Instructions for use BEROTEK (BEROTEC)
Suction
Depending on the method of inhalation and the inhalation system used, about 10-30% of the active substance released from the aerosol preparation after inhalation reaches the lower respiratory tract, and the rest is deposited in the upper respiratory tract and in the mouth and then swallowed. As a result, some amount of inhaled fenoterol enters the gastrointestinal tract. After inhalation of a metered dose aerosol, the absolute bioavailability of fenoterol is 18.7% of the administered dose. Absorption from the lungs is biphasic - 30% of fenoterol hydrobromide is rapidly absorbed with a half-life of 11 minutes, and 70% is absorbed slowly with a half-life of 120 minutes.
Cmax of the drug in blood plasma (Cmax 45.3 pg/ml) was observed 15 minutes after a single inhalation of 100 mcg of fenoterol using a metered-dose inhaler with freon in patients with bronchial asthma. However, in studies involving healthy volunteers, in which blood tests were taken more frequently, it was found that serum Cmax of the drug was achieved earlier: 2 and 3.5 minutes after dosing. Cmax of the drug in serum after inhalation of a single dose of fenoterol 200 mcg using a tetrafluoroethane (HFA) metered-dose inhaler:
- Cmax 6.9 pg/ml, tmax15 minutes.
After oral administration, the degree of absorption is 60% of the administered dose of fenoterol hydrobromide. This amount undergoes extensive first-pass metabolism, resulting in a bioavailability of approximately 1.5%. Thus, the ingested portion of the active substance has only a minor effect on the plasma concentration after inhalation.
Distribution
Fenoterol is distributed throughout the body. Vd in a stable state after intravenous administration (Vss) is 1.9–2.7 l/kg. The distribution of fenoterol in blood plasma after intravenous administration occurs according to a three-phase pharmacokinetic model. T1/2 are tα= 0.2 minutes, tβ= 14.3 minutes and tγ= 3.2 hours. Plasma protein binding ranges from 40 to 55%.
Metabolism
The biotransformation of fenoterol hydrobromide in humans occurs through conjugation with sulfates. Following oral administration, fenoterol is metabolized primarily through sulfation. This metabolic inactivation of the parent substance begins already in the intestinal walls.
Removal
Biotransformation, including biliary excretion, is due mainly (approximately 85%) to the average total clearance of 1.1-1.8 l/min. after intravenous administration. Renal excretion of fenoterol (0.27 l/min) corresponds to approximately 15% of the average total clearance of the systemically available dose. Considering the part of the drug that binds to plasma proteins, the renal clearance value indicates tubular secretion of fenoterol in addition to glomerular filtration.
After oral and IV administration, the total radioactivity excreted in urine is approximately 39% and 65% of the dose, and the total radioactivity excreted in feces is 40.2% and 14.8% of the dose over 48 hours, respectively. After oral administration, 0.38% of the dose is excreted unchanged into the urine, while with intravenous administration - 15%. After inhalation using a metered dose inhaler, 2% of the dose is excreted unchanged in the urine within 24 hours.
In unchanged form, fenoterol hydrobromide can cross the placental barrier and enter breast milk.
The metabolism of fenoterol hydrobromide in diabetes has not been sufficiently studied.
Buy Berotec N aerosol for inhalation 100 mcg/dose 200 doses 10 ml in pharmacies
Berotek N Buy Berotek N in pharmacies DOSAGE FORMS aerosol for inhalation dosed 100 mcg/dose 200 dz
MANUFACTURERS Boehringer Ingelheim Pharma GmbH and Co.KG (Germany)
GROUP Drugs that stimulate beta-adrenergic receptors
INTERNATIONAL NON-PROPENTED NAME Fenoterol
SYNONYMS Berotec, Fenoterol, Ftagirol Pharmacological action
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. Bronchial asthma Bronchial asthma is a serious disease that interferes with normal breathing, because. Due to inflammation, swelling and mucus production, the airways leading to the lungs narrow.
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. Dosage
Adults and teenagers over 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 consult a doctor.
Prevention of asthma by physical effort
1-2 inhalation doses before physical activity, up to 8 inhalations/day.
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.
It is important to keep the mouthpiece of the 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.
