Boehringer Ingelheim Lazolvan cough lozenges - “Lazolvan lozenges: use for a prolonged cough, with which I could not sleep and interfered with others. Instructions for use.». Dosing regimen for losolvan lozenges. Interaction with others

Latin name: LASOLVAN
ATX code: R05C-B06
Active substance: ambroxol
Manufacturer: BOEHRINGER INGELHEIM (Germany)
Pharmacy leave condition: Over the counter

The line of mucolytic drugs Lazolvan for children or adults is designed to facilitate the separation and removal of sputum that forms in diseases of the respiratory system. All products (except Lazolvan-Rino) contain one active substance - ambroxol hydrochloride, which helps to thin and remove bronchial secretions.

Indications for use

Drugs are prescribed for the treatment of all diseases that are accompanied by abundant mucus formation and its difficult withdrawal:

• Bronchitis
• Inflammation of the lungs
• Bronchial asthma (with poor mucus secretion)
• Bronchiectasis
• COPD

The composition of the drug

Tablets: one pill contains 30 mg of ambroxol. Additional ingredients - lactose monohydrate, silicon and magnesium compounds, starch.

Lazolvan solution for oral administration and inhalation: in 1 ml - 7.5 mg of the active ingredient. Additional substances - citric acid, sodium derivatives, benzalkonium, water.

Lozenges: in one pill - 15 mg of the active substance. As auxiliary ingredients - acacia gum, mint and eucalyptus oil, sorbitol, purified water, starch, paraffin.

Lazolvan for children is produced in the form of a sweetish syrup. The content of ambroxol in 5 ml is 15 mg. Additional substances - HEC, sorbitol, glycerol, benzoic and tartaric acids, water, food additive and other substances.

Medicinal properties

The active substance of the drug stimulates the glands in the bronchial tree, facilitates the separation and removal of mucus. In addition, it has a local analgesic and anti-inflammatory effect. As a result of the action of Lazolvan, the cough becomes more productive, the paths are cleared of mucus, pain, redness and swelling are eliminated, which has a beneficial effect on the patient's condition.

Release form

Mucolytic is made in several forms:

Mode of application

Price - about 394 rubles.

Means with ambroxol are taken orally or inhaled. With self-medication, the course should not last longer than 4-5 days. If after this period there is no improvement, you should stop the drug and consult a doctor. The same applies to the extension or repetition of the course - they are carried out with the permission of physicians.

Lazolvan lozenges instructions for use allow you to dissolve at any time, regardless of the meal. Adolescents (over 12 years old) and adults can use 2 lozenges three times a day. Children from 6 to 12 years old: 1 pc. x 3 times (enlargement up to 4-6 times is allowed to enhance the effect). The pills are absorbable and should not be crushed or swallowed whole.

Tablets are drunk whole with plenty of liquid. In the absence of an appointment, follow the recommendations of the manufacturers: three times a day, one pc. To enhance expectoration, it is allowed to take 1 tablet more: 2 pcs. x 2 times.

Lasolvan syrup, according to the instructions for use, can also be drunk at any time of the day, regardless of meals:

• Children: (2-6 years old) - 2.5 ml x 3 r., (6-12) - 5 ml x 3 r.
• Teenagers (12+) and adults - 10 ml x 3 r.

The instructions for use recommend using Lazolvan in a solution for inhalation according to the scheme: 1-2 procedures daily using 2-3 ml of the solution - for children aged 6 years and over. For small children (up to 6 years old) it is allowed to do 1 procedure with 2 ml of solution. Inhalations with Lazolvan for children are allowed to be carried out daily.

The dosage and how to take Lazolvan during pregnancy is determined only by a gynecologist. Self-administration is not recommended.

During pregnancy and HB

Price ~ 173 rubles.

The main component of the drug is able to pass through the placenta. Although clinical observations have not recorded the negative impact of the substance on the formation of the child, you cannot drink Lazolvan on your own during pregnancy. The 1st trimester is especially dangerous, therefore, at this time it is strictly forbidden to use this medicine, in the 2nd and 3rd trimester treatment is possible, but should be carried out under the supervision of doctors.

Ambroxol is also able to penetrate into milk. Therefore, lactating women need to discuss with the pediatrician the possibility of using the drug.

Contraindications

The ban on the use of mucolytics with ambroxol is:

• Individual hypersensitivity or intolerance
• First trimester of pregnancy
• Exacerbation of peptic ulcer
• Lactose intolerance, glucose-galactose malabsorption
• Children's age (6, 14 years - depends on the form of the drug).

Under medical supervision, Lazolvan mucolytics are taken during pregnancy in the 2nd and 3rd trimesters, as well as with pathologies of the kidneys and liver.

