Content

To prevent diseases of the throat and gums, the antibacterial Hexoral is used - the instructions for use of the medication contain important information about the purpose and dosage. The medicine is an antiseptic (antibiotic) and is available in several forms for convenient use. Read the instructions to be aware of the rules for using the medication.

The drug Hexoral

In ENT practice and dentistry, the drug Hexoral is used, which, according to the pharmacological classification, is an antiseptic. It is intended for topical use, plus Hexoral Tabs tablets are available for oral administration. The active ingredient of the drug is hexetidine. The medicine is suitable for children and adults.

Composition and release form

There are three forms of Hexoral release: spray or aerosol, solution and tablets. The latter do not contain hexethidine. The active ingredient of the tableted antiseptic drug is a mixture of chlorhexidine dihydrochloride and benzocaine, additional components are isomalt, menthol, water, aspartame, thymol and peppermint oil. Tablets are available in 20 pieces per package. Detailed composition of the spray and solution:

	Spray Hexoral
Hexethidine concentration, g/100 ml
Additional components of the composition	Citric acid monohydrate, sodium saccharinate, polysorbate, levomenthol, sodium calcium edetate, eucalyptus leaf oil, water, nitrogen, ethanol, sodium hydroxide	Polysorbate, ethanol, anise oil, sodium saccharinate water, azorubine, peppermint oil, citric acid monohydrate, methyl salicylate, levomenthol, eucalyptus and clove oils
Description	Transparent colorless liquid with menthol odor	Clear red liquid with mint flavor
Release format, volume	40 ml bottles with 1 or 4 spray nozzles	200 ml bottles with measuring cup

Pharmacological properties

The drug has an antimicrobial effect due to the suppression of the oxidative process in the metabolism of bacteria. Hexethidine is the opposite active ingredient of thiamine and has a broad effect on bacteria and fungi. Suppresses most strains of pathogens, including the genus Candida and Protea, does not develop resistance to them, and reduces the sensitivity of bacteria.

Effective against influenza A viruses, herpes simplex type 1, and during its action slightly anesthetizes the mucous membranes of the gums. When in contact with the mucous membranes of the oral cavity and pharynx, it adheres well and is practically not absorbed. After a single use, the active substance remains in the gum mucosa for 65 hours, in dental plaque and plaques for 10-14 hours.

Indications for use

Instructions for use indicate the following indications for use of the drug Hexoral:

• symptomatic treatment of infectious and inflammatory diseases of the oral cavity and pharynx;
• tonsillitis, pharyngitis;
• treatment of sore throat, ARVI;
• gingivitis, stomatitis, glossitis;
• periodontal disease, fungal infections of the mouth;
• prevention of infectious complications before and after operations;
• prevention of infection of the alveoli after tooth extraction, trauma;
• hygiene and oral diseases (elimination of odor).

Directions for use and dosage

According to the instructions, Hexoral is used for gargling in the form of a solution, and for irrigating the oral cavity in the form of a spray. Hexoral for angina is prescribed in the form of oral tablets. They dissolve in the mouth until completely dissolved. Adults are recommended to take one every 1-2 hours, but no more than 8 per day. Children 4-12 years old can take up to 4 tablets per day. The drug is used immediately after the first symptoms appear, for several days after they disappear.

Hexoral Aerosol

The spray is applied topically and adheres to the oral mucosa, which is reflected in the durability of the effect. The medicine should be used after meals. Adults and children over six years of age treat the mouth while holding their breath, irrigating the mucous membranes once for a couple of seconds twice a day. Children 3-6 years old can use a local antiseptic drug only after consulting a pediatrician. The doctor prescribes the duration of the course depending on the type of disease.

Instructions for use of Hexoral aerosol include the following steps for spraying in the larynx or mouth:

• put the spray nozzle on the bottle;
• direct its end to the affected area of ​​the mucous membrane;
• hold the bottle strictly vertically during administration;
• spray the required amount of spray by pressing on the head of the spray nozzle;
• Do not breathe during insertion.

