Berotek - instructions for use, reviews, analogs and formulations (solution for inhalation, inhalation aerosol H) of a drug for the treatment and prevention of asthma attacks in adults, children and pregnancy. Compound
Registration certificate holder:
BOEHRINGER INGELHEIM INTERNATIONAL GmbH
Produced:
BOEHRINGER INGELHEIM PHARMA GmbH & Co. KG
ATX code for BEROTEK N
R03AC04 (Fenoterol)
Analogues of the drug according to ATC codes:
Before using the drug BEROTEK N you should consult your doctor. These instructions for use are for informational purposes only. For more information, please refer to the manufacturer's annotation.
Clinical and pharmacological group
12.003 (Broncholytic drug - beta2-adrenergic agonist)
Release form, composition and packaging
Aerosol for inhalation dosed as a clear, colorless or light yellow or light brownish liquid, free from suspended particles.
| 1 dose | |
| 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.
10 ml (200 doses) - a metal can with a dosing valve and a mouthpiece (1) - packs of cardboard.
pharmachologic effect
Bronchodilator drug, selective stimulator of β2-adrenergic receptors.
When using the drug in higher doses, stimulation of β1-adrenergic receptors occurs (for example, when prescribed for tocolytic therapy). Binding of β2-adrenergic receptors activates adenylate cyclase through the stimulatory GS protein, followed by an increase in the formation of cAMP, which activates protein kinase A, the latter deprives myosin of the ability to bind to actin, which prevents smooth muscle contraction 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 influence of bronchoconstrictors such as histamine, methacholine, cold air and allergens. Taking fenoterol at a dose of 600 mcg 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 increased heart rate and increased heart rate.
Fenoterol prevents and quickly stops bronchospasm of various origins. The onset of action after inhalation - after 5 minutes, maximum - 30-90 minutes, duration - 3-5 hours.
Pharmacokinetics
Suction and distribution
Depending on the method of inhalation and the inhalation system used, 10-30% of the active substance released from the aerosol form of the drug after inhalation reaches the lower respiratory tract, and the rest is deposited in the upper respiratory tract and swallowed. This proportion of the active substance undergoes biotransformation due to the effect of "primary" passage through the liver. Thus, the swallowed amount of the drug does not affect the concentration of the active substance in the blood plasma, achieved after inhalation.
Fenoterol in unchanged form crosses the placental barrier and is excreted in breast milk.
Metabolism
Fenoterol is extensively metabolized in the liver by conjugation to glucuronides and sulfates. When swallowed, fenoterol is metabolized primarily by sulfation. This metabolic inactivation of the parent substance already begins in the intestinal wall.
Biotransformation, including excretion with bile, undergoes the main part - approximately 85%.
breeding
It is excreted in the urine and bile in the form of inactive sulfate conjugates. The excretion of fenoterol in the urine (0.27 l / min) corresponds to approximately 15% of the average total clearance of the systemically available dose. The volume of renal clearance indicates tubular secretion of fenoterol in addition to glomerular filtration.
After inhalation, 2% of the dose is excreted unchanged through the kidneys from a metered-dose aerosol within 24 hours.
BEROTEK N: DOSAGE
Adults and teenagers over 12 years old
If there is no effect after 2 inhalations, and additional inhalations are required, you should immediately consult a doctor.
Children from 6 to 12 years old
Asthma attacks and other conditions accompanied by reversible airway obstruction
In most cases, 1 inhalation dose is sufficient to stop bronchospasm; if within 5 minutes there is no relief from breathing, you can repeat the inhalation.
If there is no effect after 2 inhalations, and additional inhalations are required, you should immediately seek medical help.
Prevention of physical effort asthma
1-2 inhalation doses before physical activity, up to 8 inhalations / day.
Children from 4 to 6 years old
Due to limited experience with children under the age of 6 years, the drug should only be used on prescription and under adult supervision.
Asthma attacks and other conditions accompanied by reversible airway obstruction
For relief of bronchospasm, 1 inhalation dose is sufficient. If there is no effect, you should immediately seek medical help.
Prevention of physical effort asthma
1 inhalation dose before physical activity, up to 4 inhalations / day.
Rules for the use of the drug
To achieve the maximum effect, it is necessary to use the metered aerosol correctly.
Before using the metered-dose aerosol for the first time, press the bottom of the can twice.
Each time you use a metered-dose aerosol, the following rules must be observed.
1. Remove the protective cap.
2. Take a slow, deep breath.
3. While holding the can, tightly wrap your lips around the tip. In this case, the arrow and the bottom of the can must be directed upwards.
4. Taking the deepest possible breath, at the same time 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).
5. Put on the protective cap.
6. 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 balloon should be replaced. Although some contents may remain in the balloon, the amount of drug released during inhalation is reduced.
The balloon is opaque, so the amount of the drug in the balloon can be determined as follows: remove the protective cap, immerse the balloon in a container filled with water. The amount of the drug is determined depending on the position of the balloon in the water.
The inhaler should be washed 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 any accumulated medication and/or visible dust.
After cleaning, shake the inhaler and allow it to air dry without the use of heating devices. When the mouthpiece is dry, replace the container and dust cap.
The plastic mouthpiece is designed specifically for Berotek® N metered-dose aerosol and is used for precise dosing of the drug. The mouthpiece must not be used with other metered-dose aerosols. Berotek® N metered-dose aerosol must not be used with other adapters.
Overdose
Symptoms: tachycardia, palpitations, tremor, decrease / increase in blood pressure, increased pulse pressure, anginal pain, arrhythmias and flushing of the face.
