Berotek N is a selective beta 2 -adrenomimetic, bronchodilator.

Release form and composition

Dosage form - metered dose inhalation aerosol: transparent colorless or light yellow or light brown liquid, free from suspended particles [10 ml (200 doses) each in metal aerosol cans equipped with a metering valve and mouthpiece; in a cardboard box 1 can and instructions for use Beroteka N].

Composition of 1 inhalation dose of aerosol:

• active substance: fenoterol hydrobromide - 100 mcg;
• auxiliary components: purified water, tetrafluoroethane (HFA 134a, propellant), absolute ethanol, anhydrous citric acid.

Pharmacological properties

Pharmacodynamics

The active substance of Beroteka N - fenoterol hydrobromide, is a selective beta 2 -adrenomimetic, bronchodilator. The drug prevents and relieves attacks of bronchospasm in bronchial asthma and other diseases accompanied by obstruction respiratory tract(chronic obstructive bronchitis, including with emphysema).

Fenoterol, used in the therapeutic dose range, is a selective stimulant of β 2 -adrenergic receptors. When using the drug in higher doses, β 1 -adrenergic receptors are stimulated.

Due to binding to β 2 -adrenergic receptors, adenylate cyclase is activated through the stimulatory G s -protein, subsequently - the formation of cyclic adenosine monophosphate (cAMP) increases, which activates protein kinase A. Protein kinase A prevents the connection of myosin with actin, as a result of which smooth muscles relax.

Fenoterol relaxes the smooth muscles of the bronchi and blood vessels, and also protects against bronchoconstrictor stimuli such as allergens (early response), cold air, exercise, histamine and methacholine.

In addition, fenoterol inhibits the release of pro-inflammatory and bronchoconstrictor mediators from mast cells. After the use of fenoterol at a dose of 600 μg, an increase in mucociliary clearance was noted.

Having a stimulating effect on β 1 -adrenergic receptors, fenoterol (especially in higher doses than therapeutic ones) can have an effect on the myocardium, causing an increase and increase in heart rate.

The drug quickly relieves bronchospasm of various origins. The bronchodilatory effect develops within a few minutes after inhalation and lasts for 3-5 hours.

Pharmacokinetics

Depending on the used inhalation system and the technique of inhalation of the lower respiratory tract, it reaches about 10-30% of fenoterol hydrobromide, the rest of the drug is deposited in the mouth and upper respiratory tract, after which it is swallowed.

After inhalation of Beroteka N, the absolute bioavailability of fenoterol is 18.7%.

The absorption of the drug from the lungs occurs in two phases: 30% of the dose is absorbed quickly with a half-life (T ½) of 11 minutes, 70% - slowly with T ½ 120 minutes.

The maximum plasma concentration (C max) of fenoterol after inhalation at a dose of 200 μg is 66.9 pg / ml and is reached within 15 minutes.

With oral administration of fenoterol hydrobromide, approximately 60% of the dose is absorbed. The absorbed amount of the substance undergoes an extensive first phase of metabolism in the liver. Thus, oral bioavailability is about 1.5%, and its contribution to the plasma concentration of the drug after inhalation is small.

Plasma proteins bind 40–55%. After intravenous (iv) administration of the drug, the distribution of fenoterol in plasma is adequately described by a 3-component pharmacokinetic model with T ½ 0.42 min, 14.3 min and 3.2 h. After iv administration, the volume of distribution (V d) of fenoterol at equilibrium concentration is 1.9–2.7 l / kg.

Fenoterol can cross the placental barrier and be excreted in breast milk.

The drug is extensively metabolized in the liver by conjugation to glucuronides and sulfates. Part of fenoterol that has entered the gastrointestinal tract is metabolized mainly by sulfation, while the onset of metabolic activation of the parent substance occurs already in the intestinal wall.

Fenoterol is excreted in the form of inactive sulfate conjugates in urine and bile. The main part of the drug dose (approximately 85%) undergoes biotransformation. About 15% of the average total clearance of the systemically available dose is excreted in the urine. Renal clearance volume is indicative of tubular drug secretion in addition to glomerular filtration.

After inhalation, 2% of the dose is excreted unchanged through the kidneys within 24 hours.

Indications for use

• diseases accompanied by reversible airway obstruction, including chronic obstructive pulmonary disease and chronic bronchitis;
• attacks of bronchial asthma;
• prevention of bronchial asthma attacks during physical exertion.

Contraindications

Absolute:

• hypertrophic obstructive cardiomyopathy;
• tachyarrhythmia;
• childhood up to 4 years old;
• hypersensitivity to any component of the drug.

Relative (aerosol Berotek N, especially in high doses, can be used only after assessing the balance of benefits and risks):

• insufficiently controlled diabetes mellitus;
• hypokalemia;
• hyperthyroidism;
• pheochromocytoma;
• severe organic diseases of the heart and blood vessels: severe lesions of the peripheral and cerebral arteries, diseases of the coronary arteries, ischemic disease heart, heart defects (including aortic stenosis), chronic heart failure;
• recent myocardial infarction (in the previous 3 months);
• pregnancy and lactation;
• children age 4-6 years;
• simultaneous use of monoamine oxidase inhibitors (MAO), tricyclic antidepressants.

Berotek N, instructions for use: method and dosage

Aerosol Berotek N is used by inhalation. 1 dose = 1 injection.

• attacks of bronchial asthma and diseases with reversible airway obstruction: 1 dose for the development of an attack. After 5 minutes, inhalation can be repeated if breathing has not been relieved. If there is no effect after 2 inhalations, you should immediately consult a doctor. During the day, you can use no more than 8 inhalation doses;
• prevention of attacks of bronchial asthma of physical exertion: 1-2 doses before physical activity, but no more than 8 doses per day.

Dosing regimen of Beroteka N for children 4-6 years old:

• attacks of bronchial asthma and diseases with reversible airway obstruction: 1 dose for the development of an attack. If there is no effect, you should immediately consult a doctor;
• prevention of attacks of bronchial asthma of physical exertion: 1 dose before physical activity, but no more than 4 doses per day.

Achieving the maximum effect is possible only with correct use inhaler. To prepare a new inhaler for use, remove the protective cap, turn the balloon upside down and press its bottom twice (make two injections into the air). A single injection into the air must be performed if the inhaler has not been used for more than 3 days.

The following rules should be observed with every use of Berotek N:

1. Remove the protective cap.
2. Exhale fully.
3. Holding the can upside down, tightly wrap your lips around the mouthpiece.
4. Inhale as deeply as possible and simultaneously press firmly on the bottom of the balloon to release one inhalation dose. Hold your breath for a few seconds, remove the mouthpiece and exhale slowly.
5. When prescribing several doses, repeat the steps described in points 2-4.
6. Put on the protective cap.

The can is not transparent, so it is impossible to visually determine whether it is empty. Each cylinder is designed for 200 doses, but after use it may contain some more of the drug. It cannot be used, since in this case there is a risk that the patient will not be able to receive the therapeutic dose he needs.

The amount of the drug remaining in the bottle can be roughly determined as follows: remove the protective cap, immerse the bottle in a container with water and look at its position. If the cylinder floats on the surface of the water, leaning to one side, it is empty; floats upside down and bent slightly to the side - contains ¼ ​​part of the aerosol; floats upside down strictly vertically - contains ½; drowned - contains ¾.

The inhaler should be cleaned at least once a week. The mouthpiece must be clean so that the aerosol does not accumulate and block the spray.