Hexoral solution

The second form of release of Hexoral in the form of a solution is also used topically, after meals. Adults and older children fill the measuring cup to the 15 ml mark, rinse their mouth with an undiluted solution for half a minute, 2-3 times a day. Children 3-6 years old should use the drug only after consulting a doctor. The solution should not be swallowed or diluted with water or other liquids. It is allowed to treat the affected areas of the throat with tampons soaked in the medicine. They are applied for 2-3 minutes. The duration of therapy is determined by the doctor.

special instructions

The instructions for use indicate special instructions when using the antiseptic drug. Pay attention to them:

• one dose of solution contains 20.3 mg, which in terms of pure substance is 5.15%;
• the contents of the spray bottle are under pressure, do not open, pierce, or burn the packaging even after it is completely empty;
• if the medicine has expired, do not pour it into wastewater or throw it outside, tie it in a bag and throw it in a trash container;
• the antiseptic drug does not affect the speed of psychomotor reactions, can be used while driving cars or dangerous mechanisms;
• the medicine is prescribed with caution if you are sensitive to acetylsalicylic acid;
• the solution can only be used when the patient can spit it out after rinsing the cavity.

During pregnancy

According to the instructions, there is no information about undesirable effects after using the antiseptic Hexoral during pregnancy and breastfeeding, but you should consult your doctor before prescribing. If he evaluates the benefit to the mother above the risk to the baby, the drug can be used for its intended purpose. There is no data on the penetration of hexethidine across the placenta or into breast milk.

Hexoral for children

According to the instructions, the medication is contraindicated for use in children under three years of age. Hexoral can be prescribed to children when there is no danger of uncontrolled swallowing or resistance to a foreign object in the mouth (spray nozzle). If the child cannot yet independently hold his breath during injection, it is better not to use the medicine.

Drug interactions

According to the instructions for use of Hexoral, drug interactions of the aerosol and solution with other medications are not described. From this we can conclude that medications can be combined in any order, but before any treatment of infections, medical consultation is necessary. This will help avoid negative effects on the health of the body.

Side effects

Instructions for use of Hexoral indicate the following possible side effects that occur when taking it:

• allergic reactions, hypersensitivity, urticaria, angioedema;
• ageusia, dysgeusia, poisoning;
• cough, shortness of breath;
• numbness and discoloration of the tongue, short-term loss of taste;
• dry mouth, nausea, vomiting, increased salivation;
• irritation of the mucous membrane, burning, paresthesia;
• inflammation of the mucous membranes, formation of blisters and ulcers;
• darkening of the enamel color.

Overdose

According to the instructions, it is unlikely that hexethidine has a toxic effect when taken in recommended doses. If the drug is accidentally swallowed, symptoms of alcohol intoxication may appear. Treatment is gastric lavage within two hours after the child swallows the dose, symptomatic therapy. In any case of overdose, the patient should see a doctor.

An overdose of tablets is unlikely; its symptoms are suffocation, tremors of the limbs, vomiting, and convulsions. Respiratory depression can cause coma and death. Treatment consists of artificially inducing vomiting and gastric lavage with activated charcoal. For convulsions, barbiturates or diazepam are prescribed, for hypoxia - artificial respiration and suxamethonium chloride, circulatory support by administering electrolyte solutions.

Contraindications

The instructions for use of Hexoral state the following contraindications that prohibit the use of the medication:

• erosive-squamous lesions of the oral mucosa;
• age up to three years for spray and solution, up to four years for tablets;
• hypersensitivity to the components of the composition or acetylsalicylic acid;
• with caution during pregnancy and breastfeeding.

Terms of sale and storage

The drug is dispensed from pharmacies without a prescription, stored away from children and light at temperatures up to 25 degrees. The shelf life is three years, but the contents of the spray bottle must be used within six months after opening. The solution is stored for two years.

Analogs

Based on the active substance and the therapeutic effect provided, the following analogues of Hexoral are distinguished in the form of a spray and solution, produced by domestic and foreign companies:

• Stomatidin;
• Stopangin;
• Hexosept;
• Stomolik;
• Dentagel;
• Metroviol;
• Metrohex;
• Metrogil Denta;
• Metrodent;
• Stomatogel;
• Candide;
• Metrozol Denta;
• Metronidazole Denta.

