Berotek - instructions for use, reviews, analogs and forms of release (solution for inhalation, inhalation aerosol N) of the drug for the treatment and prevention of attacks of bronchial asthma 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 BEROTEK N you should consult your doctor. These instructions for use are for informational purposes only. For more complete information, please refer to the manufacturer's instructions.
Clinical and pharmacological group
12.003 (Bronchodilator - beta2-adrenergic agonist)
Release form, composition and packaging
Aerosol for inhalation dosed in the form of a transparent, colorless or light yellow or light brownish liquid, free of 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) - metal can with a dosing valve and mouthpiece (1) - cardboard packs.
pharmachologic effect
Bronchodilator, selective stimulator of β2-adrenergic receptors.
When the drug is used in higher doses, β1-adrenergic receptors are stimulated (for example, when prescribed for tocolytic therapy). 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 deprives myosin of the ability to combine with actin, which prevents smooth muscle contraction and promotes bronchodilator action and the 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 its stimulating effect on β-adrenergic receptors, fenoterol can have an effect on the myocardium (especially in doses exceeding therapeutic doses), causing increased heart rate and intensification.
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.
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 ingested amount of the drug does not affect the concentration of the active substance in the blood plasma achieved after inhalation.
Fenoterol, unchanged, penetrates the placental barrier and is excreted in breast milk.
Metabolism
Fenoterol undergoes extensive metabolism in the liver by conjugation to glucuronides and sulfates. If swallowed, fenoterol is metabolized primarily by sulfation. This metabolic inactivation of the parent substance begins already in the intestinal wall.
The main part - approximately 85% - undergoes biotransformation, including excretion in bile.
Removal
It is excreted in urine and bile in the form of inactive sulfate conjugates. Fenoterol excretion in 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 from a metered dose aerosol, 2% of the dose is excreted unchanged through the kidneys 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
Attacks of bronchial asthma and other conditions accompanied by reversible airway obstruction
In most cases, 1 inhalation dose is sufficient to relieve bronchospasm; If breathing relief does not occur within 5 minutes, inhalation can be repeated.
If there is no effect after 2 inhalations and additional inhalations are required, you should immediately seek medical help.
Prevention of asthma by physical effort
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 6 years of age, the drug should be used only as directed by a physician and under adult supervision.
Attacks of bronchial asthma and other conditions accompanied by reversible airway obstruction
To relieve bronchospasm, 1 inhalation dose is sufficient. If there is no effect, you should immediately seek medical help.
Prevention of asthma by physical effort
1 inhalation dose before physical activity, up to 4 inhalations/day.
Rules for using the drug
To achieve maximum effect, it is necessary to use a dosed 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. Hold the can and tightly wrap your lips around the tip. In this case, the arrow and the bottom of the can must be directed upward.
4. Inhaling as deeply as possible, 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 (steps 2-4).
5. Put on the protective cap.
6. If the aerosol can has not been used for more than 3 days, you should press the bottom of the can once before use.
The cylinder is designed for 200 inhalations. Then the cylinder should be replaced. Although some contents may remain in the canister, the amount of drug released during inhalation is reduced.
The cylinder is opaque, so the amount of drug in the cylinder can be determined as follows: remove the protective cap, immerse the cylinder in a container filled with water. The amount of the drug is determined depending on the position of the cylinder 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, you need to shake the inhaler and let it air dry without using heating devices. When the mouthpiece is dry, return the container and dust cap to their place.
The plastic mouthpiece is designed specifically for the Berotec® N metered aerosol and serves for precise dosing of the drug. The mouthpiece should not be used with other metered dose aerosols. Berotec® N metered dose aerosol cannot also be used with other adapters.
Overdose
Symptoms: tachycardia, increased heart rate, tremor, decreased/increased blood pressure, increased pulse pressure, anginal pain, arrhythmias and facial flushing.
Treatment: prescription of sedatives, tranquilizers; in severe cases, intensive symptomatic therapy is indicated.
The use of beta-blockers (preferably selective beta1-blockers) is recommended as specific antidotes. However, it is necessary to take into account the possibility of increased bronchial obstruction and carefully select the dose of these drugs in patients with bronchial asthma.
Drug interactions
Beta-adrenergic agonists and anticholinergics, xanthine derivatives (including theophylline), corticosteroids and diuretics can enhance the effect and side effects of fenoterol.
