Lazolvan, syrup 15 mg/5 ml 100 ml

Pharmacological action

Ambroxol, the active ingredient of Lazolvan®, has been shown in studies to increase secretion in the airways. It increases pulmonary surfactant production and stimulates ciliary activity. These effects result in increased mucus flow and transport (mucociliary clearance). Increased mucociliary clearance improves sputum discharge and eases coughing. In patients with chronic obstructive pulmonary disease, long-term therapy with Lazolvan® (for at least 2 months) led to a significant reduction in the number of exacerbations. There was a significant reduction in the duration of exacerbations and the number of days of antibiotic therapy.

Pharmacokinetics

All dosage forms of ambroxol immediate release are characterized by rapid and almost complete absorption with a linear dependence on the dose in therapeutic concentration range. Maximum plasma concentration (Cmax) with oral administration is reached after 1-2.5 hours. Volume of distribution is 552 l. In the therapeutic range of concentrations the binding to plasma proteins is approximately 90%.

The transfer of ambroxol from the blood to the tissues when administered orally is fast. The highest concentrations of the active component of the drug are observed in the lungs. Approximately 30% of the oral dose taken is subjected to the effect of primary passage through the liver. Studies on human liver microsomes have shown that CYP3A4 isoenzyme is the predominant isoform responsible for metabolism of ambroxol to dibromanthranilic acid. The remainder of ambroxol is metabolized in the liver, mainly by glucuronidation and by partial cleavage to dibromanthranilic acid (approximately 10% of the administered dose) and a small number of additional metabolites. The terminal half-life of ambroxol is 10 hours. Total clearance is within 660 ml/min; renal clearance accounts for approximately 8% of total clearance.

The radioactive labeling method has estimated that after a single dose of the drug, approximately 83% of the administered dose is excreted in the urine over the next 5 days. No clinically significant effect of age and gender on ambroxol pharmacokinetics has been found, so there is no reason to adjust the dosage according to these characteristics.

Indications

Acute and chronic respiratory diseases with production of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with sputum retention, bronchiectatic disease.

Active ingredient

Ambroxol

Composition

5 ml of syrup contains:

Active ingredient:

ambroxol hydrochloride 15 mg

Excipients:

• benzoic acid 8.5 mg,
• hyetellose (hydroxyethylcellulose) 10 mg,
• potassium acesulfame 5 mg,
• sorbitol liquid (noncrystallizable) 1750 mg,
• glycerol 85% 750 mg,
• forest berry flavoring PHL-32195 11 mg,
• vanilla flavoring 201629 3 mg,
• water purified 3047.5 mg.

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How to take, the dosage

Ingestion.

The drug is indicated for adults and children over 12 years of age: 10 ml 3 times daily;

Children from 6 to 12 years of age: 5 ml 2-3 times daily;
children from 2 to 6 years: 2.5 ml 3 times daily;
children under 2 years: 2.5 ml 2 times daily.

Lazolvan® in syrup can be used regardless of meals.

If symptoms persist for 4-5 days after the start of therapy, it is recommended to see a physician.

Interaction

No clinically significant, undesirable interactions with other drugs have been reported. Increases bronchial secretion penetration of amoxicillin, cefuroxime, erythromycin.

Special Instructions

Should not be combined with cough suppressants that make it difficult to expectorate sputum.

There have been isolated reports of severe skin lesions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding with the prescription of expectorants such as ambroxol hydrochloride. In most cases, they can be explained by the severity of the underlying disease and/or concomitant therapy.

In patients with Stevens-Johnson syndrome or toxic epidermal necrolysis, fever, body pain, rhinitis, cough, and sore throat may occur in the early phase.

In symptomatic treatment, cold medications may be mistakenly prescribed. If new lesions of the skin and mucous membranes appear, it is recommended to stop treatment with ambroxol and seek medical attention immediately.

Lazolvan® should only be used if renal function is impaired under the recommendation of a physician.

The effect of the drug on the ability to drive and operate vehicles

There have been no cases of the drug effect on the ability to drive and operate vehicles. There have been no studies on the effect of the drug on the ability to drive vehicles and to engage in other potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

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Contraindications

Hypersensitivity to ambroxol or other components of the drug, pregnancy (I trimester), lactation.

Lazolvan® Syrup (15 mg/5 ml) contains 10.5 g sorbitol in terms of the maximum recommended daily dose (30 ml). Patients with rare hereditary fructose intolerance should not take this drug.

With caution

With caution use Lazolvan® during pregnancy (II – III trimester), renal and/or hepatic impairment.

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Side effects

Gastrointestinal tract disorders

Often (1.0 – 10.0 %) – nausea, decreased sensitivity in the oral cavity or pharynx;
Infrequent (0.1 – 1.0%) – dyspepsia, vomiting, diarrhea, abdominal pain, dry mouth;
Rarely (0.01 – 0.1%) – dry throat.

Immune system disorders, skin and subcutaneous tissue lesions

Rarely (0.01 – 0.1%) – rash, urticaria; anaphylactic reactions (including anaphylactic shock)*, angioedema*, itching*, hypersensitivity*.

Nervous system disorders

Often (1.0 – 10.0%) – dysgeusia (taste disorder).

* – These adverse reactions have been observed with widespread use of the drug; there is a 95% chance the frequency of these adverse reactions is infrequent (0.1% to 1.0%), but possibly less frequent; the exact frequency is difficult to estimate because they have not been noted during clinical trials.

Overdose

No specific symptoms of overdose in humans have been described. There have been reports about accidental overdose and/or medical error, which resulted in observing the symptoms of known side effects of the drug Lazolvan®: nausea, dyspepsia, vomiting, diarrhea, abdominal pain. In this case, symptomatic therapy may be necessary.

Treatment: artificial vomiting, gastric lavage during the first 1-2 hours after taking the drug, symptomatic therapy.

Pregnancy use

Ambroxol penetrates the placental barrier. Preclinical studies have shown no direct or indirect adverse effects on pregnancy, fetal/fetal, postnatal development and on labor.

Extensive clinical experience with ambroxol after 28 weeks of pregnancy has found no evidence of adverse effects of the drug on the fetus.

However, the usual precautions should be observed when using the drug during pregnancy. It is especially not recommended to take Lazolvan® in the first trimester of pregnancy. In II and III trimesters of pregnancy the drug may be used only if the potential benefit to the mother exceeds the potential risk to the fetus.

Ambroxol may be excreted with the breast milk. Although no adverse effects have been observed in breastfed children, during lactation it is not recommended to use Lazolvan®syrup.

Preclinical studies of ambroxol showed no adverse effects on fertility.

Similarities

Ambrohexal, Lazolvan, Halixol, Ambroxol, Ambrobene, Orvis Broncho, ORVIS, Lazolvan Max, Zvezdochka, Zvezdochka for colds