Geksoral's analogue is cheaper

Not all drug analogues are affordable, but the following drugs in the form of a spray or antiseptic solution can be bought at any pharmacy cheaper than Hexoral:

• Proposol spray;
• spray and ointment Tantum Verde;
• Inhalipt spray;
• antiseptic solution Miramistin;
• Lizobact lozenges;
• medicinal aerosol Stopangin.

Hexoral price

The cost of Hexoral depends on the form of release, the manufacturer and the price category of the pharmacy. Prices on the Internet are cheaper than in traditional pharmacies, but you will have to pay for delivery. Approximate prices for medicine.

Antiseptic for topical use in ENT practice and dentistry

Active substance

Release form, composition and packaging

◊ Aerosol for topical use 0.2% in the form of a clear, colorless liquid with a menthol odor.

Excipients: polysorbate 80, citric acid monohydrate, sodium saccharinate, levomenthol, oil, sodium calcium edetate, ethanol 96%, sodium hydroxide, purified water, nitrogen.

40 ml - aluminum aerosol cans (1) complete with one spray nozzle or four spray nozzles of different colors - cardboard packs.

pharmachologic effect

The effect of the drug Hexoral is associated with the suppression of oxidative reactions of bacterial metabolism (thiamine antagonist). The drug has a wide spectrum of antibacterial and antifungal effects, in particular against gram-positive bacteria and fungi of the genus Candida.

Hexethidine has a weak anesthetic effect on the mucous membrane.

The drug has an effect against influenza A viruses, respiratory syncytial virus (RS virus), herpes simplex virus type 1, affecting the respiratory tract.

Pharmacokinetics

Hexethidine adheres very well to the mucous membrane and is practically not absorbed.

After a single use of the drug, traces of the active substance are found on the mucous membrane of the gums within 65 hours. In dental plaque, active concentrations remain for 10-14 hours after use.

Indications

As a symptomatic remedy.

• symptomatic treatment for infectious and inflammatory diseases of the oral cavity and larynx:
  • tonsillitis (including Plaut-Vincent angina, angina of the lateral ridges), pharyngitis, gingivitis, stomatitis, glossitis, periodontal disease;
  • fungal diseases.
• prevention of infectious complications before and after surgical interventions in the oral cavity and larynx, as well as in case of injuries (including prevention of infection of the alveoli after tooth extraction);
• oral hygiene (including removal from the mouth).

Contraindications

• erosive-squamous lesions of the oral mucosa;
• children under 3 years of age;
• hypersensitivity to the components of the drug.

Dosage

The drug is used topically. Hexethidine adheres to the mucous membrane and due to this gives a lasting effect. In this regard, the drug should be used after meals.

U adults and children over 6 years old treat the affected areas while holding your breath. 1 injection for 1-2 seconds 2 times a day.

During the administration of the drug, holding your breath is necessary, because inhalation of the drug can provoke laryngospasm.

U children aged 3 to 6 years The use of the drug is possible after consultation with a medical professional.

The duration of treatment is determined by the doctor.

The drug is sprayed into the mouth or throat. Using an aerosol you can easily and quickly treat the affected areas. You need to do the following:

1. put a spray nozzle on the aerosol can;

3. during administration of the drug, the bottle should be kept in a vertical position at all times;

4. Inject the required amount of the drug by pressing on the head of the spray nozzle for 1-2 seconds, do not breathe when introducing the aerosol.

Side effects

Adverse reactions identified during post-registration use of the drug are classified as follows: very often (≥1/10), often (≥1/100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10 000, <1/1000), очень редко (<1/10 000), частота неизвестна (частота возникновения не может быть оценена на основании имеющихся данных).

From the immune system: very rarely - hypersensitivity reactions (including urticaria), angioedema.

From the nervous system: very rarely - ageusia, dysgeusia.

From the respiratory system: very rarely - cough, shortness of breath due to the appearance of a hypersensitivity reaction, laryngospasm.

From the digestive system: very rarely - dry mouth, dysphagia, nausea, enlarged salivary glands, vomiting.