Treatment: the appointment of sedatives, tranquilizers, in severe cases, intensive symptomatic therapy is indicated.
As specific antidotes, the appointment of beta-blockers (preferably selective beta1-blockers) is recommended. However, it is necessary to take into account the possibility of increasing bronchial obstruction and carefully select the dose of these drugs in patients with bronchial asthma.
drug interaction
Beta-agonists and anticholinergics, xanthine derivatives (including theophylline), corticosteroids and diuretics can enhance the action and side effects of fenoterol.
Perhaps a significant weakening of the bronchodilator action of fenoterol with the simultaneous use of beta-blockers.
Berotek® N should be prescribed with caution to patients receiving MAO inhibitors and tricyclic antidepressants, tk. these drugs can 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.
Pregnancy and lactation
The results of preclinical studies, in combination with the available experience of the clinical use of the drug, did not reveal any negative effect of the drug on the course of pregnancy. However, during pregnancy (especially in the first trimester), the drug should be administered with caution and only in cases where the expected benefit to the mother outweighs the possible risk to the fetus.
The possibility of an inhibitory effect of fenoterol on uterine contractility should be considered.
Preclinical studies have shown that fenoterol is excreted in breast milk. The safety of the drug during lactation has not been studied. During lactation, the use of the drug is possible if the potential benefit to the mother outweighs the possible risk to the infant.
BEROTEK N: SIDE EFFECTS
From the immune system: hypersensitivity.
From the side of metabolism: hypokalemia.
From the nervous system: agitation, nervousness, tremor, headache, dizziness.
From the side of the cardiovascular system: myocardial ischemia, arrhythmia, tachycardia, palpitations, increased systolic blood pressure, decreased diastolic blood pressure.
From the respiratory system: paradoxical bronchospasm, irritation of the larynx and pharynx.
From the digestive system: nausea, vomiting.
From the skin and subcutaneous tissues: hyperhidrosis, skin reactions such as rash, itching, urticaria.
From the musculoskeletal system: muscle spasm, myalgia, muscle weakness.
Terms and conditions of storage
The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 3 years.
The bottle is under pressure. The cylinder must not be opened and heated to temperatures above 50°C.
Indications
- asthma attacks or other conditions with reversible airway obstruction (incl.
- Chronical bronchitis,
- COPD);
- prevention of attacks of bronchial asthma of physical effort.
Contraindications
- tachyarrhythmia;
- hypertrophic obstructive cardiomyopathy;
- children's age up to 4 years;
- hypersensitivity to fenoterol and other components of the drug.
With caution, the drug should be prescribed for hyperthyroidism, arterial hypotension, arterial hypertension, intestinal atony, hypokalemia, diabetes mellitus, recent myocardial infarction (within the last 3 months), diseases of the heart and blood vessels, such as chronic heart failure, coronary artery disease, diseases coronary arteries, 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 medical supervision.
special instructions
When using Berotek® N metered-dose aerosol for the first time, patients may notice that the new aerosol has a slightly different taste compared to the previous freon-containing aerosol. Patients should be warned about this when switching from Freon-containing Berotek® N to Freon-free Berotek® N. Patients should be aware that Freon-containing Berotek®N and Freon-free Berotek®N are completely interchangeable, and changes in taste do not affect the efficacy and safety of the drug.
Other sympathomimetic bronchodilators can be used together with Berotek®N only under medical supervision. In case of acute, rapidly worsening shortness of breath (difficulty breathing), you should immediately consult a doctor.
Long term use:
- relief of asthma attacks may be preferable to regular use of the drug (symptomatic treatment);
- patients should be evaluated for the need for additional or more intense anti-inflammatory treatment (eg,
- inhaled corticosteroids) to control inflammation of the respiratory tract and prevent prolonged exacerbations of bronchial asthma.
In the case of increased bronchial obstruction, it is considered unacceptable and it may even be risky to increase the frequency of taking β2-adrenergic agonists contained in drugs such as Berotek® N dosed 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.
In the treatment of β2-adrenergic agonists, severe hypokalemia may develop. Particular caution should be exercised in severe bronchial asthma, as this effect may be enhanced by the concomitant use of xanthine derivatives, corticosteroids and diuretics. Hypoxia may increase the effect of hypokalemia on heart rate. In such situations, regular monitoring of the concentration of potassium in the blood serum is recommended.
In rare cases, myocardial ischemia associated with β2-adrenergic agonists has been observed.
Hypokalemia in patients receiving digoxin increases sensitivity to cardiac glycosides and may cause arrhythmia.
Influence on the ability to drive vehicles and control mechanisms
The effect of the drug on the patient's ability to perform work that requires increased attention and speed of psychomotor reactions has not been established.
Registration number: P N011310/01-111212
Trade name: Berotek® N
International non-proprietary name: fenoterol
Dosage form: dosed aerosol for inhalation
Compound:
1 inhalation dose contains:
fenoterol hydrobromide 100 mcg (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:
Transparent, colorless or light yellow or light brownish liquid, free from suspended particles, placed under pressure in a metal aerosol can with a metering valve and a mouthpiece.
Pharmacotherapeutic group: bronchodilator-β2-agonist selective
ATX: R03AC04
Pharmacological properties
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 β2-adrenergic stimulant. When using the drug in higher doses, stimulation of β1-adrenergic receptors occurs (for example, when prescribed for tocolytic therapy). Binding of β2-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 deprives myosin of the ability to combine with actin, which prevents smooth muscle contraction 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 influence of bronchoconstrictors such as histamine, methacholine, cold air and allergens. Taking fenoterol in doses of 0.6 mg 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 increased heart rate and increased heart rate.
