Composition, form of production and packaging
? The syrup is transparent or almost transparent, colorless or almost colorless, slightly viscous, with the smell of forest berries.
5 ml
Ambroxol hydrochloride 15 mg
Auxiliary substances: benzoic acid 8.5 mg, hyethelose 10 mg, potassium acesulfame 5 mg, sorbitol liquid (non-crystallizing) 1.75 g, glycerol 85% 750 mg, forest berry flavor PHL-132195 11 mg, flavoring vanilla 201629 - 3 mg, purified water - 3.0475.
100 ml - bottles of amber or brown glass with a child safety plastic screw cap with thread and control of the first opening (1) complete with a measuring cup - packs of cardboard.
200 ml - amber or brown glass bottles with child safety plastic screw cap with thread and control of the first opening (1) complete with a measuring cup - packs of cardboard.
? The syrup is transparent or almost transparent, colorless or almost colorless, slightly viscous, with a strawberry smell.
5 ml
Ambroxol hydrochloride 30 mg
Auxiliary substances: benzoic acid 8.5 mg, hyethelose 10 mg, potassium acesulfame 5 mg, sorbitol liquid 1750 mg, glycerol 85% 750 mg, strawberry-cream flavor PHL-132200 12 mg, flavoring vanilla 201629 - 3 mg, purified water - 3031.5 mg.
100 ml - bottles of amber or brown glass with a child safety plastic screw cap with thread and control of the first opening (1) complete with a measuring cup - packs of cardboard.
200 ml - amber or brown glass bottles with child safety plastic screw cap with thread and control of the first opening (1) complete with a measuring cup - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Mucolytic and expectorant drug.
Studies have shown that ambroxol increases secretion in the airways. Strengthens the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased current and transport of mucus (mucociliary clearance). Strengthening mucociliary clearance improves sputum discharge and facilitates coughing.
In patients with COPD, prolonged therapy with LazolvanВ® (for at least 2 months) resulted in 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.
PHARMACOKINETICS
Suction and distribution
Ambroxol is characterized by rapid and almost complete absorption with a linear dose dependence in the therapeutic range of concentrations. C max in plasma is achieved after 1-2.5 hours. In the therapeutic concentration range, binding to plasma proteins is approximately 90%.
V d is 552 liters. The transfer of ambroxol from the blood to the tissue with oral administration occurs rapidly. The highest concentrations of the active component of the drug are observed in the lungs.
Metabolism and excretion
Approximately 30% of the dose taken is exposed to the effect of "first passage" through the liver. Studies on human liver microsomes showed that CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromoanthranilic acid. The remaining part of ambroxol is metabolized in the liver, mainly by glucuronization and by partial cleavage to dibromantranilic acid (approximately 10% of the administered dose), as well as a small number of additional metabolites.
The terminal T 1/2 ambroxol is 10 hours. The total clearance is within 660 ml / min, the renal clearance accounts for approximately 8% of the total clearance.
There is no clinically significant effect of age and sex on the pharmacokinetics of ambroxol, so there is no reason for choosing a dose for these symptoms.
INDICATIONS
Acute and chronic diseases of the respiratory tract, accompanied by the release of viscous sputum:
- Acute and chronic bronchitis;
- pneumonia;
- COPD;
- bronchial asthma with difficulty of sputum discharge;
bronchoectatic disease.
DOSING MODE
The drug is used inside, regardless of food intake.
Lazolvan В® syrup 15 mg / 5 ml is prescribed for adults and children over 12 years of age to 10 ml 3 times / day; children aged 6 to 12 years - 5 ml 2-3 times / day;children aged 2 to 6 years - 2.5 ml 3 times / day; children under 2 years - 2.5 ml 2 times / day.
Lazolvan В® syrup 30 mg / 5 ml for adults and children over 12 years of age prescribed 5 ml 3 times / day; children aged 6 to 12 years - 2.5 ml 2-3 times / day.
