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

Has a secreto-motor, secretolitic and expectorant action; stimulates serous cells of the glands of the bronchial mucosa,increases the content of mucous secretions and the release of surfactant (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 sputum. Increases the motor activity of cilia of ciliated epithelium, increases mucociliary transport.

Pharmacokinetics:

After ingestion, the effect comes in 30 minutes and lasts for 6-12 hours.

Absorption - Fast and fairly complete, time to reach the maximum concentration - 2 hours, communication with blood plasma proteins - 80%.

Distribution Ambroxol from blood in tissues occurs quickly and is fairly pronounced, with the highest concentration in the lungs. Penetrates through the blood-brain barrier, placental barrier, excreted in breast milk.

Metabolism - in the liver by conjugation, with the formation of dibromantranilic acid and glucuronic conjugates. The main isoenzyme responsible for the metabolism of ambroxol - CYP3A4. Bioavailability after oral administration is about 60%.

Excretion. It is excreted by the kidneys: 90% in the form of water-soluble metabolites, in unchanged form - 5%. The half-life is 1.3 hours, for prolonged forms, 10-12 hours; increases with severe chronic renal failure, does not change in the case of impaired liver function.

Indications:

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

- acute and chronic bronchitis

- pneumonia

- chronic obstructive pulmonary disease

- bronchial asthma with difficulty in sputum discharge

- bronchiectatic disease.

Contraindications:

- Hypersensitivity to the main and / or auxiliary components of the drug, bromhexine

- Stomach ulcer and duodenal ulcer

- Epileptic syndrome

- I trimester of pregnancy

- Age to 12 years (for this dosage form)

- Rare hereditary diseases, such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption (the preparation contains lactose).

Carefully:

II-III trimester of pregnancy, lactation period, renal and / or liver failure, diseases associated with increased accumulation of bronchial secretions (eg, primary ciliary dyskinesia).In such cases, when taking Ambroxol, a doctor's control is required.

Pregnancy and lactation:

Preclinical studies and extensive clinical experience have not revealed any undesirable effects of drug treatment in pregnancy. Nevertheless, general rules for the prescription of medicines should be observed during this period, especially in the first trimester.

Ambroxol penetrates into breast milk, however, when administered at therapeutic doses, it does not adversely affect the baby.

Dosing and Administration:

Inside, after eating, squeezed with enough liquid (water, tea, milk, fruit juices).

Adults and children over 12 years of age 1 tablet (30 mg) 3 times a day for the first 2-3 days, then 1 tablet 2 times a day. If necessary, to enhance the therapeutic effect, you can take 2 tablets (60 mg) 2 times a day. The maximum daily dose is 120 mg.

In case of missed intake of the next dose at the next admission should not double the dose of the drug.

During treatment it is necessary to use a lot of liquid (juices, tea, water) to enhance the mucolytic effect.

The duration of treatment without consulting a doctor should not exceed 4-5 days.

If the dosage regimen is not adhered to, a decrease in the effectiveness of the treatment is possible. Patients with marked impairment of kidney and / or liver function the drug should be taken 1 tablet 1-2 times a day for not more than 5 days.

Side effects:

Frequency of adverse adverse reactions (WHO classification): very often -> 10%; often -> 1% and <10%; less often -> 0.1% and <1%; rarely -> 0.01% and <0.1%; very rarely - <0.01%.

From the digestive system: rarely - gastralgia, nausea, vomiting, diarrhea, constipation, dryness of the oral mucosa, hypersalivation.

Allergic reactions: less often - skin rashes, hives, angioedema, rhinitis, extremely rarely - anaphylactic shock.

Other: rarely - weakness, headache, dryness of the mucous membrane of the respiratory tract, exanthema, dysuria.

Overdose:

Symptoms: nausea, vomiting, diarrhea, indigestion.

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

Interaction:

Joint use with drugs with antitussive activity (eg, containing codeine) leads to difficulty in withdrawing sputum from the bronchi on the background of a decrease in cough.

Increases the concentration in the lung tissue and 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.

The use of the drug in patients with impaired bronchial motor function or abundant sputum with low viscosity may lead to stagnation of bronchial secretions.

Form release / dosage:

Tablets of 30 mg.

Packaging:

10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil.

1, 2, 3, 4 or 5 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, protected from light, place, at a temperature of no higher than 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:On prescription

Registration number:P N003725 / 01

Date of registration:09.06.2009

Expiration Date:Unlimited

The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia

Manufacturer: & nbsp

SKOPINSKY FARM ZAVOD, ZAO Russia

Information update date: & nbsp01.08.2017

Illustrated instructions

Instructions

Ambroxol (Ambroxol)