Inhaler cleaning rules:

1. Remove the cap and remove the cartridge from the inhaler.
2. Rinse the body of the inhaler warm water.
3. Shake the inhaler to remove any remaining water and let it air dry. Do not use heating devices!
4. Insert the bottle and put on the protective cap.

The plastic mouthpiece serves as a dispenser for the drug and is specially designed for the Berotek N. aerosol. It cannot be used with other aerosols, it is also forbidden to use other adapters for dosing Berotek N.

The aerosol in the can is under pressure. The cylinder must not be heated above 50 ° C and must not be opened.

Side effects

• from the respiratory system: often (from ≥ 1/100 to< 1/10) – кашель; нечасто (от ≥ 1/1000 до < 1/100) – парадоксальный бронхоспазм; частота неизвестна (имеющихся данных недостаточно для определения частоты развития эффектов) – раздражение гортани и глотки;
• from the side of cardio-vascular system: infrequently - arrhythmia; the frequency is unknown - a decrease in diastolic blood pressure (BP), an increase in systolic blood pressure, palpitations, tachycardia, myocardial ischemia;
• from the digestive system: infrequently - nausea, vomiting;
• from the musculoskeletal system: frequency unknown - muscle weakness, muscle spasm, myalgia;
• on the part of the psyche and nervous system: often - tremor; infrequently - excitement; frequency unknown - dizziness, headache, nervousness;
• from the side of metabolism: infrequently - hypokalemia (including severe);
• from the immune system: frequency unknown - urticaria, hypersensitivity;
• on the part of the skin and subcutaneous tissues: infrequently - itching; frequency unknown - skin reactions (including rash), hyperhidrosis.

Overdose

The main symptoms of an overdose are due to excessive beta-adrenergic stimulation: a decrease or increase in blood pressure, an increase in pulse pressure, palpitations, arrhythmias, tachycardia, angina pectoris, tremors, facial flushing. Hypokalemia and metabolic acidosis are also possible.

In case of an overdose, Berotek N is canceled. The patient is prescribed sedatives, in severe cases, intensive symptomatic therapy is carried out. It is necessary to control the balance of electrolytes and acid-base balance.

As specific antidotes, it is possible to use beta-blockers (preferably selective beta 1-blockers). However, caution is required in the selection of the dose of these drugs, since bronchial obstruction may increase.

special instructions

The use of Berotek N for relief of attacks of bronchial asthma (for symptomatic therapy) is more preferable than regular use of the drug.

Patients should be evaluated to determine the need for or intensifying anti-inflammatory treatments (eg, inhaled glucocorticosteroids) to control airway inflammation and prevent delayed lung injury.

With an increase in bronchial obstruction, it is prohibited to increase the frequency of inhalation of Berotek N and its use in doses exceeding those prescribed by the doctor. This can be dangerous because the need for regular use of β 2 -adrenoreceptor agonists may be a sign of worsening disease control. In this case, a revision of the treatment plan is required, especially the adequacy of the anti-inflammatory therapy being carried out, in order to avoid the development of a potentially life-threatening deterioration in the control of the disease.

Like any inhalation agent, Berotek N can cause a potentially life-threatening paradoxical bronchospasm. In this case, you need to immediately cancel the drug and prescribe an alternative therapy.

Patients should immediately consult a doctor if they experience acute, rapidly developing shortness of breath.

Sympathomimetics, including Berotek N, can cause cardiovascular effects. There are rare reports of the development of myocardial ischemia. Patients with concomitant severe heart disease (eg, arrhythmias, severe heart failure, or coronary artery disease) should be warned to seek urgent medical help in case of chest pain or worsening of the course of cardiovascular disease.

Particular attention should be paid to symptoms such as chest pain and shortness of breath, as they can be both cardiac and respiratory in nature.

During therapy with beta 2 -agonists, the development of potentially serious hypokalemia is possible. Care must be taken in patients with severe bronchial asthma, since their hypokalemia can be exacerbated by the action of concomitantly used glucocorticosteroids, diuretics, xanthine derivatives. In addition, hypoxia associated with hypokalemia may increase its effect on heartbeat... In patients receiving digoxin, hypokalemia may lead to an increased susceptibility to arrhythmias. In such cases, monitoring of serum potassium levels is required.

During the period of use of Berotek N in abuse studies medicines for non-medical reasons, it is possible to obtain positive test results for the presence of fenoterol, which is important, for example, for athletes (doping control).

It is necessary to consider not a large number of ethanol in the aerosol Berotek N: in 1 dose - 15,597 mg.

The simultaneous use of other sympathomimetic bronchodilators is allowed only as directed by a doctor and under his strict supervision.

Berotec N can be used in combination with anticholinergic bronchodilators.

Influence on the ability to drive vehicles and complex mechanisms

Special studies on the effect of Berotek N on the psychophysical functions of a person have not been carried out. However, in clinical studies, rare cases of dizziness have been reported. In this regard, it is recommended to observe safety precautions while driving and performing potentially dangerous types of work.

Application during pregnancy and lactation

In preclinical and clinical studies, there was no negative effect of fenoterol on the course of pregnancy and fetal development. However, during pregnancy (especially in the first trimester), Berotek N should be used only as directed by a doctor who will assess the degree of correlation between the expected benefits and possible risks. It is important to take into account that the drug can have an inhibitory effect on the contractile activity of the uterus.

In preclinical studies, it was found that fenoterol is excreted in mother's milk, but its effect on the development of an infant has not been studied. In this regard, during lactation, Berotek N is used only if the benefits are higher than the possible risks.

Clinical studies on the effects of fenoterol on fertility have not been conducted. In preclinical studies, no adverse effects of the drug on fertility have been identified.

Childhood use

Berotek N is contraindicated in children under 4 years of age. The clinical experience of using the drug in children 4–12 years of age is limited, therefore, at this age, treatment is carried out with caution, under close medical supervision and adult supervision.

Drug interactions

Side effects of fenoterol can be enhanced by glucocorticosteroids, anticholinergics, beta-adrenomimetics, diuretics, xanthine derivatives (for example, theophylline), cromoglycic acid.

Beta-blockers can significantly weaken the bronchodilator effect of fenoterol.

Tricyclic antidepressants and MAO inhibitors can enhance the effects of β-adrenergic receptor agonists, therefore, they should be used with caution during bronchodilator therapy.

Inhalation anesthetics (eg, enflurane, trichlorethylene, halothane) increase the risk of cardiovascular exposure to fenoterol.

Hypokalemia developed under the influence of Berotek N can be exacerbated by corticosteroids, diuretics, xanthine derivatives. This phenomenon is of particular clinical importance in patients with severe airway obstruction.

Analogs

The analogues of Beroteka N are: Atimos, Astalin, Berotek, Ventolin, Vertasort, Clenbuterol, Kombipek, Onbrez Breezhaler, Oxis Turbuhaler, Salbutamol, Salgim, Foradil, Formoterol-native, Cybutol Cyclocaps and others.

Terms and conditions of storage

Keep out of the reach of children, where the temperature does not exceed 25 ° C.

Shelf life is 3 years.

The ability to breathe freely makes a person calm and confident. But as soon as some breathing problem manifests itself, there will be no trace of a calm state.

But a huge number of people live with chronic diseases respiratory organs, suffering from allergic reactions. They are trying to get along with these diseases, looking for ways to alleviate their suffering, if they cannot get rid of them.