General disorders and disorders at the injection site: very rarely - reactions at the site of application (including irritation of the mucous membrane of the mouth and pharynx, burning sensation, paresthesia of the oral cavity, discoloration of the tongue, discoloration of teeth, inflammation, blistering and ulceration).

If any of these side effects worsen or other side effects are noted, the patient should consult a doctor.

Overdose

Hexethidine is unlikely to cause toxicity when used at recommended doses.

Symptoms: Ingestion of large quantities of a drug containing ethanol may result in signs/symptoms of alcohol intoxication.

Treatment: carrying out symptomatic therapy, as with alcohol intoxication. Gastric lavage is necessary within 2 hours after ingestion of an excess dose. In any case of overdose, the patient should immediately consult a doctor.

Drug interactions

special instructions

During administration of the drug, holding your breath is necessary.

Children can use the drug from an age when there is no danger of uncontrolled swallowing or when they do not resist a foreign object (spray nozzle) in the mouth when using the aerosol and are able to hold their breath when injecting the drug.

The contents of the aerosol can are under pressure. Do not open, puncture or burn the cylinder, even if the cylinder is empty.

If the medicine has become unusable or has expired, do not pour it into wastewater or throw it outside. It is necessary to place the medicine in a bag and place it in the trash container. These measures will help protect the environment.

Impact on the ability to drive vehicles and machinery

Hexoral aerosol does not affect the ability to drive vehicles or perform other potentially hazardous activities.

Pregnancy and lactation

There is no information about any undesirable effects when using the drug Hexoral during pregnancy and breastfeeding. However, before prescribing Hexoral, pregnant or lactating women should carefully weigh the expected benefits and risks of treatment, given the lack of sufficient data on the penetration of the drug through the placental barrier and excretion in breast milk.

Use in childhood

Contraindicated for use in children under 3 years of age.

Conditions for dispensing from pharmacies

The drug is available without a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 3 years. Do not use after the expiration date stated on the package.

The contents of the aerosol can should be used within 6 months after first use.

Hexoral spray is an antiseptic drug; it is actively used in ENT practice for the treatment of various diseases of the oral cavity and throat. The drug is not intended for children, but many pediatricians prescribe it to young patients.

Responsible parents are wondering: is it possible to give Hexoral to a baby? The product shows excellent results, sometimes there are side effects. The correct use of medication for a child, dosage, and other application features are the main aspects of the material.

Pharmacological properties

Hexoral has the ability to inhibit pathogenic bacteria. The medication is effective against a wide range of pathogenic microorganisms, in particular, gram-positive bacteria and fungi of the genus Candida. The main active ingredient of the drug has an antimicrobial, hemostatic, enveloping, analgesic effect.

When using Hexoral topically, the drug is not absorbed into the blood; after a single use of the drug, the residual concentration in the oral cavity is detected after 65 hours. The positive therapeutic effect lasts for at least 10 hours. The medicine begins to act after 15 minutes, effectively copes with the task, and alleviates the baby’s condition.

Important! Use the medicinal product only after consultation with your pediatrician; it is prohibited to give your baby a potent drug on your own.

Indications for use

Pediatricians prescribe Hexoral spray to solve the following problems:

• the product effectively copes with sore throat and diseases of the oral cavity and pharynx: (the appearance of ulcers on the mucous membranes), gingivitis (characterized by inflammation of the gums), glossitis (inflammation of the tongue area), (pathological condition of the pharyngeal mucosa);
• the spray is used to eliminate unpleasant purulent symptoms, accompanied by fever, general intoxication of the child’s body;
• the drug quickly kills the fungus, copes with it not only in children, but also in adults;
• Hexoral aerosol is widely used in pediatric dentistry for the treatment of gum diseases and aphthous stomatitis (characterized by purulent formations in the oral cavity). The product is used for preventive purposes before tooth extraction, other dental procedures, especially surgery;
• ailments of other organs and systems. Used as an auxiliary antiseptic medicine. Reduced immunity cannot resist pathogenic bacteria; Hexoral spray is a kind of barrier to pathogenic microorganisms;
• prescribed for treatment, as an auxiliary medicinal product.