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 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), cromoglycic acid, corticosteroids and diuretics may 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. 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 (including chronic bronchitis, COPD);
- prevention of attacks of bronchial asthma through physical effort. Allergology
Quincke's edema Anaphylactic shock Hay fever Allergy
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 Berotec N, which contains freon, to Berotec 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:
- relief of bronchial asthma attacks 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 corticosteroids) 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 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.
Berotek solution for inhalation 1 mg/ml 20 ml bottle No. 1
BEROTEK International nonproprietary name: fenoterol Dosage form: solution for inhalation
Composition: 1 ml of solution contains 1 mg of fenoterol hydrobromide. Excipients: benzalkonium chloride, disodium edetate, sodium chloride, hydrochloric acid, purified water.
Description: transparent, colorless or almost colorless liquid, free of particles. The smell is almost imperceptible.
Pharmacotherapeutic group: drugs for the treatment of obstructive respiratory diseases. Adrenergic agents for inhalation use. ATX code: R03AC04
Pharmacological properties Pharmacodynamics Fenoterol hydrobromide is a selective stimulator of beta-adrenergic receptors when taken in therapeutic doses. Stimulation of β1-adrenergic receptors occurs when the drug is used in higher doses (for example, during tocolytic therapy). Binding of β2-adrenergic receptors activates adenyl cyclase through the stimulatory Gs protein with a subsequent increase in the formation of cAMP, which in turn activates protein kinase A, which then phosphorylates target proteins in smooth muscle cells. This in turn leads to phosphorylation of myosin light chain kinase, inhibition of phosphoinosine hydrolysis and 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 (0.6 mg), an increase in mucociliary transport is observed. Higher plasma concentrations of the drug, achieved after oral or more often after intravenous administration, inhibit uterine contractility. When taking high doses of the drug, effects are also observed at the metabolic level: lipolysis, glycogenolysis, hyperglycemia and hypokalemia (the latter is due to increased absorption of K+ by skeletal muscles). β-adrenergic effects at the level of the heart muscle, such as an increase in heart rate and increased myocardial contractility, are explained by the effect of fenoterol on blood vessels, stimulation of (32-adrenergic receptors of the heart, and when taking the drug in doses exceeding therapeutic doses, stimulation of β2-adrenergic receptors. Also As with other β-adrenergic agents, prolongation of the QTc interval has been reported. For fenoterol administered by metered-dose inhaler, these effects were discrete and observed at doses higher than recommended. However, systemic exposure after administration of the inhalation solution via nebulizers was higher than with administration of recommended doses by metered dose inhaler. A frequently observed effect of β-adrenergic receptor agonists is tremor. In contrast to the effect on bronchial smooth muscle, the systemic effects of β-adrenergic receptor agonists are associated with the development of tolerance. Fenoterol prevents and quickly relieves bronchospasm of various origins (physical activity, cold air, immediate type reaction to exposure to an allergen). The onset of action after inhalation is within a few minutes, maximum - 30-9.0 minutes, duration - 3-5 hours.
Pharmacokinetics Absorption Depending on the method of inhalation and the inhalation system used, about 10-30% of the active substance released from the aerosol preparation after inhalation reaches the lower respiratory tract, and the rest is deposited in the upper respiratory tract and in the mouth, and then swallowed. As a result, some amount of inhaled fenoterol enters the gastrointestinal tract. After inhalation of a metered dose aerosol, the absolute bioavailability of fenoterol is 18.7% of the administered dose. Absorption from the lungs is biphasic: 30% of fenoterol hydrobromide is rapidly absorbed with a half-life of 11 minutes, and 70% is absorbed slowly with a half-life of 120 minutes. Maximum concentrations of the drug in blood plasma (Cmax 45.3 pg/ml) were observed 15 minutes after a single inhalation of 100 mcg of fenoterol using a metered-dose inhaler with freon in patients with bronchial asthma. However, in studies involving healthy volunteers, in which blood tests were taken more frequently, it was found that maximum serum concentrations of the drug were achieved earlier: 2 and 3.5 minutes after dosing. Maximum concentrations of the drug in the blood serum after inhalation of a single dose of fenoterol 200 mcg using a metered-dose inhaler with tetrafluoroethane: Cmax 66.9 pg/ml, tmax 15 min. After oral administration, absorption is 60% of the administered dose of fenoterol hydrobromide. This amount undergoes extensive first-pass metabolism, resulting in a bioavailability of approximately 1.5%. Thus, the ingested portion of the active substance has only a minor effect on the plasma concentration after inhalation.
