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Ambrobene syrup: instructions for use

Ambrobene syrup: instructions for use

Production: MERCKLE, GmbH (Germany)

ATX Code: R05CB06 (Ambroxol)

Dosage Form: Syrup

Clinico-pharmacological group: Mucolytic and expectorant drug.

Release form

Colorless or light yellow transparent syrup with a slight odor of raspberry.

Composition

Active ingredient: Ambroxol hydrochloride - 15 mg / ml

Excipients:

  • 70% liquid sorbitol - 60 g;
  • Raspberry Flavor - 0.1 g;
  • Propylene glycol - 5 g;
  • Saccharin - 0.01 g;
  • Purified water - 49.44 g.

Packaging

Bottle of dark glass, 100 ml (1), measuring cup, cardboard pack.

Pharmacodynamics

Ambroxol (benzylamine) is an organic compound that is a metabolite of bromhexine. It differs from it by the presence of hydroxyl and the absence of a methyl group. It has expectorant, secretolytic and secretomotor effects. The therapeutic effect occurs 30 minutes after taking the drug. Duration of action, depending on the dose, 6-12 hours.

In the course of preclinical studies, Ambroxol (syrup) was found to have a stimulating effect on the serous glandular cells of the bronchial mucosa. It activates the work of the ciliary epithelium, reduces the viscosity of sputum, normalizes mucociliary transport (cleansing the surface of the mucous membrane from various foreign bodies). Having a direct effect on Clark's cells located in the bronchial tubes of the lungs and alveolar pneumocytes of type II, Ambroxol contributes to the activation of surfactant (surfactant that prevents alveolar collapse on expiration).

In studies on animals and cell structures, it was found that, under the influence of the drug, the formation and secretion of a substance that is active on the surface of the bronchi and alveoli of an adult and of an embryo is stimulated. There is evidence that Ambroxol has an antioxidant effect. When used in combination with antibacterial drugs (doxycycline, erythromycin, amoxicillin and cefuroxime) it increases their concentration in bronchial secretions and sputum.


Pharmacokinetics

When administered orally, Ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract into the tissue, accumulating mainly in the lungs. Maximum concentration reaches in 1-3 hours.

The absolute bioavailability due to the biotransformation of the medicinal substance is reduced by about 1/3. Dibromantralic acid and glucuronides are excreted by the kidneys due to persist metabolism.

Plasma protein binding is 80-90%. 90% of the drug is excreted in the form of metabolites by the kidneys, 10% - unchanged. Due to the high association with plasma proteins, a large initial volume of distribution and slow redistribution from tissues to blood, there is no significant excretion of the drug during forced diuresis and dialysis.

In severe liver pathologies, Ambroxol clearance is reduced by 20-40%. In severe renal impairment, T1 / 2 metabolites increase.

Ambroxol can penetrate into the cerebrospinal fluid, pass through the placenta and pass into breast milk.

Indications for use

  • Acute and chronic pathologies of the respiratory system, occurring in violation of the formation and discharge of sputum;
  • Acute bronchitis ;
  • Chronic bronchitis of unspecified etiology;
  • Bronchiectasis;
  • Bronchial asthma;
  • Chronic obstructive pulmonary disease (COPD);
  • Bacterial pneumonia, not classified elsewhere.

Dosage

The duration of treatment is chosen individually, taking into account the natural course of the pathological process. Without prescription, the drug is not recommended to take more than 4-5 days. During the period of use of the drug, the patient is prescribed plenty of drink (dilution of sputum requires the ingestion of large amounts of fluid).

Ambrobene syrup is taken after a meal, using a measuring cup for dosing.

Children up to 2 years: 1/2 measuring glassware (2.5 ml) 2 times a day (daily dose of 15 mg of Ambroxol);

Children from 2 to 6 years - 1/2 measuring ware (2.5 ml) 3 times a day (daily dose of 22.5 mg Ambroxol);

Children from 6 to 12 years old - 1 measuring cup (5 ml) 2-3 times a day (daily dose of 30-45 mg of Ambroxol);

For children over 12 years old and adults for the first 3 days of treatment - 2 measuring cups (10 ml) 3 times a day (90 mg of Ambroxol). In the absence of a therapeutic effect, adult patients are allowed to increase the dose to 4 cups (20 ml), taking the drug 2 times a day (60 mg Ambroxol).


