Lazolvan solution for oral administration and inhalation 7.5 mg/ml 100 ml
Registration Certificate Holder
SANOFI RUSSIA (Russia)
Dosage form
Medicine - Lasolvan® (Lasolvan®)
Description
Solution for oral administration and inhalation
transparent, colorless or slightly brownish.
1 ml
ambroxol hydrochloride 7.5 mg
Excipients
: citric acid monohydrate - 2 mg, sodium hydrogen phosphate dihydrate - 4.35 mg, sodium chloride - 6.22 mg, benzalkonium chloride - 225 mcg, purified water - 989.705 mg.
100 ml - amber glass bottles (1) with a polyethylene dropper and a polypropylene screw cap with first opening control, complete with a measuring cup - cardboard packs.
Indications
Acute and chronic diseases of the respiratory tract, accompanied by the release of viscous sputum and impaired mucociliary clearance:
- acute and chronic bronchitis;
- pneumonia;
- COPD;
- bronchial asthma with difficulty in sputum discharge;
- bronchiectasis.
Contraindications for use
- hypersensitivity to ambroxol or other components of the drug;
- I trimester of pregnancy;
- lactation period (breastfeeding).
Carefully
Lazolvan® should be used during pregnancy (II and III trimesters), in case of renal and/or liver failure.
pharmachologic effect
Studies have shown that ambroxol, the active ingredient in Lazolvan®, increases secretion in the respiratory tract. Enhances the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased mucus flow and transport (mucociliary clearance). Increasing mucociliary clearance improves sputum discharge and relieves cough.
In patients with COPD, long-term therapy with Lazolvan® (for at least 2 months) led to a significant reduction in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.
Drug interactions
No clinically significant, undesirable interactions with other drugs have been reported.
Ambroxol increases the penetration of amoxicillin, cefuroxime, and erythromycin into the bronchial secretions.
Dosage regimen
Oral administration (1 ml = 25 drops).
Drops can be diluted in water, tea, juice or milk. The solution can be used regardless of meals.
Adults and children over 12 years old
— 4 ml (100 drops) 3 times/day;
children aged 6 to 12 years
- 2 ml (50 drops) 2-3 times a day;
children aged 2 to 6 years
- 1 ml (25 drops) 3 times a day;
children under 2 years of age
- 1 ml (25 drops) 2 times a day.
Inhalations
Adults and children over 6 years old
— 1-2 inhalations of 2-3 ml of solution/day.
Children under 6 years of age
— 1-2 inhalations of 2 ml solution/day.
Lazolvan® solution for inhalation can be used using any modern equipment for inhalation (except steam inhalers).
To achieve optimal 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 using the drug, it is recommended to consult a doctor.
Overdose
Specific symptoms of overdose in humans have not been described.
There have been reports of accidental overdose and/or medical error resulting in
symptoms
of known side effects of Lazolvan®: nausea, dyspepsia, vomiting, diarrhea, abdominal pain.
Treatment:
provocation of vomiting, gastric lavage in the first 1-2 hours after taking the drug, symptomatic therapy.
Side effect
From the digestive system:
often (1-10%) – dysgeusia (impaired sense of taste), nausea, decreased sensitivity in the oral cavity or pharynx; infrequently (0.1-1%) - dyspepsia, vomiting, diarrhea, abdominal pain, dry mouth; rarely (0.01-0.1%) – dry throat.
For the skin and subcutaneous tissues:
rarely (0.01-0.1%) – rash, itching*.
Allergic reactions:
rarely (0.01-0.1%) – urticaria; anaphylactic reactions (including anaphylactic shock)*, angioedema*, hypersensitivity*.
* these adverse reactions were observed with widespread use of the drug; with a 95% probability, the frequency of these adverse reactions is uncommon (0.1%-1%), but possibly lower; the exact frequency is difficult to estimate, because they were not noted in clinical studies.
special instructions
Should not be used in combination with antitussives that impede the removal of sputum.
The solution contains the preservative benzalkonium chloride, which, when inhaled, may cause bronchospasm in sensitive patients with increased respiratory tract reactivity.
Lazolvan® solution for oral administration and inhalation is not recommended to be mixed with cromoglycic acid and alkaline solutions. An increase in the pH value of the solution above 6.3 may cause precipitation of ambroxol hydrochloride or the appearance of opalescence.
Patients on a low-sodium 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.
There are isolated reports of severe skin lesions (Stevens-Johnson syndrome and toxic epidermal necrolysis) that coincided with the use of expectorants such as ambroxol hydrochloride. In most cases, they are explained by the severity of the underlying disease and/or concomitant therapy. Patients with Stevens-Johnson syndrome or toxic epidermal necrolysis may present with fever, body aches, rhinitis, cough, and sore throat in the early phase. With symptomatic treatment, it is possible to erroneously prescribe anti-cold medications. If new lesions of the skin and mucous membranes develop, the patient should stop treatment with ambroxol and immediately seek medical help.
If renal function is impaired, Lazolvan® should be used only on the recommendation of a doctor.
Effect on the ability to drive vehicles and machinery
There were 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.
Storage conditions
The drug should be stored in its original packaging out of the reach of children at a temperature not exceeding 25°C.
