INSTRUCTION
for medical usage of medicinal product Ambroxol-retard
(Ambroxolum-retard)
General characteristic:
chemical name: ambroxol;
main physical - chemical properties: tablets consist of two layers: one layer is of cream colour or cream colour with yellow shadow, the other one is of white colour or white colour with cream shadow.
content: 1 tablet contains: ambroxol hydrochloride - 0,075 g
excipients: milk sugar, potato starch, iodragite RL 100, montan glycolic wax, sodium croscarmellose, low-molecular medicinal polyvinylpirrolidone, magnesium stearate.
Form of output: tablets
Pharmacological group: Mucolitic remedy.
Pharmacological properties: Ambroxol (group of benzilamides) belongs to secretolitical and secretomotoric medicinal products. It possesses expressed expectorant effect. Mechanism of action of the medicinal product is stipulated by stimulation of serous cells of tonsils of bronchial tubes' mucous membrane, increasing of mucous secretion content and changing of correlation of serous and mucous components of phlegm, breached under pathological processes in lungs. Under this hydrolyzing ferments activate and releasing of lizosoms from Clark's cells strengthens, that causes decreasing of viscosity of phlegm. Ambroxol increases content of surphactant in lungs, that is dealt with strengthening of synthesis of the last and secretion in alveolar pneumocytes, and also with breach of its disintegration. The medicinal product increases mucociliar transport of phlegm. It suppresses coughing insignificantly.
Ambroxol well penetrates through the placenta barrier, improving synthesis of surphactants during uterine life of foetus, and also it has an ability to warn syndrome of insufficient breathing in newborn. The medicinal product does not cause immense creating of saecretion, reduces spastic hyperactivity of bronchial tubes - one of the main factors of developing of bronchial asthma under allergy. Ambroxol is more effective, than its predecessor - bromhexin, it is non-toxic one and well endured by patients. Action of retard form of ambroxol is kept in 9 - 10 hours after administration inside.
Pharmacokinetics: Under peroral administration it is quickly and fully absorbed and penetrates well into the lung's tissue. Maximal concentration in blood plasma is achieved in 2 hours after administration of the medicinal product and kept during 9 - 10 hours. Ambroxol is excreted out of human organism almost exceptionally by kidneys.
Indications for administration: Acute and chronic diseases of breathing ways, accompanied by the creation of difficulty-secreted viscous secretion, chronic bronchitis with obstructive syndrome, bronchial asthma with difficult release of phlegm, bronchoectatic disease. The medicinal product can be used under mucoviscidozis of lungs, syndrome of insufficient breathing in adults (shock lung), for the prophylactics and treatment of complications after operations on lungs, under looking after tracheostome, before and after bronchoscopy.
Way of administration and dosage: For adults and children over 12 it is administrated inside by 1 tablet every day after meal (with enough quantity of water).
Side effects: Under individual hypersensitivity to ambroxol allergic reactions such as skin rash, nettle-rash, angioneurotic oedema are possible. Under the prolonged administration in large doses pain in epigastrial area, nausea, vomiting can appear.
Contraindications: It is necessary to be careful under hypersensitivity to ambroxol. It is not administrated during the first term of pregnancy, lactation period, under ulcer disease of stomach and duodenum, spasmodic states of any etiology.
Interaction with other drugs: Combination of ambroxol with theophylline is expedient; administration together with heart glycosides, diuretics and antibiotics is possible. Ambroxol increases effectiveness of ampicillin and amoxicillin, increasing their concentration in blood.
Overdose: Any cases of intoxication with the medicinal product were not revealed.
Peculiarities of administration: Under the necessity of administration of the medicine during lactation period the question about stopping of nursing should be discussed.
Conditions and shelf-life: Keep in dry place, away from direct sunlight, away from children. Shelf-life - 2 years.
Conditions of output: under prescription.
Packing: 12 tablets in contour cell package, 30, 50 or 100 tablets in polymer container.
Manufactured by SC Concern Stirol
Address. Gorlovskoi Divizii Str., 10, 84610, Gorlovka, Donetsk region, Ukraine.
Adress in Internet: http://pharm.stirol.net
E-mail:support
