Description
A wide range of flavors
Composition
1 tablet contains:
Active ingredients: Â
chlorhexidine dihydrochloride – 5 mg,
benzocaine-1.5 mg.
Auxiliary substances: Â
isomalt – 2243.681 mg,
peppermint oil-0.9 mg,
menthol-0.645 mg,
thymol-0.045 mg,
aspartame-2.29 mg,
purified water-45.789 mg.
Clinical Pharmacology
Pharmacodynamics : The double action of the drug is due to the presence of two active substances. The antibacterial activity of the drug is due to the presence of chlorhexidine. The action of a local anesthetic — benzocaine-provides a reduction in pain symptoms. Chlorhexidine chlorhexidine has a broad antibacterial spectrum of action against gram-positive and gram-negative bacteria; it acts by destroying the cytoplasmic membrane of a bacterial cell. It is poorly effective against yeast fungi, dermatophytes, mycobacteria, some types of Pseudomonas and Proteus. Chlorhexidine is most effective in neutral or slightly alkaline environments. In an acidic environment, its activity decreases. Effectiveness is reduced in the presence of soaps, blood, and purulent secretions. The use of resorption tablets with chlorhexidine leads to a significant decrease in the content of bacteria in saliva. The use of chlorhexidine for several months is accompanied by a decrease in its effectiveness due to a decrease in the sensitivity of bacteria. Benzocaine is a well-known local anesthetic that quickly and permanently relieves pain in the mouth and throat. Benzocaine penetrates through lipophilic areas of the cell membrane and acts on peripheral pain receptors of the mucous membrane and skin. The anesthetic effect of benzocaine occurs in 15-30 seconds; as the substance is diluted with saliva, the anesthetic effect gradually decreases (within 5-10 minutes). Pharmacokinetics: Chlorhexidine There are no clinical data on the absorption of chlorhexidine through the human oral mucosa. Chlorhexidine can be stored in saliva for up to 8 hours. Benzocaine is slightly soluble in water, which causes its slow absorption. Like all essential derivatives of para-aminobenzoic acid, it is broken down by esterase in the blood plasma and liver. As a result, para-aminobenzoic acid and ethyl alcohol are formed, which is metabolized to acetyl coenzyme A. Para-aminobenzoic acid undergoes conjugation with glycine or is excreted unchanged by the kidneys.
Indications
Infectious and inflammatory diseases of the throat or oral cavity: * pharyngitis, sore throat and other inflammatory diseases of the pharynx;• stomatitis;• gingivitis.
Use during pregnancy and lactation
There is no sufficient experience of using the drug in pregnant and lactating women. The use of the drug “Hexoral ® tabs” during pregnancy and lactation is possible only in cases where the expected benefit to the mother exceeds the potential risk of harmful effects to the fetus and child.
Contraindications
- Hypersensitivity to any of the components of the drug;
- wound and ulcerative lesions of the oral cavity or throat;
- low concentration of cholinesterase in blood plasma;
- phenylketonuria;
- children under 4 years of age.
Side effects
Adverse reactions identified during post-marketing use of the drug were classified as follows: very frequent (≥10%), frequent (≥1%, but <10%), infrequent (≥0.1%, but <1%), rare (≥0.01%, but <0.1%), very rare (The following adverse reactions were classified according to (1) clinical or epidemiological data, or (2) when the number of cases is unknown or information about the adverse reaction is revealed in the literature, “Frequency unknown”is indicated. According to spontaneous reports of adverse reactions*Disorders of the gastrointestinal tract. The frequency is not known: decreased sensitivity of the oral mucosa, temporary numbness of the tongue, taste disorders (dysgeusia), discoloration of teeth, discoloration of the tongue (reversible), discoloration of silicate and composite materials for dental restoration, plaque formation (tartar), stomatitis, detachment of the oral mucosa, glossodynia, enlargement of the parotid salivary glands. Immune system disorders. Frequency unknown: hypersensitivity reactions (including severe allergic reactions, urticaria, angioedema, anaphylactic reactions, anaphylactic shock). Disorders of the blood and lymphatic system. Frequency unknown: methemoglobinemia. * According to the literature data. If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.