Modern pharmacy offers a wide range of drugs that can quickly stop attacks of suffocation. One of them is the drug berotek n - instructions for the use of which are attached below. There are analogues of the drug that are interchangeable (Berodual, Salbutamol, etc.)

Berotek: aerosol instructions for use (official)

Active substance

Berotek contains fenoterol hydrobromide. This is the active ingredient. 1 mg of fenoterol hydrobromide is contained in 1 ml or 20 drops medicinal solution for inhalation.

Berotek is available in the form of a solution for inhalation, spray. It is a clear liquid that is practically colorless and odorless and is sold in a pharmacy with a prescription.

The drug is not hormonal.

Indications for use

The drug Berotec aerosol (solution for inhalation) is prescribed as an antispasmodic agent to:

1. stop the state of suffocation during an asthma attack;
2. prevent the occurrence of suffocation after exercise;
3. before using other means of expectorant, anti-inflammatory action, before using glucocorticosteroids (substitutes for endogenous hormones) as a bronchodilator;
4. to stimulate breathing.

Indications for treatment:

1. , or another disease that is accompanied by a narrowing of the airways:
2. chronic obstructive bronchitis;
3. chronic obstructive pulmonary disease.

Berotek helps to relax the muscles of blood vessels and bronchi, which protects a person from external influence environment: cold air temperature, histamine, methacholine, which are capable of provoking an immediate reaction to an irritant.

The drug is capable of accumulating in blood plasma. With oral administration of the drug, you can provoke a contraction of the uterus; a high concentration of the active substance can increase the level of glucose in the blood (this is due to the breakdown of glycogen), reduce the amount of potassium ions; cause the breakdown of fats (lipolysis).

The solution is able to affect the work of the heart muscle, increase the heart rate. The main action and therapeutic mechanism is the prevention of the appearance of a spasm of the respiratory tract, regardless of the cause of its occurrence, as well as its urgent elimination if it occurs.

The drug takes effect within 5 minutes after injection. The maximum time for the start of its action is from 30 minutes to 1.5 hours. The solution is able to have a quick relaxing effect on the spasmodic muscles of the respiratory tract. The duration of this effect reaches from 3 to 6 hours.

The effect of the medication also depends on the correctness of the inhalation. Correct conduct of the procedure allows, namely, to inhale up to 30% of the active substance in the injected portion. The rest of the medicine is swallowed and passed into the stomach. The more the drug gets inside through inhalation, the faster the action will take place.

Fenoterol hydrobromide, if ingested by a woman during pregnancy or lactation, can pass into the placenta and into breast milk.

Contraindications for taking Berotek

Attention should be paid to contraindications to the use of the medicine:

1. Hypersensitivity to the active ingredient (fenoterol hydrobromide) and other components that make up medicinal product, may cause an allergic reaction and worsening of the condition. Cardiac disorders such as hypertrophic obstructive cardiomyopathy, tachyarrhythmias.
2. Increased hormonal activity of the thyroid gland (hyperthyroidism), low and high blood pressure, intestinal atony, lowered plasma potassium levels, diabetes, diseases and blood vessels, myocardium (recently transferred), the presence of a tumor (hormonally active pheochromocytoma) in the adrenal gland, forming a large amount of catecholamines ...
3. Since the accumulation of the active substance can cause the uterus to contract, it is not advisable to use the drug during pregnancy. It is not recommended to use Berotec in the first 3 months of pregnancy. Better to look for its analogues.
4. Since the drug penetrates into breast milk, and its effect on the health of young children has not yet been sufficiently studied, it is not recommended to use berotec n aerosol during breastfeeding.

You should use the Berotec inhaler only on the recommendation of a doctor who will professionally analyze all contraindications and side effects, and will write a prescription upon appointment.

Dosage for inhaler Berotek

The solution is used by inhalation.

1 ml of solution for inhalation includes 20 drops.

1 drop of solution contains 50 μg of fenoterol hydrobromide.

Each dosage for inhalation is prescribed by a doctor, taking into account individual characteristics: age, health status, the presence of concomitant diseases. The prescription is written out for Latin... The name of the drug, dosage, number of doses per day are indicated here.

Do not use an inhaler to treat a cough.

Relief of respiratory spasm in asthma

To relieve bronchospasm during an asthma attack, 10 drops of solution (0.5 ml) are enough.

In emergency situations, the dose is increased to 1 - 1.25 ml of solution. In drops it is 20-25.

In extreme cases, the inhaler is used under medical supervision with a dose of up to 2 ml of solution, this is 40 drops.

Prevention of asthmatic attacks as a result of exercise

For the prevention of asthmatic attacks, it is recommended to carry out up to 4 inhalations a day, injecting 0.5 mg of solution (or 10 drops).

For reversible airway narrowing

Age 6-12 years old, weight 22-36 kg.

To prevent the development of bronchospasm in asthma, 5-10 drops of solution (0.25-0.5 mg) are used.

V emergency situation it is possible to use 20 drops of solution for inhalation (1 mg).

In extreme cases, the aerosol is used under medical supervision with a dose of up to 1.5 ml of solution, this is 30 drops.

Prevention of asthmatic attacks as a result of exercise.

For the prevention of asthmatic attacks, it is recommended to carry out up to 4 procedures per day, injecting 0.5 mg of solution (or 10 drops).

With reversible narrowing of the airways.

It is recommended that you contact your pediatrician for prescribing a medicine and determining a specific dose of a solution. Its effect on the body of young children is not yet well understood, so the drug should be used strictly under medical supervision.

A possible dose of the solution is from 5 to 20 drops three times a day. It is correct to start treatment procedures with the smallest doses. For this, the used dose of the solution is dissolved in physiological saline solution so that the total volume is 3-4 ml. Inject the resulting solution until this portion ends.

Do not dissolve Berotek 0.1% in distilled water. Do not prepare a solution for multiple applications at once. A freshly prepared portion of the solution should be injected each time. If there is a need to repeat the procedure, then the next portion can be injected only after 4 hours.

Overdose of the drug

Can there be an aerosol overdose? If there is an indication of an overdose, it is necessary to suspend treatment and consult a doctor.

With excessive accumulation of the active substance in the body, an overdose of the drug is possible. It can manifest itself as an increase or decrease in blood pressure, cardiac abnormalities (increased heart rate, arrhythmia, palpitations, chest pains, redness of the facial skin, tremors of certain parts of the body).

Side effects

Berotek can have side effects, the following indications take place:

• dizziness;
• headache;
• cardiac disorders (arrhythmia, tachycardia, palpitations, increased heart rate);
• increase or decrease in blood pressure;
• nervousness, irritability;
• trembling muscles;
• less often chest pain.

It is possible that a cough may appear after injecting the drug, since it can irritate the mucous membrane.

There are cases of nausea and vomiting. Weakness, excessive sweating, muscle aches and cramps, high blood glucose levels, urinary problems, and habituation may occur.

People who are sensitive to the drug may exhibit an allergic nature.

Be sure to discuss the possible side effects with your doctor so as not to harm your health. If side effects appear, stop taking the drug and go for a consultation. The doctor will tell you which analogs of Berotek can be used and write a prescription.

How does the solution interact with other drugs

The use of additional medications should also be discussed with the doctor, since Berotek is capable of both increasing the effect of certain drugs and reducing it.

Analogues of the drug Berotek

Among the drugs that can stop airway spasms, here are Berotek's analogs for the main substance:

• Partusisten;
• Fenoterol;
• Fenoterol hydrobromide.