Fenoterol prevents and quickly stops bronchospasm of various origins. The onset of action after inhalation - after 5 minutes, maximum - 30-90 minutes, duration - 3-5 hours.
10-30% of the active substance released from the aerosol preparation after inhalation reaches the lower respiratory tract, depending on the method of inhalation and the inhalation system used, and the rest is deposited in the upper respiratory tract and swallowed. This proportion of the active substance undergoes biotransformation due to the effect of "primary" passage through the liver. Metabolized in the liver. It is excreted by the kidneys and with bile in the form of inactive sulfate conjugates. Thus, the swallowed amount of the drug does not affect the concentration of the active substance in the blood plasma, achieved after inhalation.
Fenoterol in humans is extensively metabolized by conjugation to glucuronides and sulfates. When swallowed, fenoterol is metabolized primarily by sulfation. This metabolic inactivation of the parent substance already begins in the intestinal wall.
Biotransformation, including excretion with bile, undergoes the main part - approximately 85%. The excretion of fenoterol in the urine (0.27 l / min) corresponds to approximately 15% of the average total clearance of the systemically available dose. The volume of renal clearance indicates tubular secretion of fenoterol in addition to glomerular filtration.
After inhalation, 2% of the dose is excreted unchanged through the kidneys from a metered-dose aerosol within 24 hours.
Fenoterol can penetrate unchanged through the placental barrier and enter breast milk.
Indications for use
Asthma attacks or other conditions with reversible airway obstruction, chronic bronchitis, chronic obstructive pulmonary disease.
- Prevention of asthma attacks due to physical exertion.
Contraindications
Hypersensitivity to fenoterol or to other ingredients of the drug.
Hypertrophic obstructive cardiomyopathy, tachyarrhythmia.
Berotek N in the dosage form of an aerosol for inhalation dosed is not used in children under 4 years of age.
Carefully: 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, ischemic heart disease, coronary artery disease, heart defects (including aortic stenosis), severe 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 medical supervision.
Pregnancy and lactation
The results of preclinical studies, in combination with the available 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.
The possibility of an inhibitory effect of fenoterol on uterine contractility should be considered.
Preclinical studies have shown that fenoterol passes into breast milk. The safety of the drug during lactation has not been studied. During lactation, the use of the drug is possible if the potential benefit to the mother exceeds
potential risk to the child.
Dosage and administration
Asthma attacks and other conditions accompanied by reversible airway obstruction
In most cases, one inhalation dose is enough to copy bronchospasm; if within 5 minutes there is no relief from breathing, you can repeat the inhalation.
If there is no effect after two inhalations, and additional inhalations are required, you should immediately seek medical help at the nearest hospital.
Prevention of physical effort asthma
1-2 inhalation doses before exercise, up to 8 inhalations per day.
Due to limited experience with children under the age of 6 years, the drug should only be used on prescription and under adult supervision.
Asthma attacks and other conditions accompanied by reversible airway obstruction
To copy bronchospasm, one inhalation dose is sufficient.
If there is no effect, you should immediately seek medical help at the nearest hospital.
Prevention of physical effort asthma
1 inhalation dose before exercise, up to 4 inhalations per day.
To achieve the maximum effect, it is necessary to use the metered aerosol correctly.
Before using the metered-dose aerosol for the first time, double-tap the bottom of the can.
Each time you use a metered-dose aerosol, the following rules must be observed:
1. Remove the protective cap.
2. Make a slow full exhalation.
3. Holding the can, as shown in Fig. 1, tightly clasp the tip with your lips. In this case, the arrow and the bottom of the inhaler are facing up.
Fig.1
4. Taking the deepest possible breath, at the same time quickly press the bottom of the can until the 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).
5. Put on the protective cap.
6. If the aerosol can has not been used for more than three days, press the bottom of the can once before use.
The balloon is designed for 200 inhalations. After that, the bottle should be replaced. Although some drug may remain in the balloon, the amount of drug released during inhalation may be reduced. The balloon is opaque, so the amount of the drug in the balloon can only be determined in the following way: after removing the protective cap, the balloon is immersed in a container filled with water. The amount of the drug is determined depending on the position of the balloon in the water (see Fig. 2). 
pic 2.
The inhaler should be flushed at least once a week.
It is important to keep the mouthpiece of your inhaler clean so that the medication does not build up and block the spray.
To clean, first remove the dust cap and remove the container from the inhaler. Rinse the inhaler with warm water to remove any accumulated medication and/or visible dust. 
(Fig. 3)
After cleaning, shake the inhaler and allow it to air dry without the use of heating devices. When the mouthpiece is dry, replace the container and dust cap. 
(Fig. 4)
WARNING: The plastic mouthpiece is designed specifically for Berotek N and is used for precise dosing of the drug. The mouthpiece must not be used with other metered-dose aerosols. Also, you can not use Berotek H with any other adapters, except for the mouthpiece supplied with the drug.
The contents of the cylinder are under pressure. The cylinder must not be opened and exposed to heat above 50°C.
