Ambergris

General characteristics. Structure:

Active agent – Ambroxol a hydrochloride of 300.0 mg – for 40 ml, 750.0 mg – for 100 ml.

Excipients: potassium sorbate, acid of chlorohydrogen 25% (for correction рН), the water purified.

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:

At Ambro® solution reception inside: (1 ml = 25 drops (7.5 mg), measure by means of the doser).

Solution should be accepted after meal with enough liquid.

Adults and children are more senior than 12 years: in the first 2-3 days – 4 ml three times a day (90 mg a day). Then 4 ml twice a day (60 mg a day) or 2 ml three times a day (45 mg a day), according to instructions of the doctor.

Children: up to 2 years: 1 ml (25 drops) twice a day (15 mg); from 2 to 6 years: 1 ml (25 drops) three times a day (22,5 mg a day); from 6 to 12 years: 2 ml (50 drops) 2-3 times a day (30-45 mg a day).

At use of Ambro® solution in the form of inhalations: inhalation solution is applied, using the equipment for inhalations (except steam inhalers). Drug mixes up with normal saline solution (0.9% of sodium of chloride), for optimum moistening of air in a respirator it can be parted in the ratio 1:1. As at inhalation therapy the deep breath can provoke cough, inhalations should be carried out in the mode of usual breath. Before inhalation it is usually recommended to warm up inhalation solution on water to body temperature. Patients with bronchial asthma before inhalation should accept broncholitic drugs.

Adults and children are more senior than 6 years: 1-2 inhalations on 2-3 ml of solution daily (15-45 mg a day).

Children from 2 to 6 years: 1-2 inhalations on 2 ml of solution daily (15 mg-30 of mg a day).

To children up to 2 years: 1-2 inhalations on 1 ml of solution daily (7.5 mg-15 of mg).

Therapy should be carried out under observation of the doctor.

The average course of treatment makes 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.

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).

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 place protected from light, at a temperature not over 25 ºС. To store in the place, unavailable to children!

Issue conditions:

Without recipe

Packaging:

On 40 ml or 100 ml of drug in the bottles from glass melt with a screw mouth like FV-OS corked by the screwed metal caps with a control ring.

Bottles together with the approved instruction on a medical use in the state and Russian languages and the doser place in a pack from a cardboard.