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

Excipients: benzoic acid, hydroxyethylcellulose, sorbitol liquid (non-crystallizing), glycerol, propylene glycol, sodium saccharinate, tutti frutti flavor, purified water.

Description:

Slightly viscous transparent, colorless liquid, with a fruity odor.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

The drug has an expectorant, mucolytic effect.Reducing the viscosity of sputum occurs as a result of depolymerization of mucopolysaccharides that are in sputum. Depolymerization of mucopolysaccharides is primarily associated with the disruption of disulfide bonds in their molecules. Ambroxol increases the motor activity of the ciliated epithelium, increases mucociliary transport, normalizes the 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. It facilitates the excretion of sputum from the respiratory tract. Ambroxol stimulates prenatal lung development by increasing the synthesis and secretion of surfactant in the alveoli. Synthesis of the surfactant is reduced as a result of chronic diseases of the respiratory system, in addition, the properties of the surfactant change due to the formation of bonds between the surface active phospholipids and inflammatory proteins.

Pharmacokinetics:

After application, the absorption of the drug from the gastrointestinal tract is high. The drug appears for 30 minutes and is held for 6-12 hours. Time to reach the maximum concentration in the blood (TCmah) - about 2 hours.Binding to plasma proteins - 80-90%.

The drug is metabolized in the liver to inactive metabolites (dibromantranilic acid and glucuronic conjugates). The half-life (T1/2) - 9-10 hours. Penetrates through the histohematological barriers, excreted into breast milk. It is excreted by the kidneys: 90% in the form of metabolites, 10% in unchanged form.

Indications:

Infectious-inflammatory diseases of the bronchopulmonary system, accompanied by the formation of difficult-to-separate sputum: acute and chronic bronchitis, tracheitis, chronic obstructive pulmonary disease, pneumonia, bronchial asthma, bronchiectasis, cystic fibrosis. Treatment and prevention of respiratory distress syndrome.

Preventing respiratory complications in the pre- and postoperative period in elderly patients.

Contraindications:

- Hypersensitivity to any component of the drug.

- Pregnancy (I term)

- Children under 6 years old

Carefully:

The drug should be used with caution in patients with gastric ulcer and duodenal ulcer, as there may be an exacerbation of peptic 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 trimesters of pregnancy should be evaluated for potential benefits to the mother with a possible risk to the fetus.

During breastfeeding, use the drug with caution, as it is excreted into breast milk.

Dosing and Administration:

Adults: the first 2-3 days of 5 ml (30 mg) 3 times a day, and then 5 ml (30 mg) 2 times a day. In severe cases, the dose is not reduced throughout the course of treatment. Children: 6-12 years of age appoint 2.5 ml (15 mg) 2-3 times a day.

Side effects:

From the digestive system: nausea, vomiting, gastralgia, diarrhea, constipation, dry mouth.

Allergic reactions: skin rash, hives, angioedema, in rare cases - anaphylactic shock.

Rarely: weakness, headache, dry mouth, rhinorrhea.

Overdose:

Symptoms: nausea, vomiting, gastralgia.

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

Interaction:

When used with antitussive drugs, it may be difficult for sputum to escape as a result of suppressing the cough reflex.With simultaneous use with amoxicillin, cefuroxime, erythromycin, doxycycline ambroxol increases their concentration in the bronchial secretion.

Special instructions:

Do not combine with antitussive drugs that make it difficult to withdraw phlegm. Ambroxol should be used with caution in patients with a weakened cough reflex or disturbed mucociliary transport because of the possibility of sputum congestion.

Patients receiving ambroxol Do not recommend breathing exercises; In seriously ill patients, aspiration of diluted sputum should be performed.

In patients with bronchial asthma ambroxol can strengthen cough.

Do not take ambroxol just before bed.

Ambroxol should not be taken concomitantly with antitussive drugs, which can inhibit cough reflex, for example, with codeine, tk. this can make it difficult to remove diluted sputum from a bronchial tree.

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

The use of the drug does not affect the speed of psychomotor reactions.

Form release / dosage:

Syrup 30 mg / 5 ml.

Packaging:

To 100 ml of syrup in bottles of brown glass, sealed with a polyethylene lid with thread, safety ring and the included flow element.

1 bottle together with a dispensing double spoon and instructions for use in a cardboard pack.

Storage conditions:

Store at a temperature of 15-25 ° C.

Keep the drug out of the reach of children!

Shelf life:

3 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-002666/08

Date of registration:10.04.2008

The owner of the registration certificate:Gedeon Richter Romania A.O.Gedeon Richter Romania A.O. Romania

Manufacturer: & nbsp

GEDEON RICHTER ROMANIA, S.A. Romania

Representation: & nbspGEDEON RICHTER-RUS CJSCGEDEON RICHTER-RUS CJSCRussia

Information update date: & nbsp25.09.2015

Illustrated instructions

Instructions

Ambroxol Richter (Ambroxol-Richter)