Ambrohexal, 6 mg/ml syrup 100 ml

Pharmacodynamics
Has secretomotor, secretolytic and expectorant action, stimulates serous glandular cells of the bronchial mucosa, increases the mucous secretion and 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 increasing the release of lysosomes from the clara cells, reduces the viscosity of sputum. Increases the motor activity of the atrial epithelium, increases mucociliary transport, facilitates the expulsion of sputum from the airways.

On average, the effect when ambroxol is taken orally occurs within 30 minutes and lasts 6-12 hours, depending on the size of the single dose.

Pharmacokinetics

Ambroxol after oral administration is quickly and almost completely absorbed.
Time to maximum concentration (TSmax) after oral administration is reached after 1-3 hours.
Metabolized in the liver with the formation of metabolites, excreted through the kidneys (dibromanthranilic acid, glucuronides).

Binding with blood plasma proteins is approximately 85%.

Half-life period (T1/2) from blood plasma is 7-12 hours. T1/2 of ambroxol and its metabolites is approximately 22 hours. Through the kidneys 90% of ambroxol is excreted in the form of metabolites. Less than 10% of ambroxol is excreted unchanged through the kidneys.

Due to high protein binding and large volume of distribution, as well as slow reverse penetration from tissues into blood, during dialysis or forced diuresis there is no significant ambroxol excretion. Ambroxol clearance in patients with severe hepatic impairment is reduced by 20-40%.

In severe renal failure half-life of ambroxol metabolites is increased. Ambroxol penetrates through the placental barrier and into the breast milk.

Indications

Chronic obstructive pulmonary disease, Cough, Bronchitis, Lung inflammation (pneumonia), Tracheitis, Bronchial asthma

Acute and chronic respiratory diseases accompanied by viscous secretion:

• acute and chronic bronchitis;
• bronchiectasis;
• bronchiolitis;
• mucoviscidosis;
• rinitis, sinusitis.

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Active ingredient

Ambroxol

Composition

5 ml of syrup contains:

The active ingredient:

ambroxol hydrochloride 15 mg;

Excipients:

benzoic acid;

citric acid;

glycerin;

sodium cyclamate;

sodium hydroxide;

sodium metabisulfite;

polyvidone; sorbitol;

purified water;

flavorings.

How to take, the dosage

Ambrohexal® should be taken orally after meals. 1 scoop of ambrohexal® syrup (5 ml) contains 15 mg of ambroxol hydrochloride.

Adults and children over 12 years: 2 scoops 2-3 times a day (60-90 mg of ambroxol hydrochloride) during first 2-3 days of use, then 2 scoops twice a day (60 mg of ambroxol hydrochloride per day).
In severe cases of the disease the dose is not reduced during the entire course of treatment. The maximum dose is 4 scoops 2 times a day (120 mg ambroxol hydrochloride per day).

Children from 5 to 12 years of age: 1 scoop 2-3 times a day (30-45 mg ambroxol hydrochloride).
Children from 2 to 5 years of age: 1/2 scoop 3 times a day (22.5 mg ambroxol hydrochloride).
Children under 2 years of age: 1/2 scoop 2 times a day (15 mg ambroxol hydrochloride).
Children under two years of age are prescribed Ambrohexal® only under the control of physician.

During the treatment it is necessary to drink a lot of liquids (juices, tea, water) to enhance mucolytic effect of the drug.
Duration of therapy depends on the severity of disease and is determined by the attending physician. Without the doctor’s recommendation you should not take Ambrohexal® for more than 4-5 days.

Interaction

Concomitant use with anti-cough drugs leads to difficulty of expectoration of sputum against the background of suppression of the cough reflex. It increases penetration into the bronchial secretion of amoxicillin, cefuroxime, erythromycin and doxycycline.

Special Instructions

Ambroxol should not be taken simultaneously with anti-cough medications that may inhibit the cough reflex, such as codeine, because this may make it difficult to remove liquefied sputum from the airways. Ambrohexal® should be used with caution in patients with an impaired cough reflex or impaired mucociliary transport because of the potential for sputum accumulation.

Patients taking ambroxol should not be advised to perform breathing exercises; aspiration of diluted sputum should be performed in severely ill patients.

In patients with bronchial asthma, ambroxol may increase coughing.

Ambroxol should not be taken immediately before bedtime.

Please note for diabetics: 1 scoop (5 ml syrup) contains 1.75 g sorbitol (less than 0.15 IU).

Contraindications

Hypersensitivity to ambroxol and other components of the drug forms.

Side effects

According to the World Health Organization (WHO) adverse effects are classified according to their frequency of development as follows: very common (≥1/10), common (≥1/100 to < 1/10), infrequent (≥1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1,000), very rare (< 1/10,000); frequency is unknown – according to available data it was impossible to determine the frequency of occurrence.

Allergic reactions
rare: skin rash, urticaria;
frequency unknown: anaphylactic reactions, including anaphylactic shock, angioedema, pruritus and other hypersensitivity reactions.

Gastrointestinal tract
often: nausea;
infrequently: heartburn, vomiting, diarrhea, dyspepsia and abdominal pain.

Nervous system
often: change in taste.

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

Overdose

Symptoms: nausea, vomiting, gastralgia. There are reports of the occurrence of transient restlessness and diarrhea. In severe overdose there may be a drop in blood pressure.

Treatment: induction of vomiting, gastric lavage during the first 1-2 hours after taking the drug, prescription of fat-containing products.

Pregnancy use

The drug is contraindicated during the first trimester of pregnancy.

Use of the drug Ambrohexal® during pregnancy (II-III trimester) is possible only if the estimated benefit to the mother exceeds the potential risk to the fetus.

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

Ambroxol is excreted in small amounts into the breast milk, so when taking the drug Ambrohexal® the question of stopping breast-feeding should be decided.

Similarities

Ambrohexal, Lazolvan, Halixol, Ambroxol, Ambrobene, Orvis Broncho, ORVIS, Lazolvan Max, Zvezdochka, Zvezdochka for colds