Ambrohexal, 3 mg/ml syrup 100 ml

Ambrohexal is a drug with mucolytic, secretolytic and expectorant action, and the active ingredient of the drug is ambroxol. The mechanism of action of this drug is associated with reduction of sputum viscosity as a result of depolymerization of sputum mucopolysaccharides, which consists in breaking disulfide bonds in molecules, increasing the release of active hydrolyzing enzymes from Clark cells.

Ambrohexal also increases the activity of the cilia of the bronchial epithelium, and normalizes the ratio of all components of sputum and in this regard stimulates its mucociliary transport. This facilitates expectoration of sputum from the respiratory tract and stimulates secretion and blockage of surfactant breakdown.

Ambrohexal is rapidly absorbed from the gastrointestinal tract with high absorption capacity, and its optimal plasma concentration is reached within two hours after taking the drug: tablets, syrup, sustained release capsules and inhalation solution.

The action of the drug starts after 30 minutes after taking the syrup or tablets and depends on the speed of absorption of the drug in the stomach and intestines. The drug is metabolized in the liver, where it is converted to dobromanthranilic acid and glucuronic conjugates and excreted by the kidneys.

Indications

Acute, bronchitis with difficulty in sputum discharge, pneumoconiosis, bronchial asthma, tuberculosis and cystic fibrosis of the lungs, bronchiectasis, acute pneumonia, pleurisy, pulmonary emphysema, acute, prolonged and chronic sinusitis, chronic rhinitis.

Pharmacological effect

Ambrohexal is a drug that has mucolytic, secretolytic and expectorant effects, and the active ingredient of the drug is ambroxol. The mechanism of action of this drug is associated with a decrease in sputum viscosity as a result of depolymerization of sputum mucopolysaccharides, which consists of breaking disulfide bonds in the molecules, enhancing the release of active hydrolyzing enzymes from Clark cells.

Ambrohexal also increases the activity of the cilia of the bronchial epithelium, and normalizes the ratio of all components of sputum and, therefore, stimulates its mucociliary transport. This facilitates expectoration of mucus from the respiratory tract, and also stimulates secretion and blocks the breakdown of surfactant.

Ambrohexal is quickly absorbed from the gastrointestinal tract, having a high absorption capacity, and its optimal plasma concentration is achieved within two hours after taking the drug: tablets, syrup, extended-release capsules and inhalation solution.

The effect of the drug occurs when taken in the form of syrup or tablets – after 30 minutes and depends on the rate of absorption of the drug in the stomach and intestines. Metabolism of this drug occurs in the liver, where it is converted to dobramantranilic acid and glucuronic conjugates, and is excreted by the kidneys.

Special instructions

In case of impaired bronchial motility and an increase in the amount of secretion (for example, fixed cilia syndrome), due to the danger of mucus accumulation, the drug can be taken only after consultation with the attending physician and under medical supervision. In case of severe renal or liver dysfunction, it is necessary to use lower concentrations or increase the interval between doses of the drug.

Instructions for patients with diabetes: 1 scoop (5 ml of syrup) contains 2.525 g of sorbitol (0.21XE).

Active ingredient

Ambroxol

Composition

1 ml of syrup 3 mg/ml contains:

Pregnancy

The drug is contraindicated for use during the first trimester of pregnancy.

The use of Ambrohexal® during pregnancy (II-III trimester) is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

Ambroxol penetrates the placental barrier. Animal studies have shown that the drug has no effect on embryofetal development, childbirth and postnatal development.

Ambroxol is excreted in small quantities into breast milk, therefore, when taking Ambrohexal®, it is necessary to decide whether to stop breastfeeding.

Contraindications

Hypersensitivity to ambroxol or to any of the components of the drug;
pregnancy (first trimester);
breastfeeding period
fructose intolerance.

The drug should be used with caution in patients with gastric and duodenal ulcers, since exacerbation of peptic ulcer may occur, as well as in patients with renal and liver failure, pregnancy (II-III trimester).

Side Effects

According to the World Health Organization (WHO), adverse effects are classified according to their frequency as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (< 1/10,000); frequency unknown - based on available data, it was not possible to determine the frequency of occurrence.Allergic reactions
rarely: skin rash, urticaria;
frequency unknown: anaphylactic reactions, including anaphylactic shock, angioedema, pruritus and other hypersensitivity reactions.

From the gastrointestinal tract
often: nausea;
uncommon: heartburn, vomiting, diarrhea, dyspepsia and abdominal pain.

From the nervous system
often: changes in taste sensations.

Other
often: decreased sensitivity in the mouth or pharynx;
uncommon: dry mouth;
frequency unknown: dry mucous membranes of the respiratory tract.

Interaction

Combined use with antitussive drugs leads to difficulty in sputum discharge due to suppression of the cough reflex. Increases the penetration of amoxicillin, cefuroxime, erythromycin and doxycycline into the bronchial secretions.

Overdose

Symptoms: nausea, vomiting, diarrhea, gastralgia, dyspepsia.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; intake of fat-containing foods, symptomatic therapy.

Storage conditions

The drug should be stored at a temperature not exceeding 25°C. The drug in syrup form should be stored in a place protected from light.

Shelf life

2 years

Manufacturer

Lichtenheldt GmbH Pharmaceuticals Factory, Germany