Instructions for use Lasolvan solution for inhalation and oral administration 15 mg/2 ml bottle 100 ml
Composition
active ingredient: ambroxol hydrochloride;
2 ml of solution for inhalation and oral administration contain 15 mg of ambroxol hydrochloride;
Excipients: citric acid, monohydrate; sodium hydrogen phosphate, dihydrate; sodium chloride; benzalkonium chloride; purified water.
Dosage form
Solution for inhalation and oral use.
Main physicochemical properties: transparent, colorless or slightly brown solution.
Pharmacotherapeutic group
Medicines used for coughs and colds. Mucolytics.
ATX code R05C B06.
Pharmacological properties
Pharmacodynamics
Ambroxol hydrochloride, a substituted benzylamine, is a metabolite of bromhexine. It differs from bromhexine in the absence of a methyl group and the presence of a hydroxyl group in the para-trans position of the cyclohexyl ring.
Studies prove its secretolytic and secretomotor effects in the bronchial tract.
When taken orally, the effect occurs on average after 30 minutes and lasts 6-12 hours, depending on the individual dose.
Preclinical studies have shown that ambroxol hydrochloride increases the proportion of serous component of bronchial secretions. Ambroxol enhances mucus clearance by reducing viscosity and activating the ciliary epithelium.
Ambroxol activates the surfactant system by directly acting on type II pneumocytes in the alveoli and Clara cells in the small airways. It enhances the production and release of surfactant in the alveoli and bronchial tree of the fetus and adult. These effects have been demonstrated in various species in cell cultures and in vivo.
In addition, the antioxidant effects of ambroxol have been demonstrated in various preclinical studies.
Pharmacokinetics
Absorption
Ambroxol is almost completely absorbed after oral administration. Tmax after oral administration is 1-3 hours. The absolute bioavailability of ambroxol when administered orally is reduced by approximately 1/3 due to presystemic metabolism.
Distribution
Approximately 85% (80-90%) of the drug is bound to plasma proteins. In lung tissue, ambroxol reaches higher concentrations than in plasma after parenteral administration. Ambroxol can penetrate into the cerebrospinal fluid, through the placental barrier and is excreted in breast milk.
Biotransformation
The formation of metabolites capable of penetrating the kidneys (e.g., dibromantranilic acid, glucuronide) occurs in the liver.
Breeding
Almost 90% of the drug is excreted by the kidneys in the form of metabolites formed in the liver. Less than 10% of ambroxol is excreted by the kidneys unchanged. Due to the high degree of protein binding, large volume of distribution and slow redistribution of the drug from tissues to the blood during dialysis or forced diuresis, significant excretion of ambroxol is unlikely.
The terminal plasma half-life is 7-12 hours. The plasma half-life of ambroxol and its metabolites is approximately 22 hours.
Patients with impaired liver and kidney function
In patients with severe liver disorders, the clearance of ambroxol is reduced by 20-40%. In patients with severe renal impairment, accumulation of ambroxol metabolites may occur.
Indication
Secretolytic therapy for acute and chronic bronchopulmonary diseases associated with disorders of bronchial secretion and impaired mucus movement.
Contraindication
Lasolvan®, a solution for inhalation and oral administration, should not be used in patients with hypersensitivity to ambroxol hydrochloride or other components of the drug.
Interaction with other medicinal products and other types of interactions
The simultaneous use of Lasolvan® 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.
Concomitant use of ambroxol and antibiotics (amoxicillin, cefuroxime, doxycycline, and erythromycin) leads to higher concentrations of antibiotics in bronchopulmonary secretions and sputum.
Application features
Lasolvan®, solution for inhalation and oral administration, contains benzalkonium chloride as a preservative. Benzalkonium chloride may cause bronchospasm when inhaled.
In case of impaired bronchial motility and increased mucus secretion (for example, in a rare disease such as primary ciliary dyskinesia), the drug Lasolvan®, solution for inhalation and oral administration, should be used with caution due to the risk of secretion accumulation.
Patients with impaired renal function or severe hepatic insufficiency should take Lasolvan® only after consulting a doctor. When using ambroxol, as with any active substance that is metabolized in the liver and then excreted by the kidneys, there is an accumulation of metabolites that are formed in the liver in patients with severe renal insufficiency.
Lasolvan®, solution for inhalation and oral administration contains 42.8 mg of sodium in the recommended daily dose. This should be taken into account by patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
Pregnancy: Ambroxol hydrochloride crosses the placental barrier.