Interaction
Benzocaine, due to the formation of its metabolite 4-aminobenzoic acid, reduces the antibacterial activity of sulfonamides and aminosalicylates. Sucrose, polysorbate 80, and insoluble magnesium, zinc, and calcium salts reduce the effect of chlorhexidine.
How to take, course of use and dosage
Locally. Slowly dissolve the tablet in the mouth until it is completely dissolved. The drug should be started immediately after the first symptoms of the disease appear and continue taking it for several days after the symptoms disappear. General dosage recommendations:
- Adults and children over 12 years of age: 1 tablet every 1-2 hours as needed, but no more than 8 tablets per day, unless otherwise prescribed.
- Children aged 4-12 years: up to 4 tablets per day.
For use in children, consult your doctor. Do not use in children under 4 years of age. Information for diabetics: the carbohydrate content in one tablet corresponds to 0.1 bread units (BU).
Overdose
If used correctly, an overdose of the drug is impossible, since chlorhexidine is practically not absorbed into the blood, and the amount of benzocaine absorbed is extremely small. Chlorhexidine chlorhexidine hydrochloride is poorly soluble in water, all cases of overdose are described only when taking chlorhexidine gluconate, which is well soluble in water. In these cases, mucosal damage was observed in direct contact with chlorhexidine gluconate, as well as a systematic reversible increase in the concentration of liver enzyme. There is no specific treatment. Benzocaine overdose is only possible if used improperly. Symptoms: possible toxic effects on the central nervous system, manifested initially by tremor, vomiting, convulsions, and later-depression of the central nervous system. Due to respiratory depression, coma is possible. High toxic concentrations cause bradycardia, blockage of atrioventricular conduction, and cardiac arrest. Benzocaine can cause methemoglobinemia (especially in children), accompanied by suffocation and cyanosis. Treatment: induce vomiting and flush the stomach. It is possible to use activated carbon. Artificial respiration with oxygen support is recommended for hypoxia and anoxia, and cardiac massage is recommended for cardiac arrest. For convulsions, diazepam or fast-acting barbiturates are prescribed (contraindicated in anoxic convulsions); in particularly severe cases, suxamethonium chloride is used after intubation and artificial respiration. Blood circulation should be maintained by use of blood plasma or electrolyte solutions. With methemoglobinemia, up to 50 ml of 1% methylene blue solution can be used intravenously.
Description
Round biconvex opaque tablets with a rough surface from white or yellowish-white to light gray or yellowish-gray in color. Unevenness of coloring, the presence of air bubbles and slight unevenness of the edges are allowed. There may be a white coating (powdering).
Special instructions
Benzocaine can cause methemoglobinemia. This condition is manifested by symptoms such as a change in the color of the skin, lips and nail beds to gray or blue or their pallor; headache, pre-fainting, shortness of breath, fatigue and tachycardia. The appearance of these symptoms indicates the presence of moderate to high amounts of methemoglobin and a significant decrease in the oxygen transport function of the blood. Children and elderly patients may be at a higher risk of developing methemoglobinemia. In children, the drug should be used under adult supervision. The drug contains aspartame, which is a derivative of phenylalanine, which is dangerous for patients with phenylketonuria. The use of the drug is contraindicated in the presence of wound and ulcerative lesions of the mouth or throat. Caution should be exercised when using the drug in young children and in people with aspiration or swallowing disorders due to the risk of suffocation. If the medicine has become unusable or the expiration date has expired, do not throw it into the sewage system or on the street! Place the medicine in a plastic bag and put it in the trash can. These measures will help protect the environment!
Form of production
Tablets for resorption
Storage conditions
Store at a temperature not exceeding 25 °C. Keep out of reach of children.
Shelf life
3 years
Active ingredient
Benzocaine, Chlorhexidine
Dosage form
tablets for resorption
Purpose
Nursing mothers as prescribed by a doctor, Children over 4 years of age, For adults, Pregnant women as prescribed by a doctor
Indications
Sore Throat, Stomatitis, Gum Disease, Oral Inflammation, Pharyngitis
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Side effects of Hexoral pills for dissolving, 20pcs.
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