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

Excipients - propylene glycol-5.0 g, ethanol 95% (ethyl alcohol) -2.28 g, sorbitol (sorbitol) -42.0 g, methyl parahydroxybenzoate-0.05 g, propyl parahydroxybenzoate-0.02 g, banana flavor -0.10 g, water purified to 100 ml.

Description:A colorless or slightly yellowish transparent liquid with the aroma of a banana.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:Mucolytic agent, stimulates prenatal development of the lungs (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 surfactant (surfactant) in the alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolysing enzymes, and by increasing the release of lysosomes from Clark cells, reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport. After oral administration, the effect occurs after 30 minutes, and lasts for 6-12 hours.

Pharmacokinetics:

Absorption is high (for any route of administration). 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. T_1/2- 7-12 hours. It is excreted by the kidneys: 90% in the form of water-soluble metabolites, in unchanged form - 5%. T_1/2 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, chronic obstructive pulmonary disease, bronchial asthma with difficulty in sputum discharge, bronchiectatic disease.

Contraindications:

Hypersensitivity, pregnancy (I trimester). Children under 3 years.

Carefully:Hepatic failure, renal failure, peptic ulcer of stomach and duodenum, pregnancy (II-III trimester), the period of lactation.

Dosing and Administration:

Inside, during a meal, with a small amount of liquid.

Syrup (3 mg / ml) for adults - in the first 2-3 days of 10 ml, then 5 ml 3 times a day or 10 ml 2 times a day. In severe cases, the dose is not reduced throughout the course of treatment.

Children: 5-12 years of age appoint 15 mg 2-3 times a day, 3-5 years-7.5 mg 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, intense headaches, lowering blood pressure, shortness of breath, hyperthermia, chills.

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 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. In connection with the presence of ethanol in the formulation with caution to use in patients with a propensity to develop drug dependence, with liver disease, alcoholism, epilepsy, brain diseases, pregnant and children. Patients with diabetes can be prescribed as a syrup (5 ml of syrup contain sorbitol and saccharin in an amount corresponding to 0.1 8 XE).

Form release / dosage:Syrup 15mg / 5ml.

Packaging:

For 90 ml, 100 ml, 110 ml, 115 ml or 125 ml in bottles or jars of orange glass with a screw mouth, sealed with polyethylene plugs and screw caps from polymeric materials or caps of aluminum with perforation.

For 90 ml, 100 ml, 110 ml, 115 ml or 125 ml in bottles made of brown glass, sealed with lids made of polymer materials.

Each bottle or jar, together with an instruction for use and a measuring cup or measuring spoon, is placed in a pack of cardboard. It is allowed to put the full text of the instructions for medical use on the pack instead of the instructions put in the cardboard pack.

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 expiry date!

Terms of leave from pharmacies:Without recipe

Registration number:LP-000845

Date of registration:11.10.2011 / 19.11.2013

Expiration Date:11.10.2016

The owner of the registration certificate:ECOLAB, CJSC ECOLAB, CJSC Russia

Manufacturer: & nbsp

ECOLAB, CJSC Russia

Information update date: & nbsp31.07.2017

Illustrated instructions

Instructions

Ambroxol (Ambroxol)