Side effects
Hypersensitivity
hypokalemia
Excitation, nervousness
tremor, headache, dizziness
Myocardial ischemia, arrhythmia, tachycardia, palpitations, increased systolic blood pressure, decreased diastolic blood pressure
Paradoxical bronchospasm, cough, irritation of the larynx and pharynx
Nausea, vomiting
Hyperhidrosis, skin reactions such as rash, itching, urticaria
The musculoskeletal system and related tissue diseases.
muscle spasm, myalgia, muscle weakness
Overdose
Tachycardia, palpitations, tremor, decrease / increase in blood pressure, increased pulse pressure, anginal pain, arrhythmias and facial flushing, metabolic acidosis
Sedatives, tranquilizers, in severe cases, intensive symptomatic therapy is carried out
As specific antidotes, β-blockers (preferably selective β1-blockers) can be prescribed; 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.
Drug Interactions
β-Adrenergic drugs, anticholinergics, xanthine derivatives (such as theophylline), cromoglycic acid, glucocorticosteroids and diuretics may increase the action and side effects of fenoterol.
A significant decrease in bronchodilation with the simultaneous use of fenoterol and β-blockers.
β-adrenergic agonists should be used with caution in patients receiving monoamine oxidase inhibitors or tricyclic antidepressants, which can enhance the action of β-adrenergic agonists.
Inhalation of general anesthetics such as halothane, trichlorethylene, and enflurane increases the likelihood of β-adrenergic agonist effects on the cardiovascular system. Halothane contributes to the development of arrhythmias. The simultaneous appointment of bronchodilators with a similar mechanism of action leads to an additive effect and overdose phenomena.
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, not containing freon. Patients need to know that BEROTEK N, containing freon and BEROTEK N, not containing freon, are completely interchangeable and a change in taste does not affect efficacy and safety of the drug.
Other sympathomimetic bronchodilators can be used together with BEROTEK N aerosol for inhalation dosed only under medical supervision.
In case of acute, rapidly worsening shortness of breath (difficulty breathing), you should immediately consult a doctor.
Long term use:
relief of asthma attacks may be preferable to regular use of the drug (symptomatic treatment);
patients should be evaluated to determine whether additional or more intense anti-inflammatory treatment (eg, inhaled corticosteroids) is needed to control airway inflammation and prevent prolonged asthma exacerbations.
In the case of increased bronchial obstruction, it is considered unacceptable and it may even be risky to increase the frequency of taking β2-adrenergic agonists contained in drugs such as BEROTEC N aerosol for inhalation dosed, in excess of the recommended doses. In such a situation, the treatment plan and, especially, the adequacy of anti-inflammatory therapy should be reviewed. In the treatment of β2-adrenergic agonists, severe hypokalemia may develop. Particular caution should be exercised in severe bronchial asthma, as this effect may be enhanced by the concomitant use of xanthine derivatives, glucocorticosteroids and diuretics. Hypoxia may increase the effect of hypokalemia on heart rate. In such situations, regular monitoring of the concentration of potassium in the blood serum is recommended.
In rare cases, myocardial ischemia associated with β2-adrenergic agonists has been observed. Hypokalemia in patients receiving digoxin increases sensitivity to cardiac glycosides and may cause arrhythmia.
The use of the drug BEROTECA N can lead to positive results of tests for the abuse of psychoactive substances for non-medical reasons (due to the presence of fenoterol).
In athletes, the use of BEROTEC N due to the presence of fenoterol in its composition can lead to positive results of doping tests.
Influences on the ability to drive vehicles and use 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 they may experience dizziness during treatment with BEROTEC N. Therefore, care should be taken when driving or using machinery. If patients experience the above undesirable sensation, they should refrain from such potentially dangerous activities as driving a car or operating machinery.
Release form
Aerosol for inhalation dosed 0.1 mg/dose. 10 ml (200 doses) in a metal aerosol can with a dosing action valve and a mouthpiece with a protective cap with the company logo. Can with instructions for use in a cardboard box.
Storage conditions
At a temperature not higher than 25°С
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.
Terms of dispensing from pharmacies
Released by prescription
Registration certificate holder
Boehringer Ingelheim International GmbH, Germany,
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co.KG, Germany
Germany, 55216, Ingelheim am Rhein, Bingerstrasse 173
For more information about the drug, as well as to send your claims and information about adverse events, please contact the following address in Russia
OOO Boehringer Ingelheim
125171, Moscow, Leningradskoe highway, 16A, building 3
Tel/Fax: 8 800 700 99 93
Catad_pgroup Anti-asthma drugs
Berotek H - official * instructions for use
*registered by the Ministry of Health of the Russian Federation (according to grls.rosminzdrav.ru)
Registration number:
P N011310/01Trade name of the drug:
Berotek® NInternational non-proprietary name:
fenoterolDosage form:
dosed aerosol for inhalationCompound:
1 inhalation dose contains:active substance: fenoterol hydrobromide 100 mcg (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:
Transparent, colorless or light yellow or light brownish liquid, free from suspended particles, placed under pressure in a metal aerosol can with a metering valve and a mouthpiece.Pharmacotherapeutic group:
bronchodilator - ß 2 - adrenomimetic selective ATC:ATX code:
R03AC04Pharmacological properties
Pharmacodynamics
Berotek N is an effective bronchodilator for the prevention and relief of attacks of bronchospasm in bronchial asthma and other conditions accompanied by reversible airway obstruction, such as chronic obstructive bronchitis (with or without emphysema).
Fenoterol is a selective ß 2 -adrenergic stimulant in the therapeutic dose range. Stimulation in 1-adrenergic receptors occurs with the use of higher doses of the drug. Binding to ß 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 deprives myosin of the ability to bind to actin, which causes smooth muscle relaxation.