There are a large number of drugs with the same effect, which have a different basis. The most popular of them: Berodual, Berodual N, Salbutamol, Astmopent and many other drugs.

Many patients or their parents often ask questions: what is the difference between Berotek and Berodual sprays, which is better to choose: Berotek, Salbutamol or their analogue Berodual? The answers to these questions can be provided by the attending physician, or, if necessary, the action and use of each remedy provides instructions for the use of a particular drug.

Video: Allergies and Asthma (interview with Oleg Matveev)

According to the instructions, Berotek for inhalation relieves the condition of patients after the first procedures. It has been proven that the treatment has a protective effect on the respiratory tract from allergic agents, methacholine, temperature changes, and a histamine agent.

Berotek belongs to the modern drugs of the bronchodilator group. Such means are successfully used in pulmonology. They are indicated for many ailments of the respiratory tract, including asthma, bronchitis and bronchiectasis. Mainly Berotek is used as the basis for inhalation procedures.

This synthetic substance was created in laboratory conditions, therefore, it can only be used according to a special scheme, after a medical consultation. At the heart of Berotek is a highly active substance that deliberately relieves spasms in the bronchial tree. In this way, an almost instant bronchodilator effect is achieved. The drug effectively blocks mast cells, preventing the release of a huge amount of inflammatory mediators.

Inhalation use of Beroteka requires a preliminary study of the instructions for use. The medication is based on fenoterol. Therefore, the drug exhibits pronounced pharmaceutical properties and belongs to selective stimulants of beta-2-blockers. It has a tropism for the elements of the human respiratory tract. Due to this, it is possible to quickly relax the elements of the smooth muscles of the bronchi and blood vessels, to resist bronchospastic reactions.

Forms of issue

There are two forms in which Berotec is produced:

1. Berotek is a liquid without color, which is available in containers of 20, 40 and 100 ml.
2. You can often find Berotek N - metered aerosol. These are metal bottles, each of which contains 10 ml of the drug.

Compound

Fenoterol is the active ingredient in Berotek. Excipients depend on the form:

• solution for inhalation: sodium chloride, hydrochloric acid, benzalkonium chloride, disodium edetate dihydrate, water;
• aerosol: propellant - tetrafluoroethane, ethanol, citric acid anhydride, water.

Indications for use

The instructions for use clearly indicate that Berotek is used for inhalation for medical purposes to relieve asthmatic attacks, which mainly proceed as bronchial lesions. In some cases, the medicine can be used as an additional component. complex therapy ailments of an obstructive nature.

An important point in the successful use of the drug is the complete reversibility of the obstruction.

The list of indications for the use of Berotek also includes:

1. Planned bronchodilation before inhalation procedures using mucolytics, hormones, or antibiotics.
2. Berotek is often used before testing the function of external respiration. It has been proven that the drug has a quick and necessary expanding effect on the bronchi.
3. An effective prophylactic tool against new asthma attacks of the bronchial type, which usually occur during intense physical exertion.

Method of administration and dosage

The dose of the medication is always selected individually by the attending physician. The number of drops for inhalation, the frequency of carrying out depends on many factors:

• the patient's weight;
• age;
• the severity of the condition;
• the presence of concomitant pathology.

Be sure to take into account the presence of intolerance or allergic reactions to any substances. When choosing a dosage, the concentration of the drug is taken into account. Each drop of Berotek contains 50 mcg of fenoterol, 1 ml - 20 drops.

The medication has been used successfully in a variety of ways. This does not reduce the effectiveness of the medication. Berotek can be one of the components of the nebulizer mixture. Often, the solution is simply used to irrigate the oral cavity. In the latter case, an aerosol form of release is used.

In the case of inhalation, it is preferable to choose the liquid form of the medication. The required amount of the substance must be diluted in saline before the procedure. If necessary, the doctor, at his discretion, may additionally prescribe some mucolytic drugs for bronchitis.

Instructions for use

Each aerosol can contains no more than 200 doses of the medication. After using them, you cannot use a spray can, even if Berotek remains in it. The fact is that after the 200th dose, the drug is released poorly, so the patient will not receive full treatment during inhalation. After the end of operation, the cartridge should be thrown away and a new one should be bought.

A huge role in the effectiveness of inhalation is played by the patient's awareness and ability to correctly perform this procedure. Carrying out inhalations with the drug has its own characteristics. After the appointment of Berotek, the doctor should familiarize the patient with the correct technique for using the aerosol. The main subtleties of the procedure include:

1. Free the can from the protective membrane first.
2. Lips tightly cover the tip of the balloon so that there are no gaps. Thus, the entire dose can enter the oral cavity without any problems.
3. Simultaneously with pressing the bottom of the can, you need to take deep breaths, holding your breath. At the end of the procedure, the end of the balloon is pulled out of the mouth and exhaled slowly. Each repeated inhalation should be carried out in the same way.

It is important to remember that if the balloon has not been used for more than 3 days, before the therapy, you need to make preliminary pressing on the bottom of the balloon in the air.

The mouthpiece must be kept clean. It is important to flush the device at least once a month. Otherwise, Berotek will accumulate, preventing the next dose from advancing. You only need to rinse the inhaler with plain, warm water.
The type of therapy largely depends on the purpose of the appointment. To stop an attack of asthmatic origin, one injection is enough. Repeated inhalation is indicated if relief does not occur within 5 minutes.

The medication cannot be used uncontrollably. There are certain rules and regulations for the use of aerosols:

1. For emergency care inhalation starts from a single injection (this is equivalent to 10 drops of medicine).
2. For the purpose of prophylaxis, up to 8 doses of the medication can be used per day, but each dose includes no more than 2 injections.
3. With pronounced spasm in the bronchial structures, a double dose of the drug is injected once at once.

Inhalation with Berotek has its own characteristics:

1. In case of an asthmatic attack of bronchial genesis, the use of 0.5 ml of the drug is shown - this is 10 drops of Berotek.
2. In severe cases, the dosage is always increased. As a rule, a single use of the drug is enough to stop the attack.
3. About 10 drops of Berotek are enough for adequate and effective prevention of new asthma attacks.
4. The duration of drug use for an adult or a child after 12 years old is selected individually. Such a decision is always made only by the attending physician. The patient's condition and response to therapy are taken into account.

Contraindications

Berotek for inhalation is a highly effective pulmonary drug. But this does not make it completely harmless. There is a certain list of conditions and situations in which it is categorically impossible to use the medicine.

First of all, we are talking about individual intolerance to fenoterol - the main component of the drug. You can not use the medicine for episodes of tachyarrhythmias, the presence of severe cardiomyopathy.

Use the medicine with caution if you have:

• heart defects;
• hyperthyroidism;
• hypo or hypertension;
• pheochromocytomas.

In pediatrics, it is forbidden to use the medicine until the child is 6 years old. But this is a relative contraindication. In extreme, severe cases, the medicine is prescribed to babies of any age under the direct supervision of specialists.

Side effects

Infrequently, but in some cases, Berotek is capable of provoking disturbances in the work of many organs and body systems. Often, adverse reactions include:

• intense arousal;
• soreness in the head;
• tremor;
• hypokalemia;
• pressure surges;
• dyspeptic disorders;
• paradoxical bronchospasm;
• spasm of muscle elements;
• hyperhidrosis.

In the presence of severe diabetes during therapy with Berotek, it is necessary to carefully monitor blood glucose levels.

Any combination of Berotek with other medicines must be agreed with the doctor. Self-medication can lead to dire consequences and complications.

