Ambrobene dosage for children. Ambrobene: instructions for use, analogues and reviews, prices in Russian pharmacies

Colds and flu are almost always accompanied by such an unpleasant phenomenon as coughing. Cough is especially unpleasant if it is dry and unproductive, that is, it is not accompanied by sputum discharge that interferes with breathing. Many drugs have been developed by pharmacists to help those suffering from unproductive coughs. And Ambrobene is one of the most commonly prescribed funds. It can be taken by both adults and children, up to the smallest age.

Description

The basis of Ambrobene is a substance called Ambroxol. It is the main metabolite of another popular expectorant, bromhexine. Today, the substance is widely used in clinical practice. Ambroxol differs from Bromhexine in the absence of a methyl group and the presence of a hydroxyl group. Ambroxol has:

• secretolytic,
• secretomotor,
• expectorant,
• antioxidant,
• mucolytic,

properties.

In addition, the drug:

• prevents stagnation of mucus in the bronchi;
• stimulates the work of the cilia of the epithelium of the bronchi, preventing them from sticking together;
• provides transport of pathological secretion;
• activates the work of serous cells located in the bronchial mucosa;
• increases the amount of mucous secretion, helps to restore the balance of the serous and mucous components of sputum.

Ambrobene has a direct effect on type 2 alveolar pneumocytes and Clara cells of small airways. If you take Ambroxol and antibiotics at the same time, then the concentration of antibiotics in the bronchi and sputum increases.

Due to these effects, for a short time (about half an hour) after taking Ambrobene, a dry and unproductive cough turns into a productive one and leads to sputum discharge.

Studies have shown that the remedy can be effective in the prevention of infectious diseases of the respiratory tract.

Ambrobene for newborns and infants

In young children, including newborns, Ambrobene stimulates the formation of pulmonary surfactant in the alveoli and bronchi, and also blocks its decay. Pulmonary surfactant is commonly referred to as a mixture of substances that prevent the alveoli from sticking together. Often, Ambrobene is prescribed to newborns and infants in order to prevent the alveoli from sticking together, since they do not have enough surfactant. Ambrobene also protects the lungs of babies from bronchitis. At the age of one year, you can take the drug only in the form of a syrup. Ambrobene syrup is designed in such a way that it can be drunk from the first days of life. Most kids really like its taste.

Pharmacokinetics

The effect of the drug begins already half an hour after the intake has occurred, and lasts 6-12 hours (depending on the dose). When administered intravenously, the drug begins to work even faster. The maximum concentration when taken orally is observed after 1-3 hours. However, in order for the agent to demonstrate a stable and tangible effect, it is necessary to wait at least 4 days.

The half-life of the drug and its metabolites is approximately 22 hours. In patients with impaired renal function, the half-life increases. Excreted by the kidneys as metabolites (90%) and unchanged (10%).

The drug crosses the placental barrier, into the cerebrospinal fluid, and is found in breast milk.

Contraindications

Ambrobene can even be used to treat infants (as a parenteral solution). Therefore, there are very few situations when the drug cannot be used.

First of all, contraindications include bronchial asthma. It is forbidden to take tablets with a lack of lactase in the digestive system, as well as for children under 6 years old, Ambrobene syrup - with fructose intolerance. Do not use for the treatment of children under 6 years of age and injection solution. Long-acting capsules can only be taken by patients from 12 years of age.

In addition, contraindications are epilepsy and convulsive syndrome.

With caution, the drug is prescribed for immobile cilia in the bronchi, with exacerbation of peptic ulcer of the stomach and duodenum (for oral forms), with impaired renal function or liver disease. In diseases of the liver and kidneys, dose adjustment is required, as well as an increase in the intervals between doses.

Use during pregnancy and lactation

Animal experiments have not shown any negative effects on the fetus, but during pregnancy, doctors still prescribe the drug with caution, evaluating all possible risks. At least in the first trimester of pregnancy, when the main organs of the fetus are laid, it is not prescribed. During pregnancy at a later date, in the 2nd and 3rd trimesters, it can be used. When breastfeeding, the drug is also prescribed with caution.

drug interaction

Do not take ambroxol and antitussive drugs, such as codeine, at the same time, as this will lead to stagnation of sputum in the bronchi.

Ambroxol is able to increase the concentration in bronchial secretions and sputum of some antibiotics, for example, erythromycin, doxycycline, amoxicillin.

Side effects

Some types of side effects may occur relatively often, while others are less common. Also, side effects may depend on the dosage form of the drug.

When taking oral forms (tablets, capsules and syrup), patients may experience:

• headache,
• fever,
• stomach ache,
• nausea,
• or diarrhea
• vomit,
• dry mouth
• dyspepsia.