A significant weakening of the bronchodilator effect of fenoterol is possible with simultaneous use of beta-blockers.
Berotec® N should be prescribed with caution to patients receiving MAO inhibitors and tricyclic antidepressants, because these drugs can enhance the effect of fenoterol.
Inhalation anesthetics containing halogenated hydrocarbons (including halothane, trichlorethylene, enflurane) can enhance the effect of fenoterol on the cardiovascular system (possible development of arrhythmias). The simultaneous administration of bronchodilators with a similar mechanism of action leads to an additive effect and overdose phenomena.
Pregnancy and lactation
The results of preclinical studies, combined with existing experience in 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 prescribed 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 taken into account.
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.
Metabolism: hypokalemia.
From the nervous system: excitement, nervousness, tremor, headache, dizziness.
From 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.
Storage conditions and periods
The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 3 years.
The cylinder is under pressure. The cylinder must not be opened or heated to temperatures above 50°C.
Indications
- attacks of bronchial asthma or other conditions with reversible airway obstruction (incl.
- Chronical bronchitis,
- COPD);
- prevention of bronchial asthma attacks by physical effort.
Contraindications
- tachyarrhythmia;
- hypertrophic obstructive cardiomyopathy;
- children under 4 years of age;
- hypersensitivity to fenoterol and other components of the drug.
The drug should be prescribed with caution in case of 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 heart 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 Berotec® N metered-dose aerosol 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, which contains freon, to Berotek® N, which does not contain freon. Patients need to know that Berotek®N, containing freon, and Berotek®N, which does not contain freon, are completely interchangeable, and changes in taste do not affect the effectiveness and safety of the drug.
Other sympathomimetic bronchodilators can be used together with Berotec®N only under medical supervision. If you experience acute, rapidly worsening shortness of breath (difficulty breathing), consult a doctor immediately.
Long-term use:
- relieving attacks of bronchial asthma may be preferable to regular use of the drug (symptomatic treatment);
- Patients should be assessed to determine the need for additional or more intensive anti-inflammatory treatment (eg,
- inhalation of corticosteroids) in order to control inflammation of the respiratory tract and prevent long-term 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 dosing of β2-adrenergic receptor agonists contained in drugs such as Berotec® N dosed inhalation aerosol beyond the recommended doses. In such a situation, the treatment plan and, especially, the adequacy of anti-inflammatory therapy should be reconsidered.
When treated with β2-adrenergic receptor agonists, severe hypokalemia may develop. Particular caution should be exercised in severe bronchial asthma, as this effect can be enhanced by the concomitant use of xanthine derivatives, corticosteroids and diuretics. With hypoxia, the effect of hypokalemia on heart rate may increase. In such situations, regular monitoring of serum potassium concentration 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.
Impact on the ability to drive vehicles and operate machinery
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 nonproprietary name: fenoterol
Dosage form: dosed aerosol for inhalation
Compound:
1 inhalation dose contains:
fenoterol hydrobromide 100 mcg (0.100 mg)
Excipients:
anhydrous citric acid 0.001 mg,
purified water 1.040 mg,
absolute ethanol 15.597 mg,
tetrafluoroethane (HFA 134a, propellant (tetrafluoroethane)) 35.252 mg
Description:
A transparent, colorless or light yellow or light brownish liquid, free of suspended particles, placed under pressure in a metal aerosol can with a metering valve and mouthpiece.
Pharmacotherapeutic group: bronchodilator-β2-adrenomimetic 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 emphysema.
Fenoterol is a selective β2-adrenergic receptor stimulator. When the drug is used in higher doses, β1-adrenergic receptors are stimulated (for example, when prescribed for tocolytic therapy). Binding of β2-adrenergic receptors activates adenylate cyclase through the stimulatory Gs protein with a subsequent 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 the 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 its stimulating effect on β-adrenergic receptors, fenoterol can have an effect on the myocardium (especially in doses exceeding therapeutic doses), causing increased heart rate and intensification.
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.
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 is 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 bile in the form of inactive sulfate conjugates. Thus, the ingested amount of the drug does not affect the concentration of the active substance in the blood plasma achieved after inhalation.
