Ambroxol
Producer: HFZ CJSC NPTs Borshchagovsky Ukraina
Code of automatic telephone exchange: R05CB06
Release form: Liquid dosage forms. Syrup.
General characteristics. Structure:
International and chemical names: Ambroxol; trans-4-[(2-amino-3,5-dibrombenzil) amines] cyclohexanol hydrochloride;
main physical and chemical properties: colourless or slightly yellowish transparent viscous liquid, with a specific smell;
structure: 5 ml of syrup contain 30 mg of Ambroxol of a hydrochloride;
excipients: hydroxyethylcellulose, sorbite, saccharin sodium, citric acid, glycerin, propylene glycol, Natrium benzoicum, fragrance food apricot, fragrance food orange, menthol, the water purified.
Pharmacological properties:
Pharmacodynamics. Ambroxol – synthetic sekretolitichesky and sekretomotorny means from group of benzylamines. Drug shows a promoting effect of rather serous cells of glands of a mucous membrane of bronchial tubes that leads to increase in secretion of slime and change of a ratio of serous and mucous components of a phlegm. It, and also activation of hydrolytic enzymes and increase in a physical activity of a ciliary epithelium of bronchial tubes, causes department of a pathological secret from walls of bronchial tubes and improvement of its removal from respiratory tracts. Ambroxol increases the content of surfactant in lungs, and also prevents its destruction in pnevmotsita. It leads to normalization of rheological indicators of a phlegm, reducing its viscosity and adhesive properties. Drug directly stimulates a physical activity of a ciliary epithelium of bronchial tubes, prevents its adhesion and improves mukotsiliarny evacuation of a phlegm. As mucolytic drug and as an ekspektorant, Ambroxol improves function of external respiration. It is proved that drug reduces hyperreactivity of muscles of bronchial tubes of patients with bronchial asthma. Has insignificant antibechic effect. Ambroxol has antiinflammatory effect, has antioxidant properties, stimulates local immunity. The therapeutic effect develops in 30 minutes and lasts from 6 to 12 hours (depending on the accepted drug dose).
Pharmacokinetics. At oral administration Ambroxol is quickly and completely soaked up in a GIT. Well gets into tissues of lungs. The maximum concentration of Ambroxol in a blood plasma is observed through 1/2 - 3 hours after oral administration. Bioavailability of drug makes 70 - 80%. An elimination half-life – 10 - 12 hours. Cumulation of drug is not observed. Extent of linkng with blood proteins – about 90%. After intake quickly gets into all bodies and fabrics, but the greatest concentration of drug is observed in lungs. Well gets through GEB, a placental barrier, cosecretes with breast milk. Metabolism of Ambroxol happens in a liver by conjugation to formation of inactive metabolites (glucuronides and dibromoantranilovy acid). To 90% of drug it is removed with urine.
Indications to use:
Ambroxol 30 is intended for treatment of the acute and chronic respiratory diseases which are followed by formation of a viscous, hardly separable phlegm: chronic obstructive bronchitis, bronchial asthma with a slow otkhozhdeniye of a phlegm; bronchoectatic disease, pneumonia, inflammatory diseases of upper respiratory tracts (laryngitis, pharyngitis, sinusitis, rhinitis); mucoviscidosis of lungs; for prevention and treatment of complications after lung operations; during preparation for a bronkhoskopiya and after the conducted research.
Route of administration and doses:
Ambroxol 30 is applied inside measured spoons after food:
age group |
Dosing * |
reception frequency in days |
Daily dose drug (in mg) |
|
measured spoon |
ml |
|||
adults and children are more senior than 12 years |
1-2 |
5-10 |
2-3 |
to 120 mg |
children from 6 to 12 years |
1/2 |
2,5 |
2-3 |
30-45 |
children from 2 to 6 years |
1/4 |
1,25 |
3 |
22,5 |
* - in need of the first 2-3 days of treatment of a dose of drug can be increased twice.
The course of treatment makes – 4-14 days.
Features of use:
Ambroxol 30 can be used patients with a diabetes mellitus (5 ml of syrup contain sorbite and saccharin in the quantity adequate 0,18 XE). Drug cosecretes with breast milk, but use of Ambroxol 30 in therapeutic doses does not make negative impact on babies.
Side effects:
Ambroxol 30 is well transferred, but at prolonged use and reception of high doses of drug there can be heartburn, dyspepsia, feeling of overflow of a stomach, nausea, vomiting; seldom - allergic reactions in the form of skin rashes, a small tortoiseshell, a Quincke's disease. Hypersalivation, increases in secretion of a mucous membrane of a nose, a hyperthermia, a dysuria is possible.
Interaction with other medicines:
Drug raises a therapeutic effectiveness of doxycycline, a tsefuroksim and amoxicillin due to increase in their concentration in pulmonary fabric. Ambroxol 30 increases effective concentration of rifampicin in lungs; in pilot studies oppression of growth of mycobacteria of tuberculosis is revealed. Perhaps simultaneous use of drug with cardiac glycosides, diuretics. Therapeutic the Ambroxol 30 combination with theophylline is reasonable. It is not necessary to accept along with antibechic drugs which oppress removal of a phlegm.
Contraindications:
It is contraindicated in the I trimester of pregnancy, at a peptic ulcer of a stomach and a 12-perstny gut, at hypersensitivity to Ambroxol and other components of syrup.
Overdose:
Cases of overdose are not described, but digestion disturbances, discomfort or pains in epigastric area, feeling of overflow of a stomach, nausea, vomiting are possible. In such cases it is necessary to cancel administration of drug and to carry out symptomatic therapy.
Storage conditions:
In the dry, protected from light place at a temperature from 15 °C to 25 °C. A period of validity - 2 years.
Issue conditions:
Without recipe
Packaging:
Banks and bottles on 100 ml with a spoon measured or without it in a pack.