When using a solution for inhalation, the following reactions are possible:

• dry mouth
• taste disorder,
• stomach ache,
• dyspepsia,
• vomit,

However, the greatest number of side effects is observed when using a parenteral solution:

• allergic reactions (rash, itching, urticaria, Quincke's edema),
• fever,
• feeling weak and tired,
• stomach ache,
• swelling,
• nausea,
• vomiting.

The most common types of side effects, occurring in 1-10% of cases, are nausea and changes in taste perception.

The drug does not affect the speed of psychomotor reactions.

If the condition of the skin or mucous membranes of the patient changes, it is necessary to stop using the medicine and consult a doctor.

Indications

The medication can be taken with equal success by both children and adults. Indications for the use of the drug are inflammatory diseases of the lower respiratory tract, in which there is a significant accumulation of viscous sputum and difficulty in expectorating it. Such diseases include:

• bronchiectasis,
• bronchial asthma,
• chronic obstructive pulmonary disease.

The drug can also be taken by newborns. In this case, it is used to treat respiratory distress syndrome.

Release form

The drug manufacturer offers patients a large selection of forms that can be suitable for any occasion and at any age:

• tablets,
• long-acting capsules
• syrup for children
• composition for oral and inhalation,
• solution for parenteral administration.

The mass of the active substance (ambroxol hydrochloride) in various dosage forms:

The syrup is available in a 100 ml bottle. The solution for oral or inhalation is supplied in 40 and 100 ml vials. Therefore, one 100 ml bottle of syrup contains 300 mg of ambroxol. In one bottle of a solution of 100 ml for oral or inhalation - 750 mg of ambroxol, in a bottle of 40 ml - 300 mg. The solution intended for intravenous administration is available in 2 ml vials. Therefore, one such vial contains 15 mg of ambroxol.

In addition to the active substance, each Ambrobene tablet contains:

• lactose monohydrate,
• corn starch,
• magnesium stearate,
• silica,

In capsules, in addition to ambroxol, there are the following components:

• hypromellose,
• copolymer of methacrylic acid and ethyl acrylate,
• silicon dioxide,
• gelatin,
• triethylcitrate,
• titanium dioxide.

All forms of the drug, with the exception of a solution for intravenous administration, are dispensed in pharmacies without a prescription.

Solution for oral or inhalation

This liquid can be taken orally and prepared from it for inhalation. Unlike syrup, it does not have a sweet taste or smell. In addition to ambroxol, the solution contains:

• potassium sorbate - 1 mg;
• hydrochloric acid - 0.6 mg;
• purified water.

The bottle with the solution is equipped with a special measuring cup.

Syrup Ambrobene

In addition to the active substance, the following components can be found in the composition of the syrup:

• sorbitol,
• propylene glycol,
• purified water,
• saccharin,
• raspberry flavor.

The medicine in the form of a syrup is supplied with a measuring cup with a volume of 5 ml. After opening the bottle, the syrup can be used within one year.

Solution for intravenous administration

The solution is used in cases where a quick effect is needed, or the patient cannot take the drug inside.

In addition to the active substance and purified water, 2 ml (1 ampoule) of the solution contains:

• citric acid monohydrate - 1.8 mg;
• sodium chloride - 13.6 mg;
• hydrophosphate sodium heptahydrate - 4.7 mg;

Instructions for use

The most commonly used form of the drug are tablets, so it is most important to know their dosage. It depends on the age of the patient.

At the age of 6-12 years, the child is given half a tablet (15 mg) 2-3 times a day. Over the age of 12 years (children and adults), it is necessary to take a tablet (30 mg) 2-3 times a day in the first 2-3 days of treatment. If the desired effect is absent, then the dose can be increased to 2 tablets 2 times a day.

If we are talking about long-acting capsules, then the dosage regimen is very simple. One capsule should be taken per day. This dosage is valid for both children over 12 years of age and adults. It is advisable to take the capsule at the same time of day.

Instructions for use syrup Ambrobene

The dosage of Ambrobene syrup in the treatment of children depends on age:

It is worth recalling that the volume of the measuring cup attached to the drug is 5 ml.

Patients over twelve years of age in the first two days are recommended to drink 10 ml of syrup of the drug 3 times a day. If this dose is ineffective, it can be increased to 20 ml 2 times a day.

Instructions for use of a solution intended for internal use

The daily dose of this form of medication is also calculated depending on age.

Inhalation of the drug

Inhalation of the drug is also very popular. They can be done with an internal solution.

The advantages of inhalation are obvious - they allow you to deliver the medicine immediately to the area of ​​​​inflammation - to the bronchi, bypassing the gastrointestinal tract, which allows you to avoid side effects associated with it. And Ambrobene, thus, begins to show its therapeutic effect faster.