Distribution Fenoterol is distributed throughout the body. The volume of distribution at steady state after intravenous administration (Vss) is 1.9 - 2.7 l/kg. The distribution of fenoterol in blood plasma after intravenous administration occurs according to a three-phase pharmacokinetic model. The half-lives are t? = 0.2 minutes, t?= 14.3 minutes and tY = 3.2 hours. Plasma protein binding ranges from 40 to 55%.
Metabolism Biotransformation of fenoterol hydrobromide in humans occurs through conjugation with sulfates. Following oral administration, fenoterol is metabolized primarily through sulfation. This metabolic inactivation of the parent substance begins already in the intestinal walls.
Excretion Biotransformation, including biliary excretion, is due mainly (approximately 85%) to the average total clearance of 1.1-1.8 l/min. after intravenous administration. Renal excretion of fenoterol (0.27 L/min) corresponds to approximately 15% of the average total clearance of the systemically available dose. Considering the part of the drug that binds to plasma proteins, the renal clearance value indicates tubular secretion of fenoterol in addition to glomerular filtration. After oral and intravenous administration, total radioactivity, . g excreted into urine is approximately 39% and 65% of the dose, and total radioactivity excreted into feces is 40.2% and 14.8% of the dose over 48 hours, respectively. After oral administration, 0.38% of the dose is excreted unchanged in the urine, while with intravenous administration -15%. After inhalation using a metered dose inhaler, 2% of the dose is excreted unchanged in the urine within 24 hours. In unchanged form, fenoterol hydrobromide can cross the placental barrier and be excreted in breast milk. The metabolism of fenoterol hydrobromide in diabetes has not been sufficiently studied.
Indications for use: Symptomatic treatment of acute attacks of asthma and other conditions with reversible narrowing of the airways, such as chronic obstructive bronchitis. In patients with asthma attacks and chronic obstructive pulmonary disease (COPD) who respond to steroids, the need for concomitant anti-inflammatory therapy should be considered. — Prevention of bronchial asthma attacks due to physical stress.
Method of administration and dosage For oral inhalation. (20 drops = 1 ml) (1 drop = 50 mcg fenoterol hydrobromide) Doses should be adjusted to individual patient needs; in addition, during treatment the patient must be under the supervision of a physician. Unless otherwise indicated, the following dosage regimen is recommended:
Adults (including elderly patients) and children over 14 years of age: Acute attacks of asthma and other conditions with reversible narrowing of the airways: 0.5 ml (10 drops = 0.5 mg fenoterol hydrobromide) is in most cases sufficient for immediate relief of the symptom. If repeated dosing up to 4 times a day is required, a reduction in individual doses should be considered depending on the technical characteristics of the nebulizer. In severe cases, where most patients require emergency medical attention, higher doses may be required: 1 to 1.25 ml (20-25 drops = 1-1.25 mg fenoterol hydrobromide). In especially severe cases, up to 2 ml (40 drops = 2 mg of fenoterol hydrobromide) can be administered under medical supervision. Prevention of exercise asthma: 0.5 ml (10 drops = 0.5 mg fenoterol hydrobromide) before starting physical exercise.
Children from 6 to 14 years old: Acute attacks of asthma and other conditions with reversible narrowing of the airways: 0.25-0.5 ml (5-10 drops = 0.25-0.5 mg fenoterol hydrobromide) is in most cases sufficient for immediate symptom relief. If repeated dosing up to 4 times a day is required, a reduction in individual doses should be considered depending on the technical characteristics of the nebulizer. In severe cases, higher doses may be required: up to 1 ml (20 drops = 1 mg fenoterol hydrobromide). In particularly severe cases, up to 1.5 ml (30 drops = 1.5 mg of fenoterol hydrobromide) can be administered under medical supervision. Prevention of exercise asthma: 0.5 ml (10 drops = 0.5 mg fenoterol hydrobromide) before starting physical exercise.