Fenoterol in humans undergoes intensive metabolism by conjugation to glucuronides and sulfates. If swallowed, fenoterol is metabolized primarily by sulfation. This metabolic inactivation of the parent substance begins already in the intestinal wall.
The main part - approximately 85% - undergoes biotransformation, including excretion in bile. Fenoterol excretion in 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 from a metered aerosol, 2% of the dose is excreted unchanged through the kidneys within 24 hours.
Fenoterol can pass unchanged through the placental barrier and enter breast milk.
Indications for use
Attacks of bronchial asthma or other conditions with reversible airway obstruction, chronic bronchitis, chronic obstructive pulmonary disease.
- Prevention of bronchial asthma attacks due to physical stress.
Contraindications
Hypersensitivity to fenoterol or other ingredients of the drug.
Hypertrophic obstructive cardiomyopathy, tachyarrhythmia.
Berotec N in dosed inhalation aerosol dosage form 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, 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.
Pregnancy and lactation
The results of preclinical studies, combined with existing experience in 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 taken into account.
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 for the child.
Directions for use and doses
Attacks of bronchial asthma and other conditions accompanied by reversible airway obstruction
In most cases, one inhalation dose is sufficient to replicate bronchospasm; If breathing relief does not occur within 5 minutes, inhalation can be repeated.
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 asthma by physical effort
1-2 inhalation doses before physical activity, up to 8 inhalations per day.
Due to limited experience with children under 6 years of age, the drug should be used only as directed by a physician and under adult supervision.
Attacks of bronchial asthma and other conditions accompanied by reversible airway obstruction
To replicate bronchospasm, one inhalation dose is sufficient.
If there is no effect, you should immediately seek medical help at the nearest hospital.
Prevention of asthma by physical effort
1 inhalation dose before physical activity, up to 4 inhalations per day.
To achieve maximum effect, it is necessary to use a dosed aerosol correctly.
Before using 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. Exhale slowly and completely.
3. Hold the can as shown in Fig. 1 and tightly wrap your lips around the tip. In this case, the arrow and the bottom of the inhaler are facing upward.
Fig.1
4. While inhaling as deeply as possible, simultaneously 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 (steps 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 cylinder is designed for 200 inhalations. After this, the cylinder should be replaced. Although some drug may remain in the canister, the amount of drug released during inhalation may be reduced. The cylinder is opaque, so the amount of drug in the cylinder can only be determined in the following way: by removing the protective cap, the cylinder is immersed in a container filled with water. The amount of the drug is determined depending on the position of the cylinder in the water (see Fig. 2). 
Fig 2.
The inhaler should be washed at least once a week.
It is important to keep the mouthpiece of your inhaler clean so that medication does not accumulate 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 using 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 should not be used with other metered dose aerosols. Also, Berotec N should not be used with any adapters other than the mouthpiece supplied with the drug.
The contents of the cylinder are under pressure. The container must not be opened or heated above 50°C.
Side effects
Hypersensitivity
Hypokalemia
Excitement, 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, hives
Musculoskeletal system and related tissue diseases.
muscle spasm, myalgia, muscle weakness
Overdose
Tachycardia, increased heart rate, tremor, decreased/increased blood pressure, increased pulse pressure, anginal pain, arrhythmias and facial flushing, metabolic acidosis
Sedatives, tranquilizers; in severe cases, intensive symptomatic therapy
β-blockers (preferably selective β1-blockers) can be prescribed as specific antidotes; 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 effects and side effects of fenoterol.
Significant reduction in bronchodilation with simultaneous use of fenoterol and β-blockers.
β-adrenergic agonists should be prescribed with caution to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants, which can enhance the effect of β-adrenergic agonists.
Inhalation of general anesthetics such as halothane, trichlorethylene and enflurane increases the potential for cardiovascular effects of beta-agonists. Halothane promotes the development of arrhythmia. The simultaneous administration of bronchodilators with a similar mechanism of action leads to an additive effect and overdose phenomena.
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 aerosol containing freon. Patients should be warned about this when switching from BEROTEK N, which contains freon, to BEROTEK N, which does not contain freon. Patients need to know that BEROTEK N, containing freon, and BEROTEK N, which does not contain freon, are completely interchangeable and the change in taste does not affect effectiveness and safety of the drug.
Other sympathomimetic bronchodilators can be used together with BEROTEK N inhalation aerosol dosed only under medical supervision.