Fenoterol relaxes bronchial and vascular smooth muscle 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 ß 1 -adrenergic receptors, fenoterol can have an effect on the myocardium (especially at doses exceeding therapeutic ones), causing increased heart rate and increased heart rate.
Fenoterol quickly stops 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 rest is deposited in the upper respiratory tract and in the mouth, and then swallowed.
The absolute bioavailability of fenoterol after inhalation of Berotek N metered-dose aerosol is 18.7%. Absorption of fenoterol from the lungs is biphasic: 30% of the dose is absorbed rapidly (half-life 11 minutes), and 70% is absorbed slowly (half-life 120 minutes). The maximum plasma concentration after inhalation of 200 μg of fenoterol is 66.9 pg / ml (tmax 15 minutes).
After oral administration, approximately 60% of a dose of fenoterol hydrobromide is absorbed. The amount absorbed undergoes extensive first phase hepatic metabolism resulting in an oral bioavailability of approximately 1.5% and its contribution to the plasma concentration of fenoterol after inhalation is small.
The distribution of fenoterol in plasma after intravenous administration is adequately described by a 3-component pharmacokinetic model (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, plasma protein binding is from 40 to 55%.
Fenoterol is extensively metabolized in the liver by conjugation to glucuronides and sulfates. The swallowed portion of a dose of fenoterol is metabolized predominantly by sulfation. This metabolic inactivation of the parent substance already begins in the intestinal wall.
Fenoterol is excreted by the kidneys and with bile in the form of inactive sulfate conjugates. Biotransformation, including excretion with bile, undergoes the main part - approximately 85%. The excretion of fenoterol in the urine (0.27 l / min) corresponds to approximately 15% of the average total clearance of the systemically available dose. The amount of renal clearance indicates 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 unchanged can cross the placental barrier and enter breast milk.
Indications for use
- Asthma attacks or other conditions with reversible airway obstruction, chronic bronchitis, chronic obstructive pulmonary disease.
- Prevention of 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 in the dosage form of an aerosol for inhalation dosed is not used in children under 4 years of age.
Carefully
In the following conditions, Berotek N should only be used after a careful benefit/risk assessment of treatment, especially if the maximum recommended doses are used:
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), severe 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 medical supervision.
Use during pregnancy and during breastfeeding
The results of preclinical studies, in combination with the available 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.The possibility of an inhibitory effect of fenoterol on uterine contractility should be considered.
Preclinical studies have shown that fenoterol passes into breast milk. The safety of the drug during breastfeeding has not been studied. Caution should be exercised when using the drug during breastfeeding. There are no clinical data on the effect of fenoterol on fertility. Preclinical studies of fenoterol have shown no adverse effects on fertility.
Dosage and administration
Doses for adults and children over 6 years of age
In most cases, one inhalation dose is sufficient to stop bronchospasm. If within 5 minutes there is no relief from breathing, you can repeat the inhalation.
If there is no effect after two inhalation doses, and additional inhalations are required, medical attention should be sought without delay. The maximum allowable 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, the drug Berotek N should be used only after consultation with a doctor and under adult supervision.
Doses for children from 4 to 6 years
Asthma attacks and other conditions accompanied by reversible airway obstruction
For relief of bronchospasm, one inhalation dose is sufficient.
If there is no effect, you should immediately seek medical help.
Prevention of asthma attacks due to physical exertion
1 inhalation dose before exercise, up to 4 inhalation doses per day.
In children aged 4 to 6 years, the drug 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 (twice press the bottom of the cartridge).
Each time you use an inhaler, the following rules must be observed:
Side effect
Like all inhalation treatments, Berotek N may cause local irritant symptoms.From the side of the immune system
hypersensitivity
From the side of metabolism and nutrition
Hypokalemia, including severe hypokalemia
From the side of the nervous system
agitation, nervousness, tremor, headache, dizziness
From the side 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, itching, 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, tremor, a decrease or increase in blood pressure, an increase in pulse pressure, angina pectoris, arrhythmias, flushing of the face. Metabolic acidosis and hypokalemia have also been observed at doses of fenoterol in excess of the recommended doses for approved indications.
Treatment
Treatment with Berotek H should be discontinued. Acid-base balance and electrolyte balance should be monitored.
Sedatives are used for treatment; in severe cases, intensive symptomatic therapy is carried out.
As specific antidotes, ß-blockers (preferably selective ß 1 -blockers) can be prescribed; at the same time, the possibility of strengthening 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 drugs
ß-Adrenergic drugs, anticholinergics, xanthine derivatives (such as theophylline), cromoglycic acid, glucocorticosteroids and diuretics may increase the action and side effects of fenoterol.Hypokalemia caused by ß 2 agonists may 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.
ß-adrenergic agonists should be used with caution in patients receiving monoamine oxidase inhibitors or tricyclic antidepressants, which can enhance the action of ß-adrenergic agonists.
Inhalation of general anesthetics such as halothane, trichlorethylene, and enflurane increases the likelihood of ß-adrenergic agonists affecting the cardiovascular system.
special instructions
Paradoxical bronchospasm
As with 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.
Effects from the cardiovascular system
Effects from 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 (eg, coronary heart disease, arrhythmia, or severe heart failure) receiving Berotek N should be warned to seek medical attention if chest pain or worsening of heart disease occurs.
Attention should be paid to the evaluation of symptoms such as dyspnea and chest pain, as they can be both respiratory and cardiac in nature.
hypokalemia
Potentially serious hypokalemia may develop as a result of therapy with ß 2 agonists. 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 enhance the effect of hypokalemia on heart rate. Hypokalemia may lead to an increased susceptibility to arrhythmias in patients receiving digoxin.