For inhalation, any modern type of inhaler is suitable, for example, a nebulizer, which allows you to turn the liquid into the smallest suspension that can penetrate into hard-to-reach areas of the bronchi. However, a steam inhaler is not suitable in this case.

It is first necessary to prepare a mixture for inhalation based on Ambrobene solution for internal use. The mixture is prepared using an isotonic sodium chloride solution, which must be mixed with Ambrobene's internal solution in a ratio of 1 to 1. It is important to note that the mixture for inhalation should be heated to body temperature.

Inhale the suspension naturally, without taking deep breaths, as too deep breaths can provoke a cough. Patients suffering from bronchial asthma, the procedure should be done after the use of bronchodilators.

1-2 treatments per day are recommended. At the same time, for children under the age of 24 months, 1 ml of a solution intended for inhalation should be taken for one inhalation. For children 3-6 years old, 2 ml should be used, for patients over 6 years old, 3 ml can be used.

Instructions for use of the solution intended for intravenous administration

A solution intended for intravenous administration is recommended if the patient for any reason cannot take the drug in the form of tablets or liquid composition for oral administration. The solution can be administered by jet or drip. In this case, the time of introduction of the solution should be at least 5 minutes. A solution intended for intravenous administration must first be diluted in a special injection solution. As the latter, isotonic sodium chloride solution (0.9%) Ringer-Locke solution or dextrose solution (5%) can be used. The injection solution should not have a pH value of more than 6.3, otherwise ambroxol may precipitate.

Dosage of Ambrobene solution for intravenous administration

Adults in severe cases may be prescribed 4 ml 2-3 times a day. It is worth recalling that 1 ampoule contains 2 ml of a solution intended for intravenous administration.

With respiratory distress syndrome in infants, the daily dose of Ambrobene is calculated based on the patient's weight (30 mg / kg). This dose should be divided into 4 treatments.

As soon as possible, you should switch to the use of oral forms of the drug.

General instructions

The usual duration of treatment is 5 days. If after this time there is no improvement, you should consult a doctor.

Children under 2 years of age should be treated with the drug only under medical supervision.

The mucolytic effect of the drug is manifested only if a large amount of liquid is consumed. All forms for oral administration (tablets, capsules and Ambrobene in the form of syrup) should be taken only after meals. Means in the form of tablets or capsules must be swallowed with a sufficient amount of water or other liquid and without chewing. A solution intended for internal use is recommended to be added to some liquid (tea, water, juice) using a measuring cup.

Overdose

In case of an overdose, such phenomena as diarrhea and nervous excitement, nausea, increased salivation, vomiting, and a drop in blood pressure are possible. In the first two hours after the drug enters the body, gastric lavage is indicated. In the future, symptomatic therapy should be carried out. Due to the high degree of binding of ambroxol to plasma proteins, hemodialysis is ineffective.

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Using an inhalation solution Ambrobene, you can significantly reduce the dose of oral medications, get the fastest possible effect from symptomatic therapy. medicinal product Ambrobene belongs to the group of safe agents for combating viral and bacterial infections that provoke inflammation of the bronchial mucosa. The instructions for use say that Ambrobene can be used orally, but to achieve the maximum therapeutic effect, it is better to use it for inhalation through a nebulizer. Before using Ambrobene solution for the treatment of cough, it is important to read the instructions, as well as the procedure for diluting the drug for inhalation administration.

Ambrobene- a drug from the group of expectorants, which can be used for coughs of various etiologies. The active ingredient of the drug is ambroxol hydrochloride, the mechanism of action of which is aimed at thinning sputum, improving its excretion from the lungs and bronchi.

Ambroxol, as part of Ambrobene for inhalation, has the ability to reduce the viscosity of sputum, which is considered important in the treatment of unproductive (dry) cough, which is often painful and painful for a child. Inhalation with Ambrobene allows you to quickly penetrate the bronchial mucosa, alleviate the symptoms of diseases without affecting other organs. Most often, inhalation procedures are prescribed for colds, which are accompanied by a cough with sputum difficult to separate. As practice and reviews show, drugs based on ambroxol, including Ambrobene, are considered the most effective in the treatment of coughs of various origins. Such drugs have a high mucolytic property, which allows you to notice the result after the first inhalation procedures.

The introduction of Ambrobene inhalation can significantly reduce the number and frequency of taking other drugs, including antibiotics. When using the drug, a dry cough is converted into a wet one; sputum, which is the source of the inflammatory process, is brought out. The expectorant effect of inhalation with Ambrobene occurs after the first procedures and lasts for 6-8 hours.