If you experience acute, rapidly worsening shortness of breath (difficulty breathing), consult a doctor immediately.
Long-term use:
relieving attacks of bronchial asthma may be preferable to regular use of the drug (symptomatic treatment);
patients should be examined to determine the need for additional or more intensive anti-inflammatory treatment (for example, inhaled glucocorticosteroids) in order to control airway inflammation and prevent long-term 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 dosed inhalation aerosol, in excess of recommended doses. In such a situation, the treatment plan and especially the adequacy of anti-inflammatory therapy should be reconsidered. When treated with β2-adrenergic receptor agonists, severe hypokalemia may develop. Particular caution should be exercised in severe bronchial asthma, as this effect can be enhanced by the concomitant use of xanthine derivatives, glucocorticosteroids and diuretics. With hypoxia, the effect of hypokalemia on heart rate may increase. In such situations, regular monitoring of serum potassium concentration 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 BEROTEKA N may lead to positive test results for substance abuse for non-medical reasons (due to the presence of fenoterol).
In athletes, the use of BEROTEK N due to the presence of fenoterol in its composition can lead to positive results of doping tests.
Effects on the ability to drive vehicles and use machinery
No studies have been conducted on the effects of the drug on the ability to drive vehicles and use machinery.
However, patients should be advised that they may experience dizziness during treatment with BEROTEK N. Therefore, caution should be recommended when driving vehicles or using machinery. If patients experience the above unwanted sensation, they should refrain from potentially dangerous activities such as driving 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 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.
Conditions for dispensing from pharmacies
Dispensed with a doctor's prescription
Registration Certificate Holder
Boehringer Ingelheim International GmbH, Germany,
Manufacturer
Boehringer Ingelheim Pharma GmbH and Co.KG, Germany
Germany, 55216, Ingelheim am Rhein, Bingerstrasse 173
You can obtain additional information about the drug, as well as send your complaints and information about adverse events to the following address in Russia
Boehringer Ingelheim LLC
125171, Moscow, Leningradskoe shosse, 16A, building 3
Tel/Fax: 8 800 700 99 93
Catad_pgroup Antiasthmatic 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:
Berotec® NInternational nonproprietary name:
fenoterolDosage form:
dosed aerosol for inhalationCompound:
1 inhalation dose contains:active substance: fenoterol hydrobromide 100 mcg (0.100 mg)
Excipients:
anhydrous citric acid 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 of suspended particles, placed under pressure in a metal aerosol can with a metering valve and mouthpiece.Pharmacotherapeutic group:
bronchodilator -ß 2 -adrenomimetic selective ATC:ATX code:
R03AC04Pharmacological properties
Pharmacodynamics
Berotec 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 emphysema).
Fenoterol is a selective ß 2 -adrenergic receptor stimulant in a therapeutic dose range. Stimulation of β1-adrenergic receptors occurs when higher doses of the drug are used. Binding to ß 2 -adrenergic receptors activates adenylate cyclase through the stimulatory GS protein with a subsequent 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 relaxation of smooth muscle.
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 proinflammatory mediators from mast cells. An increase in mucociliary clearance has been demonstrated after the use of fenoterol (at a dose of 0.6 mg).
Due to its stimulating effect on ß 1-adrenergic receptors, fenoterol can have an effect on the myocardium (especially in doses exceeding therapeutic ones), causing increased heart rate and intensification.
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 physical activity, 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 settles in the upper respiratory tract and mouth and is then swallowed.
The absolute bioavailability of fenoterol after inhalation of Berotec N metered dose aerosol is 18.7%. Absorption of fenoterol from the lungs is biphasic: 30% of the dose is absorbed quickly (half-life 11 minutes), and 70% is absorbed slowly (half-life 120 minutes). The maximum plasma concentration after inhalation of 200 mcg of fenoterol is 66.9 pg/ml (tmax 15 min).
After oral administration, approximately 60% of the dose of fenoterol hydrobromide is absorbed. The amount absorbed undergoes extensive first-phase metabolism in the liver, resulting in oral bioavailability of approximately 1.5% and its contribution to fenoterol plasma concentrations 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 constant concentration after intravenous administration is 1.9-2.7 l/kg, binding to plasma proteins is from 40 to 55%.
