral cavity and throat and in dental plaque for 8-10 hours, and in some cases for a longer time (up to 65 hours).
There are no human studies on the absorption of hexetidine when using the topical application of StomatidinÒ 0.1% solution.
There are no specific studies for the drug StomatidinÒ 0.1% solution or hexetidine in renal/hepatic failure and for elderly patients.
Indication
Minor infections of the oral cavity, including candidiasis; as an adjunct in the prevention and treatment of gingivitis; in the treatment of sore throat and recurrent aphthous ulcers; to eliminate bad breath; before and after surgical operations in dentistry.
Contraindication
- Hypersensitivity to hexetidine or to the auxiliary components of the drug;
- atrophic pharyngitis;
- patients with bronchial asthma or any other respiratory disease associated with pre-existing hypersensitivity of the respiratory tract. Inhalation may cause bronchoconstriction.
Interaction with other medicinal products and other types of interactions
There may be an interaction with other antiseptic drugs. Hexetidine can be inactivated by alkaline solutions.
Application features
Stomatidine® should be used with caution in patients with epilepsy. The drug may lower the epileptic threshold and cause seizures in children.
Caution should be exercised in patients with allergic reactions, including bronchial asthma, especially in patients with allergy to acetylsalicylic acid.
If inflammation worsens, the use of the drug should be discontinued and a doctor should be consulted.
If signs of hypersensitivity to the drug appear, its use should be discontinued immediately.
Do not inhale while using the medicine, as the solution may enter the respiratory tract and cause laryngospasm.
Excipients:
Levomenthol. There is a risk of laryngospasm in children due to the presence of levomenthol.
Ethyl alcohol (ethanol). The drug contains 10% ethanol, so it should be prescribed with caution to patients with liver disease.
Azorubine (E122). May cause an allergic reaction (this is important in case of accidental ingestion of the medicine).
Long-term use is not recommended (do not use for longer than 10 days without a doctor's recommendation).
Use during pregnancy or breastfeeding
Adequate and well-controlled clinical studies of the use of hexetidine in women during pregnancy or breastfeeding have not been conducted. It is not known whether hexetidine or its metabolites are excreted in breast milk. A small amount of hexetidine is absorbed systemically. It is unlikely that the use of hexetidine during pregnancy or breastfeeding poses a risk to the fetus or child.
However, hexetidine should not be used during pregnancy or breastfeeding, except in cases where the potential benefit of treatment for the mother outweighs the possible risks to the developing fetus or child.
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
Stomatidin®, 0.1% solution, is intended for topical use in the oral cavity.
Rinse your mouth or gargle with 15 ml of undiluted solution for ½ minute 2-3 times a day.
The drug should not be swallowed.
Use undiluted solution for rinsing.
The duration of treatment is determined by the doctor depending on the severity and characteristics of the disease.
Do not use to treat long-term symptoms.
Children
It is not recommended to use the medicine to treat children under 6 years of age.
Overdose
Hexetidine is not toxic at the recommended dose. There are no data on cases of excessive use of hexetidine leading to hypersensitivity reactions.
Symptoms. Since the drug contains ethyl alcohol, when using the solution in the oral cavity, some of it may be absorbed. Acute alcohol poisoning is very unlikely, but theoretically possible if a small child swallows a large dose of the drug.
Treatment. In any case of overdose, consult a doctor immediately. Symptomatic therapy, as in alcohol intoxication, although such treatment is rarely necessary. Gastric lavage is advisable within 2 hours after ingestion of an excessive dose.
Keep out of reach of children. In case of overdose, seek medical attention immediately.
Adverse reactions
Stomatidine® is usually well tolerated, even with long-term use.
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" can change to the sensation of "bitter" twice).
Respiratory system: cough, shortness of breath, laryngospasm.
On the part of the digestive system: dry mouth, dysphagia, enlargement of the salivary glands, 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, angioedema.
General disorders and administration site conditions: local reactions, including reversible discoloration of teeth and tongue; mucosal sensitivity (burning, numbness); irritation (pain, heat, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paraesthesia; inflammation; blisters; mucosal ulceration.
The medicine contains azorubine, therefore it may cause allergic reactions, including bronchial asthma, especially in patients with an allergy to acetylsalicylic acid.
Medical professionals, patients, pharmacists are asked to report any suspicion of adverse reactions or lack of therapeutic effect to the email address of the Bosnalejek d.d. representative office: office@bosnalijek.com.ua
Expiration date
2 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25 ° C. Do not freeze.
Packaging
200 ml in a bottle, 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Manufacturer/Applicant
Bosnalek, PhD
Location of the manufacturer and address of its place of business
71000, Sarajevo, Jukiceva, 53, Bosnia and Herzegovina.