Children under 6 years of age (weighing less than 22 kg): Due to limited information about this age group, treatment is carried out only under medical supervision. Recommended dose: approximately 50 mcg fenoterol hydrobromide per dose (= 0.05 ml or 1 drop) per kg body weight up to 3 times a day. Treatment usually begins with the lowest recommended dose. The recommended dose is diluted with saline to a final volume of 3-4 ml, sprayed and inhaled until the resulting dilution is completely consumed. BEROTEK solution for inhalation must not be diluted with distilled water. The solution is diluted anew each time before use; the remaining diluted solution is discarded. The dosage regimen may depend on the method of inhalation and the characteristics of the inhaler. The duration of inhalation can be controlled by the volume of dilution. BEROTEK solution for inhalation can be used using commercially available inhalers. If oxygen-breathing equipment is available, the solution is best inhaled at a flow rate of 6-8 l/min. BEROTEK solution for inhalation can be inhaled simultaneously with compatible anticholinergic and mucolytic agents. This applies, first of all, to the drugs ATROVENT and LAZOLVAN in the form of solutions for inhalation. If necessary, subsequent inhalations are carried out at intervals of at least 4 hours.
Side effects Like other β-agonists, BEROTEK can cause the following side effects, including severe hypokalemia. Like other drugs used by inhalation, BEROTEK can cause local irritation. The frequency of side effects is indicated as: very common (> 1/10) ; common (>1/100 to <1/10); uncommon (>1/1000 to <1/100); rare (>1/10000 to <1/1000); very rare (<1/10000 ); unknown (cannot be assessed based on the available data). From the immune system: unknown - hypersensitivity, allergic reactions. From the metabolism: infrequently - hypokalemia. Mental disorders: infrequently - anxious agitation; unknown - nervousness. From the side nervous system: often - tremor; unknown headache, dizziness. From the cardiovascular system: infrequently arrhythmia, unknown - myocardial ischemia, tachycardia, rapid heartbeat. From the respiratory system: often - cough; infrequently paradoxical bronchospasm; unknown - irritation in the throat. From the digestive system: infrequently - nausea, vomiting. From the skin and subcutaneous tissues: infrequently - itching; unknown - increased sweating, skin reactions, rash, urticaria. From the musculoskeletal and connective tissue: unknown - muscle spasm, myalgia, muscle weakness, tremor. General disorders: feeling of weakness. From laboratory and instrumental data: unknown - increased systolic blood pressure, decreased diastolic blood pressure.
Contraindications Hypertrophic obstructive cardiomyopathy, tachyarrhythmia. Hypersensitivity to fenoterol hydrobromide, other beta-agonist, or any other component of the drug.
Overdose Symptoms Symptoms associated with excessive stimulation of |3-adrenergic receptors may occur. The most likely development is tachycardia, palpitations, tremor, hypertension, hypotension, increased pulse pressure, angina pectoris, arrhythmia, and hyperemia. In addition, metabolic acidosis may occur if doses of fenoterol exceed those recommended when taking BEROTECA for its registered indications. Treatment Prescription of sedatives, tranquilizers; in severe cases, intensive symptomatic therapy is indicated. β-blockers, especially β1-selective ones, are 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 for patients suffering from bronchial asthma.
Precautions BEROTEK should be used only after a careful assessment of the risk/benefit ratio, especially when used in doses higher than recommended, in the presence of the following diseases: uncontrolled diabetes mellitus, recent myocardial infarction, severe diseases of the cardiovascular system, hyperthyroidism, pheochromocytoma. In case of sudden development and rapid progression of shortness of breath, you should immediately consult a doctor.
