Instructions for use Lazolvan with strawberry-cream flavor syrup 30 mg/5 ml bottle 100 ml
Composition
active ingredient: ambroxol hydrochloride;
5 ml of syrup contains 30 mg of ambroxol hydrochloride;
excipients: benzoic acid (E 210), hydroxyethyl cellulose, sucralose, strawberry-cream flavor, vanilla flavor, purified water.
Dosage form
Syrup.
Main physicochemical properties: transparent or almost transparent, colorless or almost colorless, slightly viscous liquid with a fruity odor of strawberries and cream.
Pharmacotherapeutic group
Medicines used for coughs and colds. Mucolytics. ATX code R05C B06.
Pharmacological properties
Pharmacodynamics
It has been preclinically proven that the active ingredient of the drug Lasolvan® with strawberry-cream flavor, syrup, - ambroxol hydrochloride - increases the proportion of serous bronchial secretion. Ambroxol enhances the secretion of pulmonary surfactant by directly affecting type II pneumocytes in the alveoli and Clara cells in the bronchioles, and also stimulates ciliary activity, as a result of which the viscosity of sputum decreases and its excretion improves (mucociliary clearance). Improvement of mucociliary clearance has been proven during clinical and pharmacological studies.
Activation of secretion, reduction of secretion viscosity, and improvement of mucociliary clearance promote mucus excretion and facilitate expectoration of sputum.
COPD patients treated with ambroxol hydrochloride, prolonged-release capsules 75 mg for 6 months had a significant reduction in the number of exacerbations compared to placebo at the end of 2 months of treatment. Patients treated with ambroxol hydrochloride had significantly fewer days of illness and required fewer days of antibiotic therapy. Compared to placebo, treatment with ambroxol hydrochloride, prolonged-release capsules showed statistically significant improvements in sputum production, cough, dyspnea and auscultation findings.
In a rabbit eye model, a local anesthetic effect of ambroxol hydrochloride was observed, which may be explained by its sodium channel blocking properties. In vitro studies have shown that ambroxol hydrochloride blocks voltage-gated neuronal sodium channels; binding was reversible and concentration-dependent.
Ambroxol hydrochloride has demonstrated anti-inflammatory effects in vitro. Thus, ambroxol hydrochloride significantly reduces the release of cytokines from mononuclear and polymorphonuclear blood cells and tissues.
Clinical trials involving patients with pharyngitis have shown a significant reduction in pain and redness in the throat when using ambroxol hydrochloride.
Due to the pharmacological properties of ambroxol, pain was quickly relieved during the treatment of upper respiratory tract diseases, which was observed during studies of the clinical efficacy of inhaled forms of ambroxol.
The use of ambroxol hydrochloride increases the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline) in bronchopulmonary secretions and sputum. The clinical significance of this has not yet been established.
Pharmacokinetics
Absorption. Absorption of ambroxol hydrochloride from oral immediate-release formulations is rapid and fairly complete, with a linear dose dependence in the therapeutic range. Peak plasma levels are reached after 1 to 2.5 hours with oral immediate-release formulations and on average after 6.5 hours with slow-release formulations.
Distribution. When administered orally, the distribution of ambroxol hydrochloride from the blood to the tissues is rapid and pronounced, with the highest concentration of the active substance in the lungs. The volume of distribution after oral administration is 552 liters. In the blood plasma in the therapeutic range, approximately 90% of the drug is protein-bound.
Metabolism and elimination. Approximately 30% of the dose after oral administration is eliminated by first pass metabolism. Ambroxol hydrochloride is metabolized mainly in the liver by glucuronidation and cleavage to dibromanthranilic acid (approximately 10% of the dose). Studies in human liver microsomes have shown that CYP3A4 is responsible for the metabolism of ambroxol hydrochloride to dibromanthranilic acid.
After 3 days of oral administration of ambroxol hydrochloride, approximately 6% of the dose is excreted in the urine, with approximately 26% of the dose excreted as conjugates of the compound.