Ambrobene is produced in the form of a clear, odorless solution, which allows it to be used for a nebulizer. The solution is also intended for oral administration, but the effect of the treatment will not be as fast as that of inhalation. The solution contains ambroxol hydrochloride (7.5 mg), as well as auxiliary components. You can buy the drug in the form of a syrup, but it is intended for oral administration, but not for inhalation. Using syrup for inhalation, you can break the nebulizer, since only pure solutions can be poured into this device.

Indications for use

Instructions for use Ambrobene for inhalation reports that this remedy can be used in almost all diseases of the respiratory system, in which viscous sputum accumulates in the respiratory system. In practice, inhalation procedures with Ambrobene through a nebulizer are prescribed for the following diseases and conditions:

1. Bronchitis in acute or chronic form.
2. bronchiectasis.
3. Pneumonia of various etiologies.
4. Obstructive bronchitis.
5. Tracheitis.
6. Cystic fibrosis.

In bronchial asthma, obstructive bronchitis, ambroxol preparations are included in complex therapy. Before their use, in the acute period of the disease, it is recommended to take bronchodilators that will help improve the outflow of mucus from the respiratory system.

Ambrobene solution must not be combined with antitussives or medicines that also contain ambroxol.

The drug Ambrobene in the form of a solution is intended for oral administration or inhalation with
help of a nebulizer. During the inhalation procedure, the active component of the drug accumulates in the bronchi and bronchioles, which allows the drug to act for a long time. The dosage regimen depends on the age of the patient:

1. For children under 2 years of age, it is recommended to use 1 ml of the drug + 1 ml of saline for inhalation. The frequency of inhalation procedures is 1-2 times a day, lasting 5 minutes.
2. From 2 to 6 years, the daily dose should not exceed 22.5 mg, which is equal to 1 ml of solution 3 times a day.
3. For children from 6 to 12 years old, the dose can be increased to 2 ml of the drug + 2 ml of saline per inhalation. It is recommended to carry out 2 procedures for 5 minutes per day.
4. Adults and children over 12 years of age are prescribed 4 ml of the drug per day, which must be divided into 2 doses.

Treatment with inhalations of Ambrobene with saline for children and adults ranges from 3 to 7 days. It all depends on the diagnosis, the stage of the disease, the age of the patient. The instructions for the drug provide standard dosages, but in general, the dose should be determined by the attending physician.

How to carry out inhalation?

Inhalations through a nebulizer allow the drug to quickly penetrate the mucous membranes of the bronchi, alleviate the course and symptoms of the disease. For nebulizer therapy, it is important to know how to inhale with Ambrobene and how to dilute the medicine with saline in order to get the maximum therapeutic effect from the treatment.

1. Before pouring into the nebulizer tank, the Ambrobene solution must be measured using a measuring cup, which is in the package along with the bottle.
2. For inhalation, it is always necessary to dilute the drug with 9% sodium chloride in a ratio of 1:1.
3. Before the procedure, the solution must be heated to 35-37°C.
4. You need to breathe steam no more than 5 - 10 minutes.
5. When inhaling, breathing should be rhythmic, not deep.

You can do inhalation with Ambrobene at home. To do this, it is enough to buy a nebulizer and the drug itself. However, the medicine should be used only after consulting a doctor.

Ambrobene is a pharmacological drug of the mucolytic group. Ambrobene has a secretory, expectorant and secretolytic effect.

The drug is the main drug in the treatment of respiratory pathologies of infectious and inflammatory origin, such as pneumonia, bronchitis, rhinitis, etc. It is successfully used both for productive (with sputum) and dry cough.

In this article, we will consider why doctors prescribe Ambrobene, including instructions for use, analogues and prices for this drug in pharmacies. Real REVIEWS of people who have already used Ambrobene can be read in the comments.

Composition and form of release

Ambrobene comes in several types of forms: in capsules, tablets, injection solution, solution for inhalation or oral administration, and as a syrup.

• Syrup. The volume of the bottle is 100 milliliters. 1 milliliter - 3 milligrams of ambroxol hydrochloride. In addition to ambrocol, the syrup contains propylene glycol, saccharin, liquid sorbitol and water. Flavoring - raspberry.
• inhalation solution. 1 milliliter - 7.5 milligrams of ambroxol. Also contains hydrochloric acid, potassium sorbate and water. There are bottles of 40 and 100 milliliters in volume.
• Tablets. 1 tablet - 30 milligrams of ambroxol, lactose, corn starch, magnesium stearate, silicon dioxide. 20 pieces per pack.

Clinico-pharmacological group: mucolytic and expectorant drug.

What helps Ambrobene?

According to the instructions for Ambrobene, this drug is prescribed for the following diseases:

1. Pneumonia;
2. Chronic and acute bronchitis;
3. bronchiectasis;
4. Chronic obstructive pulmonary disease (including bronchial asthma with difficult sputum discharge).