Treatment with Berotek

It is enough to carry out one inhalation in order to relieve spasm in the bronchi. The manipulation is repeated if breathing does not ease within five minutes. To prevent asthma, use 1-2 inhalation doses of the agent in question. The maximum number of procedures performed is 8 per day.

The prescribed single dose of Beroteka is diluted to 3-4 ml. Then the drug is sprayed and inhaled. It is diluted with 0.9% sodium chloride solution. The manipulation is carried out before each inhalation.

Berotek for children

The decision to prescribe the drug to children is made exclusively by a specialist. The best in pediatric practice is the inhalation version of the drug for nebulizer therapy through a mask.

The dosage is selected individually, taking into account the age, weight, constitution of the child and the severity of his condition. During a period of severe exacerbation, no more than 4 inhalations per day are allowed.

Dosage of Beroteka for children

For adolescents after 12 years of age, the drug is indicated for asthma attacks and all conditions that are accompanied by reversible obstruction. Inhalation starts with 10 drops.

Berotek during pregnancy and lactation

There is no evidence regarding the undesirable effect of Berotek on the fetus after the first trimester. But it is used with caution. During lactation, inhalation is prescribed when the benefits for the mother outweigh the risk.

Use only as directed by a physician!

Interaction of Beroteka with other medicinal products

Inhalation with antidepressants is not recommended. An increase in undesirable effects is possible with the appointment of hormones. It is forbidden to practice joint use with bronchodilators, since an overdose is possible, a strong additive effect.

Analogs

Berotek has not many analogues, there are many more substitutes. Analogues:

• Partusisten;
• Aerum;
• Fenoterol;
• Aruterol;
• Fenoterol hydrobromide
• Dosberotek;
• Segamol.

A good substitute is.

Only the attending physician can replace the drug or prescribe analogs!

Price

The price for Berotek depends on the form of release.

Price for Berotek in Russia - Moscow, St. Petersburg and other cities:

• Berotek solution for inhalation 0.1%, 20 ml - 340-380 rubles;
• Berotek aerosol 100 mcg / dose, 200 doses, 10 ml - 430-490 rubles;

Price for Atrovent in Ukraine:

• Berotek solution for inhalation 0.1%, 20 ml - 280-300 hryvnia;
• Berotek N aerosol 100 mcg / dose, 200 doses, 10 ml - 260-280 hryvnia;

This page contains a list of all Berotek analogues in terms of composition and indications for use. List of cheap analogues, and you can also compare prices in pharmacies.

• The cheapest analogue of Berotek:
• The most popular analogue of Berotek:
• ATX classification: Fenoterol

Cheap analogues of Berotek

When calculating the cost cheap analogs of Berotek the minimum price was taken into account, which was found in the price lists provided by pharmacies

Popular analogues of Berotek

The list of drug analogues based on statistics of the most requested drugs

All analogues of Berotek

The above list of drug analogues, which indicates Berotek substitutes, is the most suitable, since they have the same composition of active ingredients and coincide in indications for use

Analogues by indication and method of application

Name	Price in Russia	Price in Ukraine
salbutamol	--	148 hry
salbutamol	--	34 hry
salbutamol	249 rbl	UAH 8
salbutamol	--	--
salbutamol	85 rbl	UAH 31
	123 rbl	UAH 8
salbutamol	--	UAH 4
salbutamol	--	221 hry
salbutamol	--	41 hry
salbutamol	114 rbl	--
salbutamol	--	--
salbutamol	126 rbl	--
salbutamol sulfate	--	46 hry
salbutamol hemisuccinate	119 rbl	--
salmeterol	4898 rbl	436 hry
salmeterol	--	436 hry
salmeterol	--	--
formoterol	1296 rbl	492 hry
formoterol	--	UAH 252
formoterol	--	UAH 219
formoterol	--	--
formoterol	1296 rbl	492 hry
formoterol	305 rbl	--
indacaterol	--	UAH 257

Different composition, may coincide in indication and method of application

Name	Price in Russia	Price in Ukraine
	--	--
ipratropium bromide, fenoterol	202 rbl	UAH 40
ipratropium bromide, fenoterol	374 rbl	145 hry
	176 rbl	--
salmeterol, fluticasone propionate	699 rbl	170 hry
salmeterol, fluticasone	4479 rbl	170 hry
salmeterol xinafoate, fluticasone propionate	752 rbl	UAH 1500
salmeterol, fluticasone	--	170 hry
salmeterol, fluticasone	439 rbl	--
salmeterol, fluticasone propionate	--	83 hry
salmeterol, fluticasone	--	--
salmeterol	590 rbl	--
budesonide, formoterol	698 rbl	34 hry
budesonide, formoterol	577 rbl	--
budesonide, formoterol	--	--
budesonide, formoterol fumarate dihydrate	668 rbl	--
beclomethasone, formoterol	1872 rbl	1900 UAH
mometasone, formoterol	1257 rbl	--
vilanterol, fluticasone	1563 rbl	1900 UAH
beclomethasone dipropionate, salbutamol	739 rbl	--
fenoterol hydrobromide, ipratropium bromide	--	--
ipratropium bromide, fenoterol	189 rbl	410 UAH
bromide, triphenatate	1909 rbl	502 UAH
glycopyrronium bromide, indacaterol	1653 rbl	--
olodaterol, tiotropium bromide	2194 rbl	604 UAH

To compile a list of cheap analogues of expensive drugs, we use the prices that are provided to us by more than 10,000 pharmacies throughout Russia. The database of medicines and their analogues is updated daily, so the information provided on our website is always up-to-date as of the current day. If you have not found the analogue you are interested in, please use the search above and select the drug you are interested in from the list. On the page of each of them you will find all possible variants of analogues of the desired medicine, as well as prices and addresses of pharmacies in which it is available.

How to find a cheap analogue of an expensive medicine?

To find an inexpensive analogue of a medicine, a generic or a synonym, first of all, we recommend paying attention to the composition, namely, the same active ingredients and indications for use. Identical active ingredients of the drug will indicate that the drug is synonymous with the drug, pharmaceutically equivalent or pharmaceutical alternative. However, one should not forget about the inactive components of similar drugs, which may have an impact on safety and effectiveness. Do not forget about the advice of doctors, self-medication can harm your health, so always consult your doctor before using any medication.

Berotec price

On the sites below you can find prices for Berotek and inquire about availability at a pharmacy nearby

Berotek instruction

aer. 100mcg / dose 200 doses 10ml

Compound

1 dose of aerosol contains:

Active ingredient: fenoterol hydrobromide - 100 mcg.

Excipients: anhydrous citric acid - 0.001 mg, absolute ethanol - 15.597 mg, purified water - 1.04 mg, 1,1,1,2-tetrafluoroethane (HFA 134a, propellant) - 35.252 mg.

pharmachologic effect

Bronchodilating.

Bronchodilator, selective stimulant of β2-adrenergic receptors.

When using the drug in higher doses, β1-adrenergic receptors are stimulated (for example, when prescribed for tocolytic therapy). The binding of β2-adrenergic receptors activates adenylate cyclase through the stimulatory GS-protein with a subsequent increase in the formation of cAMP, which activates protein kinase A, the latter depriving myosin of the ability to bind with actin, which prevents the contraction of smooth muscles and promotes bronchodilator action and elimination of bronchospasm.

