Composition, form of production and packaging
? The tablets for resorption are round, biconvex, opaque, with a rough surface from white or yellowish white to light gray or yellowish-gray in color; uneven staining, the presence of air bubbles and a slight unevenness of the edges; there may be a white coating (dusting).
1 tab.
chlorhexidine dihydrochloride 5 mg
benzocaine 1.5 mg
Excipients: 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.
10 pieces. - blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Combination drug for topical application. The double effect of the drug is due to the presence of 2 active substances. Antibacterial activity of the drug is due to the presence of chlorhexidine. The action of the local anesthetic of benzocaine provides a reduction in pain symptoms.
Chlorhexidine has a broad spectrum of antibacterial action against gram-positive and gram-negative bacteria; acts by destroying the cytoplasmic membrane of a bacterial cell. It is not effective for yeast fungi, dermatophytes, mycobacteria, some species of Pseudomonas and Proteus.
Chlorhexidine is most effective in a neutral or slightly alkaline environment. In an acidic environment, its activity decreases. Effectiveness is reduced in the presence of soaps, blood and purulent discharge.
The use of tablets for resorption with chlorhexidine leads to a significant decrease in the content of bacteria in the 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 - a local anesthetic, quickly and for a long time, relieves pain in the mouth and throat. Benzocaine penetrates through the lipophilic areas of the cell membrane and acts on the peripheral pain receptors of the mucous membrane and skin. Anesthetic action of benzocaine occurs in 15-30 sec; 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 oral mucosa of a person. Chlorhexidine can persist in saliva until 8 hours.
Benzocaine
Benzocaine is slightly soluble in water, which causes its slow absorption. Like all the ether derivatives of PABC, it is cleaved by esterase in the blood plasma and liver. As a result, PABA and ethanol metabolized to acetylcoenzyme A are formed. PABA is conjugated with glycine or excreted unchanged by the kidneys.
INDICATIONS
Infectious-inflammatory diseases of the pharynx or oral cavity:
- pharyngitis, tonsillitis and other inflammatory diseases of the pharynx;
- stomatitis;
- Gingivitis.
DOSING MODE
Apply locally. The tablet should be slowly resorbed in the mouth until it dissolves completely.
The drug should be started immediately after the appearance of the first symptoms of the disease and continue to take within a few days after the disappearance of symptoms.
Adults and children over 12 years of age: as a rule, 1 tab. every 1-2 hours as needed, but not more than 8 tablets / day.
Children aged 4-12 years: appoint up to 4 tablets / day.
Use in children is possible only according to the doctor's prescription.
Do not use the drug in children under the age of 4 years .
SIDE EFFECT
The undesirable reactions revealed during the 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 (<0.01%), the frequency is unknown (the incidence rate can not be estimated on the basis of available data).
The undesirable reactions listed below were classified according to clinical or epidemiological studies, either when the number of cases is unknown or the information on the undesired reaction is revealed in the analysis of literature data, the "frequency is unknown" is indicated.
According to spontaneous reports of adverse reactions *
On the part of the gastrointestinal tract: frequency unknown - decreased sensitivity of the oral mucosa, temporary numbness of the tongue, impaired taste (dysgeusia), discoloration of the teeth, discoloration of the tongue (reversible), discoloration of silicate and composite tooth restoration materials, plaque formation ), stomatitis, detachment of the oral mucosa, glossodynia, an increase in parotid salivary glands.
On the part of the immune system: the frequency is unknown - hypersensitivity reactions (including hives, angioedema, anaphylactic reactions, anaphylactic shock).
On the part of the blood and lymphatic system: the frequency is unknown - methemoglobinemia.
* According to the literature.
If any of the side effects indicated in the manual are aggravated or any other side effects not indicated in the instructions are noted, the patient should inform the physician about it.
CONTRAINDICATIONS
- wound and ulcerative lesions of the oral cavity or pharynx;
- low concentration of cholinesterase in the blood plasma;
- phenylketonuria;
- Children's age up to 4 years;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
There is insufficient experience in the use of the drug Hexorol В® tabs in pregnant and lactating women.
The use of the drug Hexoral В® tabs during pregnancy and during lactation is possible only in those cases when the expected benefit of therapy for the mother exceeds the potential risk of harmful effects on the fetus and the baby.
APPLICATION FOR CHILDREN
Contraindicated in children under 4 years.
Use in children older than 4 years is possible only by the name of the doctor.
APPLICATION IN ELDERLY PATIENTS
Elderly patients may be at a higher risk of developing methaemoglobinaemia with the drug.
SPECIAL INSTRUCTIONS
Benzocaine can cause methemoglobinemia. This condition is manifested by such symptoms as a change in the color of the skin, lips and nails in gray or blue, or their blanching, headache, pre-stupor, dyspnoea, fatigue and tachycardia. The appearance of these symptoms indicates the presence of methaemoglobin from moderate to high amounts and a significant decrease in the oxygen transport function of the blood. Children and elderly patients may be at a higher risk of developing methaemoglobinaemia.
In children, the drug should be administered 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 oral cavity and throat.
Caution should be exercised when using the drug in young children and in persons with aspiration or swallowing disorders due to the risk of suffocation.
If the medicinal product has become unusable or has expired, do not throw it into sewage and into the street. It is necessary to place the drug in a bag and put it in a garbage container. These measures will help protect the environment.
Impact on the ability to drive vehicles and manage mechanisms
Hecoral В® tabs do not affect the ability to drive vehicles and engage in other potentially hazardous activities.
OVERDOSE
If used correctly, an overdose of the drug is not possible, because Chlorhexidine is practically not absorbed into the blood, and the amount of absorbed benzocaine is extremely low.
Chlorhexidine
Chlorhexidine hydrochloride is poorly soluble in water, all cases of overdose are described only with the intake of a readily water-soluble chlorhexidine gluconate.
Symptoms: damage to the mucous membrane with direct contact with chlorhexidine gluconate, as well as a systematic reversible increase in the concentration of the hepatic enzyme.
Treatment: there is no specific treatment.
Benzocaine
Overdose is possible only if used improperly.
Symptoms: possibly a toxic effect on the central nervous system, manifested initially tremor, vomiting, convulsions, and later - oppression of the central nervous system. Due to respiratory depression, a coma is possible. High toxic concentrations cause bradycardia, blockade of AV conduction and cardiac arrest. Benzocaine can cause methemoglobinemia (especially in children), accompanied by suffocation and cyanosis.
Treatment: induce vomiting and rinse the stomach. It is possible to use activated carbon. With hypoxia and anoxia, artificial respiration with oxygen support is recommended, with cardiac arrest - cardiac massage. When convulsions are prescribed diazepam or high-speed barbiturates (contraindicated in anoxic convulsions); in especially severe cases after intubation and artificial respiration, suxamethonium chloride is used. Blood circulation is maintained by the introduction of blood plasma or electrolyte solutions. With methemoglobinemia, up to 50 ml of a 1% solution of methylene blue IV may be used.
DRUG INTERACTION
Benzocaine due to the formation of metabolite 4-aminobenzoic acid reduces the antibacterial activity of sulfonamides and aminosalicylates.
Sucrose, polysorbate 80, insoluble salts of magnesium, zinc and calcium reduce the effect of chlorhexidine.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
