LAZOLVAN

Active material: Amʙroksol
When ATH: R05CB06
CCF: Mucolytic and expectorant drugs
ICD-10 codes (testimony): J15, J20, J42, J44, J45, J47, R05
When CSF: 12.02.02
Manufacturer: BOEHRINGER INGELHEIM THEY A.E. (Greece)

Pharmaceutical form, composition and packaging

◊ Pills round, white or slightly yellowish, flat on two sides, with beveled edges, with a break line on one side and engraved “67FROM”, embossed on both sides of the separation risks, on the other side of the tablet – a symbol of the company.

Excipients: lactose, dried corn starch, silica colloidal, magnesium stearate.

10 PC. – blisters (2) – packs cardboard.
10 PC. – blisters (5) – packs cardboard.

◊ Syrup clear or almost clear, colorless or near colorless, slightly viscous, with a fruity aromatic odor.

Excipients: hydroxyethyl, sorʙitola 70% solution, glycerol 85%, benzoic acid, propylene glycol, flavor D9599, tartaric acid, Purified water.

100 ml – vials of dark glass (1) – packs cardboard.
250 ml – vials of dark glass (1) – packs cardboard.

◊ Syrup clear or almost clear, colorless or near colorless, slightly viscous, with a fruity aromatic odor.

Excipients: hydroxyethyl, sorʙitola 70% solution, glycerol 85%, sodium saccharin dihydrate, benzoic acid, propylene glycol, Orange Essence 9/055600, apricot flavor 208166/40988, menthol, Purified water

100 ml – vials of dark glass (1) – packs cardboard.
250 ml – vials of dark glass (1) – packs cardboard.

Pharmacological action

Mucolytic drugs. It has sekretomotornym, sekretoliticheskim and expectorant. Lazolvan^® liquefies phlegm due to the stimulation of serous cells of glands of bronchial mucosa, It increases the amount of mucous secretion and stimulates the production of surfactant in the alveoli and bronchi; normalizes impaired ratio of serous and mucous components of sputum. By activating the hydrolyzing enzymes and increasing the release of lysosomes from cells Clarke, reduces the viscosity of sputum. It increases motor activity of the cilia of the ciliated epithelium, increases mucociliary transport sputum.

After oral administration, the therapeutic effect develops after 30 minutes and persists for 6-12 no.

Pharmacokinetics

Absorption

After oral ambroxol almost completely absorbed from the gastrointestinal tract. C_max plasma levels achieved after 2 no.

Distribution

Plasma protein binding is 80%.

Ambroxol penetrates the blood-brain barrier and the placental barrier, excreted in breast milk.

Metabolism

Ambroxol is metabolized in the liver to form dibromantranilovoy acid and glucuronic conjugates.

Deduction

T_1/2 – 1.3 no. Excreted by the kidneys in the form of water-soluble metabolites – 90%, in unchanged form – 5%.

Pharmacokinetics in special clinical situations

T_1/2 increases in chronic renal failure, severe, but changes in the human liver.

Testimony

Acute and chronic respiratory disease, accompanied by the release of viscous mucus:

- Acute and chronic bronchitis;

- Pneumonia;

- COPD;

- Bronchial asthma with obstruction of sputum discharge;

- Bronchiectasis.

Dosage regimen

The drug is administered in tablet form adult by 30 mg 3 times / day.

If you want to enhance the therapeutic effect can be assigned for 60 mg 2 times / day. Tablets are taken after a meal, with some liquid.

Preparation in syrup 15 mg / 5 ml administered adults and children over 12 years by 10 ml (2 teaspoons) 3 times / day; children aged 6 to 12 years – by 5 ml (1 tea spoon) 2-3 times / day; children aged 2 to 6 years appoint 2.5 ml (1/2 teaspoon) 3 times / day; Children up to 2 years – by 2.5 ml 2 times / day.

Preparation in syrup 30 mg / 5ml adults and children over 12 years appoint 5 ml (1 tea spoon) 3 times / day; children aged 6 to 12 years – by 2.5 ml (1/2 teaspoon) 2-3 times / day.

Taking the drug more 4-5 day is possible only under medical supervision.

Lazolvan^® in the form of syrup to be taken with meals, with some liquid.

Side effect

From the digestive system: long-term use in high doses – heartburn, gastralgia, nausea, vomiting.

Allergic reactions: skin rash, hives, angioedema; in some cases – contact type allergy; in a few cases – anaphylactic-type reactions (incl. anaphylactic shock).

Lazolvan^®, usually, well tolerated.

Contraindications

- I trimester of pregnancy;

- Hypersensitivity to the drug.

FROM caution should be prescribed in II and III trimesters of pregnancy, lactation (breast-feeding), patients with renal and / or hepatic insufficiency.

Pregnancy and lactation

Preclinical studies and a large clinical experience has not identified the negative impact of the use of Mucosolvan^® on pregnancy and fetal development. Nonetheless, use Mucosolvan^® contraindicated in the I trimester of pregnancy. In appointing the drug in the II and III trimester should be careful.

Ambroxol is excreted in breast milk, but when used in therapeutic doses has no adverse effect on the infant.

Cautions

Do not use in combination with an antitussive, hampering the removal of sputum.

Overdose

Symptoms of overdose in humans have not been described.

Symptoms: nausea, vomiting, diarrhea, dyspepsia.

Treatment: , induce vomiting, gastric lavage shown in the first 1-2 h after administration; receiving fat-containing products; symptomatic therapy.

Drug Interactions

The simultaneous use of antitussive drugs leads to difficulty sputum discharge on the background reduce the cough.

Ambroxol increases the penetration of the bronchial secretion of amoxicillin, tsefuroksyma, Erythromycin, doxycycline.

Lazolvan^® compatible with drugs, inhibiting generic activities.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug is in the form of tablets should be stored in a place inaccessible to children at temperature not exceeding 30 ° C. Shelf life – 5 years.

Preparation in syrup 15 mg / 5 mL should be stored out of reach of children at or above 30 ° C; Do not freeze. Shelf life – 3 year.

Preparation in syrup 30 mg / 5 mL should be stored out of reach of children at or above 30 ° C; Do not freeze. Shelf life – 5 years.