MEDOKS

Active material: Amʙroksol
When ATH: R05CB06
CCF: Mucolytic and expectorant drugs
When CSF: 12.02.02
Manufacturer: ZENTIVA a.s. (Czech Republic)

Pharmaceutical form, composition and packaging

◊ Syrup from light-yellow to yellow with brownish tint, slightly opalescent, with a characteristic smell of honey, allowed a small residue of honey.

Excipients: purified honey, Sorbitol liquid (amorphous), glycerol 85%, hydroxyethyl, Sodium benzoate, honey flavor 78845-33, sodium saccharin, dye Fuscum aureum CH (Quinoline yellow (E104), Yellow SY (E110), Brilliant black BN (E151), Azorubine (E122), sodium sulfate calcined (E514)), Purified water.

100 ml – vials of dark glass (1) complete with measuring spoon – packs cardboard.

DESCRIPTION OF ACTIVE SUBSTANCES

Pharmacological action

Mucolytic agent with expectorant. It stimulates serous cells of glands of bronchial mucosa, increasing the content of mucous secretion and, thus, changes disrupted ratio of serous and mucous components of sputum. This activated hydrolyzing enzymes, and enhanced by the release of Clara cell lysosomes, which reduces the viscosity of sputum. Ambroxol increases the amount of surfactant in the lungs, that it is associated with increased synthesis and secretion in alveolar pneumocytes, as well as a violation of its decay. Increases mucociliary transport sputum. Slightly suppresses cough.

Pharmacokinetics

After oral ambroxol almost completely absorbed from the gastrointestinal tract. C_max in plasma is approximately 0.5-3 no. Not accumulates. Plasma protein binding is about 90%.

After oral and parenteral administration of ambroxol rapidly distributed in body tissues, The highest concentration in the lungs is determined.

Penetrates the GEB and placental barrier, excreted in breast milk.

It is metabolized in the liver by conjugation to form a pharmacologically inactive metabolites.

T_1/2 is 7-12 no. Write mainly by the kidneys as metabolites – 90%, in unchanged form – 5%.

T_1/2 increases in chronic renal failure, severe.

Testimony

Acute and chronic respiratory diseases are accompanied by the release of viscous mucus (chronic bronchitis with a broncho-obstructive syndrome, bronchial asthma, bronchiectasis). Respiratory distress syndrome in premature infants and neonates.

Dosage regimen

Inside adults and children over 12 years – by 30 mg 2-3 times / day.

The dosage regimen for children under the age of 12 years presented in the following table.

By inhalation for adults and children older 5 years – by 15-22.5 mg 1-2 times / day.

Parenteral (/ m, I /) adult – by 15 mg, in severe cases – by 30 mg 2-3 times / day; children – 1.2-1.6 mg / kg 3 times / day.

For treatment of respiratory distress syndrome in premature neonates ambroxol introducing / or in V / m at a dose 10 mg / kg / day, multiplicity of introduction – 3-4 times / day, if necessary, the dose can be gradually increased to 30 mg / kg / day.

Side effect

From the digestive system: rarely – nausea, vomiting, diarrhea, stomach ache.

Allergic reactions skin rash, hives, angioedema.

Other: rarely – weakness, headache.

Contraindications

Peptic ulcer and duodenal, convulsive syndrome of various etiologies, I trimester of pregnancy, Hypersensitivity to ambroxol.

Pregnancy and lactation

Ambroxol is contraindicated in the I trimester of pregnancy. If you want to use in the II and III trimester should evaluate the potential benefit of therapy for the mother and the potential risk to the fetus.

If necessary, use ambroxol lactation should decide the issue of termination of breastfeeding.

Cautions

Patients, asthmatic, in order to avoid non-specific respiratory irritation and spasm before the inhalation of ambroxol can be used bronchodilators.

Drug Interactions

In an application with antitussive phlegm difficult against the background of reducing cough; with amoxicillin, doxycycline, tsefuroksymom, Erythromycin – strengthening their penetration in bronchial secretion.

Ambroxol is compatible with drugs, inhibiting generic activities.