Best before date
Shelf life: 5 years.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - With caution. Restrictions when breastfeeding - Contraindicated.
Ambroxol penetrates the placental barrier. Preclinical studies have not revealed direct or indirect adverse effects on pregnancy, embryonic/fetal, postnatal development and labor.
Extensive clinical experience with the use of ambroxol after the 28th week of pregnancy has not found evidence of a negative effect of the drug on the fetus. However, the usual precautions should be taken when using the drug during pregnancy. It is especially not recommended to take Lazolvan® in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the use of the drug is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.
Ambroxol can be excreted in breast milk. Despite the fact that no undesirable effects were observed in breastfed children, it is not recommended to use Lazolvan® solution for oral administration and inhalation during lactation.
Preclinical studies of ambroxol did not reveal any negative effects on fertility.
Use for renal impairment
Restrictions for impaired renal function - With caution.
Carefully
prescribe for renal failure.
Use for liver dysfunction
Restrictions for liver dysfunction - With caution.
Carefully
prescribe for liver failure.
Use in elderly patients
Restrictions for elderly patients - No restrictions.
No clinically significant effect of age on the pharmacokinetics of ambroxol was found, so there is no basis for selecting the dose based on these characteristics.
Use in children
Restrictions for children - No restrictions.
Terms of sale
The drug is available without a prescription.
Contacts for inquiries
SANOFI (Unknown)
Representative office of JSC "Sanofi-aventis group" (France) 125009 Moscow, st. Tverskaya, 22 Tel. Fax
Syrup 30 mg/5 ml
Cough is one of the most common complaints with which people consult a doctor.1 It can be a symptom of a number of diseases and conditions that require medications that affect the viscosity of sputum and have an expectorant effect. And one of the frequently used mucolytic agents in Russia is Lazolvan®, used in adults and children.2 It is available in various forms, including syrup with a dosage of 30 mg/5 ml, intended for use in adult practice.
Use during pregnancy
The active ingredient of Lazolvan® syrup, ambroxol, penetrates the hematoplacental barrier, which separates the blood circulation of the mother and fetus. Consequently, when a woman takes the drug, it enters the child’s blood. The experience of using the drug in pregnant women after 28 weeks is quite extensive. Both clinical practice data and the results of animal studies have not demonstrated any undesirable effects of Lazolvan® on the health of the growing fetus, the course of pregnancy, childbirth, or the condition of the child after birth. In addition, the use of ambroxol in the second and third trimesters of pregnancy (after 28 weeks) has been deeply studied. The research results confirmed that ambraxol does not have a negative effect on the fetus.3
However, when prescribing medication to expectant mothers, a healthcare professional takes into account several factors and carefully weighs the balance between the benefit to the woman and the risk to the developing fetus.3, 4 Special precautions when using medications are observed during critical periods of pregnancy, in particular before 12 weeks, when all the organs and systems of the unborn child are formed. Therefore, it is not recommended to take Lazolvan® syrup in the first trimester.3, 5 But in the second and third trimesters, a cough drug based on ambroxol can be prescribed after a thorough assessment of the potential benefit to the mother and the possible risk to the fetus.4
When breastfeeding
Many medications are excreted in breast milk and, accordingly, enter the baby’s body with it. The concentration of the active substance in the baby’s blood depends on various factors, including the duration of feeding, the volume of milk the child received, and the child’s body’s ability to eliminate the drug. Because a breastfed baby's digestive system is immature, the half-life of drugs in the baby's body may be much longer than in the mother's body.5
Medicines that pass into breast milk include Lazolvan® syrup. Despite the fact that in therapeutic doses it did not have a negative effect on the child, it is not recommended to be taken during breastfeeding. Moreover, lactation, according to the instructions for use, is a contraindication to the use of Lazolvan® syrup.3
If kidney function is impaired
In kidney disease, the elimination of drugs is impaired. As a rule, this takes much longer than usual. In this regard, medications for impaired renal function are prescribed very carefully. Before recommending a drug, a healthcare professional will consider possible changes in the rate of elimination, taking into account a number of factors, including what drug is being prescribed, the severity of the kidney problem in a particular case, and so on. Only after a thorough assessment does a healthcare professional decide to prescribe the medication and adjust the dosage individually.6
For liver disorders
One of the main functions of the liver is the breakdown of substances entering the body, including medications. When a person is healthy, this process occurs harmoniously and efficiently. However, in some cases, when liver function is impaired, medications that are not normally harmful to humans can become toxic. Particular care must be taken in severe liver disease such as cirrhosis.7
The active ingredient of Lazolvan® syrup, ambroxol, like other drugs, is metabolized in the liver. Therefore, if its operation is disrupted, it is necessary to take the medicine with caution, as indicated in the instructions for use, and as prescribed by a healthcare professional.3
Active substance
The active substance of the drug Lazolvan® syrup is ambroxol hydrochloride. It helps to enhance the transport of sputum, improve its discharge and relieve cough.
The dosage of the active substance (ambroxol) is 30 mg in 5 ml of syrup, which is a clear viscous liquid with a pleasant strawberry aroma.3