Side effects

  • : боли в животе, тошнота, рвота, диарея, запоры (от ≥0.1% до <1%); On the part of the digestive tract : abdominal pain, nausea, vomiting, diarrhea, constipation (≥0.1% to <1%);
  • : кожная сыпь, зуд, крапивница , ангионевротический отек лица (от ≥0.1% до <1%); Allergic reactions : skin rash, itching, urticaria , angioedema of the face (from ≥0.1% to <1%);
  • , в т. ч. анафилактический шок (<0.01%); Anaphylactic reactions , including anaphylactic shock (<0.01%);
  • : головная боль, слабость, лихорадочное состояние (от ≥0.1% до <1%); General disorders : headache, weakness, fever (from ≥0.1% to <1%);
  • : ринорея, пересыхание слизистой оболочки ротовой полости и дыхательных путей, дизурические расстройства, экзантематозные высыпания (от ≥0.1% до <1%). Other disorders : rhinorrhea, drying of the mucous membrane of the mouth and respiratory tract, dysuric disorders, exanthematic rash (from ≥0.1% to <1%).

Contraindications to use

  • Hypersensitivity to the drug;
  • Individual intolerance to fructose;
  • Glucose and malabsorption;
  • Isomaltose / sucrose deficiency;
  • I trimester of pregnancy.

Patients with increased sputum formation (immotile cilia syndrome), impaired bronchial motor function, exacerbation of gastric ulcer and 12 p. intestines, in the II and III trimesters of pregnancy and in the period of lactation when using the drug should strictly follow the rules of admission and precautions.

Special care should be exercised in case of severe renal and hepatic pathologies. In this situation, Ambrobene syrup should be taken in a smaller dose, or between intervals, a long interval is maintained.

To date, medicine does not have accurate data on the use of the drug in the first 28 weeks of pregnancy. In the II and III trimesters, the use of the drug should be carried out only with the permission of the doctor, after carefully weighing the ratio of the intended benefits of therapy for the mother and the potential risk to the fetus.

The use of Ambrobene syrup by women during the breastfeeding period has also been studied insufficiently. Therefore, the decision on the appropriateness of the use of medication should be made by the attending physician, taking into account the risk to the child and the expected benefits to the mother.

When conducting experiments on animals, it was found that Ambroxol does not have a teratogenic effect (does not violate the processes of embryogenesis), is reabsorbed from human milk.

Interaction with other drugs

With simultaneous use of Ambroxol syrup with other antitussive agents that inhibit the cough reflex, sputum stagnation can occur, leading to the development of fairly dangerous conditions. Therefore, such combinations of drugs should be chosen with extreme caution.

With the combined use of Ambroxol and antibacterial drugs ( amoxicillin , erythromycin, cefuroxime and doxycycline) there is a significant increase in the concentration of etiotropic components in the bronchial secretions.

Due to the fact that the difference between the pH value of the solutions may cause precipitation of Ambroxol base (pH 5) in the sediment, the drug is not recommended to be used together with solutions whose pH exceeds 6.3.

Special instructions for admission

At the slightest changes in the skin and mucous membranes of the patient should stop taking the drug and consult a doctor.

The sweetener sorbitol, which is part of the syrup, has a mild laxative effect. At the same time, the caloric content of sorbitol is 2.6 kcal / g. One measuring cup contains 2.1 grams of sorbitol.

For children under 2 years of age, Ambrobene syrup can be used only with the permission of a doctor.

Data on the impact on the ability to drive vehicles and control of various mechanisms to date is not available.

Overdose

In case of overdose of the drug, intoxication was not detected. Possible development of diarrhea and the emergence of signs of nervous excitement. When taking excessively large doses, there may be a decrease in blood pressure, increased salivation, nausea and vomiting. In this situation, in the first 1-2 hours after use, the victim should do a gastric lavage, and, if necessary, apply other methods of intensive therapy. The patient is then given symptomatic treatment.

Conditions for the sale of the drug in pharmacy organizations

Ambrobene syrup refers to non-prescription drugs.

Storage conditions

Store in a dark, out of reach of children, at a temperature not exceeding 25 C.

Shelf life

The drug Ambrobene syrup in the form of suitable for use within 5 years from the date of issue. After opening the bottle - 1 year. Use of the product after the expiration date indicated on the package is prohibited.

Analogs

  • Ambrohexal Syrup
  • Ambroxol Syrup
  • Ambroxol-Vial syrup
  • Ambroxol Vramed Syrup
  • Ambroxol-hemofram syrup
  • Bronchus syrup
  • Vicks Active Ambromed Syrup
  • Lasolvan syrup

Prices for Ambrobene syrup

Ambrobene syrup 15 mg / 5 ml, 100 ml - from 130 rub.

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