According to the instructions for Ambrobene, the drug can also be prescribed as part of complex therapy for newborns and premature babies with respiratory distress syndrome. The purpose of the application in this case is to stimulate the synthesis of surfactant.

pharmachologic effect

The active substance of the drug Ambrobene is ambroxol hydrochloride - a chemical compound that has a pronounced effect on the glandular cells of the bronchi and alveoli of the lungs.

Reduces the viscosity of sputum (mucolytic action) by stimulating its secretion with increased secretion of surfactant - a surfactant contained in the lungs and bronchi with normalization of serous and mucosal, that is, liquid and viscous components of sputum.

It affects the mobility of the cilia of the ciliated epithelium lining the respiratory tract, accelerating the movement of sputum outward (secretory effect).

Ambrobene solution for inhalation: instructions for use

When using Ambrobene in the form of inhalation, any modern equipment is used (except for steam inhalers). Before inhalation, the drug should be mixed with a 0.9% sodium chloride 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 the mode of normal breathing, so as not to provoke coughing shocks.

• Children under the age of 2 years are inhaled 1 ml of the solution 1-2 times / day (7.5-15 mg / day).
• Children aged 2 to 6 years are inhaled 2 ml of the solution 1-2 times / day (15-30 mg / day).
• Adults and children over the age of 6 are inhaled 2-3 ml of the solution 1-2 times / day (15-45 mg / day).

The solution for oral administration and inhalation is taken orally after a meal, adding to water, juice or tea using a measuring cup.

• Children under the age of 2 years are prescribed 1 ml of solution 2 times / day (15 mg / day).
• Children aged 2 to 6 years are prescribed 1 ml of solution 3 times / day (22.5 mg / day).
• Children aged 6 to 12 years are prescribed 2 ml of a solution 2-3 times / day (30-45 mg / day).
• Adults and adolescents in the first 2-3 days are prescribed 4 ml of solution 3 times / day (90 mg / day). In the following days - 4 ml 2 times / day (60 mg / day).

The duration of treatment is set individually depending on the course of the disease. It is not recommended to take Ambrobene without a doctor's prescription for more than 4-5 days. The mucolytic effect of the drug is manifested when taking a large amount of liquid. Therefore, during treatment, it is recommended to drink plenty of water.

Ambrobene syrup - instructions for use

The syrup should be taken after meals using the measuring cup provided.

• Children under the age of 2 years should take 1/2 measuring cup (2.5 ml of syrup) 2 times / day (15 mg ambroxol / day).
• Children aged 2 to 6 years should take 1/2 measuring cup (2.5 ml syrup) 3 times / day (22.5 mg ambroxol / day).
• Children aged 6 to 12 years should take 1 measuring cup (5 ml of syrup) 2-3 times / day (30-45 mg of ambroxol / day).
• Adults and children over 12 years old in the first 2-3 days of treatment should take 2 measuring cups (10 ml of syrup) 3 times / day (90 mg ambroxol / day). If therapy is ineffective for adults, you can increase the dose to 4 measuring cups (20 ml of syrup) 2 times / day (120 mg of ambroxol / day). In the following days, 2 measuring cups (10 ml of syrup) should be taken 2 times / day (60 mg of ambroxol / day).

The duration of treatment is selected individually depending on the course of the disease. It is not recommended to take Ambrobene without a doctor's prescription for more than 4-5 days.

Contraindications

Ambrobene also has some contraindications for use. It is not prescribed if the patient has a history of such diseases: hypersensitivity to one of the substances that make up the drug, epileptic syndrome, gastric and duodenal ulcers, pregnancy (especially the first trimester) and lactation.

It is also necessary to be careful when prescribing Ambrobene in cases where the patient's history includes: a severe form of hepatic diseases, kidney dysfunction, large volumes of excreted secretions, impaired bronchial motility.

Side effects

Undesirable effects from taking this drug are rare. It can be:

• From the digestive system - abdominal pain, diarrhea, nausea, vomiting, constipation;
• Allergic reactions - skin rash, urticaria, shortness of breath, itching, angioedema of the face;
• Others - weakness, headache, fever, rhinorrhea, dryness of the oral mucosa, exanthema, dysuria.

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

Ambrobene's analogs

Structural analogues for the active substance:

• AmbroGEXAL;
• Ambroxol;
• Ambroxol Vramed;
• Ambroxol retard;
• Ambroxol-Verte;
• Ambroxol-Vial;
• Ambroxol-Richter;
• Ambroxol-Teva;
• Ambroxol-Hemofarm;
• Ambrolan;
• Ambrosan;
• Ambrosol;
• Bronchoxol;
• Bronchorus;
• Deflegmin;
• Drops Bronchovern;
• Lazolangin;
• Lazolvan;
• Medox;
• Mucobron;
• Neo-Bronchol;
• Remebrox;
• Suprima-cof;
• Fervex for cough;
• Flavamed;
• Halixol.

