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

Active substance: Ambroxol hydrochloride Excipients:	- 0.75 g
Methylparahydroxybenzoate (Methylparaben)	- 0.13 g
Propyl parahydroxybenzoate (Propylparaben)	- 0.02 g
Sodium disulfite	- 0.02 g
Sodium cyclamate	- 0.90 g
Sodium Sodium	- 0.10 g
Citric acid monohydrate	- 0.25 g
Sodium hydroxide (Sodium hydroxide)	- 0.10 g
Purified water	up to 100 g

Description:Transparent colorless liquid with a specific odor.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Ambroxol has mucolytic (secretolitic) action.

Ambroxol is a metabolite of bromhexine and is formed by N-demethylation. Stimulates the serous cells of the glands of bronchial mucosa, normalizing the disturbed ratio of serous and mucous components, dilutes sputum, increases its volume and facilitates the outflow of secretion; increases the content of surfactant in the lungs, which is associated with increased synthesis and secretion in alveolar pneumocytes. The drug has a weak antitussive effect. The effect of the drug occurs 30 minutes after admission.

Pharmacodynamics

Mucolytic agent, stimulates prenatal lung development (increases synthesis, secretion of surfactant and blocks its disintegration). Has a secreto-motor, secretolitic and expectorant action; stimulates serous cells of the glands of the mucous membrane of the bronchi, increases the content of mucous secretion and the release of surface-active substance (surfactant) in the alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolysing enzymes and enhancing the release of lysosomes from Clara cells, reduces the viscosity of phlegm.

Increases the motor activity of the ciliated epithelium, increases mucociliary transport.

After ingestion, the effect occurs 30 minutes later, with rectal administration - after 10-30 minutes. and lasts for 6-12 hours. With parenteral administration, the action occurs rapidly and lasts for 6-10 hours.

Pharmacokinetics:

Absorption is high (for any route of administration), Tcmah - 2 hours, connection with plasma proteins 80%. Penetrates through the BBB, the placental barrier, excreted in breast milk.

Metabolism - in the liver, forms dibromantranilic acid and glucuronic conjugates. T1 / 2 - 7-12 hours. It is excreted by the kidneys: 90% in the form of water-soluble metabolites, in unchanged form - 5%. T1 / 2 increases with severe chronic renal failure, it does not change when liver function is impaired.

Indications:

Acute and chronic diseases of the respiratory tract, accompanied by the formation of viscous, hard to separate sputum (tracheobronchitis, bronchitis, obstructive bronchitis, bronchial asthma, pneumonia, bronchiectasis, cystic fibrosis, etc.).

Inflammation of the nasopharynx cavity (to improve mucus liquefaction).

Contraindications:

Hypersensitivity to ambroxol or other constituent components of the drug, epileptic syndrome; pregnancy (I trimester), the period of breastfeeding.

Carefully:

Renal and / or hepatic insufficiency (it is necessary to use lower concentrations, or increase the interval between doses), peptic ulcer and 12 duodenal ulcer; pregnancy (II and III trimester).

Dosing and Administration:

Inside. (1 ml = 20 drops)

Adults: 3 times a day for 4 ml (30 mg Ambroxol g / x).

With prolonged treatment, a single dose can be reduced to 2 ml (15 mg ambroxol g / x).

For children:

at the age of 2 years: 2 times a day for 1 ml (7.5 mg ambroxol g / h); from 2 to 5 years: 3 times a day for 1 ml (7.5 mg Ambroxol g / x); from 5 to 12 years: 2-3 times a day for 2 ml (15 mg Ambroxol g / x).

Bronchoxol is taken after meals in diluted form with tea, fruit juices, milk or water. During treatment, to increase the mucolytic effect, it is necessary to consume a lot of liquid (juices, tea, water). The duration of therapy depends on the severity of the disease and is determined by the attending physician. Without a doctor's recommendation, Bronhoxol should not be taken for more than 4-5 days.

Side effects:

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

Rarely - weakness, headache, diarrhea, dry mouth and respiratory tract, exanthema, rhinorrhea, dysuria. With prolonged use in high doses - gastralgia, nausea, vomiting.

At the first signs of the development of side effects should be canceled taking the drug. Inform your doctor about their severity and consult about the necessary activities in this situation.

If you observe the development of side effects described or not described in the proposed instructions for use, inform your doctor.

Overdose:

Symptoms: nausea, vomiting, diarrhea, indigestion.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug, taking fat-containing foods.

Interaction:Simultaneous administration of Bronhoxol with amoxicillin, cefuroxime, doxycycline and erythromycin improves the penetration of antibiotics into the lung tissue. Bronchoxol should not be given concomitantly with antitussive drugs. this makes it difficult to move the diluted sputum out of the bronchi while suppressing the cough reflex.

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

Does not affect.

Form release / dosage:Solution for ingestion 7.5 mg / ml.

Packaging:

To 50 ml in bottles of droppers of orange glass or in bottles of brown glass with a screw mouth, ukuporennyh stoppers-droppers polymeric and caps polymeric screwed, or lids with a dropper.

Each vial or dropper along with the instruction for use is placed in a pack of cardboard.

To 100 ml in bottles of orange or brown glass with a screw neck, ukuporennye caps aluminum with perforation or plastic caps.

Each vial, along with a pipette or spoon, or a measuring cup and instruction for use, is placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the date indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-000458

Date of registration:21.06.2010 / 21.07.2014

Expiration Date:Unlimited

The owner of the registration certificate:MOSCOW PHARMACEUTICAL FACTORY, CJSC MOSCOW PHARMACEUTICAL FACTORY, CJSC Russia

Manufacturer: & nbsp

MOSCOW PHARMACEUTICAL FACTORY, CJSC Russia

Information update date: & nbsp07.03.2017

Illustrated instructions

Instructions

Bronhoxil® (Bronchoxol®)