In addition, fenoterol inhibits the release of inflammatory mediators from mast cells, thereby providing a protective effect against the effects of bronchoconstrictors such as histamine, methacholine, cold air and allergens. Taking fenoterol at a dose of 600 μg increases the activity of the ciliated epithelium of the bronchi and accelerates mucociliary transport. Due to the stimulating effect on β-adrenergic receptors, fenoterol can have an effect on the myocardium (especially at doses exceeding therapeutic ones), causing an increase in heart rate and increase.

Fenoterol prevents and quickly relieves bronchospasm of various origins. The onset of action after inhalation is 5 minutes, maximum is 30-90 minutes, duration is 3-5 hours.

Indications

Prevention and relief of bronchospasm in bronchial asthma, chronic obstructive bronchitis, pulmonary emphysema. ... Symptomatic treatment of bronchial asthma and chronic obstructive pulmonary disease.

Contraindications

Hypersensitivity, hypertrophic obstructive cardiomyopathy, tachyarrhythmias, heart disease, aortic stenosis, decompensated diabetes mellitus, thyrotoxicosis, glaucoma, threatened abortion, pregnancy (I trimester), children under 4 years of age, hypersensitivity to fenoterol and other components of the drug.

Carefully the drug should be prescribed for hyperthyroidism, arterial hypotension, arterial hypertension, intestinal atony, hypokalemia, diabetes mellitus, recent myocardial infarction (within the last 3 months), heart and vascular diseases such as chronic heart failure, coronary artery disease, coronary artery disease , with heart defects (including aortic stenosis), severe lesions of the cerebral and peripheral arteries, pheochromocytoma. Because information on the use of the drug in children under 6 years of age is limited, treatment is carried out with caution, only under the supervision of a doctor.

Application during pregnancy and lactation

Contraindicated in the first trimester of pregnancy, the appointment of the drug is possible in the II-III trimester of pregnancy and during breastfeeding only if the expected effect of therapy outweighs the potential risk to the fetus or child.

Method of administration and dosage

Adults and adolescents over 12 years old

If the effect is absent after 2 inhalations, and additional inhalations are required, you should immediately consult a doctor.

Prevention of exercise asthma

Children from 6 to 12 years old

Bronchial asthma attacks and other conditions accompanied by reversible airway obstruction

In most cases, 1 inhalation dose is sufficient to relieve bronchospasm; if there is no relief of breathing within 5 minutes, inhalation can be repeated.

If the effect is absent after 2 inhalations, and additional inhalations are required, you should immediately seek medical help.

Prevention of exercise asthma

1-2 inhalation doses before physical activity, up to 8 inhalations / day.

Children from 4 to 6 years old

Due to limited experience in children under 6 years of age, the drug should only be used as directed by a physician and under adult supervision.

Bronchial asthma attacks and other conditions accompanied by reversible airway obstruction

To stop bronchospasm, 1 inhalation dose is sufficient. If there is no effect, you should immediately seek medical attention.

Prevention of exercise asthma

1 inhalation dose before exercise, up to 4 inhalations / day.

Terms of use of the drug

To achieve the maximum effect, it is necessary to use the metered aerosol correctly.

Before using the metered aerosol for the first time, double-click on the bottom of the can.

Each time you use a metered aerosol, the following rules must be observed.

Remove the protective cap.
Exhale slowly, deeply.
While holding the can, clasp the tip tightly with your lips. In this case, the arrow and the bottom of the can should be directed upwards.
Making the deepest possible inhalation, simultaneously quickly press the bottom of the can until 1 inhalation dose is released. Hold your breath for a few seconds, then remove the mouthpiece from your mouth and exhale slowly. If repeated inhalation is required, repeat the same steps (points 2-4).
Put on the protective cap.
If the aerosol can has not been used for more than 3 days, press the bottom of the can once before use.

The balloon is designed for 200 inhalations. Then the cylinder should be replaced. Although some content may remain in the balloon, the amount of drug released by inhalation is reduced.

The inhaler should be flushed at least once a week.

To clean, first remove the dust cap and remove the container from the inhaler. Rinse the inhaler with warm water to remove accumulated medication and / or visible dust.

After cleaning, you need to shake the inhaler and let it air dry without using heating devices. When the mouthpiece is dry, replace the container and dust cap.

The plastic mouthpiece for the mouth is specially designed for the metered aerosol of Berotek® N and serves for accurate dosing of the drug. The mouthpiece should not be used with other metered aerosols. Do not use metered-dose aerosol Berotek® N with other adapters.

Side effects

WITH on the side of the central nervous system: minor tremor, nervousness; rarely - headache, dizziness, disturbance of accommodation; in isolated cases - a change in the psyche.

From the side of the cardiovascular system: tachycardia, palpitations (especially in patients with aggravating factors); rarely (when used in high doses) - decrease in DBP, increase in SBP, arrhythmia.

From the respiratory system: in rare cases - cough, local irritation; very rarely - paradoxical bronchospasm.

From the digestive tract: nausea, vomiting.

Allergic reactions: rarely - rash, angioedema of the tongue, lips and face, urticaria.

Others: hypokalemia, increased sweating, weakness, myalgia, convulsions, urinary retention.

special instructions

When using the metered-dose aerosol Berotek® N for the first time, patients may notice that the new aerosol has a slightly different taste compared to the previous aerosol containing freon. Patients should be warned about this when switching from Berotek® N containing freon to Berotek® N which does not contain freon. Patients need to know that Berotek®N containing freon and Berotek®N containing freon are completely interchangeable, and a change in taste does not affect the effectiveness and safety of the drug.

Other sympathomimetic bronchodilators can be used together with Berotek® N only under medical supervision. Acute, rapidly worsening shortness of breath (shortness of breath) should see a doctor immediately.

Long-term use:

Relief of attacks of bronchial asthma may be preferable to regular use of the drug (symptomatic treatment).
Patients should be examined to identify the need for additional or more intensive anti-inflammatory treatment (for example, inhalation of corticosteroids) in order to control inflammation of the airways and prevent prolonged exacerbations of bronchial asthma.

In the case of increased bronchial obstruction, it is considered unacceptable and may even be risky to increase the frequency of administration of β2-adrenergic receptor agonists contained in drugs such as Berotek® N metered dose inhalation aerosol in excess of the recommended doses. In such a situation, the treatment plan and, especially, the adequacy of anti-inflammatory therapy should be reviewed.

When treated with β2-adrenergic receptor agonists, severe hypokalemia may develop. Particular care should be taken in severe bronchial asthma, since this effect can be enhanced by the concomitant use of xanthine derivatives, GCS and diuretics. With hypoxia, it is possible to increase the effect of hypokalemia on the heart rate. In such situations, regular monitoring of serum potassium concentration is recommended.

In rare cases, myocardial ischemia associated with β2-adrenergic receptor agonists was observed.

Hypokalemia in patients receiving digoxin increases sensitivity to cardiac glycosides and can cause arrhythmias.

Influence on the ability to drive vehicles and use mechanisms

The effect of the use of the drug on the patient's ability to perform work requiring increased attention and speed of psychomotor reactions has not been established.

Drug interactions

Beta-adrenomimetics and anticholinergics, xanthine derivatives (including theophylline), cromoglycic acid, corticosteroids and diuretics can enhance the action and side effects of fenoterol. A significant weakening of the bronchodilator effect of fenoterol is possible with the simultaneous use of beta-blockers.

Care should be taken to prescribe Berotek® N to patients receiving MAO inhibitors and tricyclic antidepressants, because these drugs are able to enhance the effect of fenoterol.

