Lazolvan children's cough syrup with sputum 15 mg/5ml 100ml

Lazolvan children's cough syrup with sputum 15 mg/5ml 100ml

A country

France
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Active substance

Ambroxol

Compound

Active substance: ambroxol hydrochloride.

pharmachologic effect

Studies have shown that ambroxol, the active ingredient in the drug, increases secretion in the respiratory tract. It enhances the production of pulmonary surfactant and stimulates cipiary activity. These effects lead to increased mucus flow and transport (mucociliary clearance). Increasing mucociliary clearance improves sputum discharge and relieves cough. Pharmacokinetics: Ambroxol is characterized by rapid and almost complete absorption with a linear dose dependence in the therapeutic concentration range. Maximum plasma levels after oral administration are achieved within 1-2.5 hours. The distribution volume is 552 l. In the therapeutic concentration range, binding to plasma proteins is approximately 90%. The transition of ambroxol from the blood to tissues when administered orally occurs quickly. The highest concentrations of the active component of the drug are observed in the lungs. Approximately 30% of the administered oral dose undergoes first pass through the liver. Studies in human liver microsomes have shown that CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromoantranilic acid. The remainder of ambroxol is metabolized in the liver, mainly by glucuronidation and by partial degradation to dibromoantranilic acid (approximately 10% of the administered dose), as well as a small number of additional metabolites. The terminal half-life of ambroxol is 10 hours. The total clearance is within 660 ml/min, renal clearance accounts for approximately 8% of the total clearance. No clinically significant effect of age and gender on the pharmacokinetics of ambroxol was found. therefore, there is no basis for selecting the dosage based on these characteristics.

Indications for use

Acute and chronic diseases of the respiratory tract with the release of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty in sputum discharge, bronchiectasis.

Mode of application

Orally. The drug is prescribed for adults and children over 12 years old: 10 ml 3 times a day; children from 6 to 12 years old: 5 ml 2-3 times a day; children from 2 to 6 years old: 2.5 ml 3 times a day ;children under 2 years of age: 2.5 ml 2 times a day. The drug can be used regardless of meals. If symptoms of the disease persist within 4-5 days from the start of treatment, it is recommended to consult a doctor.

Interaction

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

Side effect

Gastrointestinal disorders. Often – nausea; uncommon - heartburn, dyspepsia, vomiting, diarrhea, abdominal pain, dry mouth; rarely - dry throat. Immune system disorders, damage to the skin and subcutaneous tissues. Rarely - rash, urticaria; anaphylactic reactions (including anaphylactic shock), angioedema, itching, hypersensitivity. Disorders of the nervous system. Often - dysgeusia (impaired taste).

Contraindications

Hypersensitivity to ambroxop or other components of the drug, pregnancy (first trimester), lactation period.

Overdose

Specific symptoms of overdose in humans have not been described. There are reports of accidental overdose and/or medical error, as a result of which symptoms of known side effects of the drug Lazolvan were observed: nausea, dyspepsia, diarrhea, vomiting, abdominal pain. In this case, there may be a need for symptomatic therapy Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; symptomatic therapy.

special instructions

The syrup contains 10.5 g of sorbitol based on the maximum recommended daily dose (30 ml). Patients with rare hereditary fructose intolerance should not take this drug. Use the drug with caution during pregnancy (II - III trimester), with renal and/or liver failure. Use during pregnancy and breastfeeding. Ambroxol penetrates the placental barrier. Preclinical studies have not revealed direct or indirect adverse effects on pregnancy, embryonic, fetal, postnatal development and childbirth. Extensive clinical experience with the use of ambroxol after 28 weeks of pregnancy has not found evidence of a negative effect of the drug on the fetus. However, normal precautions must be taken when using the medicine during pregnancy. It is especially not recommended to take the drug in the first trimester of pregnancy. Ambroxol can be excreted in human milk. Despite the fact that no undesirable effects were observed in breast-fed children, it is not recommended to use the drug during lactation. Preclinical studies of ambroxol have not revealed a negative effect on fertility. It should not be combined with antitussives that impede the removal of sputum. Included in the syrup sorbitol may have a mild laxative effect. In patients with severe skin lesions - Stevens-Johnson syndrome or toxic epidermal necrolysis - fever, body pain, rhinitis, cough and sore throat may appear in the early phase. During symptomatic treatment, it is possible to erroneously prescribe mucolytic agents such as ambroxol hydrochloride. There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis. coinciding with the prescription of the drug: however, there is no cause-and-effect relationship with taking the drug. If the above syndromes develop, it is recommended to stop treatment and immediately seek medical help. If renal function is impaired, the drug should be used only on the recommendation of a doctor. Effect of the drug on the ability to drive vehicles and machinery. There have been no cases of the drug influencing the ability to drive vehicles and machinery. Studies on the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions have not been conducted.

