Ambroksol-Zdorovye, syrup (15mg/5 ml) 100 ml in фл.
Producer: LLC Pharmaceutical Company Zdorovye Ukraine
Code of automatic telephone exchange: R05C B06
Release form: Liquid dosage forms. Syrup.
General characteristics. Structure:
International and chemical names: ambroxol; trans-4-[(2-amino-3,5-dibromine-Benzylium) of amine] - cyclohexanol a hydrochloride; main physical and chemical properties: colourless or slightly yellowish transparent liquid with a specific smell; structure: 5 ml of syrup contain Ambroxol of a hydrochloride 15 mg; excipients: sorbitol, глицерол, propylene glycol, the benzoic acid, citric acid monohydrate, sodium hydroxide, fragrance food Malines, the water purified.
Pharmacological properties:
Pharmacodynamics. Mucolytic drug; possesses sekretomotorny, sekretolitichesky and expectorant action. Liquefies a phlegm, reducing its viscosity and adhesiveness, facilitates expectoration and evacuation of a phlegm from respiratory tracts.
The mechanism of action is caused by stimulation of serous cells of glands of a mucous membrane of bronchial tubes, increase in 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. Activates the hydrolyzing enzymes and strengthens release of lysosomes from bezresnichny cells of an epithelium of terminal bronchioles that leads to reduction of viscosity of a phlegm. Increases physical activity of a ciliary epithelium, increasing mukotsiliarny transport of a phlegm. Thanks to increase in products of surfactant has also antiinflammatory effect, has antioxidant properties, increases local immunity. Shows weak antibechic action.
The therapeutic effect begins to be shown in 30 min. after reception, proceeds during 6 – 12 h. The maximum therapeutic effect develops in 3 days of treatment.
Pharmacokinetics. After intake it is quickly and almost completely soaked up from digestive tract; the maximum concentration in blood is registered in 0,5 – 3 h after reception. Well gets into fabrics, especially into a mucous membrane of bronchial tubes and pulmonary fabric; the highest concentration of Ambroxol is found in lungs. Bioavailability makes 70 – 80%. Linkng with blood proteins – about 90%. Is exposed to active metabolism at "the first passing" through a liver; it is metabolized by glucuronic conjugation with formation pharmacological of inactive metabolites. The elimination half-life makes about 1,3 h. It is removed preferential by kidneys (90%).
Gets through hematoencephalic and placental barriers (concentration in an organism of a fruit is 2-4 times higher, than at mother), it is found in cerebrospinal fluid, it is allocated with breast milk.
At a heavy chronic renal failure the elimination half-life increases.
Indications to use:
The acute and chronic diseases of a respiratory organs which are followed by difficulty of evacuation of a phlegm as a result of formation of the viscous and hardly separated secret: acute and chronic bronchitis, pneumonia, a chronic obstructive pulmonary disease, bronchial asthma with difficulty of an otkhozhdeniye of a phlegm, a bronchoectatic disease, a mucoviscidosis, rhinitis, sinusitis.
Route of administration and doses:
Appoint inside during meal, washing down with a small amount of water.
To adults and children 12 years are more senior appoint in the first 2–3 days 10 ml of syrup (2 measured spoons) 2 - 3 times a day, further – on 5 ml of syrup (1 measured spoon) 3 times a day or on 10 ml of syrup (2 measured spoons) 2 times a day. In hard cases the dose is not reduced during all course of treatment. The maximum daily dose – 30 ml.
To children aged from 5 up to 12 years appoint 5 ml of syrup (1 measured spoon) 2–3 times a day; aged from 2 up to 5 years – on 2,5 ml of syrup (½ measured spoons) 3 times a day; aged up to 2 years – on 2,5 ml of syrup (½ measured spoons) 2 times a day. The maximum daily dose for children, aged from 5 up to 12 years – 15 ml of syrup (3 measured spoons), aged from 2 up to 5 years – 10 ml of syrup (2 measured spoons), aged up to 2 years – 5 ml of syrup (1 measured spoon).
Duration of treatment is defined individually and depends on disease severity. In need of drug use more than 4 - 5 days control of the doctor is required. At non-compliance with the mode of dosing reduction of efficiency of treatment is possible.
Features of use:
With care appoint at a liver and/or renal failure, at the diseases connected with the increased accumulation of a bronchial secret (for example, a malignant ciliate syndrome), in II and III trimesters of pregnancy.
It is not necessary to combine with the antibechics complicating removal
phlegms.
In case of the admission of reception of the next dose at the subsequent reception it is not necessary to exceed a drug dose.
Patients with a diabetes mellitus have to consider that 5 ml of drug contain 1,75 g of sorbitol.
At the first signs of development of allergic reactions administration of drug should be cancelled.
During treatment it is necessary to use a lot of liquid (juice, tea, water) for strengthening of mucolytic effect of drug.
Use during pregnancy and feeding by a breast. Drug is contraindicated in the I trimester of pregnancy. In other durations of gestation appointment is possible only in case the expected therapeutic advantage for mother exceeds potential risk for a fruit. In need of use in the period of a lactation, feeding by a breast should be stopped.
Influence on an opportunity to manage vehicles and mechanisms. Data are absent.
Side effects:
From system of digestion: seldom – diarrhea, dryness in a mouth, a lock, salivation strengthening; at prolonged use in high doses – a gastralgia, nausea, vomiting. From respiratory system: seldom – increase in secretion of slime in a nasal cavity, dryness in respiratory tracts. From the central and peripheral nervous system: seldom – weakness, a headache. Allergic reactions: seldom – skin rash, reddening and puffiness of the person, an itch, temperature increase, a fever; very seldom – a Quincke's disease, allergic contact dermatitis, an acute anaphylaxis. Other: seldom – difficulty of an urination.
Interaction with other medicines:
The concomitant use with antibiotics (amoxicillin, doxycycline, tsefuroksy, erythromycin) leads to increase in their concentration in pulmonary fabric. At simultaneous use with the antibechics oppressing a tussive reflex is at a loss otkhozhdeny phlegms and expectorant effect of Ambroxol decreases. Combined use with theophylline leads to increase in its concentration in blood. Drug is compatible to the means which are slowing down patrimonial activity.
Contraindications:
The increased individual sensitivity to drug components, a peptic ulcer of a stomach and duodenum, a convulsive syndrome, the I trimester of pregnancy, feeding by a breast.
Overdose:
Symptoms: dyspepsia, nausea, diarrhea, short-term concern. At strong overdose sharp arterial hypotension, vomiting, salivation strengthening are possible. Treatment: artificially caused vomiting then to appoint drink (milk or tea), reception of fat-containing products. The gastric lavage is recommended in the first 1–2 h after administration of drug. Symptomatic therapy.
Storage conditions:
To store in the place protected from light at a temperature from 15 °C to 25 °C. To store in the place, unavailable to children. After opening of a bottle to store in the cool place no more than 30 days.
Period of validity –2 years.
Issue conditions:
Without recipe
Packaging:
On 100 ml in a bottle or to bank and together with a measured spoon in a pack.