Fenoterol undergoes extensive metabolism in the liver by conjugation to glucuronides and sulfates. The ingested portion of a dose of fenoterol is metabolized primarily 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. The main part, approximately 85%, undergoes biotransformation, including excretion in bile. Fenoterol excretion in 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 within 24 hours.
Fenoterol hydrobromide in unchanged form can cross the placental barrier and enter breast milk.
Indications for use
- Attacks of bronchial asthma or other conditions with reversible airway obstruction, chronic bronchitis, chronic obstructive pulmonary disease.
- Prevention of bronchial asthma attacks due to physical stress.
Contraindications
Hypersensitivity to fenoterol or to any of the excipients of the drug.Hypertrophic obstructive cardiomyopathy, tachyarrhythmia.
Berotec N in dosed inhalation aerosol dosage form is not used in children under 4 years of age.
Carefully
For the following conditions, Berotec N should only be used after a careful assessment of the benefits/risks of treatment, especially if the maximum recommended doses are used:
hyperthyroidism, hypokalemia, poorly 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 breastfeeding
The results of preclinical studies, combined with existing experience in 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 taken into account.
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 effects of fenoterol on fertility. Preclinical studies of fenoterol have shown no adverse effects on fertility.
Directions for use and doses
Doses for adults and children over 6 years of age
In most cases, one inhalation dose is sufficient to relieve bronchospasm. If breathing relief does not occur within 5 minutes, inhalation can be repeated.
If there is no effect after two inhalation doses and additional inhalations are required, seek medical attention without delay. The maximum permissible dose per day is 8 inhalation doses.
1-2 inhalation doses before physical activity, up to 8 inhalation doses per day.
In children aged 6 to 12 years, Berotec N should be used only after consultation with a doctor and under adult supervision.
Doses for children from 4 to 6 years
Attacks of bronchial asthma and other conditions accompanied by reversible airway obstruction
To relieve bronchospasm, one inhalation dose is sufficient.
If there is no effect, you should immediately seek medical help.
Prevention of asthma attacks due to physical stress
1 inhalation dose before physical activity, up to 4 inhalation doses per day.
In children aged 4 to 6 years, Berotec N should be used only after consultation with a doctor and under adult supervision.
Mode of application
To achieve maximum effect, it is necessary to use a dosed aerosol correctly.
To prepare your new inhaler for use, remove the protective cap, turn the inhaler upside down and make two injections into the air (press the bottom of the can twice).
Each time you use your inhaler, you must follow these rules:
Side effect
Like all other types of inhalation treatment, Berotec N may cause symptoms of local irritation.From the immune system
hypersensitivity
Metabolism and nutrition
Hypokalemia, including severe hypokalemia
From the nervous system
agitation, nervousness, tremor, headache, dizziness
From 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
Musculoskeletal system and related tissue diseases.
muscle spasm, myalgia, muscle weakness
Overdose
Symptoms
In case of overdose, the expected symptoms are those caused by excessive beta-adrenergic stimulation. The most pronounced are tachycardia, palpitations, tremor, decreased or increased blood pressure, increased pulse pressure, angina pectoris, arrhythmias, facial hyperemia. Metabolic acidosis and hypokalemia have also been observed when fenoterol was used in doses higher than recommended doses for its approved indication.
Treatment
Treatment with Berotec N should be discontinued. Acid-base and electrolyte balance should be monitored.
Sedatives are used for treatment; in severe cases, intensive symptomatic therapy is carried out.
ß-blockers (preferably selective ß 1 -blockers) can be prescribed as specific antidotes; 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 drugs
ß-Adrenergic drugs, anticholinergics, xanthine derivatives (such as theophylline), cromoglycic acid, glucocorticosteroids and diuretics may increase the effects and side effects of fenoterol.Hypokalemia caused by ß 2 -agonists may be enhanced by concomitant therapy with xanthine derivatives, corticosteroids and diuretics. This should especially be taken into account in patients with severe airway obstruction (see section "Special instructions").
Significant reduction in bronchodilation with simultaneous use of fenoterol and ß-blockers.
ß-adrenergic agonists should be prescribed with caution to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants, which can enhance the effect of ß-adrenergic agonists.
