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

One tablet contains: active substance: Ambroxol hydrochloride 30 mg; Excipients: lactose monohydrate (sugar milk) - 171.0 mg, potato starch - 36.0 mg, silicon dioxide colloid (aerosil) - 1.8 mg, magnesium stearate - 1.2 mg.

Description:

Tablets of white or almost white color, flat-cylindrical shape with a risk and a facet.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

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 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 Clark cells, reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport.

After ingestion, the action occurs after 30 minutes and lasts for 6-12 h.

Pharmacokinetics:

Absorption is high, the time to reach the maximum concentration in the blood (TSmah) -2 h, the connection with plasma proteins - 80%. Penetrates through the blood-brain barrier, placental barrier, excreted in breast milk.

Metabolism - in the liver, forms dibromantranilic acid and glucuronic conjugates. The half-life period (T1 / 2) is 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, does not change when the liver function is impaired.

Indications:

Diseases of the respiratory tract with the formation of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease (COPD), bronchial asthma with difficulty in sputum discharge, bronchiectasis, cystic fibrosis.

Contraindications:

Hypersensitivity, children under 6 years of age, pregnancy (I trimester).

Carefully:The drug should be used with caution in patients with gastric ulcer and duodenal ulcer, as well as in patients with renal and hepatic insufficiency.

Pregnancy and lactation:

The drug is not recommended for use during the first trimester of pregnancy. If it is necessary to use ambroxol in II-III trimester of pregnancy and during breastfeeding should evaluate the potential benefit to the mother with a possible risk to the fetus / child.

Dosing and Administration:

Inside, during meals, with a small amount of liquid. Adults and children over 12 years of age are prescribed - 30 mg three times a day for the first 2-3 days, then 30 mg twice a day or 15 mg (half a tablet) 3 times a day, children 6-12 years old 15 mg (half a tablet) 2-3 times a day.

It is not recommended to use without medical appointment 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, constipation, dysuria. With prolonged use in high doses - gastralgia, nausea, vomiting.

Overdose:

Symptoms: nausea, vomiting, diarrhea.

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

Interaction:

Joint use with antitussive drugs leads to difficulty in getting away from sputum while reducing the cough. Increases penetration into the bronchial secretion of amoxicillin, cefuroxime, erythromycin and doxycycline.

Special instructions:

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

Form release / dosage:Tablets of 30 mg.

Packaging:

For 10 tablets in a planar cell package.1, 2, 3, 4 or 5 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

In dry, protected from light and out of reach of children, at a temperature of no higher than 25 ° C.

Shelf life:

3 years. Do not use after the date shown on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-003587/07

Date of registration:06.11.2007 / 06.08.2010

Expiration Date:Unlimited

The owner of the registration certificate:ALSI Pharma, ZAO ALSI Pharma, ZAO Russia

Manufacturer: & nbsp

ALSI Pharma, ZAO Russia

Information update date: & nbsp01.08.2017

Illustrated instructions

Instructions

Ambroxol (Ambroxol)