Hexoral is very popular among pediatricians due to its wide spectrum of action, high efficiency, and ease of use. The spray sprays well and reaches the most remote corners of the mouth. Little children do not like taking pills; the aerosol is perceived as a game, not a medicine, which makes the treatment process easier.

Composition of the drug and release form

The main active ingredient of Hexoral, which has an antifungal, antiseptic, and analgesic effect, is hexetidine. It copes well with pathogenic bacteria and fungi. The drug is not addictive and is well tolerated by children.

In addition to the main component, Hexoral aerosol contains natural ingredients:

• eucalyptol,
• peppermint ether,
• lemon acid.

Additional substances provide the spray with the desired consistency, pleasant taste and aroma, relieve inflammation, and have a softening effect.

The solution and pills contain other auxiliary components, but the main ingredient remains unchanged. Hexoral is used for children from three years old, Sometimes it is prescribed for younger children, but such manipulations have some peculiarities.

Instructions for use and dosage

The effectiveness of the drug is high, do not exceed the indicated dosage, follow the instructions carefully. Hexoral spray is recommended for irrigating the baby's mouth and throat. Carry out therapeutic manipulations only after eating, the medicine remains on the surface of the mucous membranes and continues to destroy pathogenic bacteria. When irrigating, tell your child to hold their breath to prevent the substance from entering the lungs.

Hexoral in bottles is called a spray; in fact, it is an aerosol. It differs from a spray in the aggressiveness of its spraying. If you do not hold your breath, the active particles of the drug, when they enter the lungs, can provoke an attack of suffocation, especially this aspect applies to children prone to allergies and having a disease called asthma. The drug is sprayed into the mouth or throat twice a day, the duration of irrigation is no more than 1-2 seconds, the duration of the course of treatment is determined by the doctor.

The medication has a pronounced local effect, after a little time the pain in the throat disappears, the ulcers heal, the cough subsides, and the swelling of the mucous membranes subsides. Use the drug only after consulting a doctor.

Can it be used by children under three years old?

The instructions for the medication do not recommend giving Hexoral spray to children under three years of age, but pediatricians often prescribe the drug for the treatment of sore throat, pharyngitis, and stomatitis. Parents are alarmed by this aspect; they refuse to give medicine to the baby. However, in some cases, on the recommendation of a doctor, the remedy is used for young children.

The product in the form of an aerosol is almost not absorbed into the blood and does not pose any particular danger to the baby’s life. Small children cannot rinse their mouths on their own. Any aerosols are contraindicated for children under three years of age. The only way out is to apply the medicine to the mucous membranes of the baby’s throat and mouth using gauze soaked in the medicine.

To treat the mucous membranes of the mouth for stomatitis, spray a little Hexoral spray onto sterile gauze and gently lubricate the affected areas of the baby. Pediatricians recommend giving children under one year of age a pacifier, onto which a medicinal aerosol is first sprayed. The spray can be used only after the possibility of laryngospasm has been eliminated.

If after use the baby develops a cough or hoarseness, give him warm water to drink, do not give him the product again, or use the aerosol only on moistened gauze. Carry out all medical manipulations carefully, try not to damage the mucous membranes with the applicator when you insert it into the baby’s mouth.

Contraindications and side effects

There are no special contraindications to the use of Hexoral spray; it is not recommended to be given to children under 3–4 years of age, due to their inability to hold their breath. It is prohibited to use the medication if you are hypersensitive to certain components of the medicinal product. The medication does not interact in any way with other drugs; at least, there have been no reports of unpleasant phenomena.

Hexoral in the indicated dosage is non-toxic and absolutely safe for the child’s body. Swallowing large amounts of the product may cause vomiting. In case of individual intolerance, local allergic reactions (rashes, itching) may occur. Due to the fact that the drug is not absorbed into the blood, no special side effects are detected.

