BRONXORUS (tablets)
Active material: Amʙroksol
When ATH: R05CB06
CCF: Mucolytic and expectorant drugs
ICD-10 codes (testimony): J15, J20, J42, J44, J45, J47, J80
When CSF: 12.02.02
Manufacturer: Synthesis of (Russia)
PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING
◊ Pills white, round, ploskotsilindricheskoy form chamfered.
| 1 tab. | |
| ambroxol hydrochloride | 30 mg |
Excipients: corn starch, lactose, magnesium stearate, talc.
10 PC. – packings Valium planimetric (2) – packs cardboard.
10 PC. – packings Valium planimetric (3) – packs cardboard.
10 PC. – packings Valium planimetric (5) – packs cardboard.
10 PC. – packings Valium planimetric (10) – packs cardboard.
◊ Syrup as a clear liquid from colorless to slightly yellowish.
| 5 ml | |
| ambroxol hydrochloride | 15 mg |
Excipients: Sorbitol liquid, metilparagidroksiʙenzoat (nipagin or methyl paraben), propilparagidroksibenzoat (nipazol), propylene glycol, sodium saccharin, food flavoring liquid, Purified water (to 1 ml).
100 ml – vials of dark glass (1) – packs cardboard.
100 ml – vials of dark glass (1) complete with a dosing spoon or cup – packs cardboard.
Pharmacological action
Mucolytic and expectorant drugs. It has sekretomotornym, sekretoliticheskim and expectorant.
Ambroxol stimulates the motor activity of the cilia of the ciliated epithelium of the bronchial mucosa (mukokineticheskoe or sekretomotornym action).
Peristaltic spiral ciliated (ciliary) bronchial epithelial cells derive mucus from the bronchial tree (mucociliary transport or mucociliary clearance). Ambroxol improves mucociliary transport.
Ambroxol stimulates serous cells of glands of bronchial mucosa, increases the amount of phlegm and mucus component normalizes impaired ratio of serous and mucous components of sputum. By activating the hydrolyzing enzymes and increasing lysosomal release of Clara cells, It reduces the viscosity of mucus and its adhesive properties (mukoliticeskoe or sekretoliticeskoe dejstvie).
Ambroxol increases the synthesis and secretion of surfactant (surfactant) in the alveoli and bronchi.
As a result of these mechanisms is significantly reduced sputum viscosity and improving its expectoration.
If ingestion occurs through the action of the drug 30 minutes and lasts for 6-12 no.
Pharmacokinetics
Absorption
Absorption – high, Tmax – 2 no.
Distribution
Plasma protein binding – 80%. It penetrates through the BBB, placenta, excreted in breast milk.
Metabolism
It is metabolized in the liver to form dibromantranilovoy acid and glucuronic conjugates.
Deduction
T1/2 – 7-12 no. Report the news: 90% in the form of water-soluble metabolites, in unchanged form – 5%.
Pharmacokinetics in special clinical situations
T1/2 increases in chronic renal failure, severe, It does not change with abnormal liver function.
Testimony
Acute and chronic respiratory disease, accompanied by the formation of viscous mucus:
- Acute and chronic bronchitis;
- Pneumonia;
- Bronchial asthma with obstruction of sputum discharge;
- Bronchiectasis;
- COPD;
- Treatment and prevention of respiratory distress syndrome.
Dosage regimen
The drug is taken orally, mealtime, with a small amount of liquid.
Adults and children over 12 years appoint 30 mg (1 tab. or 10 ml syrup) 3 times / day. If you want to enhance the therapeutic effect can be assigned for 60 mg (2 tab.) 2 times / day.
IN severe cases do not reduce the dose over the entire course of treatment.
Children under 12 years the drug is prescribed in the form of a syrup.
For children 5-12 years appoint 15 mg (5 ml syrup, ie one teaspoonful) 2-3 times / day, aged 2-5 years – 7.5 mg (2.5 ml syrup, ie. half teaspoon) 3 times / day, to 2 years – 7.5 mg (2.5 ml syrup) 2 times / day.
The need for more preparation 4-5 days, the doctor will determine individually.
Side effect
From the digestive system: diarrhea, constipation; long-term use in high doses – gastralgia, nausea, vomiting.
Allergic reactions: skin rash, hives, angioedema; in some cases – atopic dermatitis, anaphylactic shock.
Other: rarely – generalized weakness, headache, exanthema, dizurija, rhinorrhea.
Contraindications
- Hypersensitivity to the drug;
- I trimester of pregnancy;
- Children up to age 12 years (for use in the form of tablets).
FROM caution used in liver failure, renal failure, gastric ulcer and duodenal ulcer, in the II and III trimesters of pregnancy, lactation (breast-feeding).
Pregnancy and lactation
If necessary, use of the drug in II-III trimesters of pregnancy should evaluate the potential benefit of therapy for the mother and the potential risk to the fetus.
During the period of breast-feeding to use the drug with caution, because ambroxol excreted in breast milk.
Cautions
Should not be combined with antitussive drugs, hampering the removal of sputum.
Patients, suffering from diabetes, You can assign syrup: 5 ml syrup containing sorbitol and saccharin in an amount, appropriate 0.18 HE.
Overdose
Symptoms: nausea, vomiting, diarrhea, dyspepsia.
Treatment: artificial vomiting, gastric lavage in the first 1-2 h after dosing; eating high-fat foods.
Drug Interactions
Simultaneous use of the drug Bronhorus® with antitussive drugs leads to difficulty sputum discharge on the background reduce the cough.
Ambroxol increases the penetration of the bronchial secretion of amoxicillin, tsefuroksyma, erythromycin and doxycycline.
Conditions of supply of pharmacies
The drug is resolved to application as an agent Valium holidays.
Conditions and terms
Tablets should be stored in a dry, dark place at a temperature no higher than 25 ° C. Shelf life – 2 year.
Syrup should be stored in a dark place at a temperature of 15 ° to 25 ° C. Shelf life – 2 year.
The drug should be stored out of reach of children.
