Hexoral aerosol for external use 0.2% 40ml, 4 nozzles

Product description

The spray with several individual nozzles ensures hygienic use by different family members.

Composition

100 ml of the drug contains: Active ingredient: hexetidine – 0.200 g; excipients: polysorbate 80-1,400 g, citric acid monohydrate-0.070 g, sodium saccharinate-0.040 g, levomentol-0.070 g, eucalyptus rod-shaped leaf oil-0.0011 g, sodium calcium edetate-0.100 g, ethanol 96% – 4.333 g, sodium hydroxide-q. s. up to pH 5.5 ± 0.2, purified water-q. s. up to 100 ml, nitrogen-q. s. up to 5 bar.

Clinical Pharmacology

Pharmacodynamics : The antimicrobial effect of the drug “Geksoral®” is associated with the suppression of oxidative reactions of bacterial metabolism (thiamine antagonist). The drug has a wide range of antibacterial and antifungal effects, in particular against gram-positive bacteria and fungi of the genus Candida, but the drug “Geksoral®” 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 suppresses most bacterial strains. No stability development was observed. Hexetidine has a weak anesthetic effect on the mucous membrane. The drug has an antiviral effect against influenza A viruses, respiratory syncytial virus (MS-virus), herpes simplex virus type 1, affecting the respiratory tract. Pharmacokinetics: Hexetidine adheres very well to the mucous membrane and is practically not absorbed. After a single application of the Active ingredient, its traces are found on the gum mucosa for 65 hours. In dental plaque, active concentrations persist for 10-14 hours after application.

Indications

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

Use during pregnancy and lactation

There is no information about any undesirable effects of the drug “Geksoral®” during pregnancy and lactation. However, before prescribing the drug “Hexoral®” to pregnant or lactating women, the doctor should 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.

Contraindications

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

Side effects

Adverse reactions identified during post-marketing use of the drug were classified as follows: very frequent (≥1/10), frequent (≥1/100, <1/10), infrequent (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (Immune system disorders. Very rare: hypersensitivity reactions (including urticaria), angioedema. Nervous system disorders. Very rare: ageusia, dysgeusia. Respiratory, thoracic, and mediastinal disorders. Very rare: cough, shortness of breath due to the appearance of a hypersensitivity reaction. Disorders of the gastrointestinal tract. Very rare: dry mouth, dysphagia, nausea, enlarged salivary glands, vomiting. General disorders and disorders at the injection site. Very rare: reactions at the site of application (including irritation of the oral and pharyngeal mucosa, burning sensation, oral paresthesia, discoloration of the tongue, discoloration of the 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.

Interaction

No data available.

How to take, course of use and dosage

Locally. Children from 3 to 6 years: the use of the drug is possible after consultation with a medical professional. Adults and children over 6 years of age: treat the affected areas while holding their breath,1 injection for 1-2 seconds 2 times a day. Hexetidine adheres to the mucous membrane and thus gives a lasting effect. In this regard, the drug should be used after meals. General recommendations for introduction. The drug is sprayed in the mouth or pharynx. With the help of an aerosol, you can easily and quickly treat the affected areas. Follow these steps: : • put a spray nozzle on the aerosol can• * point the end of the spray nozzle at the affected area of the mouth or pharynx;• during the use of the drug, the bottle should be held constantly in an upright position, as shown in the figure;• enter 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. The duration of treatment is determined by the doctor.

Overdose

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

Special instructions

There are no special requirements.

Use in pediatrics

In children, the drug can be used from an age when there is no danger of uncontrolled ingestion 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.

Influence on the ability to drive motor vehicles and manage mechanisms

Hexoral® aerosol does not affect the ability to drive vehicles and other potentially dangerous activities.

Rules for drug disposal

The patient should be informed that if the medicine has become unusable or the expiration date has expired, then it should not be thrown into the sewer or on the street. It is necessary to put the medicine in a bag and put it in a garbage container. These measures will help protect the environment.

Form of production

Spray for topical application

Storage conditions

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

Shelf life

3 years

Active ingredient

Hexatidine

Dosage form

oral spray

Description

Children over 3 years of age, Nursing mothers as prescribed by a doctor, Pregnant women as prescribed by a doctor, For adults

Indications

Thrush, Sore Throat, Periodontitis, Flu, Stomatitis, Gum Disease, Periodontitis, Cold, Tonsillitis, Oral Inflammation, Pharyngitis