Precautionary measures

Average cost: No20 - 168 rubles, No50 - 267 rubles.

Cross-drug interactions

When using Lazolvan in any form, several features should be considered:

• Joint reception with other mucolytics can provoke an abundant accumulation of mucus, a weakening of its output due to the suppression of the cough reflex. Therefore, the use of any antitussive drugs must be agreed with the doctor.
• When combined with antibiotics (penicillin and tetracycline groups, Erythromycin), Ambroxol enhances the penetration of their components into bronchial mucus.
• It can be combined with means that inhibit labor activity.
• Patients with asthma should take into account that the use of Lazolvan for inhalation can result in bronchospasm, since the drug contains an allergenic preservative.

Side effects

Perhaps the development of skin allergies, it is not excluded the development in isolated cases of contact dermatitis. Anaphylactic shock is extremely rare. Too long intake contributes to heartburn, nausea, abdominal pain.

Overdose

There are no data on the negative effects of an overdose. In the case of the development of intoxication, the symptoms are similar to side effects. To eliminate them, it is necessary to induce vomiting, rinse the stomach (if no more than 1-2 hours have passed since the time of admission), and carry out symptomatic treatment.

Terms and conditions of storage

Syrup and lozenges can be used within 3 years from the date of issue, tablets - 5. Mucolytics should be kept in a dark place, away from heat sources, at a temperature not exceeding 25-30 ° C.

Analogues

The question of replacing the drug should be dealt with by the doctor, based on the individual characteristics of each patient.

Ambrobene

Ratiopharm GmbH (Germany)

Price:

• Tab. (20 pcs.) - 147 rubles.
• Amp. (5 pcs.) - 184 rubles.
• Solution (40) - 119 rubles, (100 ml) - 176 rubles.
• Caps. (10 pcs.) - 183 rubles, (20 pcs.) - 256 rubles.

Mucolytic, the action of which is due to the active ingredient - ambroxol. It is used to improve the productivity of cough: thinning and accelerating the removal of mucus from the respiratory tract in diseases of the respiratory system.

The tool has several forms:

• Syrup for children - a clear liquid with a raspberry flavor
• Tablets - biconvex, white
• The solution is a clear, odorless liquid.
• Capsules - pills with prolonged action, contain granular powder
• Solution for injection - a clear liquid in ampoules. Prescription drug.

Although the action and features of Ambrobene therapy are similar to Lazolvan, before using the drug, it is necessary to clarify the conditions for admission and restrictions on use.

Advantages:

• Efficiency
• Availability.

Flaws:

• Unpleasant aftertaste
• Doesn't always help.

1 lozenge contains:
active substance- ambroxol hydrochloride 15 mg;
Excipients- acacia gum 1 850 mg, sorbitol 2 307.4 mg, carion 83 [sorbitol, mannitol, hydrolyzed hydrogenated starch] 2 614.8 mg, peppermint leaf oil 10 mg, eucalyptus rod leaf oil 2 mg, sodium saccharinate 1.8 mg, liquid paraffin (purified mixture of liquid saturated hydrocarbons) 2.4 mg, purified water3 196.6 mg.
1 Quantity indicated based on 85% average solids content
2 Quantities are given with reference to an average solids content of 70%
3 Quantity indicated with reference to the residual moisture content in the lozenge after drying

Description

Round lozenges of light brown color and peppermint smell.

Pharmacotherapeutic group

Expectorant, mucolytic agent

Pharmacological properties

Studies have shown that ambroxol, the active ingredient in Lazolvan, increases secretion in the airways. It enhances the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased flow and mucus transport (mucociliary clearance). Increased mucociliary clearance improves sputum discharge and relieves cough. In patients with chronic obstructive pulmonary disease, 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.

Pharmacokinetics

For all dosage forms of ambroxol immediate release, rapid and almost complete absorption is characteristic with a linear dose dependence in the therapeutic concentration range. The maximum plasma concentration (Cmax) when taken orally is reached after 1-2.5 hours. The volume of distribution is 552 liters.
In the therapeutic concentration range, plasma protein binding is approximately 90%. The transition of ambroxol from the blood to the tissues when administered orally occurs quickly. The highest concentrations of the active ingredient of the drug are observed in the lungs.
Approximately 30% of the oral dose taken is subject to the effect of the primary passage through the liver. Studies in human liver microsomes have shown that the CYP3A4 isoenzyme is the predominant isoform responsible for the metabolism of ambroxol to dibromanthranilic acid. The remainder of ambroxol is metabolized in the liver, mainly by glucuronidation and by partial degradation to dibromanthranilic acid (approximately 10% of the administered dose), as well as a small number of additional metabolites. The terminal half-life of ambroxol is 10 hours.
The total clearance is in the range of 660 ml / min, renal clearance accounts for approximately 8% of the total clearance. Using the radiolabel method, it was calculated that after taking a single dose of the drug over the next 5 days, about 83% of the dose taken was excreted in the urine.
No clinically significant effect of age and gender on the pharmacokinetics of ambroxol was found, so there is no reason to select a dosage based on these features.