Inhalation of general anesthetics such as halothane, trichlorethylene and enflurane increases the potential for cardiovascular effects of beta-adrenergic agonists.
special instructions
Paradoxical bronchospasm
Like other inhaled drugs, Berotec 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 cardiovascular system can be observed with the use of sympathomimetic drugs, including the drug Berotec 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 artery disease, arrhythmia, or severe heart failure) receiving Berotec N should be warned to seek medical attention if chest pain or worsening of heart disease occurs.
Care should be taken to evaluate symptoms such as shortness of breath and chest pain, as they may be either respiratory or cardiac in nature.
Hypokalemia
Potentially serious hypokalemia may occur due to therapy with ß 2 -agonists. Particular caution is recommended 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 serum potassium levels.
Acute progressive dyspnea
Patients should be advised to seek immediate medical attention in the event of acute, rapidly worsening shortness of breath.
Regular use
- Relieving attacks of bronchial asthma (symptomatic treatment) is preferable to regular use of the drug;
- Patients should be assessed for the need for initiation or intensification of anti-inflammatory treatment (eg, inhaled corticosteroids) to control airway inflammation and prevent delayed lung injury.
Concomitant use with sympathomimetic and anticholinergic bronchodilators
Other sympathomimetic bronchodilators should be used in conjunction with Berotec N only under medical supervision. Anticholinergic bronchodilators can be inhaled simultaneously with Berotec N.
Impact on laboratory results
The use of Berotec N may result in positive test results for fenoterol in drug abuse studies for non-medical indications, such as performance enhancement in athletes (doping).
Impact on the ability to drive vehicles and machinery
No studies have been conducted on the effects of the drug on the ability to drive vehicles and use machinery.
However, patients should be informed that symptoms such as dizziness were observed during clinical studies. Therefore, it is recommended to exercise caution 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 with a doctor's 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 production of the medicinal product
Boehringer Ingelheim Pharma GmbH and Co.KG, Germany
Germany, 55216, Ingelheim am Rhein, Bingerstrasse 173
You can obtain additional information about the drug, as well as send your complaints and information about adverse events to the following address in Russia
Boehringer Ingelheim LLC
125171, Moscow, Leningradskoe shosse, 16A building 3
The drug Berotec for inhalation sessions is a drug from the brocholytic range of medications; 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 using Berotek for inhalation provide for the treatment of spastic phenomena in the bronchial region.
The medicinal solution for inhalation Berotec has a relaxing effect on smooth muscle tissue with subsequent treatment of bronchospasm. This result is due to the active component present in Berotek - fenoterol hydrobromide. A person feels relief from suffocation within two minutes after using the nebulizer procedure. Use of one dose is effective for at least five hours.
When the constituent substances of the drug enter the circulatory system, the compression of the patient’s heartbeat may intensify and become more frequent. For this reason, Berotec should be handled with extreme caution so as not to cause a negative load on the cardiovascular system.
If Berotec inhalation procedures are prescribed by doctors 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 lowest age limit for people who can undergo inhalation treatment with Berotec is four years.
Forms of production of the drug Berotec
Pharmacists produce the drug Berotec in the following forms:
- solutions for inhalers, which are contained in dropper containers with different capacities (for dosage);
- a sprayer packaged in a stainless steel container. 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 analogue, although their instructions are similar.
The drug is available in two forms Instructions for the use of inhalation sessions with Berotec
The dosage of dissolving medicine for adults is made taking into account the fact that one milliliter contains about twenty drops. One of them contains about 49 mcg 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 cylinders. To use an inhalation session, use the medicine in drop form, first determining the dosage of the drug prescribed by the doctor.
Nebulizer inhaler Berotek is diluted with saline solution. When there is special instruction, the effectiveness of the drug is complemented by auxiliary drugs of a mucolytic nature against bronchial pathologies.
The aerosol cylinder for the inhalation procedure is designed for two hundred times use. Then it is replaced with a new one. Despite the sufficient amount of liquid that may occur after a course of inhalation treatment, you should not use it due to the evaporation of the beneficial substances that make up Berotec. The components are not released in full, therefore, the medicine will cause more harm than the expected result.
To carry out inhalation through a nebulizer, you must follow a simple technique:
- Initially, the protective cap is removed from the spray bottle;
- you need to hold the balloon tightly, your lips clasp the end part very tightly, without gaps. Then the entire dose enters the oral cavity;
- The person presses the bottom of the nebulizer to activate spraying of the solution onto the respiratory tract and inhales it. Then the final part is removed and a slow exhalation is made. Repeated inhalation procedures will be carried out in the same way.