Solution for oral administration and inhalation 7.5 mg/ml

Use in children

Lazolvan® solution for oral administration and inhalation is approved for use in adults and children from birth. The following methods of administration and doses are distinguished:

1. In the form of an oral solution:

• Children under 2 years old - 1 ml or 25 drops 2 times a day.
• At the age of 2 - 6 years - 1 ml or 25 drops 3 times a day.
• Children aged 6 - 12 years: 2 ml or 50 drops 2-3 times a day.
• Adults and children over 12 years old – 4 ml (=100 drops) 3 times a day.3

How to take Lazolvan® correctly? To make it easier for children to take the solution, you can add Lazolvan® to liquid: drinking water, tea, juice or milk. You can take the drug regardless of meals.

2. Lazolvan® solution can be used for inhalation using modern models of inhalers, except steam ones. Before inhalation, Lazolvan® is mixed with 0.9% sodium chloride solution (saline solution) in a one-to-one ratio.

• For children under 6 years of age, 2 ml of Lazolvan® solution is used for 1 inhalation. Accordingly, you need to add 2 ml of a 0.9% sodium chloride solution to the inhaler bowl. Inhalations can be done 1-2 times a day.
• Adults and children over 6 years old take 2-3 ml of Lazolvan® solution per inhalation, which is mixed with 2 ml of 0.9% sodium chloride solution. It is recommended to take 1-2 inhalations per day.3

It is recommended to warm the prepared diluted solution for oral administration and inhalation of Lazolvan® to body temperature (36 - 37°C).

It is important that the child breathes deeply, slowly, through the mouth during the procedure. You need to breathe normally, calmly. Inhalation should be carried out in a sitting position, with the inhaler held in front of you. It is not recommended to talk during the procedure.4

Lazolvan® solution for oral administration and inhalation is not recommended to be mixed with cromoglycic acid and alkaline solutions.3

During lactation

During lactation, the use of the drug, including in the form of tablets, solution, syrup, is contraindicated, since ambroxol, the active substance of Lazolvan®, passes into breast milk. In this case, it is the mother who is being treated, not the baby, so he does not need this drug.3

Use during pregnancy

Lazolvan® solution for oral administration and inhalation is not used to treat women in the first trimester of pregnancy, regardless of the route of administration.3

Any form of Lazolvan® can be used in the 2nd and 3rd trimesters, but only if the effectiveness and benefit to the mother are higher than the possible negative risks to the fetus.

The expectant mother's body functions a little differently than the body outside of pregnancy. To reduce the risk of negative effects of the drug on a woman and her fetus, a careful approach to the selection of drug therapy is necessary. The decision to prescribe a drug can only be made by a healthcare professional after assessing the balance of risk and benefit for the patient.1, 2

For impaired renal function

The use of Lazolvan® solution for oral administration and inhalation for adults with impaired renal function or renal failure should be done with caution.3 The fact is that about 83% of ambroxol, the active substance of Lazolvan®, is excreted through the kidneys within a few days. However, if your kidney function is impaired, the elimination of the drug may be slower.1

With kidney failure, toxins accumulate in the blood. They also change the functioning of many organs and systems (in particular, the heart and blood vessels, blood, thyroid gland, etc.) and this can also affect how the drug will work.