Name:

Hexoral

Pharmacological
action:

Antiseptic.
The antimicrobial effect of the drug Hexoral is associated with the suppression of oxidative reactions of bacterial metabolism (thiamine antagonist).
The drug has a wide spectrum of antibacterial and antifungal action, in particular against gram-positive bacteria and fungi of the genus Candida, however Hexoral can also have an effect in the treatment of infections caused, for example, by Pseudomonas aeruginosa or Proteus.
At a concentration of 100 mg/ml the drug suppresses most strains of bacteria. No development of resistance was observed.
Hexethidine has a weak anesthetic effect on the mucous membrane.
Pharmacokinetics
Hexethidine adheres very well to the mucous membrane and is practically not absorbed.
After a single use of the drug, traces of the active substance are found on the gum mucosa for 65 hours.
In plaques on teeth, active concentrations remain for 10-14 hours after application.

Indications for
application:

Inflammatory and infectious diseases of the oral cavity and pharynx;
- in the complex treatment of severe febrile or purulent
diseases of the oral cavity and pharynx requiring prescription
antibiotics and sulfonamides, tonsillitis;
- tonsillitis (including tonsillitis with damage to the lateral ridges, tonsillitis
Plaut-Vincent);
- pharyngitis;
- gingivitis and bleeding gums;
- periodontopathies (periodontal diseases and their symptoms);
- stomatitis (inflammation of the oral mucosa), glossitis
(inflammation of the tongue), aphthous ulcers (painful inflammation with
surface tissue defects) for the purpose of prevention
superinfections;
- infection of the alveoli (tooth sockets) after tooth extraction;
- fungal infections of the oral cavity and pharynx, especially candidal stomatitis (thrush);
- before and after operations in the oral cavity and pharynx;
- additional oral hygiene for general diseases;
- elimination of bad breath, especially in the case of
collapsing tumors of the oral cavity and pharynx;
- an aid in the treatment of colds.

Mode of application:

Hexoral is a remedy for topical use in the oral cavity.
Spray
Adults and children over 6 years of age.
Procedure technique:
- install the flexible tube into the corresponding hole on the head of the bottle, pressing lightly on it. Point the end of the flexible tube away from you;
- holding the flexible tube in your mouth, direct it to the appropriate area of ​​the mouth or throat. During the procedure, always keep the bottle upright;
- holding your breath, inject Hexoral spray by pressing the head of the balloon for 1–2 s.

Apply 2 times a day, preferably in the morning and evening, after meals.
The duration of treatment is determined by the doctor depending on the severity and characteristics of the disease.

Solution
Adults, elderly people, teenagers and children over 6 years of age.
You should rinse your mouth or gargle with 15 ml of undiluted solution for 30 seconds 2 or 3 times a day.
Do not swallow the drug.
For rinsing, use undiluted solution.
The duration of treatment is determined by the doctor depending on the severity and characteristics of the disease.

Side effects:

- from the skin and subcutaneous tissue: the occurrence of ulcers on the mucous membrane, allergic contact dermatitis, angioedema;
- general disorders: change in taste sensations over 48 hours (the feeling of “sweet” can change twice to the feeling of “bitter”); sensitivity of the mucous membrane, namely burning, numbness; irritation (pain, sensation of heat, itching) of the tongue and/or oral mucosa, decreased sensitivity; hypersensitivity;
- other adverse reactions: reversible change in the color of teeth and tongue; Azorubine may cause allergic reactions;
- in case of accidental ingestion The drug may cause gastrointestinal disturbances, primarily nausea and vomiting.

Contraindications:

Hexoral spray:
- age up to 6 years;
- the spray is contraindicated in patients with asthma or any other respiratory tract diseases associated with their hypersensitivity. Inhalation may cause bronchoconstriction.

Hexoral solution:
- hypersensitivity to hexetidine, azorubine, eucalyptus oil, levomenthol, peppermint oil or any other component of the drug;
- age up to 6 years.

There are no special instructions.
Hexoral solution for topical use can be used to rinse the mouth and throat only if the patient can spit out the solution after rinsing.
Hexoral solution for topical use contains ethanol 96% (4.33 g/100 ml solution).

Use in pediatrics
In children, the drug can be used from an age when there is no danger of uncontrolled swallowing when using the solution.

The ability to influence reaction speed when driving vehicles or other mechanisms.
Hexoral does not affect the ability to drive or operate other machinery.

