It is confirmed that Ambroxol a hydrochloride, active ingredient of medicine, increases secretion of slime in airways. It also strengthens discharge of pulmonary surfactant and stimulates activity of a tsiliarny epithelium. These actions improve department of slime and to its removal (mukotsiliarny clearance). Activation of secretion of liquid and increase in mukotsiliarny clearance facilitate removal of slime and facilitate cough.

Knows that under the influence of Ambroxol of a hydrochloride the amount of cytokines and also quantity of the mononuklear circulating and connected with fabric and polimorfonuklearny cages decreases.

Also observed antioxidant effects of Ambroxol.

After use of Ambroxol of a hydrochloride the concentration of antibiotics (amoxicillin, a tsefuroksim, erythromycin) in a bronchopulmonary secret and in a phlegm increases.

Pharmacokinetics. Ambroxol the hydrochloride contacts proteins of blood plasma for 90% at adults and for 60-70% at newborns. Drug gets through a placental barrier and reaches fruit lungs. The large volume of distribution - 410 l - indicates bigger accumulation in fabrics, than in plasma, concentration in tissues of lungs exceeds the corresponding indicator in plasma with coefficient> 17.

Metabolism and removal. Ambroxol the hydrochloride is metabolized in a liver by a glyukuronization and to a lesser extent by splitting to acid dibromantranilovo (the last makes about 10% of a dose) also other insignificant metabolites are formed. The research microsomes of a liver of the person was shown that CYP3A4 enzyme is responsible for hydrochloride Ambroxol metabolism in acid dibromantranilovo.

In 3 days after introduction of 4.6% of a dose it is removed in not changed look whereas 35.6% of a dose are removed in the conjugated form with urine.

Elimination half-life of Ambroxol of a hydrochloride makes about 10:00 of blood plasma. At newborns after repeated introduction the elimination half-life doubles approximately, indicating reduction of clearance.

In a serious illness of a liver the clearance of Ambroxol decreases by 20-40%. In heavy renal failures the accumulation of metabolites of Ambroxol, namely a dibromantranilovoa of acid and glucuronides is possible.

Ambroxol gets through hematoencephalic and placentary barriers and is removed in breast milk.

Indication

For strengthening of production of pulmonary surfactant at premature children and newborns with a syndrome of respiratory insufficiency.

Contraindication

Hypersensitivity to Ambroxol of a hydrochloride or other components of medicine.

Route of administration and doses

It is proved that the general daily dose is effective, makes 30 mg of Ambroxol of a hydrochloride on 1 kg of body weight.

in 4 receptions by slow infusion; it is recommended to apply each separate dose by infusion by means of the pompovy device to infusions within not less than 5 minutes.

in 250-500 ml of normal saline solution or Ringera solution.

From the microbiological point of view if opening of ampoules and cultivation is connected with risk of microbiological contamination, solution should be used right after preparation. If it did not occur, responsibility for conditions and periods of storage is born by the user. If any of these solvents is inaccessible, solution of glucose of 5% can be applied as alternative. At use of solution of glucose of 5% the contents of ampoules should be parted just before use. If solution was not used right after preparation, it needs to be utilized.

treatment Duration - 5 days.

Overdose

is not present messages about specific overdose symptoms Yet. The symptoms which are observed at accidental overdose or a medical mistake similar to the known side reactions at application in the recommended doses can also demand symptomatic treatment.

Structure

active ingredient: ambroxol;

1 ml of Ambroxol of a hydrochloride of 7.5 mg

Excipients: sodium chloride, citric acid monohydrate, sodium phosphate, dodecahydrate; water for injections.

to Store

at a temperature not above 25 °C in original packing.

to Store

out of children's reach.

Expiration date - 5 years.