If symptoms persist for 4-5 days from the beginning of the drug should consult a doctor.
SIDE EFFECT
On the part of the digestive system: often (1-10%) - nausea, decreased sensitivity in the oral cavity and pharynx; infrequently (0.1-1%) - dyspepsia, vomiting, diarrhea, abdominal pain, dry mouth; rarely (0.01-0.1%) - dryness in the throat.
From the nervous system: often (1-10%) - dysgeusia (a violation of taste sensations).
Allergic reactions: rarely (0.01-0.1%) - rash, hives, anaphylactic reactions (including anaphylactic shock) *, angioedema, * itching *, hypersensitivity *.
* - these adverse reactions were observed with a wide application of the drug; with 95% probability, the frequency of these adverse reactions is infrequent (0.1-1%), but possibly lower; the exact frequency is difficult to estimate; they were not noted during clinical trials.
CONTRAINDICATIONS
- I trimester of pregnancy;
- lactation period;
- Children under 6 years of age (for a dose of 30 mg / 5 ml);
- hereditary intolerance to fructose;
- Hypersensitivity to ambroxol or other components of the drug.
With caution should prescribe the drug in the II and III trimesters of pregnancy, patients with renal and / or liver failure.
PREGNANCY AND LACTATION
Ambroxol penetrates the placental barrier.
Preclinical studies showed no direct or indirect adverse effects on pregnancy, fetal / fetal, postnatal development, and on generic activities.
Clinical experience with ambroxol after 28 weeks of gestation found no evidence of a negative effect of the drug on the fetus. Nevertheless, it is necessary to observe the usual precautions when using the drug during pregnancy. Especially it is not recommended to take Lazolvan В® in the first trimester of pregnancy. In the II and III trimesters of pregnancy, the drug is only possible if the intended benefit to the mother is greater than the potential risk to the fetus.
Ambroxol can be excreted in breast milk. Despite the fact that adverse effects were not observed in breast-fed infants, lazolvanВ® syrup is not recommended during lactation.
Preclinical studies of ambroxol showed no adverse effects on fertility.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution appoint to patients with renal insufficiency.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution appoint patients with hepatic insufficiency.
APPLICATION FOR CHILDREN
Lazolvan syrup (30 mg / 5 ml) is contraindicated in children under 6 years of age.
SPECIAL INSTRUCTIONS
Do not use Lazolvan В® syrup in combination with antitussive drugs that hamper the excretion of sputum.
Sorbitol, which is part of the syrup, can have a mild laxative effect.
Lazolvan В® syrup (30 mg / 5 ml) contains 5 g of sorbitol in terms of the maximum recommended daily dose (20 ml), Lazolvan В® syrup (15 mg / 5 ml) - 10.5 g sorbitol in terms of the maximum recommended daily dose (30 ml ). Patients with a rare hereditary intolerance to fructose should not take this drug.
Single cases of severe skin lesions have been reported, for example, Stevens-Johnson syndrome and Lyell syndrome, coinciding with the appointment of ambroxol;but the connection with the drug is not proven. With the development of the above syndromes, it is recommended to stop treatment and immediately seek medical help.
In case of impaired renal function, Lazolvan В® should be taken only as prescribed by the doctor.
Impact on the ability to drive vehicles and manage mechanisms
There were no cases of drug effects on the ability to drive vehicles and mechanisms. 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 carried out.
OVERDOSE
Specific symptoms of an overdose in humans are not described.
There are reports of a random overdose and / or medical error that resulted in symptoms of known side effects of LazolvanВ®: nausea, dyspepsia, diarrhea, vomiting, abdominal pain.
Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug, symptomatic therapy.
DRUG INTERACTION
No clinically significant adverse interaction with other drugs has been reported.
Ambroxol increases the penetration into the bronchial secret of amoxicillin, cefuroxime, erythromycin.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug in the form should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
