Ambroxol-HEMOFARM (Effervescent tablets)
Active material: Amʙroksol
When ATH: R05CB06
CCF: Mucolytic and expectorant drugs
ICD-10 codes (testimony): J15, J20, J42, J44, J45, J47, J80
When CSF: 12.02.02
Manufacturer: HEMOFARM A.D. (Serbia)
Pharmaceutical form, composition and packaging
◊ Effervescent tablets round, Valium, with chamfer on both sides, and scored on one side, from white to white with a yellowish tint, with a faint odor of lemon.
| 1 tab. | |
| ambroxol hydrochloride | 60 mg |
Excipients: sodium gidrozitrat, natriya carbonate, povidone K25, sodium saccharin, Aspartame, sodium sulfate, sodium cyclamate, lemon acid, lactose monohydrate, lemon flavor 502336, lemon flavor (lemon tetraromat 987323), mannitol, macrogol 6000.
10 PC. – Plastic tubes (1) – packs cardboard.
10 PC. – Plastic tubes (2) – packs cardboard.
20 PC. – Plastic tubes (1) – packs cardboard.
20 PC. – Plastic tubes (2) – packs cardboard.
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. Cmax 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.
T1/2 is 7-12 no. Write mainly by the kidneys as metabolites – 90%, in unchanged form – 5%.
T1/2 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.
| Age | Single dose | Reception frequency |
| 5-12 years | 15 mg | 2-3 times / day |
| 2-5 years | 7.5 mg | 3 times / day |
| to 2 years | 7.5 mg | 2 times / day |
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.
