Halixol syrup 30mg / 10ml, 100ml

• Acute and chronic obstructive respiratory diseases, accompanied by the formation of viscous sputum: bronchitis, bronchial asthma, chronic obstructive pulmonary disease, pneumonia, bronchiectasis.

• Inflammatory diseases of the ENT organs (sinusitis, otitis media), in which it is necessary

Inside, after meals and drinking plenty of fluids.

The syrup can be taken using the measuring cap supplied with the preparation. Abundant fluid intake helps to thin the mucus during treatment with HalixolЃ.

Adults and children over 12 years old: the usual daily dose in the first 2-3 days of treatment: 10 ml of syrup 3 times a day, and on the following days - 10 ml of syrup 2 times a day or 5 ml of syrup 3 times a day.

In severe cases of the disease, the dose is not reduced during the entire course of treatment.

Children under 2 years of age: 2.5 ml of syrup 2 times a day. 2-5 years: 2.5 ml of syrup 3 times a day. 6-12 years: 5 ml of syrup 2-3 times a day.

In severe renal failure, lower doses should be prescribed or the intervals between doses of the drug should be increased.

When taking HalixolЃ for more than 4-5 days, it is recommended to consult a doctor.

100 ml of syrup contains 0.300 g of the active ingredient ambroxol hydrochloride (3 mg / ml);

excipients: sorbitol 24,000 g, povidone (K-90) 3,000 g, citric acid monohydrate 0.200 g, sodium cyclamate 0.200 g, strawberry flavor 0.150 g, banana flavor 0.100 g, sodium benzoate 0.100 g, sodium citrate dihydrate 0.069 g, purified water up to 100.00 ml.

• Hypersensitivity to ambroxol or to any of the components of the drug.

• Ulcerative lesion of the gastrointestinal tract (GIT).

• Pregnancy (I trimester).

• Fructose intolerance (the drug contains sorbitol).

  Carefully

• Severe liver failure, severe renal failure, impaired motor function of the bronchi, increased production of sputum (with immobile cilia syndrome).

Pharmacodynamics

It has a secretomotor, secretolytic and expectorant effect, stimulates serous cells of the glands of the bronchial mucosa, increases the content of mucous secretion and the release of surfactant (surfactant) in the alveoli and bronchi, normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolyzing enzymes and enhancing the release of lysosomes from Clara cells, it reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport, facilitates the excretion of sputum from the respiratory tract. On average, the effect when taking Ambroxol inside occurs after 30 minutes and lasts 6-12 hours, depending on the size of the single dose.

Pharmokinetics

After oral administration, Ambroxol is rapidly and almost completely absorbed. The time to reach the maximum concentration (TCmax) after oral administration is reached after 1-3 hours. It is metabolized in the liver with the formation of metabolites excreted through the kidneys (dibromantranilic acid, glucuronides). Plasma protein binding is approximately 85%. The half-life (T1 / 2) from blood plasma is 7-12 hours. T1 / 2 of ambroxol and its metabolites is approximately 22 hours. 90% of ambroxol is excreted through the kidneys in the form of metabolites. Less than 10% of ambroxol is excreted unchanged through the kidneys. Due to the high binding to plasma proteins and the large volume of distribution, as well as the slow reverse penetration from tissues into the blood, during dialysis or forced diuresis, no significant excretion of Ambroxol occurs.Ambroxol clearance in patients with severe renal failure is reduced by 20-40%. In severe renal failure, T1 / 2 of ambroxol metabolites increases. Ambroxol crosses the placental barrier and into breast milk.

Overdose

Symptoms: nausea, vomiting, diarrhea, dyspepsia. Treatment: induce vomiting, then prescribe a drink (milk or tea), taking fat-containing foods. Gastric lavage is recommended within 1-2 hours after taking the drug. Symptomatic therapy.

Side effects

Immune system disorders: Rarely: hypersensitivity reactions Frequency unknown: anaphylactic reactions, including anaphylactic shock, angioedema, pruritus

From the nervous system: Often: taste disturbances Rarely: headache, weakness

From the respiratory system, chest and mediastinal organs: Often: numbness in the throat Rarely: nasal discharge

From the gastrointestinal tract: Often: nausea, numbness in the mouth Uncommon: indigestion, diarrhea, vomiting, dyspepsia, dry mouth, abdominal pain Rarely: salivation, heartburn, constipation Frequency unknown: dry throat, stomach upset

Skin and subcutaneous tissue disorders Rarely: skin rash, urticaria Frequency unknown: severe skin reactions (including Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis, TEN) and acute generalized eczematous pustulosis)

On the part of the kidneys and urinary tract: Rarely: disorders of urinary excretion Very rarely: dysuria General disorders and disorders at the injection site: Uncommon: fever, mucosal reactions

Drug interactions

Antitussives (including codeine) can make it difficult to produce sputum diluted with ambroxol. Ambroxol promotes the penetration of certain antibiotics into the bronchial secretions (amoxicillin, cefuroxime, erythromycin, doxycycline, etc.). Special conditions Should not be prescribed with antitussive drugs - difficulty in excreting sputum.

The use of the drug in patients with impaired motor function of the bronchi or abundant sputum with low viscosity requires caution due to the danger of stagnation of bronchial secretions.

The syrup contains nonspecific sweeteners, sorbitol (1.2 g per 5 ml of syrup) and sodium cyclamate, so patients with diabetes using this drug should take this into account.

Ambroxol should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.

Patients taking the drug should not be advised to perform breathing exercises; in patients with severe pathology, it is necessary to aspirate liquefied sputum.

In patients with severe skin lesions - Stevens-Johnson syndrome or Lyell's syndrome - in the early phase, body pain, rhinitis, fever, and sore throat may appear.

With symptomatic treatment, it is possible that mucolytic agents such as ambroxol are mistakenly prescribed. There are reports of the detection of Stevens-Johnson syndrome or toxic epidermal necrolysis that coincided with the use of the drug; however, there is no causal relationship with the drug intake.

With the development of the above syndromes, it is recommended to stop treatment and immediately seek medical attention. In case of impaired renal function, Ambroxol is recommended to be used only as directed by a doctor.

Children under 2 years old who are taking HalixolЃ syrup need constant medical supervision.

Influence on the ability to drive vehicles, mechanisms

Care should be taken when driving vehicles and when engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Application during pregnancy and during breastfeeding

The drug is contraindicated in the first trimester of pregnancy, in the second and third trimesters of pregnancy, the use of the drug is possible only if the potential benefit to the mother outweighs the potential risk to the fetus. The drug is excreted in breast milk, therefore, when taking the drug during lactation, the issue of stopping breastfeeding should be decided.