In such situations, it is recommended to monitor the level of potassium in the serum.
Acute progressive dyspnea
Patients should be advised to seek immediate medical attention in the event of acute, rapidly worsening dyspnoea.
Regular use
- Relief of asthma attacks (symptomatic treatment) is preferable to regular use of the drug;
- Patients should be evaluated for the need for or intensification of anti-inflammatory treatment (eg, inhaled corticosteroids) to control airway inflammation and prevent delayed lung injury.
Co-use with sympathomimetic and anticholinergic bronchodilators
Other sympathomimetic bronchodilators should be used in conjunction with Berotek N only under medical supervision. Anticholinergic bronchodilators may be inhaled simultaneously with Berotek N.
Impact on laboratory results
The use of the drug Berotek N can lead to positive test results for the presence of fenoterol in studies on the abuse of drugs for non-medical reasons, for example, due to increased physical performance in athletes (doping).
Influence on the ability to drive 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 informed that symptoms such as dizziness have been observed during clinical studies. Therefore, it is recommended to be careful while 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 action valve and a mouthpiece with a protective cap with the company logo. 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.
Holiday conditions
Released by prescriptionManufacturer
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
For more information about the drug, as well as to send your claims and information about adverse events, please contact the following address in Russia
OOO Boehringer Ingelheim
125171, Moscow, Leningradskoe highway, 16A building 3
The drug Berotek for inhalation sessions is a drug from the brocholytic series of medicines, they are used for therapy through a nebulizer for asthma of the upper and lower respiratory tract. The solution is synthetic, therefore it is used only according to the schematic instructions prescribed by the attending doctor. Instructions for the use of Berotek for inhalation provides for the treatment of spastic phenomena in the bronchial region.
The drug solution for inhalation Berotek has a relaxing effect on smooth muscle tissue, followed by therapy for bronchospasm. This result is manifested due to the active component present in Berotek - fenoterol hydrobromide. A person feels relief from suffocation within two minutes after applying the procedure with a nebulizer. The use of one dose is valid for a minimum of five hours.
During the entry of the constituent substances of the drug into the circulatory system, the compression of the patient's heartbeat may increase and become more frequent. For this reason, Berotek should be handled with extreme care so as not to cause a negative load on the cardiosystem.
If Berotek inhalation procedures are prescribed by physicians for a long time, there is a need for regular examinations to amend the instructions for use. Almost always, there may be a need for complex anti-inflammatory treatment in combination with the use of other therapeutic drugs to stabilize the functioning of organs.
Important! The lower age degree of people who can undergo inhalation treatment with Berotek is four years.
Forms of production of the drug Berotek
Pharmacists produce the drug Berotek in the following forms:
- solutions for inhalers, which are contained in a dropper container with different capacities (for dosage);
- atomizer packaged in a stainless steel cylinder. The aerosol is a structural analogue of Berotek, therefore it is called Berotek-N.
As a number of medical studies show, a solution for inhalation through a nebulizer is more effective than its counterpart, although their instructions are similar.
The drug is available in two forms Instructional guide for the use of inhalation sessions with Berotek
The dosage of the dissolving drug for adults is made taking into account the factor that one milliliter contains about twenty drops. One of them contains about 49 micrograms of the main component fenoterol hydrobromide.
The solution for inhalation sessions can be used as a dose in a nebulizer and as an oral irrigator using special aerosol cans. To use the inhalation session, they use the medicine in a drop form, first determining the dosage of the drug prescribed by the physician.
Inhaler-nebulizer Berotek is diluted with saline. When there is a special instruction, the effectiveness of the remedy is supplemented by auxiliary drugs of a mucolytic nature against bronchial pathologies.
An aerosol balloon for an inhalation procedure is calculated for two hundred times a day. Then it is replaced with a new one. Despite the sufficient amount of liquid, which, perhaps, after a course of inhalation treatment, you should not use it in connection with the evaporation of useful substances that make up Berotek. The components are allocated in an incomplete volume, therefore, the medicine will bring more harm than the expected result.
To carry out inhalation through a nebulizer, you must follow a simple technique:
- the protective cap is initially removed from the spray bottle;
- it is necessary to hold the balloon firmly, the lips wrap around the end part very tightly, without gaps. Then the entire dose enters the oral cavity;
- A person presses the bottom of the nebulizer in order to activate the spraying of the solution into the respiratory tract, inhales it. Then the final part is removed, a slow exhalation is made. Repeated inhalation procedures will be carried out in a similar way.
Important! If the nebulizer has not been used by the patient for more than 3 days, to stop the stagnation in the duct, it is necessary to release the solution into space for the first time, and only then apply it.
The final part of the nebulizer must be kept sterile, washed at least once a month. The inhaler itself with the balloon removed from it is washed with warm liquid.
Under what pathologies is the use of inhalations through a nebulizer with Berotek medicine indicated?
If you follow the instructions for the use of Berotek, it is prescribed when there is a need to remove the asthmatic component with a bronchial form, as well as in other obstructive pathologies of the respiratory tract.
The obstructive form must contain reversible views. Inhalation procedures with the drug are effective during chronic bronchitis and diseases with a mild obstructive nature.
The instructions prescribe the following indications for the treatment of pathological phenomena:
- the need to enlarge the bronchi, if the physician plans to prescribe another inhalation such as a mucolytic, glucocortidic, antibiotic;
- upcoming examination of diseases of the external respiratory tract;
- a preventive measure against asthmatic types of pathology, which was caused by systematic physical overstrain.
