Instruction for use: Ambroxol (Ambroxolum)

International Nonproprietary Name (INN): Ambroxol

Pharmaceutic group: Expectorants

Presentation: Tablets 30 mg ¹20.

Available without prescription

Indications for Ambroxol

Ambroxol is a secretolytic agent used in the treatment of respiratory diseases associated with viscid or excessive mucus. The substance is a mucoactive drug with several properties including secretolytic and secretomotoric actions that restore the physiological clearance mechanisms of the respiratory tract, which play an important role in the body’s natural defence mechanisms. It stimulates synthesis and release of surfactant by type II pneumocytes. Surfactants acts as an anti-glue factor by reducing the adhesion of mucus to the bronchial wall, in improving its transport and in providing protection against infection and irritating agents.

Ambroxol is indicated as "secretolytic therapy in bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport. It promotes mucus clearance, facilitates expectoration and eases productive cough, allowing patients to breathe freely and deeply". There are many different formulations developed since the first marketing authorization in 1978.

INDICATIONS: All forms of tracheobronchitis, emphysema with bronchitis pneumoconiosis, chronic inflammatory pulmonary conditions, bronchiectasis, bronchitis with bronchospasm asthma. During acute exacerbations of bronchitis it should be given with the appropriate antibiotic.

Ambroxol is a clinically proven systemically active mucolytic agent. When administered orally onset of action occurs after about 30 minutes. The breakdown of acid mucopolysaccharide fibers makes the sputum thinner and less viscous and therefore more easily removed by coughing. Although sputum volume eventually decreases, its viscosity remains low for as long as treatment is maintained.

SIDE EFFECTS. Occasional gastrointestinal side effects may occur but these are normally mild.

PRECAUTIONS. It is advisable to avoid use during the first trimester of pregnancy.

Trade name of the drug – Ambroxol

Dosage Form: tablets

Active substance:

Active ingredient: ambroxol hydrochloride - 30 mg;

Excipients: lactose monohydrate (milk sugar) - 171.0 mg, potato starch - 36.0 mg colloidal silicon dioxide (Aerosil) - 1.8 mg of magnesium stearate - 1.2 mg.

Description:

Tablets white or nearly white. flat cylindrical shape with the notch and chamfer.

Pharmacotherapeutic group: Expectorants

ATX code: R05CB06

Pharmacological Properties of CytoflavinPharmacodynamics

Mucolytic tool that stimulates the prenatal development of the lungs (increased synthesis of surfactant secretion and blocks its decay). It has secretolytic, and expectorant action; stimulates serous cells of glands of bronchial mucosa, increases the amount of mucous secretion and release of a surface-active substance (surfactant) in the alveoli and bronchi; normalizes impaired ratio of serous and mucous components of phlegm. By activating the hydrolyzing enzymes and increasing the release of lysosomes of cells Clarke, reduces the viscosity of sputum. It increases motor activity of ciliated epithelium, increases mucociliary transport.

Once inside the action occurs within 30 minutes and lasts for 6-12 hours.

Pharmacokinetics

Absorption - high, time to maximum blood concentration (TCmax) - 2 hours contact with plasma proteins - 80%. It penetrates through the blood-brain barrier, placental barrier, excreted in breast milk.

Metabolism - in liver forms dibromantranilovuyu and glucuronic acid conjugates. . The half-life (T1 / 2) - 7-12 hours excreted by the kidneys: 90% in the form of water-soluble metabolites in unmodified form - 5%. T1 / 2 is increased in severe renal insufficiency, it does not change with impaired hepatic function.

Indications for Ambroxol

Diseases of the respiratory tract to form a viscous mucus: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with obstruction of sputum discharge, bronchiectasis, cystic fibrosis.

Contraindications for Ambroxol

Hypersensitivity, children under 6 years of age, pregnancy (I term).

Precautions: The product should be used with caution in patients with gastric ulcer and duodenal ulcers, as well as in patients with renal and hepatic insufficiency.

pregnancy and lactation:

The drug is not recommended for use during the I trimester of pregnancy. If necessary, the use of ambroxol in II-III trimesters of pregnancy and during breast-feeding should evaluate the potential benefits for the mother and the possible risk to the fetus / baby.

Ambroxol Dosage and Administration

Inside, during a meal, with a small amount of liquid. Adults and children over 12 years - 30 mg 3 times a day during the first 2-3 days, followed by 30 mg two times daily or 15 mg (half tablet) 3 times a day for children 6-12 years - 15 mg (half tablet) 2-3 times a day.

Not recommended for use without a doctor's appointment more than 4-5 days.

Side effect ofAmbroxol

Allergic reactions: skin rash, urticaria, angioedema, in some cases - allergic contact dermatitis, anaphylactic shock.

Rarely - weakness, headache, diarrhea, dry mouth and respiratory tract, rash, runny nose, constipation, dysuria. With prolonged use at high doses - gastralgia, nausea, vomiting.

overdose

Symptoms include nausea, vomiting, diarrhea.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; reception of fat-containing products.

Interaction

Combined application with antitussive drugs leads to difficulty sputum discharge on the background to reduce coughing.

Increases penetration in bronchial secretion of amoxicillin, cefuroxime, erythromycin and doxycycline.

special instructions for Ambroxol

It should not be combined with antitussive drugs that prevent removal of phlegm.

Release form of Ambroxol

Tablets of 30 mg. 10 tablets in blisters. 1, 2, 3, 4 or 5, the contour of cellular packaging together with instructions for use are placed in a pile of cardboard.

Storage conditions of Ambroxol

In the dark place at a temperature from 0 to 25 ° C. Keep out of the reach of children.

Shelf life of Ambroxol

3 years.

Do not use beyond the expiration date printed on the package.

Conditions of supply of Ambroxol from pharmacies

Without prescription.