Attention: the use of analogues must be agreed with the attending physician.

Prices

The average price of AMBROBEN in pharmacies (Moscow) is 130 rubles.

Terms of sale

Ambrobene in oral dosage forms belongs to the category of over-the-counter drugs.
To purchase a solution for intravenous administration, a doctor's prescription is required.

Licorice root syrup - instructions, reviews, analogues

Tradename: Ambrobene

International non-proprietary name (INN): ambroxol

Dosage form:

Compound

100 ml syrup contains: Active substance: Ambroxol hydrochloride 0.30 g Excipients:

Liquid sorbitol 70%, propylene glycol, raspberry flavor, saccharin, purified water.

Description

Clear, colorless to slightly yellow solution with a raspberry odour.

Pharmacological group: mucolytic expectorant. ATC code: R05CB06

pharmachologic effect

Pharmacodynamics

Ambroxol is a benzylamine, 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. It has a secretomotor and secretolytic and expectorant action.

After oral administration, the effect occurs after 30 minutes and lasts for 6-12 hours (depending on the dose taken).

Preclinical studies have shown that ambroxol stimulates the serous cells of the glands of the bronchial mucosa. By activating the cells of the ciliated epithelium and reducing the viscosity of sputum, it improves mucociliary transport. Ambroxol activates the formation of surfactant, having a direct effect on type 2 alveolar pneumocytes and Clara cells of the small airways.

Cell culture research and research in vivo on animals have shown that ambroxol stimulates the formation and secretion of a substance (surfactant) active on the surface of the alveoli and bronchi of the embryo and adult.

Also, in preclinical studies, the antioxidant effect of ambroxol has been proven. Ambroxol, when used together with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline), increases their concentration in sputum and bronchial secretions.

Pharmacokinetics

When taken orally, Ambroxol is almost completely absorbed from the gastrointestinal tract. The maximum concentration is reached 1-3 hours after ingestion. Due to first pass metabolism, the absolute bioavailability of ambroxol after oral administration is reduced by approximately Uz. The resulting metabolites (such as dibromoanthranilic acid, glucuronides) are eliminated in the kidneys. Plasma protein binding is about 85% (80-90%). The plasma half-life is 7 to 12 hours. The total half-life of ambroxol and its metabolites is approximately 22 hours.

It is excreted mainly by the kidneys in the form of metabolites - 90%, less than 10% is excreted unchanged.

Given the high binding to plasma proteins, the large volume of distribution and the slow redistribution from tissues to the blood, there is no significant elimination of ambroxol during dialysis or forced diuresis.
In patients with severe liver disease, ambroxol clearance is reduced by 20-40%. In patients with severely impaired renal function, the half-life of ambroxol metabolites is increased. Ambroxol penetrates into the cerebrospinal fluid and through the placental barrier, and is also excreted in breast milk.

Indications for use

Acute and chronic diseases of the respiratory tract, accompanied by a violation of the formation and discharge of sputum.

Contraindications

Hypersensitivity to ambroxol or to one of the excipients;
- pregnancy (I trimester);
- sucrase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Carefully

Violation of the motor function of the bronchi and increased sputum production (with immovable cilia syndrome), peptic ulcer of the stomach and 12 duodenal ulcer during an exacerbation, pregnancy (II-III trimester), lactation. Patients with impaired renal function or severe liver disease should take Ambrobene with extreme caution, observing large intervals between doses or taking the drug at a lower dose.

Use during pregnancy and lactation

Pregnancy

There are insufficient data on the use of ambroxol during pregnancy. In particular, this applies to the first 28 weeks of pregnancy. Animal studies have not shown a teratogenic effect. The use of Ambrobene during pregnancy (II-III trimester) is possible only on prescription, after a thorough assessment of the risk / benefit ratio.

breastfeeding period

Animal studies have shown that Ambroxol passes into breast milk. Due to the insufficient study of the use of the drug in women during lactation, the use of Ambrobene is possible only on prescription, after a thorough assessment of the risk/benefit ratio.

Dosage and administration

The syrup should be taken after meals using the measuring cup provided.

Children under 2 years old should be taken according to Uh measuring cup (2.5 ml syrup) 2 times a day (15 mg ambroxol per day). Children from 2 to blet should be taken according to Uh measuring cup (2.5 ml syrup) 3 times a day (22.5 mg ambroxol per day). Children from 6 to 12 years old 1 measuring cup (5 ml of syrup) should be taken 2-3 times a day (30-45 mg of ambroxol per day).