The elimination half-life of ambroxol hydrochloride is approximately 10 hours. Total clearance is approximately 660 ml/min, with renal clearance accounting for approximately 8% of the total. After 5 days, approximately 83% of the total dose is excreted in the urine.
Pharmacokinetics in special patient groups. In patients with impaired liver function, the excretion of ambroxol hydrochloride is reduced, which results in a 1.3-2 times higher level in the blood plasma. Since the therapeutic range of ambroxol hydrochloride is quite wide, it is not necessary to change the dosage.
Age and gender have no clinically significant effect on the pharmacokinetics of ambroxol hydrochloride, therefore no dose adjustment is necessary.
Food intake does not affect the bioavailability of ambroxol hydrochloride.
Indication
Secretolytic therapy for acute and chronic bronchopulmonary diseases accompanied by disorders of bronchial secretion and impaired mucus movement.
Contraindication
Lasolvan® with strawberry-cream flavor, syrup, should not be used in patients with hypersensitivity to ambroxol hydrochloride or other components of the drug.
Lasolvan® with strawberry-cream flavor, syrup, should not be used in children under 2 years of age without a doctor's prescription.
Interaction with other medicinal products and other types of interactions
Simultaneous use of the drug Lazolvan® with strawberry-cream flavor, syrup, 30 mg/5 ml, and cough suppressants may lead to excessive mucus accumulation due to suppression of the cough reflex. Therefore, such a combination is possible only after a careful assessment by the doctor of the ratio of the expected benefit and the possible risk of use.
Application features
Severe skin reactions, including erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP), have been reported in association with the use of ambroxol hydrochloride. If signs of progression of the skin rash (sometimes associated with blistering or mucosal involvement) are present, ambroxol hydrochloride treatment should be discontinued immediately and medical advice should be sought.
In case of impaired bronchial motility and increased mucus secretion (for example, in a rare disease such as primary ciliary dyskinesia), the drug Lazolvan® with strawberry-cream flavor, syrup, should be used with caution due to the risk of promoting the accumulation of secretions.
Patients with impaired renal function or severe hepatic insufficiency should take Lasolvan® with strawberry-cream flavor, syrup, only after consulting a doctor. In patients with severe renal insufficiency, when using ambroxol, as with any active substance that is metabolized in the liver and then excreted by the kidneys, accumulation of metabolites formed in the liver is possible.
Lasolvan® strawberry-cream flavour, syrup 30 mg/5 ml, contains 1.2 g of sorbitol per 5 ml (equivalent to 4.9 g at the maximum recommended daily dose). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Use during pregnancy or breastfeeding
Pregnancy. Ambroxol hydrochloride crosses the placental barrier. Preclinical studies have not revealed any direct or indirect harmful effects of the drug on the course of pregnancy, embryonal/fetal development, childbirth or postnatal development. As a result of extensive clinical experience with the drug after the 28th week of pregnancy, no harmful effects on the fetus have been identified. However, the usual precautions for use during pregnancy should be observed. Especially in the first trimester of pregnancy, it is not recommended to use Lazolvan® with strawberry-cream flavor, syrup.
Breastfeeding. Ambroxol hydrochloride passes into breast milk. Lazolvan® with strawberry-cream flavor, syrup, is not recommended for use during breastfeeding.
Fertility: Preclinical studies do not indicate direct or indirect harmful effects with respect to fertility.
The ability to influence the reaction speed when driving or working with other mechanisms
There are no data on the effect on the reaction speed when driving vehicles or working with other mechanisms. Studies on the effect on the reaction speed when driving vehicles or working with other mechanisms have not been conducted.
Method of administration and doses
Unless otherwise stated, the following dosage regimen for Lazolvan® with strawberry-cream flavor, syrup, 30 mg/5 ml is recommended:
Children under 2 years of age: 1.25 ml 2 times a day (equivalent to 15 mg ambroxol hydrochloride per day).
