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

Excipients: a solution of sorbitol non-crystallisable-600.0 g, propylene glycol-50.0 g, ethanol (ethyl alcohol) 95% -22.8 g, methyl parahydroxybenzoate-1.2 g, propyl parahydroxybenzoate 0.4 g, hydrochloric acid 0.004 g, additive flavoring "Strawberry AE 1920" (maltol, linalool, methylcinnamate, orange oil, ethyl butyrate, ethyl-2-methylbutyrate, strawberry extract) - 1 g, water purified to 1000 ml.

Description:

Transparent, from colorless to slightly yellowish, slightly viscous liquid with a characteristic smell of strawberry.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

The drug has an expectorant and mucolytic effect. It is a metabolite of bromhexine. Ambroxol stimulates the cells of the glands of the bronchial mucosa, normalizing the disturbed ratio of serous and mucous components of sputum. This improves the rheological properties of sputum, reduces its viscosity and adhesive properties. Increases the secretion of the glycoprotein, stimulates the motor activity of the cilia of the ciliated epithelium and increases mucociliary transport, facilitating the excretion of sputum from the bronchi.

Ambroxol activates the release of lysosomes from Clark cells, which also leads to a decrease in the viscosity of sputum. All this contributes to the normalization of bronchopulmonary secretion, improves the rheological properties of the secret, its "slip" along the epithelium and facilitates the release of sputum from the respiratory tract, including mucus from the nasopharyngeal cavity.

Ambroxol increases the content of surfactant in the lungs, which is associated with increased synthesis and secretion in alveolar pneumocytes and inhibition of decay. Has a slight antitussive effect.

The therapeutic effect begins after 30 minutes and persists for 6-12 hours (depending on the dose).

Pharmacokinetics:

Ingestion ambroxol almost completely absorbed from the gastrointestinal tract and subjected to the effect of presystemic elimination. The maximum concentration in the blood plasma is achieved 2 hours after ingestion. Binding to plasma proteins is about 80%. Ambroxol penetrates the blood-brain and placental barrier, excreted in breast milk. The liver undergoes biotransformation with the formation of inactive metabolites of dibromantranilic acid and glucuronic conjugates.

It is excreted in the urine (about 90%) in the form of metabolites, about 5% - in unchanged form. The half-life is 7-12 hours. The elimination half-life increases with severe chronic renal failure, but does not change if the liver function is impaired.

Indications:

Acute and chronic diseases of the respiratory tract, accompanied by the formation of viscous, hard to separate sputum: laryngitis, acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease (COPD), bronchial asthma with difficulty in sputum discharge, bronchiectasis, cystic fibrosis, pulmonary alveolar proteinosis,as well as for liquefaction and improvement of mucus discharge in inflammation of the nasopharynx cavity (sinusitis, rhinitis).

Contraindications:

- Hypersensitivity to ambroxol or other constituent components of the drug;

- Pregnancy;

- the period of breastfeeding;

- epilepsy and other diseases of the brain;

- Children under 6 years (for syrup 30 mg / 5 ml), up to 2 years (for syrup 15 mg / 5 ml).

Carefully:

Due to the fact that a single dose of ambroxol (2,5ml, 5ml, 10ml) contained respectively 57mg, 117mg, 228mg of alcohol, its effects can be dangerous for people with kidney and liver failure, patients with gastric ulcer and duodenal ulcer , as well as for patients with alcoholism and children.

Dosing and Administration:

Inside.

Dosage regimen of syrup "Ambroxol" 15 mg / 5ml:

Adults and children over 12 years of age appoint a single dose of 10 ml of syrup (2 teaspoons), the frequency of reception - in the first 2-3 days 3 times / day, then 2 times / day.

Children aged from 12 to 12 years old appoint a single dose of 5 ml of syrup (1 teaspoon), the frequency of reception - 2-3 times / day.

Children aged 2 to 5 years appoint a single dose of 2.5 ml of syrup (1/2 teaspoon), the frequency of reception - 3 times / day.

Dosing regimen of syrup "Ambroxol" 30 mg / 5ml:

Adults and children over 12 years of age appoint a single dose of 5 ml of syrup (1 teaspoon), the frequency of reception - in the first 2-3 days 3 times / day, then 2 times / day.

Children aged 6 to 12 years appoint a single dose of 2.5 ml of syrup (1/2 teaspoon), the frequency of reception - 2-3 times / day Ambroxol should be taken orally with food or after eating, squeezed with enough liquid. The use of a large amount of liquid during the treatment increases the mucolytic effect of the drug. In the presence of patients with impaired renal or hepatic function, it is necessary to increase the interval between doses of ambroxol or to reduce the dose.

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.

At the first signs of the development of side effects should be canceled taking the drug.

Overdose:

Symptoms: nausea, vomiting, diarrhea.

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

Interaction:

- Simultaneous reception of ambroxol with amoxicillin, cefuroxime, doxycycline and erythromycin improves the penetration of the antibiotic into the lung tissue;

- Ambroxol should not be given concomitantly with antitussive agents, as this makes it difficult to divert the diluted sputum from the bronchi while suppressing the cough reflex.

Special instructions:

Do not combine ambroxol with antitussive drugs that make it difficult to divert sputum.

In extremely weakened patients, patients with anatomical narrowing of the bronchi and increased mucus secretion with ambroxol, difficulties in evacuating bronchial secretions may occur.

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

Form release / dosage:

Syrup 15 mg / 5 ml, 30 mg / 5 ml.

Packaging:100 and 150 ml into plastic bottles of the type FP-F-100/150 by TU BY 100048311.017-2007, sealed with polymer caps with gaskets according to TU RB 28996716.002-98. The label is self-adhesive on the bottle. TU BY 190488625.001-2005.

Vial with a dispensing cup according to TU BY 100048311.014-07 and the instructions for use are placed in a pack of cardboard for consumer packaging subgroups chrome or chromium-ersatz according to GOST 7933-89.

Group packing and transport packaging in accordance with GOST 17768-90.

Marking. The name of the manufacturer, its trademark and address, the name of the medicinal product, the form of the release, the method of use, the concentration, the international non-proprietary name in Latin, the volume of the preparation in the vial, the composition (name and quantity of active and auxiliary substances), "Expectorant mucolytic agent", storage conditions, "Keep out of reach of children", "Do not use after expiry date", registration number, number series, the expiration date.

The package is additionally indicated by the conditions of the release, "Instructions for use: see the instructions for usephone / fax of the manufacturer, bar code, the name of the organization that accepts claims from consumers.

The label of the group container is additionally indicated by the number of packages, the bar code. Marking of the transport packaging in accordance with the requirements of art. 46. Federal Law No. 61-FZ "On the circulation of medicines".

Storage conditions:

List B. In the dark place at a temperature of + 15 ° C - + 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:LSR-007012/08

Date of registration:02.09.2008

Expiration Date:Unlimited

The owner of the registration certificate:FARMTECHNOLOGIYA, LLC FARMTECHNOLOGIYA, LLC Republic of Belarus

Manufacturer: & nbsp

FARMTECHNOLOGIYA, LLC Republic of Belarus

Information update date: & nbsp01.08.2017

Illustrated instructions

Instructions

Ambroxol (Ambroxol)