Lasolvan solution for oral use and inhalation 7.5mg/ml vials, 100ml

Composition

Active ingredients:

ambroxol hydrochloride 7.5 mg.

Auxiliary substances:

citric acid monohydrate – 2 mg,

sodium hydrophosphate dihydrate-4.35 mg,

sodium chloride-6.22 mg,

benzalkonium chloride-225 mcg,

purified water-989.7 mg

Pharmacological action

Ambroxol-active ingredient of the drug Lasolvan. It has secretomotor, secretolytic and expectorant effects. It stimulates the serous cells of the glands of the bronchial mucosa. Ambroxol enhances the production of pulmonary surfactant, stimulates ciliary activity and normalizes the disturbed ratio of serous and mucosal components of sputum. By activating hydrolyzing enzymes and increasing the release of lysosomes from Klara cells, it reduces the viscosity of sputum. Ambroxol increases mucus flow and transport (mucociliary clearance). Increased mucociliary clearance improves sputum discharge and eases coughing.

Pharmacokinetics

Ambroxol is characterized by rapid and almost complete absorption with a linear dose dependence in the therapeutic range of concentrations. Cmax with oral use is reached in 1-2.5 hours. Vd after oral use is 552 liters. In the therapeutic range of concentrations, plasma protein binding is approximately 90%.

The transfer of ambroxol from the blood to the tissues when administered orally is rapid. The highest concentrations of the active component of the drug are observed in the lungs. Approximately 30% of the orally administered dose is primarily metabolized. Studies on human liver microsomes have shown that CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromanthranilic acid. The remaining part of ambroxol is metabolized in the liver, mainly by glucuronidation and by partial cleavage to dibromantrapylic acid (preferably 10% of the administered dose), as well as a small number of additional metabolites. The terminal T1/2 of ambroxol is 10 hours. Total clearance is within 660 ml / min, with renal clearance accounting for approximately 8% of total clearance.

There was no clinically significant effect of age and gender on the pharmacokinetics of ambroxol, so there is no reason to change the dosage for these reasons.

In patients with hepatic insufficiency, the excretion of ambroxol is slowed down, which leads to an increase in the level of ambroxol in plasma by 1.3-2 times. Due to the wide therapeutic range of ambroxol, no dose reduction is required.

Indications

• acute and chronic bronchitis;
• pneumonia;
• chronic obstructive pulmonary disease;
• bronchial asthma with difficulty expectorating;
• bronchiectatic disease.

Contraindications

• Hypersensitivity to ambroxol or other components of the drug;
• I trimester of pregnancy;
• lactation period (breastfeeding).

Use with caution in the second and third trimesters of pregnancy, in patients with renal and / or hepatic insufficiency.

Side effects

Allergic reactions:  skin rash, urticaria, angioedema, in some cases — allergic contact dermatitis. Extremely rare cases of acute severe reactions of the anaphylactic type (anaphylactic shock) have been reported.

With prolonged use in high doses — heartburn, gastralgia, nausea, vomiting.

Interaction

It should not be combined with antitussive agents that make it difficult to remove sputum.

The solution for oral use and inhalation contains benzalkonium chloride. In patients with airway hyperactivity, this preservative may cause bronchial spasm during inhalation.

How to take, course of use and dosage

Inside and by inhalation.

Inside in the form of drops (1 ml = 25 drops), during meals, adding to tea, fruit juice, milk or water. Adults at the beginning of treatment — 4 ml 3 times a day, children over 6 years-2 ml (50 drops) 2-3 times a day, children from 2 to 6 years-1 ml (25 drops) 3 times a day, children under 2 years-1 ml (25 drops) 2 times a day.

By inhalation, adults and children over 6 years-1-2 inhalations of 2-3 ml of solution daily, children under 6 years-1-2 inhalations of 2 ml of solution daily.

The inhalation solution can be used using any modern equipment for inhalation (except steam inhalers). The drug is mixed with saline solution, it can be diluted in a ratio of 1: 1 to achieve optimal humidification of the air in the respirator. Since deep inhalation therapy can cause coughing tremors, inhalation should be carried out in the mode of normal breathing. Before inhalation, it is usually recommended to warm up the inhaled solution to body temperature.

Patients with bronchial asthma are recommended to be inhaled after taking bronchodilators.

Overdose

Symptoms:  possible — nausea, vomiting, diarrhea, dyspepsia, gastralgia.

Treatment:  induction of vomiting, gastric lavage in the first 1-2 hours after taking the drug; taking fat-containing products, symptomatic therapy.

Special instructions

It should not be combined with antitussive agents that make it difficult to remove sputum.

The solution for oral use and inhalation contains benzalkonium chloride. In patients with airway hyperactivity, this preservative may cause bronchial spasm during inhalation.

Form of production

Solution for oral use and inhalation

Storage conditions

In a dark place, at a temperature not exceeding 25 °C (do not freeze)

Shelf life

5 years

Active ingredient

Ambroxol

Dosage form

oral solution