Ambroxol, 7.5 mg/ml 100 ml

Ambroxol has secretomotor, secretolytic and expectorant action: it stimulates serous glandular cells of bronchial mucosa, increases the content of 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 it reduces the viscosity of sputum.

Increases motor activity of the cilia of the atopic epithelium. Increases motor activity of the atopic epithelium, increases mucociliary transport, facilitates expulsion of sputum from the airways.

Indications

Respiratory diseases accompanied by viscous sputum production and difficulty in phlegm discharge: acute and chronic bronchitis; pneumonia; bronchial asthma; bronchiectatic disease; COPD.

Active ingredient

Ambroxol

Composition

1 ml of the solution contains:
Active ingredient: ambroxol hydrochloride – 7.500 mg
Excipients:
benzalkonium chloride – 0.225 mg,
sodium chloride – 6.220 mg,
citric acid – 2.000 mg,
sodium hydrophosphate dihydrate – 4.350 mg,
water – 989.705 mg

Interaction

Anticough agents (e.g., codeine) – due to suppression of the cough reflex, sputum may accumulate in the airway lumen with difficulty in its discharge (simultaneous use is not recommended).

Amoxicillin, doxycycline, cefuroxime, erythromycin – increased penetration of antibiotics into the bronchial secretion.

Directions for use

Orally the drug is used after meals, adding it to water, tea, milk or fruit juice.

Adults and children over 12 years old: first 2-3 days 4 ml 3 times per day (corresponding to 90 mg ambroxol daily), then 4 ml 2 times per day (corresponding to 60 mg ambroxol daily);

Children from 6 to 12 years old: 2 ml 2-3 times a day (corresponding to 30 or 45 mg ambroxol per day);

Children from 2 to 6 years: 1 ml 3 times a day (corresponding to 22.5 mg ambroxol per day);

Children under 2 years: 1 ml 2 times a day (corresponding to 15 mg ambroxol per day).

Children under 2 years old are prescribed the preparation only under the control of the physician.

Maximal daily dose for oral administration: For adults – 90 mg, for children 6-12 years old – 45 mg, for children 2-6 years old – 22.5 mg, for children under 2 years old – 15 mg.

Special Instructions

Ambroxol should not be taken simultaneously with anti-cough drugs that may inhibit the cough reflex, such as codeine, because this may impede removal of liquefied sputum from the bronchi.

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

Patients taking ambroxol are not recommended to perform breathing exercises due to difficulty in sputum discharge. In patients who are in a serious condition, aspiration of liquefied sputum should be performed.

Ambroxol should not be taken immediately before going to bed.

In patients with bronchial asthma, ambroxol may increase coughing.

In patients with severe skin lesions – Stevens-Johnson syndrome or toxic epidermal necrolysis – a flu-like condition may be observed in the early phase: fever, body pain, rhinitis, cough, pharyngitis. In symptomatic therapy, mucolytic agents such as ambroxol hydrochloride may be prescribed incorrectly.

Contraindications

Hypersensitivity to ambroxol or auxiliary components of the drug; I trimester of pregnancy; period of lactation (breast-feeding); congenital fructose intolerance (for dosage forms containing fructose); childhood under 6 years (for tablets); childhood under 12 years (for sustained release capsules).

With caution: impaired bronchial motility and increased mucus secretion (e.g., rare fixed cilia syndrome); renal failure and/or severe hepatic failure; gastric and duodenal ulcer (including anamnesis); II and III trimesters of pregnancy; children under 2 years of age (solution for oral administration; only by prescription).

Side effects

Allergic reactions: rare – skin rash, urticaria, exanthema, facial edema, dyspnea, itching, fever; frequency unknown – anaphylactic reactions, including anaphylactic shock, angioedema, skin itching, allergic contact dermatitis.

The digestive system: frequently – nausea; infrequently – vomiting, diarrhea, dyspepsia, abdominal pain.

Nervous system disorders: often – dysgeusia.

Skin and subcutaneous tissue disorders: very rare – toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome; frequency unknown – acute generalized eczematous pustulosis.

Respiratory system: often – decreased sensitivity in the oral cavity or pharynx; rarely – dry mucous membrane of the airways, rhinorrhea; in single cases – dry mucous membrane of the throat.

Overdose

Symptoms: heartburn, dyspepsia, diarrhea, nausea, vomiting, upper abdominal pain. There are reports of the occurrence of transient anxiety. In severe overdose a significant decrease in blood pressure is possible.

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

Similarities

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