Indications for use

Acute and chronic diseases of the respiratory tract with the release of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty in sputum discharge, bronchiectasis.

Contraindications

Hypersensitivity to ambroxol or other components of the drug, pregnancy (I trimester), lactation period, children under 6 years of age. One lozenge Lazolvan contains 366 mg of sorbitol. The maximum recommended daily dose (120 mg) contains 2.9 g of sorbitol.
Patients with rare hereditary fructose intolerance should not take this drug.

Carefully

II - III trimesters of pregnancy, renal and / or liver failure.

Use during pregnancy and during breastfeeding

Ambroxol crosses the placental barrier. Preclinical studies have not revealed direct or indirect adverse effects on pregnancy, embryonic / fetal, postnatal development and labor activity. Extensive clinical experience with the use of ambroxol after the 28th week of pregnancy did not reveal evidence of a negative effect of the drug on the fetus.
However, the usual precautions should be observed when using the medicine during pregnancy. It is especially not recommended to take Lazolvan in the first trimester of pregnancy. In the II and III trimesters of pregnancy, the use of the drug is possible only if the potential benefit to the mother outweighs the potential risk to the fetus. Ambroxol can be excreted in breast milk. Despite the fact that undesirable effects have not been observed in children receiving breastfeeding, it is not recommended to use Lazolvan lozenges during lactation. Preclinical studies of ambroxol did not reveal a negative effect on fertility.

Method of application and dosage

inside. The lozenges slowly dissolve in the mouth.
Adults and children over 12 years old: 30 mg (2 lozenges) 3 times a day.
If necessary, to enhance the therapeutic effect, you can prescribe 30 mg (2 lozenges) 4 times a day.
Children 6-12 years old: 1 lozenge 2-3 times a day.
Pastilles can be used regardless of the meal.
If the symptoms of the disease persist or worsen, you should consult a specialist.

Side effect

Gastrointestinal disorders

Often (1.0-10.0%) - nausea, decreased sensitivity in the oral cavity or pharynx;
Infrequently (0.1-1.0%) - dyspepsia, vomiting, diarrhea, abdominal pain, dry mouth;
Rarely (0.01-0.1%) - dryness in the throat.
Disorders of the immune system, lesions of the skin and subcutaneous tissues

Rarely (0.01-0.1%) - rash, urticaria; anaphylactic reactions (including anaphylactic shock)*, angioedema*, itching*, hypersensitivity*.
Disorders from the nervous system

Often (1.0-10.0%) - dysgeusia (violation of taste sensations).
* - these adverse reactions were observed with widespread use of the drug; with a 95% probability, the frequency of these adverse reactions is infrequent (0.1% -1.0%), but possibly less often; the exact frequency is difficult to estimate, since they have not been noted during clinical trials.

Overdose

Specific symptoms of overdose in humans are not described.
There are reports of accidental overdose and / or medical error, as a result of which - symptoms of known side effects of the drug Lazolvan were observed: nausea, dyspepsia, diarrhea, vomiting, abdominal pain. This may require symptomatic therapy.
Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug, symptomatic therapy.

Interaction with other drugs

No clinically significant, undesirable interactions with other medicinal products have been reported. Ambroxol increases the penetration of amoxicillin, cefuroxime, erythromycin into the bronchial secretion.

special instructions

It should not be combined with antitussives that make it difficult to remove sputum. There are isolated reports of severe skin lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis coinciding with the administration of expectorants such as ambroxol hydrochloride. In most cases, they can be explained by the severity of the underlying disease and/or concomitant therapy. Patients with Stevens-Johnson syndrome or toxic epidermal necrosis in the early phase may present with fever, body pain, rhinitis, cough, and sore throat. With symptomatic treatment, an erroneous prescription of anti-cold drugs is possible. If new lesions of the skin and mucous membranes appear, it is recommended to stop treatment with Ambroxol and immediately seek medical help. In case of impaired renal function, Lazolvan should be used only on the advice of a doctor.

Description of the dosage form of losolvan lozenges

Pharmacological action of losolvan lozenges

After oral administration, the action occurs after 30 minutes, with rectal administration - after 10-30 minutes and lasts for 6-12 hours. With parenteral administration, the action occurs quickly and lasts for 6-10 hours.