Means for inhalation anesthesia containing halogenated hydrocarbons (including halothane, trichlorethylene, enflurane) can enhance the effect of fenoterol on the cardiovascular system (arrhythmias may develop). The simultaneous appointment of bronchodilators with a similar mechanism of action leads to an additive effect and overdose phenomena.

Overdose

Symptoms: tachycardia, palpitations, tremors, decrease / increase in blood pressure, increased pulse pressure, anginal pain, arrhythmias and facial flushing.

Treatment: the appointment of sedatives, tranquilizers, in severe cases, intensive symptomatic therapy is indicated. The appointment of beta-blockers (preferably selective beta1-blockers) is recommended as specific antidotes. However, it is necessary to take into account the possibility of increasing bronchial obstruction and carefully select the dose of these drugs for patients with bronchial asthma.

Storage conditions

At a temperature not exceeding 25 ° C. Protect from direct sunlight, high and low temperatures.

Keep out of the reach of children.

Best before date

All information is presented for informational purposes only and is not a reason for self-prescribing or replacing a medicine.

Catad_pgroup Anti-asthma drugs

Berotek H - instructions for use

Registration number:

P N011310 / 01

Trade name of the drug:

Berotek® N

International non-proprietary name:

fenoterol

Dosage form:

metered dose inhalation aerosol

Compound:

1 inhalation dose contains:
active substance: fenoterol hydrobromide 100 μg (0.100 mg)
Excipients:
citric acid anhydrous 0.001 mg
purified water 1,040 mg
ethanol absolute 15.597 mg
tetrafluoroethane (HFA 134a, propellant (tetrafluoroethane)) 35.252 mg

Description:

A transparent, colorless or light yellow or light brownish liquid, free from suspended particles, placed under pressure in a metal aerosol can with a dosing valve and a mouthpiece.

Pharmacotherapeutic group:

bronchodilating agent - ß 2 - selective ATX adrenergic agonist:

ATX code:

R03AC04

Pharmacological properties

Pharmacodynamics

Berotek N is an effective bronchodilator for the prevention and relief of bronchospasm attacks in bronchial asthma and other conditions accompanied by reversible airway obstruction, such as chronic obstructive bronchitis (with or without pulmonary emphysema).
Fenoterol is a selective stimulant of ß 2 -adrenergic receptors in the therapeutic dose range. Stimulation in 1-adrenergic receptors occurs with the use of higher doses of the drug. Binding to β 2 -adrenergic receptors activates adenylate cyclase through the stimulatory GS-protein, followed by an increase in the formation of cyclic adenosine monophosphate (cAMP), which activates protein kinase A, the latter depriving myosin of the ability to bind with actin, which causes relaxation of smooth muscles.
Fenoterol relaxes the smooth muscles of the bronchi and blood vessels and protects against bronchoconstrictor stimuli such as histamine, methacholine, cold air and allergens (early response). In addition, fenoterol inhibits the release of bronchoconstrictor and pro-inflammatory mediators from mast cells. An increase in mucociliary clearance was demonstrated after the use of fenoterol (at a dose of 0.6 mg).
Due to the stimulating effect on β 1 -adrenergic receptors, fenoterol can have an effect on the myocardium (especially at doses exceeding therapeutic ones), causing an increase in heart rate and increase.
Fenoterol quickly relieves bronchospasm of various origins. Bronchodilation develops within a few minutes after inhalation and lasts 3-5 hours. Fenoterol also protects against bronchoconstriction, which occurs under the influence of various stimuli, such as exercise, cold air and allergens (early response).

Pharmacokinetics
After inhalation, 10-30% of the active substance released from the aerosol preparation reaches the lower respiratory tract, depending on the inhalation technique and the inhalation system used. The remainder is deposited in the upper respiratory tract and in the mouth and then swallowed.
The absolute bioavailability of fenoterol after inhalation of the metered aerosol of Berotek N is 18.7%. The absorption of fenoterol from the lungs is two-phase: 30% of the dose is absorbed quickly (half-life is 11 minutes), and 70% is absorbed slowly (half-life is 120 minutes). The maximum plasma concentration after inhalation of 200 μg fenoterol is 66.9 pg / ml (tmax 15 min).
After oral administration, approximately 60% of the dose of fenoterol hydrobromide is absorbed. The absorbed amount undergoes an extensive first phase of metabolism in the liver, resulting in an oral bioavailability of approximately 1.5%, and its contribution to plasma fenoterol concentration after inhalation is small.
The distribution of fenoterol in plasma after intravenous administration is adequately described by a 3-component pharmacokinetic model (the half-life is t α = 0.42 min, t β = 14.3 min and t γ = 3.2 h). The volume of distribution of fenoterol at a constant concentration after intravenous administration is 1.9-2.7 l / kg, binding to plasma proteins is from 40 to 55%.
Fenoterol is extensively metabolized in the liver by conjugation to glucuronides and sulfates. The swallowed portion of the fenoterol dose is metabolized predominantly by sulfation. This metabolic inactivation of the parent substance begins already in the intestinal wall.
Fenoterol is excreted by the kidneys and bile in the form of inactive sulfate conjugates. Biotransformation, including excretion with bile, undergoes the main part - about 85%. Excretion of fenoterol in the urine (0.27 L / min) corresponds to approximately 15% of the mean total clearance of the systemically available dose. The volume of renal clearance is indicative of tubular secretion of fenoterol in addition to glomerular filtration. After inhalation, 2% of the dose is excreted through the kidneys unchanged within 24 hours.
Fenoterol hydrobromide in unchanged form can cross the placental barrier and pass into breast milk.

Indications for use

• Bronchial asthma attacks or other conditions with reversible airway obstruction, chronic bronchitis, chronic obstructive pulmonary disease.
• Prevention of bronchial asthma attacks due to physical exertion.

Contraindications

Hypersensitivity to fenoterol or to any of the excipients of the drug.
Hypertrophic obstructive cardiomyopathy, tachyarrhythmia.
Berotek N v dosage form metered dose inhalation aerosol is not used in children under 4 years of age.
Carefully

In the following conditions, Berotek N should be used only after a careful assessment of the benefits / risks of treatment, especially if the maximum recommended doses are applied:
hyperthyroidism, hypokalemia, insufficiently controlled diabetes mellitus, recent myocardial infarction (within the last 3 months), severe organic diseases of the heart and blood vessels, such as chronic heart failure, coronary heart disease, coronary artery disease, heart defects (including aortic stenosis), pronounced lesions of the cerebral and peripheral arteries, pheochromocytoma.
Since information on the use of the drug in children under 6 years of age is limited, treatment is carried out with caution, only under the supervision of a doctor.

Application during pregnancy and during breastfeeding

The results of preclinical studies in combination with the existing experience of the clinical use of the drug did not reveal any adverse events during pregnancy. However, the drug should be used with caution during pregnancy, especially in the first trimester, if the potential benefit to the mother outweighs the potential risk to the fetus.
Consideration should be given to the possibility of an inhibitory effect of fenoterol on the contractile activity of the uterus.
Preclinical studies have shown that fenoterol passes into breast milk. The safety of the drug during breastfeeding has not been studied. Care should be taken when using the drug during breastfeeding. There are no clinical data on the effects of fenoterol on fertility. Preclinical studies of fenoterol have shown no adverse effects on fertility.