Clinical studies of the use of the drug after the 28th week of pregnancy have not revealed any harmful effects on the fetus and the course of pregnancy. Animal studies have not revealed direct or indirect harmful effects on the course of pregnancy, embryonal/fetal development, childbirth or postnatal development. However, the usual precautions regarding the use of drugs during pregnancy should be observed. The use of Lasolvan® is especially not recommended in the first trimester of pregnancy.
Breastfeeding. Ambroxol hydrochloride passes into breast milk. Lasolvan® is not recommended for use during breastfeeding.
Fertility: Non-clinical 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 rate when driving vehicles or working with other mechanisms. Studies on the effect on the reaction rate when driving vehicles or working with other mechanisms have not been conducted.
Method of administration and doses
1 ml of solution for oral administration and inhalation = 25 drops.
Inhalation solution
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.
Lasolvan®, an inhalation solution, can be used in all modern inhalation devices (except steam inhalers).
Lasolvan®, inhalation solution, should be diluted in a 1:1 ratio with saline to ensure optimal humidification of the air released by the device.
Lasolvan®, solution for inhalation, should not be mixed with cromoglycic acid. It should also not be mixed with other solutions with a pH greater than 6.3, such as alkaline inhalation salt (Emser Salt). Due to the increase in pH, the ability of the free base of ambroxol hydrochloride to precipitate or the solution to become cloudy may increase.
It is usually recommended to warm the inhalation solution to body temperature before starting inhalation.
If only one inhalation per day is possible, Lazolvan® for oral administration should be used additionally.
Given that the inhalation process itself can provoke coughing, patients are advised to breathe normally during inhalation.
Patients with bronchial asthma should use bronchodilators to open the lungs before inhalation.
Oral solution
Adults and children over 12 years of age: 4 ml 3 times a day for the first 2-3 days, which is equal to 90 mg of ambroxol per day, then 2 ml 3 times a day, which is equal to 45 mg of ambroxol per day. The dosage of 4 ml 3 times a day can be continued after consultation with a doctor;
children aged 6 – 12 years: 2 ml 2 – 3 times a day, which is equal to 30 – 45 mg of ambroxol per day;
children aged 2 to 6 years: 1 ml (25 drops) 3 times a day, which is equal to 22.5 mg of ambroxol per day;
children under 2 years of age: 1 ml (25 drops) 2 times a day, which is equal to 15 mg of ambroxol per day.
Dosage in patients with renal and/or hepatic impairment
Patients with severe renal impairment or severe hepatic impairment should use the drug only after consulting a doctor, as it may be necessary to reduce the maintenance dose or extend the interval between administrations of the drug.
Lasolvan®, solution for inhalation and oral administration, should not be used for longer than 4-5 days without consulting a doctor.
In acute illnesses, you should consult a doctor if the symptoms do not disappear or worsen despite taking the drug Lasolvan®.
Lasolvan®, a solution for oral administration, can be diluted in water, tea, fruit juice, milk. Lasolvan® can be taken regardless of meals.
The secretolytic effect of the drug Lasolvan® is maintained provided that a sufficient amount of fluid enters the body.
Children
The drug can be used in children. Children under 2 years of age should only use the drug as prescribed by a doctor.
Overdose
To date, there are no reports of overdose. Symptoms known from isolated reports of overdose and/or cases of medication misuse correspond to known side effects when using Lasolvan® in recommended doses and require symptomatic treatment.
Side effects
The following classification was used to assess the frequency of adverse events:
| Very often | ≥ 1/10. |
| Often | ≥ 1/100 - < 1/10. |
| Infrequently | ≥ 1/1000 - < 1/100. |
| Rarely | ≥ 1/10000 - < 1/1000. |
| Very rare | < 1/10000. |
| Unknown | cannot be estimated based on available data. |
On the part of the immune system:
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 (changes in taste sensations).
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;
very rarely - dyspnea and bronchospasm;
unknown - dyspnea (as a symptom of a hypersensitivity reaction).
General disorders:
infrequently - 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
5 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children!
Packaging
100 ml in a glass bottle equipped with a polyethylene dropper and closed with a screw cap; 1 bottle complete with a polystyrene measuring cap in a cardboard box.
Vacation category
Without a prescription.
Producer
Istituto de Angeli S.r.l., Italy/
Istituto de Angeli Srl, Italy.
Address
Localita Prulli, 103/s - 50066 Regello (Florence), Italy/
Localita Prulli n.103/c - 50066 Reggello (FI), Italy.
Applicant
Opela Healthcare Ukraine LLC, Ukraine.
Location of the applicant and/or the applicant's representative.
Ukraine, 01033, Kyiv, Zhylyanska St., 48-50A.
