Ambroxol - instructions for use, dose, side effects, contraindications

Composition:1 tablet contains:
active substance: ambroxol hydrochloride-30 mg;
auxiliary substances: lactose monohydrate - 70.6 mg, corn starch - 35 mg, povidone (polyvinylpyrrolidone low molecular weight) - 3 mg, calcium stearate -1,4 mg.

Description:Ploskotsilindricheskie tablets white or white with a yellowish shade of color, with a bevel.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:The drug has an expectorant, mucolytic effect.Reducing the viscosity of sputum occurs as a result of depolymerization of mucopolysaccharides that are in sputum. Depolarization of mucopolysaccharides is associated, first of all, with the disruption of disulfide bonds in their molecules. Ambroxol increases the motor activity of the ciliated epithelium, increases mucociliary transport, normalizes the ratio of serous and mucous components of sputum. By activating hydrolysing enzymes and enhancing the release of lysosomes from Clark cells, reduces the viscosity of phlegm. It facilitates the excretion of sputum from the respiratory tract. Ambroxol stimulates parenteral lung development by increasing the synthesis and secretion of surfactant in the alveoli. Synthesis of the surfactant is reduced as a result of chronic diseases of the respiratory system, in addition, the properties of the surfactant change due to the formation of bonds between the surface active phospholipids and inflammatory proteins.

Pharmacokinetics:

After application, the absorption of the drug from the gastrointestinal tract is high. The drug appears for 30 minutes and is held for 6-12 hours. Time to reach the maximum concentration in the blood (TCmah) - about 2 hours.Binding to plasma proteins- 80-90 %.

The drug is metabolized in the liver to inactive metabolites (dibromantranilic acid and glucuronic conjugates). The half-life (T1 / 2) is 9-10 hours. Penetrates through the histohematological barriers, excreted into breast milk. It is excreted by the kidneys: 90% in the form of metabolites, 10% in unchanged form.

Indications:

Infectious and inflammatory diseases of the bronchopulmonary system, accompanied by the formation of difficult to separate sputum: acute and chronic bronchitis, chronic obstructive pulmonary disease, pneumonia, bronchial asthma with difficulty in sputum discharge, bronchoectatic disease.

Treatment and prevention of respiratory distress syndrome.

Contraindications:

- Hypersensitivity to any component of the drug.

- Pregnancy (first trimester).

- Children under 6 years.

- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Carefully:

The drug should be used with caution in patients with gastric ulcer and duodenal ulcer, as there may be an exacerbation of peptic ulcer, as well as in patients with renal and hepatic insufficiency.

Pregnancy and lactation:

The drug is not recommended for use during the first trimester of pregnancy. If it is necessary to use ambroxol in II-III trimesters of pregnancy should be evaluated for potential benefits to the mother with a possible risk to the fetus.

During breastfeeding, use the drug with caution, as it is excreted into breast milk.

Dosing and Administration:

The drug is administered orally, with food, with a small amount of liquid.

Adults and children over 12 years of age:

1 tablet 30 mg 3 times a day for the first 2-3 days, then the dose of the drug should be reduced to 1 tablet 2 times a day.

Children aged 6 to 12 years:

Half a tablet (15 mg) 2-3 per day for the first 2-3 days, then the dose of the drug should be reduced to 1/2 tablets 2 times a day.

It is not recommended to use without medical appointment for more than 4-5 days.

Side effects:

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

Rarely: weakness, headache, dry mouth and respiratory tract, rhinorrhea, dysuria. With prolonged use in high doses - gastralgia, nausea, vomiting, diarrhea.

Overdose:

Symptoms: nausea, vomiting, diarrhea, gastralgia.

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

Interaction:

When used with antitussive drugs, it may be difficult for sputum to escape as a result of suppressing the cough reflex.

With simultaneous use with amoxicillin, cefuroxime, erythromycin, doxycycline ambroxol increases their concentration in the bronchial secretion.

Special instructions:

Do not combine with antitussive drugs that make it difficult to withdraw phlegm.

Ambroxol should be used with caution in patients with a weakened cough reflex or disturbed mucociliary transport due to the possibility of sputum congestion.

Patients receiving ambroxol, do not recommend performing respiratory gymnastics; In seriously ill patients, aspiration of diluted sputum should be performed.

In patients with bronchial asthma ambroxol can strengthen cough.

Do not use ambroxol just before bed.

Effect on the ability to drive transp. cf. and fur:The use of the drug does not affect the speed of psychomotor reactions.

Form release / dosage:Tablets of 30 mg.

Packaging:For 10 or 20 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil. 1, 2, 3, 5 or 6 contour cell packs of 10 tablets or 1 or 3 contour packs of 20 tablets together with the instructions for use are placed in a pack of cardboard.

Storage conditions:In the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:

3 years. Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LS-001080

Date of registration:31.08.2010

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp

VERTEKS, AO Russia

Information update date: & nbsp24.09.2015

Illustrated instructions

Instructions

Ambroxol (Ambroxol)