Depending on the problems that the use of the drug solution is aimed at, different dosages and a schematic prescription for therapy are prescribed. The duration is also selected by the medical researcher on an individual basis.
Respiratory treatment List of contraindications to the use of inhalation procedures with Berotek
It is strictly forbidden to prescribe a course of inhalation sessions for such pathologies:
- tachyarrhythmic state;
- hypertrophied obstructive cardiomyopathy;
- hypersensitivity, individual non-perception of one or more substances;
Inhalations with Berotek solution are undesirable, but acceptable (in a special case) for:
- arterial hypertension;
- atony of the intestinal tract;
- hyperthyroid phenomenon;
- chronic heart failure;
- ischemia;
- defect of the cardiosystem;
- hypokalemia.
Aerosols are not recommended for women in the first trimesters of pregnancy What side effects should be expected from inhalation through a nebulizer with the drug?
Doctors have determined the presence of a side effect of the drug on such body areas:
- respiratory: coughing, burning of the mucous membrane, paradoxical bronchospasm;
- cardiovascular: tachycardia, rhythm acceleration, pressure surges, angina pectoris;
- nervous system: dizziness, pain, deterioration of visualization, nervousness;
- digestive system: vomiting, diarrhea, nausea;
- general weakness, fatigue, strong sweating, hypokalemia, pain in muscle areas, urinary problems.
Perhaps the appearance of an allergic reaction - hives, rash, swelling. Overdose leads to certain symptoms from the list.
Possible side effects How is Berotek nebulizer therapy carried out?
For the inhalation procedure, a special device is used - a nebulizer. The instructions for use state that the individual dosage prescribed by the attending physician is dissolved with saline, but not with distilled liquid. After preparation, the solution must be used immediately. Intermediate time between therapeutic sessions is limited to four hours.
A sick patient, whose age has exceeded twelve years, should take about 10 drops. If the case is complicated, the dose is increased up to four times.
Therapy of pathologies in children with Berotek drug solution
How many inhalation sessions and dosing is necessary for a child to cure the pathology, only a doctor can say after a selective examination of the respiratory tract. Despite the indication of Berotek for children only after four years, medicine allows therapy even for small ones, but on condition that it takes place in stationary medical centers under systematic supervision.
Spray bottles, which are analogues, are used strictly after four years. The physician obligatory instructs the child and elders about proper breathing through a nebulizer with a minimally harmful substitute.
Dosage for children
The proportion of dilution of the drug is selected not from the planned dosing, but from the age category of the child. Depending on age, there are recommendations for the combination of saline:
- children under the age of six years, the quantitative warehouse of the solution up to ten drops is diluted with three milliliters of saline;
- For a child aged six to twelve, the volume of saline is 2.6-2.9 ml, regardless of the amount of Berotek. If the measure is preventive, the dose is increased to 3.4 ml.
The proportions of saline to the drug are observed steadily in order to avoid aggravation of the pathology.
The dosage of the drug is determined depending on the age Inhalation procedures with Berotek solution during childbearing
Using the medicine, pregnant women were not under the negative influence of a bronchodilator. But the drug acts in such a way that it does not exclude the effect on the muscular muscles of the uterus. Therefore, it is prescribed to a pregnant woman only when the expected result should far exceed the risks.
How does Berotek affect the body in combination with other medications?
An increase in the medicinal effect of the drug is observed when combined with a group of drugs such as a tricyclic antidepressant, an inhibitor of monoamine oxidase enzymes, and an anticholinergic substance. The hospital has a positive effect on therapeutic intervention in combination with Berotek in the use of anti-inflammatory substances.
Instructions for use
Berotek N instructions for use
Dosage form
Aerosol for inhalation dosed as a clear, colorless or slightly yellowish or slightly brownish liquid, free from suspended particles.
Compound
fenoterol hydrobromide 100 mcg
Excipients: anhydrous citric acid, absolute ethanol, purified water, 1,1,1,2-tetrafluoroethane (HFA 134a, propellant).
Pharmacodynamics
Bronchodilator drug, selective beta2-agonist.
It activates adenylate cyclase through the stimulatory Gs protein with a subsequent increase in the formation of cAMP, which in turn activates protein kinase A. The latter phosphorylates target proteins in smooth muscle cells, which in turn leads to phosphorylation of myosin light chain kinase, inhibition of phosphoinosine hydrolysis and the opening of calcium activated fast potassium channels.
Thus, fenoterol relaxes the smooth muscles of the bronchi and blood vessels, and also prevents the development of bronchospasm caused by exposure to bronchoconstrictor factors such as histamine, methacholine, cold air and allergens (immediate type reaction). After taking the drug, the release of inflammatory mediators from mast cells is inhibited. In addition, after taking fenoterol in high doses, there is an increase in mucociliary transport.
The beta-adrenergic effect of the drug on cardiac activity, such as an increase in the frequency and strength of heart contractions, is due to the vascular action of fenoterol, stimulation of beta2-adrenergic receptors of the heart, and when using doses exceeding therapeutic, stimulation of α1-adrenergic receptors.
When taking the drug in high doses, effects are observed at the metabolic level: lipolysis, glycogenolysis, hyperglycemia and hypokalemia (the latter is due to increased absorption of potassium by skeletal muscles). Fenoterol (in high concentrations) inhibits the contractile activity of the uterus.
