Instructions for Trahisan lozenges blister pack No. 20
Composition
active ingredients: tyrothricin, lidocaine hydrochloride monohydrate, chlorhexidine digluconate;
1 tablet contains tyrothricin 0.5 mg, lidocaine hydrochloride monohydrate 1 mg, chlorhexidine digluconate 1 mg;
excipients: sorbitol (E 420), magnesium stearate, peppermint oil;
1 tablet contains 0.69 g of sorbitol (a sweetener), which corresponds to 0.057 bread units.
Dosage form
Lozenges.
Main physicochemical properties: white round flat tablets with beveled edges.
Pharmacotherapeutic group
Drugs used in throat diseases. ATX code R02A.
Pharmacological properties
Pharmacodynamics
The drug contains a combination of substances that have antimicrobial properties and a local anesthetic effect.
Tyrothricin is a mixture of various cyclic and linear (aliphatic) polypeptides that exhibit antibacterial activity due to the similarity of tyrothricin to the structure of endotoxins of spore-forming Bacillus brevis. The mixture contains up to 70-80% tyrocidine - an alkaline cyclic decapeptide and 20-30% gramicidin - a neutral linear pentadecapeptide.
Tyrocidine causes the release of nitrogen- and phosphorus-containing substances from bacterial cells, which, like cationic detergents, destroy the osmotic barrier of the bacterial cell membrane. Tyrocidine has a bactericidal effect on growing and dividing microorganisms.
Gramicidin creates cation-conducting channels in the bacterial cell membrane, which leads to a change in the intracellular concentration of cations and cytolysis. The gramicidin component contributes to the further uncoupling of tissue respiration and oxidative phosphorylation.
The spectrum of action of tyrothricin extends to gram-positive cocci, bacteria, and some types of fungi, such as Candida albicans.
Unlike antibiotics, there is no cross-resistance of microorganisms when using tyrothricin. This property is due to the special mechanism of action of tyrothricin.
Chlorhexidine and its salts have a broad spectrum of antimicrobial activity against gram-positive and gram-negative bacteria.
The mechanism of action of chlorhexidine is based on its affinity for the cell membrane of microorganisms, the properties of which change as a result of contact with the active substance.
The lipophilic groups of chlorhexidine cause disaggregation of the lipoprotein membrane of the cell envelope, disrupting the osmotic balance in the cells, which destroys the cytoplasmic membrane of the pathogen cell.
The effect on some gram-negative bacteria (Pseudomonas, Proteus), yeasts, dermatophytes and mycobacteria is insignificant. Chlorhexidine is ineffective against fungal spores, putrefactive fungi, viruses.
Lidocaine hydrochloride monohydrate is a local anesthetic of the amide type. The drug causes blockade of sodium channels of the nerve fiber. This blocks the transmission of excitation in the fibers of sensory nerves.
With prolonged use (more than several months), the effectiveness of the drug decreases, which is possibly due to changes in the bacterial spectrum of the microflora of the oral cavity and tooth surface.
Indication
Inflammatory and infectious diseases of the oral cavity and pharynx - such as stomatitis, gingivitis, periodontitis, glossitis, tonsillitis, pharyngitis and other conditions accompanied by swallowing disorders. For the prevention of infections before and after surgical interventions in the oral cavity and pharynx (tooth extraction, surgical treatment of the gums, tonsillectomy).
Contraindication
Hypersensitivity to any of the components of the drug or to other amide local anesthetics. Erosive and desquamative changes in the oral mucosa, fresh large wounds in the oral cavity and pharynx, fructose intolerance.
Interaction with other medicinal products and other types of interactions
Not detected.
Application features
Trahisan does not contain sugar and therefore does not contribute to the occurrence of dental caries. The drug can be used in patients with diabetes mellitus, using the conversion of the sugar substitute sorbitol into bread units (0.69 g of sorbitol corresponds to 0.057 bread units).
Use during pregnancy or breastfeeding
There is no information about the negative effects of the drug during pregnancy or breastfeeding. However, special studies have not been conducted in this category of patients. Therefore, before using the drug, the doctor should weigh the risk/benefit ratio for this group of patients.
The ability to influence the reaction speed when driving or working with other mechanisms
Does not affect.
Method of administration and doses
As a rule, the symptoms of the disease disappear after a few days, but to achieve a stable therapeutic effect, it is recommended to continue therapy for another 2-3 days. If after 5 days of using the drug the patient's condition does not improve, you should consult a doctor for further treatment.
Continuous use of Trahisan lozenges without a doctor's prescription should not last longer than 2 weeks.
Children
It is not recommended to use the drug in children under 4 years of age, as the drug must be dissolved.
Overdose
Cases of overdose have not been described. In case of accidental ingestion of an excessive number of tablets, gastric lavage is recommended.
Treatment is symptomatic.
Side effects
In rare cases, hypersensitivity reactions may occur, including: local irritation, swelling of the throat, swelling of the face, itching, hives, skin rashes or shortness of breath.
Short-term changes in taste, temporary numbness of the tongue, which disappear on their own after stopping the drug, are possible. With prolonged use, in rare cases, a slight yellow or light brown discoloration of the teeth, dental fillings and dentures or the tongue is possible, which can be eliminated with oral hygiene.
Expiration date
5 years.
Do not use after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 ºC in a dry place, out of the reach of children.
Packaging
10 tablets in a blister, 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Engelhard Arcnaymittel GmbH & Co. KG.
Manufacturer responsible for import, control and batch release.
LLC "PIK-PHARM".
Address
Herzbergstrasse 3, 61138 Niederdorfelden, Germany.
Address of the manufacturer responsible for import, control and batch release.
02121, Kyiv, Kolektorna St., 17 A, Ukraine.