Renal failure may affect the elimination of substances. Therefore, prescribing a drug to patients with renal failure requires additional tests to adjust the dose to the required one.1

For liver dysfunction

Lazolvan® should be used with caution in case of liver disease, and especially in case of liver failure.3

The liver plays one of the leading roles in biotransformation (conversion of medicinal substances into a form accessible for absorption and excretion), their distribution in the body, and excretion. Liver disease can lead to various changes in these processes.

Active substance

The active substance, that is, the agent that has a therapeutic effect, is ambroxol hydrochloride at a dose of 7.5 mg per 1 ml of solution.3

Ambroxol is a mucolytic agent. It helps protect the lungs because... stimulates the formation of surfactant, a substance that prevents the collapse of alveoli, and stimulates ciliary activity.5, 6

Its effectiveness in coughing is associated with the ability to thin mucus and promote its removal by enhancing the movement of cilia - special cells lining the inner surface of the respiratory tract. The cilia move synchronously towards the exit into the nasopharynx, directing mucus there.3, 6

Lazolvan solution

Release form

Solution for oral administration and inhalation. Transparent, colorless or slightly brownish.

Compound

Active ingredient : ambroxol hydrochloride (7.5 mg/1 ml).

Excipients : citric acid monohydrate; sodium hydrogen phosphate dihydrate; sodium chloride; benzalkonium chloride; purified water.

Pharmacological group

Secretolytics and stimulants of motor function of the respiratory tract.

Action

Mucolytic agent with expectorant action. Ambroxol increases the secretion of the glands of the respiratory tract, stimulates the activity of the villi of the respiratory tract, and enhances the formation of surfactant in the lungs. Ambroxol is a metabolite of bromhexine.

Ambroxol: description of the substance

Indications

Diseases of the respiratory tract with the formation of viscous sputum:

• acute and chronic bronchitis;
• pneumonia;
• COPD;
• bronchial asthma with difficulty in sputum discharge;
• bronchiectasis.

Contraindications and restrictions

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

Carefully:

• II–III trimester of pregnancy;
• renal and/or liver failure.

Application and dosage

Inside, inhalation.

Inside

Regardless of food intake (1 ml = 25 drops).

• Adults - 4 ml (= 100 drops) 3 times a day;
• children over 6 years old - 2 ml (= 50 drops) 2-3 times a day;
• children from 2 to 6 years old - 1 ml (= 25 drops) 3 times a day;
• children under 2 years old - 1 ml (= 25 drops) 2 times a day.

Drops can be diluted in water, tea, juice or milk.

Inhalation

• Adults and children over 6 years of age: 1–2 inhalations of 2–3 ml of solution per day;
• children under 6 years of age: 1–2 inhalations of 2 ml of solution per day.

Lazolvan solution for inhalation can be used using any modern equipment for inhalation (except steam inhalers). To achieve maximum hydration during inhalation, the drug is mixed with 0.9% sodium chloride solution in a 1:1 ratio. Since during inhalation therapy a deep breath can provoke a cough, inhalations should be carried out in normal breathing mode. Before inhalation, it is usually recommended to warm the inhalation solution to body temperature. Patients with bronchial asthma are recommended to carry out inhalation after taking bronchodilators to avoid nonspecific irritation of the respiratory tract and their spasm.

If symptoms of the disease persist within 4-5 days from the start of taking the drug, it is recommended to consult a doctor.

special instructions

The solution contains the preservative benzalkonium chloride, which, when inhaled, may cause bronchospasm in sensitive patients with increased respiratory tract reactivity.

Patients on a hyposodium diet should take into account that Lazolvan solution for oral administration and inhalation contains 42.8 mg of sodium in the recommended daily dose (12 ml) for adults and children over 12 years of age.

Production

• JSC Sanofi Russia;
• Instituto de Angeli S.r.L. (Italy).

Package

100 ml dark amber glass bottle with a beaker and a polypropylene screw cap with tamper evident in a cardboard box.

Recipe

Available without a prescription.