Fenoterol prevents and quickly relieves bronchospasm of various origins (exercise, cold air, early response to allergen exposure).
The onset of action of the drug after inhalation is 5 minutes, the duration of action is 3-5 hours.
Pharmacokinetics
Suction
Depending on the inhalation system used, about 10-30% of fenoterol hydrobromide reaches the lower respiratory tract, while the rest is deposited in the upper respiratory tract and swallowed. As a result, a certain amount of inhaled fenoterol hydrobromide enters the gastrointestinal tract. After inhalation of a single dose, the degree of absorption is 17% of the dose. Absorption is biphasic: 30% of fenoterol hydrobromide is absorbed with a half-life of 11 minutes; 70% is absorbed slowly with a half-life of 120 minutes.
There is no correlation between the plasma concentrations of fenoterol achieved after inhalation and the pharmacodynamic time-effect curve. The long-term bronchodilator effect of the drug (3-5 hours) after inhalation, comparable with the corresponding effect achieved after intravenous administration, is not supported by high concentrations of the active substance in the systemic circulation. After oral administration, about 60% of the oral dose is absorbed. This part of the active substance undergoes biotransformation due to the "first pass" effect through the liver. As a result, the bioavailability of the drug after oral administration is reduced to 1.5%. This explains the fact that the swallowed amount of the drug has practically no effect on the concentration of the active substance in the blood plasma, achieved after inhalation.
Distribution
Fenoterol hydrobromide crosses the placental barrier and is excreted in breast milk.
Metabolism
Biotransformirovatsya by conjugation with sulfates mainly in the intestinal wall.
breeding
It is excreted in the urine and bile in the form of inactive sulfate conjugates.
Side effects
From the side of the central nervous system: often - a small tremor; possible (especially in patients with risk factors) dizziness, headache, nervousness; in some cases - changes in the psyche.
From the side of the cardiovascular system: often - tachycardia, palpitations; rarely (when used in high doses) - a decrease in diastolic pressure, an increase in systolic pressure, arrhythmias, angina pectoris.
From the side of metabolism: an increase in the concentration of glucose in the blood, severe hypokalemia are possible.
On the part of the respiratory system: cough, local irritation are possible; rarely - paradoxical bronchospasm.
From the digestive system: nausea, vomiting are possible.
Others: possible increased sweating, weakness, muscle pain, convulsions; rarely - local inflammatory and allergic reactions (especially in patients with hypersensitivity).
Selling Features
prescription
Special conditions
Perhaps the simultaneous use of the drug Berotek® H and anticholinergic bronchodilators.
In case of sudden onset and rapid progression of shortness of breath, the patient should also immediately consult a doctor.
Regular use of the drug Berotek® N in increasing doses for the relief of bronchial obstruction can cause an uncontrolled worsening of the course of the disease. In the case of increased bronchial obstruction, a simple increase in the dose of Berotek N more than recommended for a long time is not only not justified, but also dangerous. To prevent a life-threatening deterioration in the course of the disease, consideration should be given to revising the patient's treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids.
Other sympathomimetic bronchodilators should be administered simultaneously with Berotek N only under medical supervision.
When prescribing beta2-agonists, hypokalemia may develop. In this regard, special care is required in severe asthma, because. in this case, hypokalemia may result from the simultaneous administration of beta2-agonists, xanthine derivatives, glucocorticoids and diuretics. In addition, hypoxia may increase the effect of hypokalemia on heart rate. It is recommended to monitor the level of potassium in the blood plasma.
In patients with diabetes, it is necessary to regularly monitor the content of glucose in the blood plasma.
It should be borne in mind that symptomatic treatment is preferable to regular use of the drug. It is necessary to conduct regular examination of patients in order to determine the need for additional or more intensive anti-inflammatory treatment (for example, inhaled corticosteroids).
Pediatric use
There is no experience of clinical use of the drug in children under the age of 4 years.
Indications
Relief of attacks of bronchial asthma;
Prevention of physical effort asthma;
Symptomatic treatment of bronchial asthma or other conditions accompanied by reversible narrowing of the airways (including obstructive bronchitis). In patients with bronchial asthma and chronic obstructive pulmonary disease responding to GCS therapy, the need for concomitant anti-inflammatory therapy should be considered.
Contraindications
tachyarrhythmia;
Hypertrophic obstructive cardiomyopathy;
Children's age up to 4 years;
Hypersensitivity to fenoterol hydrobromide and other components of the drug.
With caution, the drug should be prescribed for decompensated diabetes mellitus, recent myocardial infarction, severe diseases of the cardiovascular system, uncontrolled arterial hypertension, hyperthyroidism, pheochromocytoma.
drug interaction
Beta-agonists and anticholinergics, xanthine derivatives (including theophylline), cromoglycic acid, corticosteroids can enhance the effect of fenoterol.
With the simultaneous use of other beta-agonists, anticholinergics, xanthine derivatives (for example, theophylline), corticosteroids, diuretics that enter the systemic circulation, side effects may increase.
Perhaps a significant weakening of the bronchodilator action of fenoterol with the simultaneous use of beta-blockers.
Against the background of the use of Berotek N, hypokalemia may develop, which can be aggravated by simultaneous administration with xanthine derivatives, steroids and diuretics.
Berotek® N should be prescribed with caution to patients receiving MAO inhibitors and tricyclic antidepressants, tk. these drugs can enhance the effect of fenoterol.
Means for inhalation anesthesia containing halogenated hydrocarbons (including halothane, trichlorethylene, enflurane)
Prices for Berotek N in other cities
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