Interaction
other medicinal
by other means:

Pregnancy:

There is no data on the negative impact of Hexoral on the body of the fetus (child) or pregnant woman (nursing mother), however, due to insufficient data on the possibility of penetration of the drug components into breast milk or through the placental barrier, the use of the drug during lactation and pregnancy is possible only after a thorough analysis of the relationship between potential harm to the fetus and benefit to the mother.

Overdose:

Hexetidine in the indicated dosage is non-toxic.
Symptoms: Ingestion of large quantities of the drug results in vomiting, so significant absorption is not expected.
No cases of alcohol poisoning due to overdose have been described.
Acute alcohol poisoning is very unlikely, but theoretically possible if a large dose of the drug is swallowed by a small child.
Treatment: Gastric lavage is necessary within 2 hours after ingestion of an excess dose.
Carrying out symptomatic therapy, as for alcohol intoxication.
In any case of overdose, the patient should immediately consult a doctor.

Release form:

Hexoral solution 0.1% in 100 ml bottles.
Hexoral aerosol 0.2% in a 40 ml aerosol can.

Storage conditions:

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Best before date- 2 years.
The drug is approved for use as a means of OTC.

Spray for mouth. cavities 0.2% contains:
- active ingredient: hexetidine 2 mg/ml;
- excipients: sodium saccharin, citric acid monohydrate, sodium hydroxide, glycerin, macrogol lauryl ether, mint flavor, purified water, nitrogen.

R-r d/rotov. cavities 0.1% fl. 200 ml contains:
- active ingredient: hexetidine 1 mg/ml;
- excipients: polysorbate 60, sodium saccharin, citric acid monohydrate, methyl salicylate, azorubine (E122), levomenthol, peppermint oil, anise oil, eucalyptus oil, clove oil, ethanol 96%, purified water.

INSTRUCTIONS
on medical use of the drug

Registration number:

ND 42-11460-06

Tradename:

Hexoral ®

International nonproprietary name:

hexethidine.

Dosage form:

solution for topical use.

Composition per 100 ml solution:

active substance: hexethidine 0.1 g;
Excipients: ethanol 96% – 4.3333 g, polysorbate 60 – 0.7 g, peppermint oil – 0.064 g, anise oil – 0.0392 g, citric acid monohydrate – 0.0418 g, sodium saccharin – 0.022 g, levomenthol – 0.0186 g, methyl salicylate - 0.0186 g, clove oil - 0.0084 g, eucalyptus oil - 0.0011 g, azorubine 85% (E 122) - 0.0023 g, purified water - up to 100 ml.

Description: transparent red liquid with a mint odor.

Pharmacotherapeutic group:

antiseptic.

ATX code: A01AB12.

Pharmacological properties

Pharmacodynamics
The antimicrobial effect of the drug "Hexoral ®" is associated with the suppression of oxidative reactions of bacterial metabolism (thiamine antagonist). The drug has a wide spectrum of antibacterial and antifungal effects, in particular against gram-positive bacteria and fungi of the genus Candida, however, Hexoral ® can also have an effect in the treatment of infections caused, for example, by Pseudomonas aeruginosa or Proteus spp. At a concentration of 100 mg/ml, the drug inhibits most strains of bacteria. No development of resistance was observed. Hexethidine has a weak anesthetic effect on the mucous membrane.
The drug has an antiviral effect against influenza A viruses, respiratory syncytial virus (RS virus), and herpes simplex virus type 1, which affect the respiratory tract.
Pharmacokinetics
Hexethidine adheres very well to the mucous membrane and is practically not absorbed.
After a single use of the active substance, traces of it are found on the gum mucosa within 65 hours. In dental plaque, active concentrations remain for 10-14 hours after application.

Indications for use

As a symptomatic remedy.
Symptomatic treatment for inflammatory and infectious diseases of the oral cavity and larynx:
- tonsillitis, tonsillitis (including Plaut-Vincent tonsillitis, tonsillitis of the lateral ridges), pharyngitis, gingivitis, stomatitis, glossitis, periodontal disease;
- fungal diseases;
prevention of infectious complications before and after surgical interventions on the oral cavity and larynx and in case of injuries, including prevention of infection of the alveoli after tooth extraction;
oral hygiene, including to eliminate bad breath.