Adults and children over 12 years old in the first 2-3 days of treatment, 2 measuring cups (10 ml of syrup) should be taken 3 times a day (90 mg of ambroxol per day). If therapy is ineffective, adults can increase the dose to 4 measuring cups (20 ml of syrup) 2 times a day (120 mg of ambroxol per day). In the following days, 2 measuring cups (10 ml of syrup) should be taken 2 times a day (60 mg of ambroxol per day).

The duration of treatment is selected individually depending on the course of the disease. It is not recommended to take Ambrobene without a doctor's prescription for more than 4-5 days.

The mucolytic effect of the drug is manifested when taking a large amount of liquid. Therefore, during treatment, it is recommended to drink plenty of water.

Side effect

General violations:

Rare (>0.1% to< 1 %): аллергические реакции (крапивница, кожная сыпь, ангионевротический отек лица, одышка, зуд), лихорадка, слабость, головная боль.
Very rarely (< 0,01 %): анафилактические реакции, в том числе анафилактический шок.
So sides of the gastrointestinal tract:
Rare (>0.1% to<1 %): тошнота, боли в животе, рвота, диарея, запоры.
Others:
Rare (>0.1% to<1 %): сухость слизистой оболочки полости рта и дыхательных путей, экзантемы, ринорея, дизурия.

Overdose

Symptoms

Signs of intoxication with an overdose of ambroxol have not been identified. There are reports of nervous excitement and diarrhea. Ambroxol is well tolerated when taken orally at doses up to 25 mg/kg/day.

In case of severe overdose, increased salivation, nausea, vomiting, and a decrease in blood pressure are possible. Treatment

Intensive therapy methods, such as induction of vomiting, gastric lavage, should be used only in cases of severe overdose, in the first 1-2 hours after taking the drug. Symptomatic treatment is shown.

Interaction with other drugs

With the simultaneous use of ambroxol and antitussives, due to the suppression of the cough reflex, secretion stagnation may occur. Therefore, such combinations should be chosen with caution.

With the joint use of ambroxol and antibiotics amoxicillin, cefuroxime, erythromycin and doxycycline, the concentration of the latter in sputum and bronchial secretions increases. special instructions

It should not be combined with antitussive drugs that make it difficult to remove sputum. In children under the age of 2 years, the use of the drug is possible only as directed by a doctor. Extremely rarely, severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, have been observed with the use of ambroxol. If the skin or mucous membranes change, you should immediately consult a doctor and stop taking the drug. The effect on the ability to drive vehicles and on the control of machines and mechanisms is not known to date.

Calorie content is 2.6 kcal/g sorbitol. Sorbitol may have a mild laxative effect. 1 measuring cup (5 ml of syrup) contains 2.1 g of sorbitol, which corresponds to 0.18 XE. Release form Syrup 15 mg/5 ml.

100 ml of the drug in a dark glass bottle, sealed with a jet stopper and a plastic screw cap.

One bottle with instructions for use and a measuring cup in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of the reach of children!

Best before date 5 years.

After opening the vial, the drug is suitable for use within 1 year. Do not use after the expiration date!

Holiday conditions Without recipe.

Registration certificate holder: "ratiopharm GmbH", Germany.

Manufacturer:

Ludwig-Merkle Strasse 3, D-89143, Blaubeuren, Germany.

Claim address: 119049, Moscow, st. Shabolovka, 10, building 1,

Ambrobene (Ambroxol hydrochloride) is a drug that facilitates expectoration of sputum and has mucolytic activity. It is used in otorhinolaryngological practice for acute and chronic respiratory diseases, accompanied by a violation of sputum production and evacuation. Violation of sputum excretion from the respiratory tract is one of the key factors underlying the pathogenesis of inflammatory diseases of various parts of the respiratory tract. The stagnation of the contents of the bronchi causes a deterioration in the ventilation and respiratory abilities of the lungs and an increased risk of infection. The production of bronchial secretions is an essential condition for the proper functioning of the respiratory system. The composition of the sputum produced by the bronchi is complex and depends on the well-coordinated work and proper condition of a number of physiological links. Inflammation of any part of the respiratory tract (trachea, bronchi) by a compensatory mechanism increases the production of mucus, along with which, in turn, the consistency of sputum changes in the direction of increasing viscosity. Accordingly, the more viscous the sputum is, the lower the rate of its evacuation from the respiratory tract. The insufficiency of the drainage function of the ciliated epithelium of the bronchi and trachea contributes to the retention of sputum in the respiratory tract, as a result of which a cough develops. In this case, taking antitussive drugs will not only not improve the situation, but will also aggravate it. And here, drugs that facilitate sputum discharge come to the fore and, in particular, Ambrobene as one of the most effective and safe representatives of this pharmacological group.

