Ambroksol-Zdorovye forte, syrup (30 mg / 5 ml) on 100 ml

General characteristics. Structure:

Active ingredient: ambroxol; 5 ml of syrup contain Ambroxol of a hydrochloride 30 mg; excipients: sorbite (Е 420); glycerin; propylene glycol; the benzoic acid (Е 210); citric acid, monohydrate; sodium hydroxide; fragrance of Malines; the water purified.

Pharmacological properties:

Ambroxol – mucolytic means; possesses sekretomotorny, sekretolitichesky and expectorant action.
Ambroxol strengthens release of pulmonary surfactant and stimulates tsiliarny activity owing to what department of slime and its removal (mukotsiliarny clearance) is facilitated. Activation of secretion of liquid and increase in mukotsiliarny clearance facilitate removal of slime and reduce cough.
Has the local anesthetizing effect; quickly weakens pain and the discomfort connected with pain in a nasal cavity, in an ear and a trachea at a breath.
Considerably reduces release of cytokine from blood and quantity of fabric mononuclear and polymorphonuclear cells.
The therapeutic effect begins to be shown in 30 minutes after reception, proceeds within 6-12 hours. The maximum therapeutic effect develops in 3 days of treatment.
Ambroxol after intake is quickly and almost completely soaked up from digestive tract. Absorption of Ambroxol has linear dependence in the therapeutic range. The maximum concentration in blood is registered in 0,5-3 hours after reception. Linkng with blood proteins – about 90%. 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%. Is exposed to active metabolism at "the first passing" through a liver with participation of an isoenzyme of CYP3A4. It is removed preferential by kidneys (90%).
Plasma elimination half-life makes 10 hours. The general clearance is in limits of 660 ml/min., the renal clearance makes about 8% of the general clearance.
Gets through hematoencephalic and placental barriers, it is found in cerebrospinal fluid, it is allocated in breast milk.
The age and floor have no clinically significant influence on Ambroxol pharmacokinetics therefore any dose adjustment is not required.

Indications to use:

Sekretolitichesky therapy at the acute and chronic bronkhopulmonalny diseases connected with disturbance of bronchial secretion and weakening of advance of slime.

Route of administration and doses:

Appoint to adults and children 12 years are more senior. Accept inside 5 ml of syrup (1 measured spoon; 30 mg) 3 times a day. Drug is accepted after food, washing down with a small amount of water.
The therapeutic effect can be strengthened at use of 10 ml of syrup (2 measured spoons; 60 mg) 2 times a day.
Duration of treatment is defined individually and depends on disease severity.
Drug is used by no more than 14 days.
It is necessary to consult with the doctor if symptoms of a disease last more than 14 days and/or amplify, despite of administration of drug.
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).
It is not necessary to combine with the antibechics complicating removal of a phlegm.
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 (1 measured spoon) 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 or feeding by a breast.
Drug is contraindicated in the I trimester of pregnancy. Use of drug in ІІ-ІІІ trimesters of pregnancy is possible only if the expected positive effect for mother exceeds potential risk for a fruit.
In case of need in the period of a lactation, for treatment feeding is recommended to interrupt with a breast uses of drug.
Ability to influence speed of response at control of motor transport or work with other mechanisms.
Does not influence.
Children. Drug is contraindicated for use to children aged up to 12 years. To children aged up to 12 years use the drug Ambroksol-Zdorovye containing in 5 ml of syrup (1 measured spoon) of Ambroxol of a hydrochloride of 15 mg.

Side effects:

Neurologic frustration: seldom – weakness, a headache.
From respiratory system: seldom – increase in secretion of slime in a nasal cavity, dryness in respiratory tracts.
From digestive tract: seldom – diarrhea, dryness in a mouth, a lock, salivation strengthening; at prolonged use in high doses – a gastralgia, nausea, vomiting, heartburn.
From an urinary system: seldom – difficulty of an urination.
From skin and hypodermic cellulose: seldom – skin rash, reddening and puffiness of the person, an itch; very seldom – allergic contact dermatitis.
At emergence of damages of skin or mucous membrane it is necessary to ask immediately for medical care and to stop treatment by Ambroxol as a precautionary measure.
From immune system: seldom – temperature increase, a fever; very seldom – a Quincke's disease, an acute anaphylaxis, a small tortoiseshell.
Extremely seldom reported about severe damages of skin, such as Stephens-Johnson's syndrome
and a Lyell's disease which are temporarily connected with reception of mucolytic means, such as Ambroxol. Often they could be explained with weight of a basic disease or reception of the accompanying drug.

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 Ambroxol or to auxiliary components of drug, a peptic ulcer of a stomach and duodenum, a convulsive syndrome, the I trimester of pregnancy, children's age up to 12 years.

Overdose:

Symptoms: nausea, dyspepsia, diarrhea, short-term concern. At strong overdose sharp arterial hypotension, vomiting, salivation strengthening are possible. Treatment: it is artificial to cause vomiting then to appoint drink (milk or tea), reception of fat-containing products. The gastric lavage is recommended in the first 1-2 hours after administration of drug. Symptomatic therapy.

Storage conditions:

To store in original packaging at a temperature not above 25 °C.
To store in the place, unavailable to children. Not to use drug after the termination of the period of validity specified on packaging!

Period of validity - 2 years. 

Issue conditions:

Without recipe

Packaging:

Syrup on 100 ml in a bottle; one bottle together with a measured spoon in a pack.