Composition, form of production and packaging
? Topical solution 0.1% in the form of a transparent liquid of red color with the smell of mint.
100 ml
hexiethidine 0.1 g
Auxiliary substances: 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 saccharinate - 0.022 g, levomenthol - 0.0186 g, methyl salicylate - 0.0186 g, clove oil - 0.0084 g, eucalyptus oil 0.0011 g, azorubin 85% (E122) 0.0023 g, purified water up to 100 ml.
200 ml - bottles of colorless glass (III type) (1) complete with a measuring cup - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Antiseptic.
The antimicrobial effect of the drug Hexoral В® is associated with the suppression of oxidative reactions of the metabolism of bacteria (thiamine antagonist). The drug has a broad spectrum of antibacterial and antifungal effects, in particular against gram-positive bacteria and fungi of the genus Candida, however, HexoralВ® 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. The development of stability was not observed.
The drug has antiviral effect against influenza A viruses, respiratory syncytial virus (PC virus), herpes simplex virus type 1, affecting the respiratory tract.
Hexetidine has a weak anesthetic effect on the mucosa.
PHARMACOKINETICS
Hexetidine adheres very well on the mucous membrane and is not practically absorbed.
After a single use of the drug, traces of the active substance are found on the mucosa of the gums for 65 hours. In dental plaque, active concentrations persist for 10-14 hours after application.
INDICATIONS
As a symptomatic agent in the treatment of infectious and inflammatory diseases of the oral cavity and pharynx:
- tonsillitis;
- angina (including angina with lesion of lateral ridges, Plout-Vincent's angina);
pharyngitis;
- gingivitis;
- stomatitis;
- glossitis;
- Parodontosis;
- fungal diseases.
In order to prevent infectious complications before and after surgery in the oral cavity and pharynx, as well as in traumas (including prevention of infection of the alveoli after extraction of the tooth).
Hygiene of the oral cavity (including to eliminate bad breath).
DOSING MODE
The drug is used topically. Hexetidine adheres to the mucosa and thus gives a lasting effect. In this regard, the drug should be used after meals.
Adults and children over the age of 6: fill the measuring cup to 15 ml mark and rinse the oral cavity and pharynx with undiluted solution for at least 30 seconds, 2-3 times / day.
In children aged 3 to 6 years , the drug is possible after consultation with a doctor.
HexoralВ® solution for topical use can only be used to rinse the mouth and throat. The solution must not be swallowed.
Always use undiluted mortar.
When treating diseases of the oral cavity, the drug can also be applied with a tampon for 2-3 minutes.
The duration of treatment is determined by the doctor.
SIDE EFFECT
The undesirable reactions revealed during the post-marketing use of the drug are classified as follows: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely ? 1/10 000, <1/1000), very rarely (<1/10 000), the frequency is unknown (the incidence rate can not be estimated on the basis of available data).
Allergic reactions: very rarely - hypersensitivity reactions (including urticaria), angioedema.
From the nervous system: very rarely - agevzia, dysgeusia.
On the part of the respiratory system: very rarely - cough, shortness of breath, caused by the appearance of a hypersensitivity reaction.
From the digestive system: very rarely - dry mouth, dysphagia, nausea, enlarged salivary glands, vomiting.
Other: very rarely - reactions at the site of application (including irritation of the mucous membrane of the mouth and throat, burning sensation, paresthesia of the mouth, discoloration of the teeth, inflammation, blistering and ulceration).
If any side effects indicated in the manual are aggravated or other side effects are noted, the patient should consult a doctor.
CONTRAINDICATIONS
- erosive-squamous lesions of the mucous membrane of the oral cavity;
- children's age till 3 years;
- Hypersensitivity to the components of the drug.
Caution should be given to the drug with increased sensitivity to acetylsalicylic acid.
PREGNANCY AND LACTATION
Information about any undesirable effects with the use of the drug Hexoral В® during pregnancy and during breastfeeding is not present. However, before prescribing HexoralВ® to pregnant or lactating women, a physician should carefully weigh the expected benefit and risk of treatment, given the lack of sufficient data on penetration of the drug through the placental barrier and excretion in breast milk.
APPLICATION FOR CHILDREN
Contraindicated in children under 3 years.
SPECIAL INSTRUCTIONS
HexoralВ® topical solution can be used to rinse the mouth and throat only if the patient can spit out the solution after rinsing.
HexoralВ® topical solution contains ethanol 96% (4.3333 g / 100 ml solution).
The patient should be informed that if the medicinal product has become unusable or has expired, it should not be poured into sewage or thrown out 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.
Use in Pediatrics
In children, the drug can be used from this age, when there is no danger of uncontrolled ingestion when applying the solution.
Impact on the ability to drive vehicles and manage mechanisms
HexoralВ® solution for topical application does not affect the ability to drive vehicles and perform other potentially hazardous activities.
OVERDOSE
It is unlikely that hexaethidine can have toxic effects when administered at recommended doses.
Symptoms: swallowing a large amount of hexethidine solution containing ethanol can lead to the appearance of signs / symptoms of alcohol intoxication.
Treatment: the conduct of symptomatic therapy, as with alcohol intoxication. Gastric lavage is necessary within 2 hours after swallowing an excessive dose. In all cases of overdose, the patient should immediately consult a physician.
DRUG INTERACTION
Drug interaction of the drug Hexorol В® is not described.
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 - 2 years.
