Composition, form of production and packaging
? The tablets are white or slightly yellow, round, flat on both sides, with beveled edges, on one side - the risk separating and engraving "67C" squeezed on both sides of the separation hazard, on the other side of the tablet is a company symbol.
Ambroxol hydrochloride 30 mg
Excipients: lactose monohydrate - 171 mg, corn starch dried - 36 mg, silicon dioxide colloid - 1.8 mg, magnesium stearate - 1.2 mg.
10 pieces. - blisters (2) - packs of cardboard.
10 pieces. - blisters (5) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
Mucolytic and expectorant drug.
Studies have shown that ambroxol increases secretion in the airways. It increases 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.
Suction and distribution
For all immediate-release ambroxol dosage forms, rapid and almost complete absorption with a linear dose-response in the therapeutic range of concentrations is characteristic. C max in plasma is achieved in 1-2.5 hours. Absolute bioavailability of tablets LazolvanВ® 30 mg is 79%.
V d is 552 liters. In the therapeutic concentration range, binding to plasma proteins is approximately 90%. 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 administered oral dose is subjected to the effect of a "first pass" 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 about 10 hours. The total clearance is within 660 ml / min, the renal clearance accounts for approximately 83% 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.
Acute and chronic diseases of the respiratory tract, accompanied by the release of viscous sputum:
- Acute and chronic bronchitis;
- bronchial asthma with difficulty of sputum discharge;
The drug is prescribed by mouth 30 mg (1 tab.) 3 times / day. If necessary, to increase the therapeutic effect, you can appoint 60 mg (2 tablets) 2 times / day.
Tablets are taken with a liquid. You can take the pill regardless of the meal.
If the symptoms persist for 4-5 days after the start of treatment, it is recommended that you consult a doctor.
From the digestive system: often (1-10%) - nausea; infrequently (0.1-1%) - dyspepsia, vomiting, diarrhea, abdominal pain.
From the immune system, from the skin and subcutaneous tissues: rarely (0.01-0.1%) - rash, urticaria; angioedema, anaphylactic reactions (including anaphylactic shock) *, 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.
- I trimester of pregnancy;
- lactation period;
- children and adolescence under 18;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- Hypersensitivity to ambroxol or other components of the drug.
With caution should prescribe the drug in the II and III trimesters of pregnancy, 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.
The extensive clinical experience of using ambroxol after the 28th week of pregnancy found no evidence of a negative effect of the drug on the fetus.
However, it is necessary to observe the usual precautions when using the medication 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 expected benefit to the mother exceeds the potential risk to the fetus.
Ambroxol can be excreted in breast milk. Despite the fact that adverse effects in children receiving breastfeeding were not observed, LazolvanВ® 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
Contraindicated in children and adolescents under the age of 18 years.
Do not use in combination with antitussive drugs that make it difficult to remove phlegm.
One tablet contains 162.5 mg of lactose. The maximum daily dose (4 tablets) contains 650 mg of lactose.
In patients with severe skin lesions (Stevens-Johnson syndrome or toxic epidermal necrolysis), the temperature, body pain, rhinitis, cough and inflammation of the pharynx may appear in the early phase. With symptomatic treatment, it is possible to erroneously administer mucolytic agents, such as ambroxol. There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding with the appointment of the drug; but there is no causal relationship with taking the drug. With the development of the above syndromes, it is recommended to stop treatment and immediately seek medical help.
If renal dysfunction is disturbed, LazolvanВ® should be used only on the advice of a physician.
For children and adolescents under the age of 18, it is possible to use other medicinal forms of Lazolvan (syrup, troches, solution for ingestion and inhalation).
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.
Specific symptoms of an overdose in humans are not described.
There are reports of accidental overdose and / or medical error, which resulted in symptoms of known side effects of Lazolvan В® : nausea, dyspepsia, vomiting, abdominal pain.
Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; symptomatic therapy.
No clinically significant adverse interaction with other drugs has been reported.
Ambroxol increases 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 should be stored out of reach of children at a temperature of no higher than 30 В° C. Shelf life - 5 years.