Hexoral aerosol (Hexetidine) 0.2% 40 ml

Instructions for Hexoral

PHARMACOLOGICAL Hexoral:

PROPERTIES pharmacodynamics Hexoral
Hexetidine is an active substance with a quick and long-lasting effect, which belongs to the group of local antiseptics used gingivodentally and oropharyngeally. It has antibacterial and antifungal effects against a wide range of pathogenic microorganisms that cause oropharyngeal infections. When applied, it also exhibits wound healing, hemostatic and local anesthetic properties in the oral cavity and pharynx.

Hexetidine is a broad-spectrum antimicrobial agent. This agent is effective both in vivo and in vitro against gram-positive and gram-negative bacteria, as well as yeast ( Candida albicans ) and fungi. Specific pharmacokinetic studies on the use of Hexoral spray in humans have not been performed. When using the drug, plaque and residual concentrations of hexetidine on the mucous membranes can be determined. Studies using labeled hexetidine have shown that it can be detected on the tissues of the oral cavity from 8 to 10 hours after a single application, and in some cases, it can appear on the tissues of the oral cavity 65 hours after treatment. Pharmacokinetics .

There are no clinical data on the pharmacokinetics of hexetidine in humans. The drug Hexoral acts topically on the mucous membrane of the mouth, therefore it is expected to be absorbed only in small amounts. The high affinity of hexetidine for proteins and polymers with electronegative sites explains its binding to bacteria and directly contributes to its action on the oral mucosa due to the residual concentration of hexetidine. This affinity also explains the plaque binding and hence the anti-plaque effect. The antibacterial effect can be determined 10-14 hours after application. The study of absorption after topical application of Hexoral ® spray or hexetidine in humans has not been performed. Specific studies spray Geksoral ® or hexetidine in patients with impaired liver function and / or renal patients and elderly was carried out.

INDICATIONS Hexoral:

Hexoral is used for minor infections of the oral cavity, including candidiasis; as an adjunct for the prevention and treatment of gingivitis; with sore throat and recurrent aphthous ulcers; to eliminate bad breath; before and after surgical interventions in dentistry.

APPLICATION Hexoral:

adults and children over the age of 6 Hexoral spray is a topical application in the oral cavity. Technique of the procedure: install the flexible tube into the corresponding hole on the head of the bottle by slightly pressing it. Direct the end of the flexible tube away from you; while holding the flexible tube in your mouth, direct it to the appropriate area of the mouth or throat. Always keep the bottle upright during the procedure; holding your breath, inject Hexoral ® spray by pressing the cylinder head for 1–2 s. Apply no more than 3 times a day (depending on the severity of the disease or the doctor's recommendations). The duration of treatment is determined by the doctor individually, depending on the severity and characteristics of the course of the disease. Not used to treat symptoms that persist over a long period. Do not inhale, may provoke laryngospasm. You should consult your doctor before using the drug.

CONTRAINDICATIONS Hexoral:

spray is contraindicated: in the presence of hypersensitivity to hexetidine, eucalyptus oil, levomenthol or to any other component of the drug; patients with asthma or with any other respiratory diseases associated with airway hypersensitivity. Inhalation may cause bronchoconstriction; atrophic pharyngitis.

SIDE EFFECTS Hexoral:

from the immune system : hypersensitivity reactions, including urticaria, angioedema, allergic reactions, including laryngospasm, bronchospasm. From the nervous system : ageusia, dysgeusia, change in taste sensations within 48 hours (the sensation of "sweet" can change twice to the sensation of "bitter"). From the respiratory system, chest and mediastinal organs : cough, shortness of breath, laryngospasm. From the digestive tract : dry mouth, dysphagia, enlargement of the salivary glands, pain when swallowing. If the drug is accidentally swallowed, gastrointestinal disturbances may occur, especially nausea and vomiting. On the part of the skin and subcutaneous tissue : allergic contact dermatitis, angioedema.

General disorders and conditions at the site of application: local reactions, including reversible discoloration of teeth and tongue; sensitivity of the mucous membrane, namely, burning, feeling of numbness; irritation (soreness, feeling of heat, itching) of the tongue and / or oral mucosa; decreased sensitivity; paresthesia of the mucous membrane; inflammation; bubbles; the occurrence of ulcers on the mucous membrane.

SPECIAL INSTRUCTIONS Hexoral:

the drug Hexoral should be used with caution in patients with epilepsy. The drug can reduce the epileptic threshold and cause seizures in children. The drug should be used with caution in patients with allergic reactions, including BA, especially in patients with allergy to acetylsalicylic acid. The drug contains ethanol, so it should be used with caution in patients with liver disease.

During the use of the drug Hexoral, you should not inhale, since the spray can enter the respiratory tract and cause laryngospasm. There is a risk of laryngospasm in children due to the presence of levomenthol in the drug. If inflammation increases, treatment should be discontinued. Long-term use is not recommended (do not use for more than 10 days without a doctor's recommendation).

Application during pregnancy and lactation . Appropriate and well-controlled clinical studies of the use of hexetidine during pregnancy and lactation have not been conducted. It is not known whether hexetidine or its metabolites are excreted in breast milk. A small amount of hexetidine is absorbed systemically. It is unlikely that the use of hexetidine during pregnancy and lactation causes a risk to the fetus or baby. However, hexetidine should not be used during pregnancy and lactation, unless the potential benefit of treatment to the mother outweighs the potential risks to the development of the fetus or baby. Children . Do not use Hexoral ® spray in children under 6 years of age. The ability to influence the reaction rate when driving vehicles or other mechanisms . The drug contains ethanol. Drivers are not recommended to drive a car within 30 minutes after using the drug.

INTERACTIONS Hexoral:

interactions with other antiseptic drugs may occur. Heksetidine can be inactivated with alkaline solutions.

OVERDOSE Hexoral:

swallowing a large amount of the spray may cause nausea, so significant systemic absorption will not occur. Due to the absorption of a sufficient amount of Hexoral ® spray, alcohol intoxication may occur due to the content of ethyl alcohol.

The concentration of hexetidine, which is contained in Hexoral ® oral spray, is non-toxic if used as directed . There are no cases of excessive use of hexetidine, which leads to the occurrence of hypersensitivity reactions. Keep out of the reach of children. In case of overdose, seek immediate medical attention.Hexoral