This mucolytic agent in most clinical situations is the best choice in the treatment of infectious and inflammatory diseases of the respiratory tract, incl. in younger patients. Ambrobene is a new generation secretolytic, which is a derivative of bromhexine and has a powerful expectorant effect. Ambrobene does not affect the production of bronchial secretions produced by mucosal cells. It liquefies sputum by destroying acid mucopolysaccharides and DNA, while facilitating secretion. In addition, the drug increases the concentration of pulmonary surfactant, which improves lung compliance, which indirectly improves mucociliary transport and gives a pronounced expectorant effect. However, Ambrobene does not cause bronchial obstruction. The effect of taking the drug is noticeable after half an hour. It is dose-dependent and is maintained at a clinically significant level for another 6-12 hours. Ambroxol is also an antioxidant that protects the cells of the respiratory tract from the aggressive effects of free radicals. The simultaneous use of antitussive drugs with Ambrobene is contraindicated, because. in this case, the cough reflex will be suppressed, which will lead to stagnation of sputum in the airways.

Pharmacology

Mucolytic agent with expectorant action. Stimulates the serous cells of the glands of the bronchial mucosa, increasing the content of the mucous secretion and, thus, changes the disturbed ratio of the serous and mucous components of sputum. At the same time, hydrolyzing enzymes are activated, and the release of lysosomes from Clara cells is enhanced, which leads to a decrease in sputum viscosity. Ambroxol increases the content of surfactant in the lungs, which is associated with an increase in its synthesis and secretion in alveolar pneumocytes, as well as with a violation of its decay. Increases mucociliary transport of sputum. Slightly suppresses cough.

Pharmacokinetics

After oral administration, Ambroxol is almost completely absorbed from the gastrointestinal tract. C max in blood plasma is reached in about 0.5-3 hours. It does not accumulate. Plasma protein binding is about 90%.

After oral and parenteral administration, ambroxol is rapidly distributed in body tissues, the highest concentration is determined in the lungs.

Penetrates through the BBB and the placental barrier, excreted in breast milk.

It is metabolized in the liver by conjugation to form pharmacologically inactive metabolites.

T 1 / 2 is 7-12 hours. It is excreted mainly by the kidneys in the form of metabolites - 90%, unchanged - 5%.

T 1/2 increases in severe chronic renal failure.

Release form

The solution for oral administration and inhalation is clear, from colorless to light yellow with a brown tint, odorless.

Excipients: potassium sorbate - 1 mg, hydrochloric acid - 0.6 mg, purified water - 991.9 mg.

40 ml - dark glass bottles with a stopper-dropper (1) complete with a measuring cup - cardboard boxes.
100 ml - dark glass bottles with a stopper-dropper (1) complete with a measuring cup - cardboard boxes.

Dosage

Inside adults and children over 12 years old - 30 mg 2-3 times / day.

The dosage regimen for children under the age of 12 is presented in the following table.

In the form of inhalations for adults and children over 5 years old - 15-22.5 mg 1-2 times / day.

Parenterally (in / m, in / in) adults - 15 mg, in severe cases - 30 mg 2-3 times / day; children - 1.2-1.6 mg / kg 3 times / day.

For the treatment of respiratory distress syndrome in premature and newborn infants, ambroxol is administered intravenously or intramuscularly at a dose of 10 mg/kg/day, the frequency of administration is 3-4 times/day, if necessary, the dose can be gradually increased to 30 mg/kg / day

Interaction

With simultaneous use with antitussives, sputum separation is difficult against the background of a decrease in cough; with amoxicillin, doxycycline, cefuroxime, erythromycin - increasing their penetration into the bronchial secret.

Ambroxol is compatible with drugs that inhibit labor activity.

Side effects

From the digestive system: rarely - nausea, vomiting, diarrhea, abdominal pain.

Allergic reactions: skin rash, urticaria, angioedema.

Other: rarely - weakness, headache.

Indications

Acute and chronic diseases of the respiratory tract, accompanied by the release of viscous sputum (chronic bronchitis with broncho-obstructive syndrome, bronchial asthma, bronchiectasis). Respiratory distress syndrome in newborns and premature babies.

Contraindications

Peptic ulcer of the stomach and duodenum, convulsive syndrome of various etiologies, I trimester of pregnancy, hypersensitivity to ambroxol.

Application features

Use during pregnancy and lactation

Ambroxol is contraindicated in the first trimester of pregnancy. If necessary, use in the II and III trimesters should evaluate the potential benefit of therapy for the mother and the possible risk to the fetus.

If it is necessary to use ambroxol during lactation, the issue of stopping breastfeeding should be resolved.

Use in children

special instructions