Bronchorus - instructions for use, dose, side effects, contraindications

Auxiliary substances: sorbitol 600 mg, methylparahydroxybenzoate (nipagin or methylparaben) 0.8 mg, propyl parahydroxybenzoate (nipazole or propylparaben) 0.2 mg, propylene glycol 80 mg, sodium saccharinate dihydrate 0.5 mg, povidone (kollidone 90 F, Plasdon-K90) - 15 mg, raspberry flavor - 2 mg, purified water-to obtain 1 ml of syrup.

Description:Transparent liquid from colorless to slightly yellowish color.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Mucolytic and expectorant.

Has secretolitic, secretory and expectorant action.

Ambroxol stimulates serous cells of the glands of the bronchial mucosa, increases the content of the mucous component of sputum and normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolysing enzymes (cleavage bonds between polysaccharides of sputum) and enhancing the release of lysosomes from Clara cells, reduces the viscosity of the sputum and its adhesive properties (mucolytic or secretolytic action).

Ambroxol stimulates and increases the motor activity of cilia epithelium of bronchial mucosa (mukinetic or secretory-motor action), prevents ciliary coughing. Peristaltic contractions in the spiral of ciliary cells of the bronchial epithelium excrete mucus from the bronchial tree (mucociliary transport or mucociliary clearance). Ambroxol significantly improves mucociliary transport.

Ambroxol increases the synthesis and secretion of surfactant (surfactant) in the alveoli and bronchi.

As a result of these mechanisms, the viscosity of sputum is significantly reduced and its expectoration is improved.

Pharmacokinetics:

Absorption is high (for any route of administration). After ingestion, the effect comes in 30 minutes and lasts for 6-12 h. The time to reach the maximum concentration is 2 hours. The connection with plasma proteins is 80%. Penetrates through the blood-brain barrier, placental barrier, excreted in breast milk.

Metabolism - in the liver, forms dibromantranilic acid and glucuronic conjugates. Half-life (T1/2) - 7-12 hours. It is excreted by the kidneys: 90% in the form of water-soluble metabolites, in unchanged form - 10%.

The half-life period increases with severe chronic renal failure, does not change if the liver function is impaired.

Indications:

Diseases of the respiratory tract with the formation of viscous sputum:

* acute and chronic bronchitis;

* pneumonia;

* bronchial asthma with difficulty in sputum discharge;

* bronchiectatic disease;

* chronic obstructive pulmonary disease (COPD).

Contraindications:

Hypersensitivity to the components of the drug, pregnancy (I trimester).Patients with hereditary intolerance to fructose should not take the drug (due to the presence of sorbitol in the composition).

Carefully:Hepatic insufficiency, renal failure, peptic ulcer of stomach and duodenum.

Pregnancy and lactation:

If it is necessary to use the drug in II-III trimesters of pregnancy should evaluate the potential benefit of therapy for the mother and the possible risk to the fetus.

During the period of breastfeeding, the drug should be used with caution, since ambroxol excreted in breast milk.

Dosing and Administration:

Inside, during a meal or after a meal, with enough liquid (half a glass of water, tea or juice).

1 teaspoon (5 ml) of syrup contains 15 mg of ambroxol hydrochloride.

Adults and children over 12 years of age - first 2-3 days by 10 ml syrup (2 teaspoons) 3 times a day, then 10 ml of syrup (2 teaspoons) 2 times a day or 5 ml of syrup (1 teaspoonful) 3 times a day.

In severe cases, the dose is not reduced throughout the course of treatment - 10 ml of syrup (2 teaspoons) 3 times a day.

Children aged 5-12 years prescribe 5 ml of syrup (1 teaspoon) 2-3 times a day;

children aged 2-5 years - 2,5 ml syrup (1/2 teaspoon) 3 times a day;

from birth to 2 years - 2,5 ml syrup (1/2 teaspoon) 2 times a day.

It is not recommended to take the drug for more than 4-5 days without consulting a doctor.

Treatment children under 2 years should be carried out only under the supervision of a doctor.

During the use of the drug is a plentiful drink.

Side effects:

From the digestive system: rarely - diarrhea, dry mouth, constipation; with prolonged use in high doses - gastralgia, nausea, vomiting.

From the respiratory system: dryness of the mucous membranes of the respiratory tract, rhinorrhea.

Allergic reactions: skin rash, hives, angioedema; in some cases - allergic dermatitis, anaphylactic shock.

Other: rarely - weakness, headache, exanthema, dysuria.

Overdose:

Symptoms: nausea, vomiting, diarrhea.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; eating high in fat.

Interaction:

Joint use with antitussive drugs leads to difficulty in getting away from sputum while reducing the cough.

Increases the penetration into the bronchial secret of amoxicillin, cefuroxime, erythromycin and doxycycline.

Special instructions:

Do not combine with antitussive drugs that make it difficult to withdraw phlegm.

Does not contain sugar! Patients suffering from diabetes can be given a syrup: 5 ml of syrup contain sorbitol and saccharin in an amount corresponding to 0.18 XE. The drug may cause a lax effect, as the content of sorbitol in a daily dose can exceed 10 mg (600 mg of sorbitol in 1 ml of syrup, and the daily dose can reach 30 ml, 18 g of sorbitol, respectively).

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:Syrup 3 mg / ml.

Packaging:

100 ml in bottles of orange glass with a screw neck, sealed with plastic caps and plastic screw caps.

For 100 ml in bottles of orange glass with a screw mouth or a bottle of dark glass with a screw mouth,Corked with aluminum caps with threaded thread and control of the first opening or caps with plastic screw-on. Each bottle, a bottle with instructions for use and a spoonful of dosage pharmacy or without a dose of a dispensing chemist is placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of 15 ° C to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LS-002636

Date of registration:30.08.2011 / 13.02.2014

Expiration Date:Unlimited

The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Information update date: & nbsp07.03.2017

Illustrated instructions

Instructions

Bronchorus® (Bronchorus®)