Important! If the nebulizer has not been used by the patient for more than 3 days, to relieve congestion in the duct, it is necessary to release the solution into the space for the first time, and only then use it.
The end part of the nebulizer must be kept sterile and washed at least once a month. The inhaler itself with the balloon removed from it is washed with warm liquid.
For what pathologies is the use of inhalation through a nebulizer with the drug Berotek indicated?
If you follow the instructions for use of Berotek, it is prescribed when there is a need to remove the asthmatic component with the bronchial form, as well as for other obstructive pathologies of the respiratory areas.
The obstructive form must contain reversible species. 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, glucocorticoid, or antibiotic;
- upcoming examination of external respiratory tract diseases;
- a preventive measure against asthmatic types of pathology, which was caused by systematic physical overexertion.
Depending on the problems addressed by the use of the medicinal solution, different dosages and a schematic prescription for therapy are prescribed. The medical researcher also selects the duration on an individual basis.
Respiratory treatment List of contraindications to the use of inhalation procedures with Berotec
Prescribing a course of inhalation sessions is strictly prohibited for the following pathologies:
- tachyarrhythmic condition;
- hypertrophied obstructive cardiomyopathy;
- excessive sensitivity, individual intolerance to one or more substances;
Inhalations with Berotec solution are undesirable, but acceptable (in special cases) if:
- arterial hypertension;
- atony of the intestinal tract;
- hyperthyroidism phenomenon;
- chronic heart failure;
- ischemia;
- cardiac system defect;
- 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 side effects of the drug on the following body areas:
- respiratory: cough, burning of the mucous membrane, paradoxical bronchospasm;
- cardiovascular: tachycardia, accelerated rhythm, pressure surges, angina pain;
- nervous system: dizziness, pain, decreased visualization, nervousness;
- digestive system: vomiting, diarrhea, nausea;
- general weakness, fatigue, severe sweating, hypokalemia, pain in muscle areas, urinary problems.
An allergic reaction may occur - hives, rash, swelling. An overdose leads to certain symptoms from the list.
Possible side effects How is nebulizer therapy with Berotec 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 solution, but not with distilled liquid. After preparation, the solution must be used immediately. The interim time between therapeutic sessions is within four hours.
A sick patient over twelve years of age should take approximately 10 drops. If the case is complicated, the dose is increased up to four times.
Therapy of pathologies in children using Berotek medicinal solution
How many inhalation sessions and dosages are 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 of age, medicine allows therapy for children, but on the condition that it takes place in stationary medical centers under systematic supervision.
Spray bottles, which are analogues, are used strictly after four years. The doctor must instruct 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 dosage, but from the age category of the child. Depending on age, there are recommendations for the combination of saline solution:
- for children under six years of age, a quantitative solution of up to ten drops is diluted with three milliliters of saline;
- For a child aged six to twelve, the volume of saline solution 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 solution to the medicine are strictly observed to avoid worsening the pathology.
The dosage of the drug is determined depending on age Inhalation procedures with Berotec solution during pregnancy
When using the medicine, pregnant women were not under the negative influence of the 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 used in combination 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 Berotec in the use of anti-inflammatory substances.
Instructions for use
Berotek N instructions for use
Dosage form
Aerosol for inhalation dosed in the form of a clear, colorless or slightly yellowish or slightly brownish liquid, free of 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, selective beta2-adrenergic agonist.
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 the influence of bronchoconstrictor factors such as histamine, methacholine, cold air and allergens (immediate 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 effect of fenoterol, stimulation of beta2-adrenergic receptors of the heart, and when using doses exceeding therapeutic doses, stimulation of β1-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 potassium absorption by skeletal muscles). Fenoterol (in high concentrations) inhibits the contractile activity of the uterus.
Fenoterol prevents and quickly relieves bronchospasm of various origins (physical activity, cold air, early response to allergen exposure).
The onset of action of the drug after inhalation is after 5 minutes, the duration of action is 3-5 hours.
