Амбро®

General characteristics. Structure:

Active agent – Ambroxol a hydrochloride of 30.0 mg.

Excipients: lactoses monohydrate, potato starch, silicon dioxide colloid anhydrous (aerosil), calcium stearate.

Pharmacological properties:

Pharmacokinetics. Absorption high and almost full, is linearly dependent on a therapeutic dose. The maximum plasma concentration is reached within 1-2,5 hours. After intake action comes in 30 min. and continues within 6-12 hours. Distribution bystry with the greatest concentration in tissue of lungs. Communication with proteins of a blood plasma makes about 90%. About 30% of the dose accepted inside eliminirutsya through the first passing of metabolism. Ambroxol is metabolized preferential in a liver with formation of conjugates. The final elimination half-life makes 10 hours. It is removed by kidneys of 90% in the form of water-soluble metabolites, in not changed look – 5%. The elimination half-life increases at a heavy chronic renal failure, but does not change at an abnormal liver function.

The gender and age does not exert clinically significant impact on pharmacokinetics of Ambroxol and do not demand dose adjustment.

Pharmacodynamics. Ambroxol - mucolytic drug. Possesses sekretomotorny, sekretolitichesky and expectorant action; stimulates serous cells of glands of a mucous membrane of bronchial tubes, increases the maintenance of a mucous secret and release of surfactant (surfactant) in alveoluses and bronchial tubes; normalizes the broken ratio of serous and mucous components of a phlegm. Activating the hydrolyzing enzymes and strengthening release of lysosomes from cells Klara, reduces viscosity of a phlegm. Increases physical activity of a ciliary epithelium, prevents its adhesion, increases mukotsiliarny transport. Ambroxol has antiinflammatory effect, and also antioxidant properties, stimulates local immunity, increases concentration of antibiotics in a phlegm and a bronchial secret.

Indications to use:

- acute and chronic bronchitis;

- pneumonia;

- chronic obstructive pulmonary disease (COPD);

- bronchial asthma with the complicated phlegm otkhozhdeniye;

- bronchoectatic disease.

Route of administration and doses:

Inside, after meal, washing down with enough liquid, not chewing.

Adults and children are more senior than 12 years: on 1 tablet (30 mg) 3 times a day within the first 2-3 days, then on 1 tablet 2 times a day.

Children from 6 to 12 years: on ½ tablet (15 mg) 2-3 times a day.

Duration of treatment depends on features of a course of a disease. Without medical appointment drug has to be accepted no more than 4-5 days.

Features of use:

With care appoint at an abnormal liver function or kidneys, motor dysfunction of bronchial tubes or at allocation of a large number of a secret (because of slime accumulation threat). At a heavy liver and renal failure it is necessary to reduce a dosage or to increase intervals between administrations of drug.

This dosage form is not recommended for reception to children 6 years are younger.

Drug is not recommended to be accepted to patients with rare hereditary intolerance of a galactose, deficit of lactase (like Lapp) or a glucose galactose sprue.

Side effects:

Seldom:

- weakness, headache;

- gastralgias, nausea, vomiting, diarrhea;

- dryness in a mouth and airways, a rhinorrhea;

- allergic reactions (skin rash, itch, small tortoiseshell, Quincke's disease, anaphylactoid reactions).

Very seldom:

- breath disturbance.

Interaction with other medicines:

Simultaneous use of Ambro® with the medicines having antibechic activity is not recommended (for example, containing codeine). Simultaneous use of Ambro® with antibiotics (amoxicillin, tsefuroksy, erythromycin, doxycycline and others) improves receipt of antibiotics in pulmonary ways that can reduce treatment terms.

Contraindications:

- hypersensitivity to Ambroxol and/or other components of drug;

- peptic ulcer of a stomach and duodenum;

- I trimester of pregnancy.

Overdose:

Symptoms: nausea, vomiting, diarrhea, dyspepsia.

Treatment: to wash out a stomach in the first 1-2 hours after administration of drug, symptomatic therapy.

Storage conditions:

To store in the dry, protected from light place, at a temperature not above 30 °C.
To store in places, unavailable to children!

 

Issue conditions:

Without recipe

Packaging:

On 10 tablets in a blister strip packaging from a film of polyvinyl chloride and aluminum foil.

On the 2nd blister strip packagings together with the approved instruction on a medical use in the state and Russian languages place in a pack from a cardboard for a retail container.