Method of administration and dosage

Doses for adults and children over 6 years old

In most cases, one inhalation dose is sufficient to relieve bronchospasm. If there is no relief of breathing within 5 minutes, you can repeat the inhalation.
If the effect is absent after two inhalation doses, and additional inhalations are required, you should immediately seek medical attention. The maximum permissible dose during the day is 8 inhalation doses.

1-2 inhalation doses before exercise, up to 8 inhalation doses per day.
In children aged 6 to 12 years, Berotek N should be used only after consultation with a doctor and under adult supervision.
Doses for children from 4 to 6 years old
Bronchial asthma attacks and other conditions accompanied by reversible airway obstruction
To stop bronchospasm, one inhalation dose is enough.
If there is no effect, you should immediately seek medical attention.
Prevention of attacks of bronchial asthma due to physical exertion
1 inhalation dose before exercise, up to 4 inhalation doses per day.
In children aged 4 to 6 years, Berotek N should be used only after consultation with a doctor and under adult supervision.
Mode of application
To achieve the maximum effect, it is necessary to use the metered aerosol correctly.
To prepare a new inhaler for use, remove the protective cap, turn the inhaler upside down and make two injections into the air (double-click on the bottom of the can).
Each time you use the inhaler, the following rules must be observed:

Side effect

Like all other types of inhalation treatment, Berotek N can cause local irritant symptoms.
From the immune system

hypersensitivity
On the part of metabolism and nutrition
Hypokalemia, including severe hypokalemia
From the nervous system
agitation, nervousness, tremor, headache, dizziness
On the part of the cardiovascular system
myocardial ischemia, arrhythmia, tachycardia, palpitations, increased systolic blood pressure, decreased diastolic blood pressure
From the respiratory system
paradoxical bronchospasm, cough, irritation of the larynx and pharynx
From the digestive system:
nausea, vomiting
Skin and subcutaneous tissue
hyperhidrosis, skin reactions such as rash, pruritus, urticaria
The musculoskeletal system and related tissue diseases.
muscle spasm, myalgia, muscle weakness

Overdose

Symptoms
In overdose, the expected symptoms are those caused by excessive beta-adrenergic stimulation. The most pronounced are tachycardia, palpitations, tremors, decreased or increased blood pressure, increased pulse pressure, angina pectoris, arrhythmias, facial flushing. Metabolic acidosis and hypokalemia have also been observed with the use of fenoterol in doses in excess of the recommended doses for the approved indications.
Treatment
Treatment with Berotek N should be discontinued. The acid-base balance and electrolyte balance should be monitored.
For treatment, sedatives are used; in severe cases, intensive symptomatic therapy is carried out.
As specific antidotes, you can prescribe ß-blockers (preferably selective ß 1 -blockers); at the same time, the possibility of increased bronchial obstruction should be taken into account and the doses of these drugs should be carefully selected in patients with bronchial asthma.

Interaction with other medicinal products

ß-Adrenergic drugs, anticholinergics, xanthine derivatives (such as theophylline), cromoglycic acid, glucocorticosteroids and diuretics can increase the action and side effects of fenoterol.
Hypokalemia caused by ß 2 -agonists can be exacerbated by concomitant therapy with xanthine derivatives, corticosteroids, and diuretics. This should be especially taken into account in patients with severe airway obstruction (see section "Special instructions").
A significant decrease in bronchodilation with the simultaneous use of fenoterol and ß-blockers.
Β-adrenergic receptor agonists should be used with caution in patients receiving monoamine oxidase inhibitors or tricyclic antidepressants, which can enhance the action of β-adrenergic receptor agonists.
Inhalation of general anesthetics such as halothane, trichlorethylene, and enflurane increases the likelihood of cardiovascular exposure to ß-adrenergic agonists.

special instructions

Paradoxical bronchospasm

Like other inhaled drugs, Berotek N can cause paradoxical bronchospasm, which can be life threatening. If paradoxical bronchospasm occurs, the drug should be immediately discontinued and replaced with alternative therapy.
Cardiovascular effects
Effects on the part of the cardiovascular system can be observed with the use of sympathomimetic drugs, including the drug Berotek N. There are data from post-registration studies and publications in the literature on rare cases of myocardial ischemia associated with the use of beta-agonists.
Patients with underlying severe heart disease (for example, ischemic heart disease, arrhythmia, or severe heart failure) receiving Berotek N should be warned to seek medical attention if they experience chest pain or worsening heart disease.
Consideration should be given to assessing symptoms such as shortness of breath and chest pain, as they can be respiratory or cardiac.
Hypokalemia
Potentially serious hypokalemia can develop with ß 2 -agonist therapy. It is recommended to take special care in severe bronchial asthma, since hypokalemia can be potentiated by concomitant therapy with xanthine derivatives, glucocorticosteroids and diuretics. In addition, hypoxia can increase the effect of hypokalemia on heart rate. Hypokalemia can lead to an increased susceptibility to arrhythmias in patients receiving digoxin.
In such situations, it is recommended to monitor serum potassium levels.
Acute progressive dyspnea
Patients should be advised to seek immediate medical attention in case of acute, rapidly worsening shortness of breath.
Regular use

• Relief of attacks of bronchial asthma (symptomatic treatment) is preferable to regular use of the drug;
• Patients should be evaluated to determine the need for the appointment or intensification of anti-inflammatory treatment (for example, inhaled glucocorticosteroids) in order to control airway inflammation and prevent delayed lung damage.

In the case of increased bronchial obstruction, it is unacceptable and may be risky to increase the frequency of administration of β 2 -adrenoreceptor agonists, such as Berotek N, in excess of the recommended doses and for a long time. The use of higher doses of ß 2 -agonists, such as Berotek N, on a regular basis to control the symptoms of bronchial obstruction, may indicate a deterioration in disease control. In such a situation, the treatment plan, and especially the adequacy of anti-inflammatory therapy, should be reviewed to prevent a potentially life-threatening deterioration in disease control.
Concurrent use with sympathomimetic and anticholinergic bronchodilators

Other sympathomimetic bronchodilators should be used in conjunction with Berotek N only under medical supervision. Anticholinergic bronchodilators can be inhaled simultaneously with Berotek N.
Influence on the results of laboratory tests
The use of the drug Berotek N can lead to positive test results for the presence of fenoterol in studies of drug abuse for non-medical indications, for example, due to increased physical capabilities in athletes (doping).

Impact on the ability to manage vehicles and mechanisms

Studies of the effects of the drug on the ability to drive vehicles and use mechanisms have not been conducted.
However, patients should be advised that symptoms such as dizziness have been observed during clinical trials. Therefore, it is recommended to be careful when driving or using machinery.

Release form

Aerosol for inhalation dosed 0.1 mg / dose. 10 ml (200 doses) in a metal aerosol can with a dosing valve and a mouthpiece with a protective cap with the company logo. A can with instructions for use in a cardboard box.

Storage conditions

At a temperature not higher than 25 ° C.
Keep out of the reach of children.

Best before date

3 years.
Do not use the drug after the expiration date indicated on the package.

Vacation conditions

Dispensed by prescription

Manufacturer

Name and address of the legal entity in whose name the registration certificate was issued

Boehringer Ingelheim International GmbH, Germany,

Name and address of the place of manufacture of the medicinal product
Boehringer Ingelheim Pharma GmbH & Co.KG, Germany
Germany, 55216, Ingelheim am Rhein, Bingerstrasse 173

You can get additional information about the drug, as well as send your claims and information about adverse events to the following address in Russia
OOO Boehringer Ingelheim
125171, Moscow, Leningradskoe shosse, 16A, building 3