Pharmacokinetics
Suction
Depending on the inhalation system used, approximately 10-30% of fenoterol hydrobromide reaches the lower respiratory tract, and the rest is deposited in the upper respiratory tract and is swallowed. As a result, some amount of inhaled fenoterol hydrobromide enters the gastrointestinal tract. After inhalation of one dose, the degree of absorption is 17% of the dose. Absorption is biphasic: 30% of fenoterol hydrobromide is absorbed with a half-absorption period of 11 minutes; 70% is absorbed slowly with a half-absorption period 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 to 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 ingested 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 ingested amount of the drug has virtually 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
Biotransformed by conjugation with sulfates mainly in the intestinal wall.
Removal
It is excreted in urine and bile in the form of inactive sulfate conjugates.
Side effects
From the side of the central nervous system: often - small tremor; possible (especially in patients with risk factors) dizziness, headache, nervousness; in some cases - mental changes.
From the cardiovascular system: often - tachycardia, palpitations; rarely (when used in high doses) - decreased diastolic pressure, increased systolic pressure, arrhythmias, angina pectoris.
From the metabolic side: increased concentrations of glucose in the blood and severe hypokalemia are possible.
From the respiratory system: cough, local irritation are possible; rarely – paradoxical bronchospasm.
From the digestive system: nausea and vomiting are possible.
Other: increased sweating, weakness, muscle pain, cramps are possible; rarely - local inflammatory and allergic reactions (especially in patients with hypersensitivity).
Selling Features
prescription
Special conditions
The simultaneous use of Berotec® N and anticholinergic bronchodilators is possible.
In case of sudden onset and rapid progression of shortness of breath, the patient should also immediately consult a doctor.
Regular use of Berotec® N in increasing doses to relieve bronchial obstruction may cause uncontrolled worsening of the disease. In case of increased bronchial obstruction, simply increasing the dose of Berotec N above the recommended dose for a long time is not only not justified, but also dangerous. To prevent life-threatening worsening of the disease, consideration should be given to reviewing the patient's treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids.
Other sympathomimetic bronchodilators should be prescribed concomitantly with Berotec N only under medical supervision.
When prescribing beta2-adrenergic agonists, hypokalemia may develop. In this regard, special caution is required in severe asthma, because in this case, hypokalemia may occur as a result of the simultaneous administration of beta2-adrenergic agonists, xanthine derivatives, glucocorticoids and diuretics. In addition, with hypoxia, the effect of hypokalemia on heart rate may be enhanced. It is recommended to monitor plasma potassium levels.
In patients with diabetes mellitus, it is necessary to regularly monitor plasma glucose levels.
It should be borne in mind that symptomatic treatment is preferable to regular use of the drug. Patients should be regularly assessed to determine the need for additional or more intensive anti-inflammatory treatment (for example, inhaled corticosteroids).
Use in pediatrics
There is no experience of clinical use of the drug in children under 4 years of age.
Indications
Relieving attacks of bronchial asthma;
Prevention of asthma by physical effort;
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 who respond to GCS therapy, the need for concomitant anti-inflammatory therapy should be considered.
Contraindications
Tachyarrhythmia;
Hypertrophic obstructive cardiomyopathy;
Children under 4 years of age;
Hypersensitivity to fenoterol hydrobromide and other components of the drug.
The drug should be prescribed with caution in cases of decompensated diabetes mellitus, recent myocardial infarction, severe diseases of the cardiovascular system, uncontrolled arterial hypertension, hyperthyroidism, pheochromocytoma.
Drug interactions
Beta-adrenergic agonists and anticholinergics, xanthine derivatives (including theophylline), cromoglycic acid, and corticosteroids may enhance the effect of fenoterol.
With the simultaneous use of other beta-adrenergic agonists, anticholinergics, xanthine derivatives (for example, theophylline), corticosteroids, diuretics that enter the systemic circulation, increased side effects may occur.
A significant weakening of the bronchodilator effect of fenoterol is possible with simultaneous use of beta-blockers.
During the use of Berotec N, hypokalemia may develop, which may increase when administered simultaneously with xanthine derivatives, steroids and diuretics.
Berotec® N should be prescribed with caution to patients receiving MAO inhibitors and tricyclic antidepressants, because these drugs can enhance the effect of fenoterol.
Inhalation anesthetics containing halogenated hydrocarbons (including halothane, trichlorethylene, enflurane)
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