Composition, form of production and packaging
? Aerosol for topical application 0.2% in the form of a transparent colorless liquid with a smell of menthol.
hexiethidine 0.2 g
Auxiliary substances: polysorbate 80 - 1.4 g, citric acid monohydrate - 0.07 g, sodium saccharinate - 0.04 g, levomentol - 0.07 g, leaf eucalyptus oil of rod-like - 0.0011 g, sodium calcium edetate - 0.1 g, ethanol 96% - 4.333 g, sodium hydroxide - qs to pH 5.5 В± 0.2, purified water - qs to 100 ml, nitrogen - qs to 5 bar.
40 ml - aerosol aluminum cylinders (1) complete with one nozzle-sprayer or four nozzles-sprayers of different colors - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
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.
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.
As a symptomatic agent in the treatment of infectious and inflammatory diseases of the oral cavity and pharynx:
- angina (including angina with lesion of lateral ridges, Plout-Vincent's angina);
- 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).
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.
In adults and children older than 6 years, treated affected areas with respiratory arrest. Assign 1 injection in 1-2 seconds 2 times / day.
In children aged 3 to 6 years , the drug is possible after consultation with a doctor.
The duration of treatment is determined by the doctor.
General recommendations for use
The drug is sprayed into the mouth or throat. Using aerosol, it is possible to easily and quickly treat affected areas. It is necessary to perform the following actions:
1. put the spray nozzle on the aerosol can;
2. Direct the end of the nozzle-sprayer to the affected area of вЂ‹вЂ‹the mouth or pharynx;
3. During the introduction of the drug, the vial should be kept constantly in an upright position;
4. Enter the required amount of the drug, pressing on the head of the nozzle-sprayer for 1-2 seconds, do not breathe when injecting the aerosol.
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.
- erosive-squamous lesions of the mucous membrane of the oral cavity;
- children's age till 3 years;
- Hypersensitivity to the components of the drug.
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, the expected benefit and risk of treatment should be weighed carefully, given the lack of sufficient data on the penetration of the drug through the placental barrier and excretion in breast milk.
APPLICATION FOR CHILDREN
Contraindicated in children under 3 years.
Children can use the drug from such an age when there is no danger of uncontrolled ingestion or when they do not resist the foreign object (nozzle-spray) in the mouth when using an aerosol and are able to hold their breath when injecting the drug.
There are no special regulations.
The content of ethanol in the preparation is 5.15%. One dose of the drug contains 20.3 mg of ethanol (in terms of absolute alcohol).
The contents of the aerosol can is under pressure. Do not open, puncture and burn the cylinder, even if it is empty.
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
Children can use the drug from such an age when there is no danger of uncontrolled ingestion or when they do not resist the foreign object (nozzle-spray) in the mouth when using aerosol and are able to hold their breath when injecting the drug.
Impact on the ability to drive vehicles and manage mechanisms
HexoralВ® aerosol does not affect the ability to drive vehicles and perform other potentially hazardous activities.
It is unlikely that hexaethidine can have toxic effects when administered at recommended doses.
Symptoms: swallowing a large amount of a drug 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 of the drug Hexoral В® aerosol 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 - 3 years.
The contents of the aerosol canister should be used within 6 months after the first application.