Children aged 2 to 5 years: 1.25 ml 3 times a day (equivalent to 22.5 mg ambroxol hydrochloride per day).
Children aged 6 to 12 years: 2.5 ml 2 - 3 times a day (equivalent to 30 - 45 mg of ambroxol hydrochloride per day).
Adults and children over 12 years of age: the usual dose is 5 ml 3 times a day (equivalent to 90 mg ambroxol hydrochloride per day) for the first 2 to 3 days and then 5 ml 2 times a day (equivalent to 60 mg ambroxol hydrochloride per day).
If necessary, the therapeutic effect for adults and children over 12 years of age can be enhanced by increasing the dose to 10 ml 2 times a day (equivalent to 120 mg ambroxol hydrochloride/day).
Lasolvan® with strawberry-cream flavor, syrup, 30 mg/5 ml can be used regardless of food intake. The dose of Lasolvan® with strawberry-cream flavor, syrup, can be measured using the measuring cap provided.
In general, there are no restrictions on the duration of use, but long-term therapy should be carried out under medical supervision.
Lasolvan® with strawberry-cream flavor, syrup, 30 mg/5 ml should not be used for longer than 4 - 5 days without consulting a doctor.
Lasolvan® with strawberry-cream flavor, syrup, 30 mg/5 ml is suitable for use in patients with diabetes; 5 ml of syrup corresponds to 1.2 g of carbohydrates.
Children
The drug can be used in pediatric practice. For children under 2 years of age, use as prescribed by a doctor.
Overdose
To date, there are no reports of specific symptoms of overdose. Symptoms known from isolated reports of overdose and/or cases of medication misuse correspond to the known side effects of Lasolvan® at recommended doses and require symptomatic treatment.
Side effects
The following classification was used to assess the frequency of adverse events:
very common ≥1/10
common ≥1/100 – <1/10
uncommon ≥1/1000 – <1/100
rare ≥1/10000 – <1/1000
very rare <1/10,000
unknown cannot be estimated based on available data
On the part of the immune system and skin and subcutaneous tissue:
rarely - hypersensitivity reactions;
not known - anaphylactic reactions, including anaphylactic shock, angioedema and pruritus.
Skin and subcutaneous tissue disorders:
rarely - rash, urticaria;
not known - serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
From the nervous system:
often – dysgeusia (taste disorder).
From the gastrointestinal tract:
often - nausea, decreased sensitivity in the oral cavity;
infrequently - vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth;
rarely - dry throat;
very rarely - drooling.
From the respiratory system, chest organs and mediastinum:
often - decreased sensitivity in the throat;
unknown - dyspnea (as a symptom of a hypersensitivity reaction).
General disorders:
uncommon – fever, mucous membrane reactions.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after registration of a medicinal product is an important procedure. This allows for continued monitoring of the benefit/risk balance of this medicinal product. Healthcare professionals are asked to report all suspected adverse reactions to the State Expert Center of the Ministry of Health of Ukraine.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
The shelf life after first opening the bottle is 6 months.
Storage conditions
Store at a temperature not exceeding 25 °C in a place inaccessible to children.
Packaging
100 or 200 ml in a glass bottle; 1 bottle complete with a plastic measuring cap in a cardboard box.
Vacation category
Without a prescription.
Producer
Boehringer Ingelheim Espana, SA, Spain/ Boehringer Ingelheim Espana, SA, Spain
or
Delpharm Reims, France.
Address
Prat de la Riba, 50, 08174 Sant Cugat Del Valles (Barcelona), Spain/Prat de la Riba, 50, 08174 Sant Cugat Del Valles (Barcelona), Spain.
or
10 rue Colonel Charbonneaux, 51100 Reims, France.
Applicant
Opela Healthcare Ukraine LLC, Ukraine.
Location of the applicant and/or applicant's representative
Ukraine, 01033, Kyiv, Zhylyanska St., 48-50A.