Contraindications

Hypersensitivity to any of the components of the drug;
erosive-desquamous lesions of the oral mucosa;
children under 3 years of age.

Carefully: with hypersensitivity to acetylsalicylic acid.

Use during pregnancy and breastfeeding

There is no information about any undesirable effects of the drug Hexoral ® during pregnancy and breastfeeding. However, before prescribing Hexoral ® to pregnant or lactating women, the doctor must carefully weigh the benefits and risks of treatment, given the lack of sufficient data on the penetration of the drug through the placenta and into breast milk.

Directions for use and doses

Locally. Children from 3 to 6 years old: The use of the drug is possible after consultation with a medical professional. Children can use the drug from an age when there is no danger of uncontrolled ingestion when using the solution.
Adults and children over 6 years of age: Fill the measuring cup to the 15 ml mark and rinse the mouth and larynx with 15 ml of undiluted solution for at least 30 seconds 2-3 times a day.
Hexethidine adheres to the mucous membrane and due to this gives a lasting effect. In this regard, the drug should be used after meals.
The drug "Hexoral ®", a solution for topical use, can only be used for rinsing the mouth and larynx. The solution should not be swallowed.
An undiluted solution should always be used.
When treating diseases of the oral cavity, the drug can also be applied using a tampon for 2-3 minutes.
The duration of treatment is determined by the doctor.

Side effect

Adverse reactions identified during post-registration use of the drug were classified as follows: very frequent (>1/10), frequent (≥1/100, <1/10), not frequent (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare(<1/10000), frequency unknown(incidence cannot be estimated from available data).
Immune system disorders. Very rarely: hypersensitivity reactions (including urticaria), angioedema.
Nervous system disorders. Very rarely: ageusia, dysgeusia.
Disorders of the respiratory system, chest and mediastinal organs. Very rarely: cough, shortness of breath due to the appearance of a hypersensitivity reaction.
Gastrointestinal disorders. Very rarely: dry mouth, dysphagia, nausea, enlarged salivary glands, vomiting.
General disorders and disorders at the injection site. Very rarely: reactions at the site of application (including irritation of the oral mucosa and pharynx, burning sensation, oral paresthesia, discoloration of the tongue, discoloration of teeth, inflammation, blistering and ulceration).
If any of the side effects listed in the instructions get worse, or you notice other side effects, it is recommended to consult a doctor.

Overdose

It is unlikely that hexetidine can have a toxic effect when used according to the instructions for use of the drug.
Ingestion of large quantities of hexethidine solution containing ethanol may result in signs/symptoms of alcohol intoxication.
In any case of overdose, consult your doctor immediately. Treatment is symptomatic, as for alcohol intoxication. Gastric lavage is necessary within 2 hours after ingestion of an excess dose.

Interaction with other drugs

No data available.

special instructions

The drug "Hexoral", a solution for topical use, can be used to rinse the mouth and throat only if the patient can spit out the solution after rinsing. The drug "Hexoral ®", solution for topical use, contains ethanol 96% (4.3333 g/100 ml of solution).
If the medicine has become unusable or has expired, do not pour it into wastewater or throw it outside! Place the medication in a bag and place it in the trash. These measures will help protect the environment!

Impact on the ability to drive vehicles and engage in other potentially hazardous activities

The drug "Hexoral", a solution for topical use, does not affect the ability to drive vehicles and engage in other potentially hazardous activities.

Release form

Solution for topical use 0.1%.
200 ml of the drug in a bottle made of colorless glass (type III) with an aluminum screw cap with first opening control.
1 bottle along with a measuring cup and instructions for use in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25°C. Keep out of the reach of children.

Best before date

2 years.
Do not use the drug after the expiration date indicated on the package.

Vacation conditions

Over the counter.

Manufacturer

Famar Orleans, France
Legal address: Famar Orleans, 5 avenue de Concyr, 45071 Orleans Cedex 2, France / Famar Orleans, 5 avenue de Concyr, 45071 Orleans Cedex 2, France
Organization receiving complaints: Johnson & Johnson LLC, Russia, 121614, Moscow, st. Krylatskaya, 17, building 2.