Pharmacokinetics of lozenges Lazolvan

Metabolism - in the liver, forms dibromanthranilic acid and glucuronic conjugates. T1 / 2 - 7-12 hours. Excreted by the kidneys: 90% in the form of water-soluble metabolites, unchanged - 5%.

T1 / 2 increases with severe chronic renal failure, does not change with impaired liver function.

Caution lozenges Lazolvan

Dosing regimen of losolvan lozenges

Oral solution (7.5 mg / ml) for adults during the first 2-3 days - 4 ml, and then 2 ml 3 times a day or 4 ml 2 times a day; children under 2 years - 1 ml 2 times a day, 2-5 years - 1 ml 3 times a day, 5-12 years - 2 ml 2-3 times a day.

Syrup (3 mg / ml) for adults - in the first 2-3 days, 10 ml, and then 5 ml 3 times a day or 10 ml 2 times a day. In severe cases of the disease, the dose is not reduced during the entire course of treatment. Children 5-12 years old are prescribed 15 mg 2-3 times a day, 2-5 years old - 7.5 mg 3 times a day, up to 2 years old - 7.5 mg 2 times a day.

In the form of inhalations, adults and children over 5 years old are prescribed 15-22.5 mg, children under 2 years old - 7.5 mg, children from 2-5 years old - 15 mg 1-2 times a day. In the case when it is not possible to carry out more than one inhalation per day, tablets, solution or syrup are additionally used orally.

Parenterally administered intramuscularly, intravenously (slowly, stream or drip) or s / c: adults - 15 mg, in severe cases - 30 mg 2-3 times a day; children - 1.2-1.6 mg / kg 3 times a day. Usually for children under 2 years old - 7.5 mg 2 times a day, from 2 to 5 years old - 7.5 mg 3 times a day, from 5 years old - 15 mg 2-3 times a day. For the treatment of respiratory distress syndrome in premature and newborn babies, 10 mg/kg/day is administered intravenously or intramuscularly, the frequency of administration is 3-4 times, if necessary, the dose can be increased to 30 mg/kg/day.

For intravenous drip, 50 ml is diluted in 500 ml of an infusion solution (0.9% NaCl solution, 5% dextrose solution, Ringer-Locke solution or other basic solution with a pH not higher than 6.3 is used as a solvent), injected within 2 hours at a rate of 84 drops / min. Repeated treatment according to the above scheme can be carried out after 14 days (while maintaining the indications).

Parenteral administration is stopped after the disappearance of acute manifestations of the disease (switch to oral or rectal administration).

Rectally, adults and children over 12 years old - 1 suppository (30 mg) 3 times a day for 2-3 days, then 60 mg 2 times a day, the maximum daily dose is 0.12 g; children 6-12 years old - 15 mg 2-3 times a day.

Contraindications lozenges Lazolvan

Indications for use of losolvan lozenges

Stimulation of prenatal maturation of the lungs, treatment and prevention (with the threat of preterm labor and with indicated artificial preterm labor between 28 and 34 weeks of gestation, if the clinical picture suggests an extension of the gestational age by 3 days) of respiratory distress syndrome in preterm infants and newborns.

Side effects of losolvan lozenges

Rarely - weakness, headache, diarrhea, dry mouth and respiratory tract, exanthema, rhinorrhea, constipation, dysuria. With prolonged use in high doses - gastralgia, nausea, vomiting.

With a quick on / in the introduction - a feeling of numbness, weakness, intense headaches, lowering blood pressure, shortness of breath, hyperthermia, chills.

Overdose of losolvan lozenges

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; intake of fatty foods.

Special instructions losolvan lozenges Lazolvan

The inhalation solution can be used using any modern inhalation equipment (except for steam inhalers). Before inhalation, the drug is mixed with a 0.9% NaCl solution (for optimal air humidification, it can be diluted in a ratio of 1: 1) and heated to body temperature. Inhalations should be carried out in normal breathing mode (so as not to provoke coughing shocks).

Patients suffering from bronchial asthma, in order to avoid non-specific irritation of the respiratory tract and their spasm, it is necessary to use bronchodilators before inhalation of ambroxol.

Patients suffering from diabetes can be administered as a syrup (5 ml of syrup contains sorbitol and saccharin in an amount corresponding to 0.18 XE).

Children under 5 years of age are not recommended to use 15 mg suppositories, up to 12 years - 30 mg (15 mg suppositories are used for them).

Description of losolvan lozenges

Interaction of lozenges Lazolvan

Increases penetration into the bronchial secretion of amoxicillin, cefuroxime, erythromycin and doxycycline.

Solution for injection should not be used with solutions with a pH higher than 6.3.