Salbroksol

General characteristics. Structure:

Active ingredients: Ambroxol, salbutamol; sostav:1 the tablet contains Ambroxol of a hydrochloride 15 mg, salbutamol of sulfate of 4 mg; excipients: lactoses monohydrate, кросповидон, calcium stearate, silicon dioxide colloid anhydrous. Main physical and chemical properties: tablets of a round form, white color, with a flat surface with slanted edges and risky.

Pharmacological properties:

Pharmacodynamics. Ambroxol – секретолитик and секретомоторик groups of benzylamines. Normalizes patholologically the changed formation of a bronchial secret due to stimulation of serous cells of glands of a mucous membrane of bronchial tubes owing to what the maintenance of a mucous secret increases and the ratio of mucous and serous components of a phlegm changes. Ambroxol activates the hydrolyzing enzymes and strengthens release of lysosomes from Clark's cells, changes structure of a bronchial secret by reduction and fragmentation of mukopolisakharidny fibers, selectively inhibits sodium absorption by an epithelium of respiratory tracts that leads to decrease in viscosity of a phlegm. Strengthens the movement of cilia of a ciliary epithelium of bronchial tubes, increasing mukotsiliarny transport of a phlegm, than facilitates its otkhozhdeniye. Besides, Ambroxol stimulates synthesis of phospholipids of surfactant with alveolar pnevmotsita, possesses antioxidant action. Ambroxol well gets through a placental barrier and improves synthesis of surfactant in the period of pre-natal fetation.
Salbutamol – the selection agonist β2-адренорецепторов. Renders broncholitic effect, warns and stops a bronchospasm, reduces resistance in respiratory tracts, increases the vital capacity of lungs. Increases resistance of mast cells and basophiles to degranulation at contact with allergen and by that prevents release of a histamine, slowly reacting substance of an anaphylaxis and a factor of a chemotaxis of neutrophils. In comparison with others β2-адреномиметиками, salbutamol renders less expressed positive hrono-and inotropic influence on a myocardium, practically does not change the arterial pressure and heart rate.

Pharmacokinetics. Ambroxol after use inside is quickly and completely soaked up from digestive tract. The pharmacological effect occurs in 30 min. after administration of drug, the maximum concentration in plasma comes to light in 1 – 3 h and keeps during 6 – 12 h. Bioavailability of Ambroxol makes 30%. It is connected with effect of "the first passing" through a liver. Linkng with proteins of plasma – about 85%. About 90% of Ambroxol are removed from an organism in the form of metabolites with urine, less than 10% are removed in not changed look.
Salbutamol in insignificant degree contacts proteins of a blood plasma, its bioavailability at oral administration makes 40 – 50%. The elimination half-life for salbutamol and its active metabolite makes 6 h. The main metabolites of salbutamol are the conjugated sulfates (42%), main of which – the radio sulfate of salbutamol possessing b2 adrenostimuliruyushchy effect. The conjugated sulfates are removed preferential with urine and in insignificant degree - with bile.
Salbutamol and Ambroxol get through a placental barrier and cosecrete with breast milk.

Indications to use:

• Bronchial asthma;
• chronic obstructive bronchitis;
• emphysema of lungs.

Route of administration and doses:

Apply inside. To adults and children 12 years are more senior appoint on 1 tablet 3–4 times a day.
Drug needs to be accepted between meals. Intervals between receptions have to make not less than 6 h.
For adults if necessary the dose of drug can be increased to 2 tablets 4 times a day.
At emergence of by-effects it is recommended to lower a dose to ½ tablets 4 times a day.
Duration of treatment is determined by the doctor depending on a clinical picture of a disease.

Features of use:

Increase in a dose or reduction of intervals between administrations of drug should be carried out under control of the doctor. Reduction of an interval is possible only in exceptional cases and has to be strictly reasonable.
At use of a salbroksol development of a hypopotassemia therefore during treatment it is necessary to control potassium level in blood is possible.
It is necessary to apply with care at diseases of a liver and/or kidneys.

Ability to influence speed of response at control of motor transport or other mechanisms.
Use of drug can worsen reaction during the driving and work with mechanisms. This effect amplifies at simultaneous alcohol intake and use of tranquilizers.

Use during pregnancy or feeding by a breast.
Use of drug in the first trimester of pregnancy is contraindicated. At appointment in the second and third trimesters of pregnancy it is necessary to consider a ratio advantage/risk.
In need of drug use by the women nursing feeding is recommended to be stopped.

Children.
Experience of use of drug for treatment of children up to 12 years is absent.

Side effects:

Tremor of hands, tension; more rare – passing expansion of peripheral vessels, a headache, dizziness, moderate tachycardia, nausea, vomiting, feeling of overflow of a stomach, morbidity in epigastriums, a diarrhea, anorexia, difficulty of an urination, perspiration, increase in level of glucose in blood.
In rare instances – a Quincke's disease, allergic reactions in the form of skin rashes, arterial hypotension, a collapse, a paradoxical bronchospasm, muscular spasms.

Interaction with other medicines:

Antagonistic action (in relation to salbutamol) β-adrenoblockers not only weakens broncholitic effect of drug, but also can strengthen a bronchospasm.
The combination to m-holinoblokatorami and theophylline increases expressiveness and duration of a bronkhodilatation, however the risk of development of tachycardia and arrhythmia, in particular supraventricular premature ventricular contraction increases.
Glucocorticoids increase sensitivity of receptors to β-adrenostimulyator, including to salbutamol.
Ambroxol which is a part of drug improves penetration of antibiotics into a bronchial secret.
Co-administration of antibechics (codeine, глауцин, etc.) can worsen otkhozhdeny phlegms.
At a concomitant use of derivatives of xanthine, glucocorticoids, cardiac glycosides, diuretics there is a risk of development of a hypopotassemia.
At simultaneous use with antidepressants and MAO inhibitors strengthening of effect of salbutamol and a sharp lowering of arterial pressure is possible.

Contraindications:

• Hypersensitivity to drug components;
• tachyarrhythmia;
• arterial hypertension;
• myocarditis;
• heart diseases;
• acute heart failure;
• peptic ulcer of a stomach and duodenum;
• diabetes mellitus;
• hyperthyroidism;
• thyrotoxicosis;
• glaucoma;
• use of β-adrenoblockers, especially non-selective;
• first trimester of pregnancy;
• feeding period breast;
• children's age up to 12 years.

Overdose:

It is shown by tachycardia, arrhythmia, a sleep disorder, pain in a breast, a tremor of hands and all body. At reception of high doses heavy complications are possible: arterial hypotension, collapse, Quincke's disease.
Symptomatic treatment – carry out a gastric lavage, appoint cardioselective blockers β1-адренорецепторов.

Storage conditions:

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

Period of validity-3 years.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in the blister, on 2 or 4 blisters in a pack.