Long-term use of the drug: - treatment on demand (symptom-oriented) 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). Regular use of drugs containing β2-adrenergic antagonists, such as BEROTEK, in doses exceeding the recommended ones to relieve bronchial obstruction can cause uncontrolled worsening of the disease. In the case of increased bronchial obstruction, a simple increase in the dose of β2-adrenergic agonists, including BEROTECA, for a long time is not only not justified, but also dangerous. To prevent life-threatening worsening of the disease, a review of the patient's treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids should be considered. When prescribing β2-adrenergic agonists, serious hypokalemia may develop. In this regard, special caution is required in severe asthma, since in this case hypokalemia can occur as a result of the simultaneous administration of β2-adrenergic agonists, xanthine derivatives, glucocorticoids and diuretics. In addition, with hypoxia, the effect of hypokalemia on heart rate may be enhanced. In patients taking digoxin, hypokalemia may cause an increased susceptibility to arrhythmias. In such cases, it is recommended to monitor the level of potassium in the blood plasma. The use of sympathomimetic drugs, including BEROTECA, may have effects on the cardiovascular system. In connection with the use of β-adrenergic agonists, there is a small likelihood of myocardial ischemia. Patients with severe heart disease (for example, coronary artery disease, arrhythmia or acute heart failure) taking BEROTEK should be warned that if they experience chest pain or other symptoms of worsening heart disease, they should consult a doctor. Particular attention should be paid to symptoms such as chest pain and shortness of breath, because... their cause can be both disorders of the respiratory system and the functioning of the heart. BEROTEK solution for inhalation contains the preservative (antimicrobial) benzalkonium chloride and the stabilizer disodium edetate. It has been found that the above components may cause bronchoconstriction in some patients.
Pregnancy and lactation The results of preclinical studies, combined with existing experience in the clinical use of the drug, indicate that it does not cause any adverse effects during pregnancy. However, normal caution should be exercised regarding the use of medications during pregnancy (especially in the first third). We should not forget that fenoterol inhibits the contractile function of the uterus. Preclinical studies have shown that fenoterol passes into breast milk. The safety of the drug during lactation has not been established. There are no clinical data on the effect of fenoterol on fertility. Preclinical studies conducted with fenoterol have shown no negative effects on fertility.
Effect on the ability to drive a car and use machinery. No studies have been conducted on the effect of the drug on the ability to drive a car or use machinery. However, patients should be informed that dizziness has been reported as a side effect in clinical studies. Therefore, it is recommended to exercise caution when driving and operating machinery. If patients experience the above side effects, they should avoid such potentially dangerous activities as driving a car or using machinery.
Interactions with other drugs: β-adrenergic drugs, anticholinergics and xanthine derivatives (for example, theophylline) may increase the effect and side effects of fenoterol. A significant decrease in the bronchodilator effect is possible with simultaneous administration of fenoterol and β-adrenergic receptor blockers. β-adrenergic agonists should be prescribed with caution to patients receiving MAO inhibitors or tricyclic antidepressants, which can enhance the effect of β-adrenergic agonists. Inhalation of fluorinated hydrocarbon anesthetics such as halothane, fluorothane, trichlorethylene and enflurane may increase the likelihood of β-agonist action at the cardiovascular level.
Release form: 20 ml in a dark glass bottle with a polyethylene dropper and a screw-on polypropylene cap. The bottle along with the instructions is placed in a cardboard box.
Storage conditions Store at a temperature not exceeding 30C. Do not freeze. Keep out of the reach of children.
Shelf life: 5 years. Do not use the drug after the expiration date indicated on the package.
Conditions for dispensing from pharmacies By doctor's prescription. List B.
Berotec® N
Paradoxical bronchospasm
Like other inhaled drugs, BEROTEK N can cause paradoxical bronchospasm, which can be life-threatening. If paradoxical bronchospasm occurs, the drug should be immediately discontinued and replaced with alternative therapy.
Cardiovascular effects
Effects on the 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 artery 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.
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 beta 2-agonist therapy. 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
— Relief of 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.
In case of increased bronchial obstruction, it is unacceptable and may be risky to increase the dosage of β2-adrenergic agonists. such as the drug BEROTEK N, in excess of recommended doses and for a long time. The use of increased doses of beta 2-agonists, such as BEROTEK N, on a regular basis to control symptoms of bronchial obstruction may indicate deterioration of disease control. In such a situation, the treatment plan and especially the adequacy of anti-inflammatory therapy should be reconsidered to prevent potentially life-threatening deterioration of disease control. Concomitant use with sympathomimetic and anticholinergic bronchodilators
Other sympathomimetic bronchodilators should be used in conjunction with BEROTEK N only under medical supervision. Anticholinergic bronchodilators can be inhaled simultaneously with BEROTEK N. Effect on laboratory results
The use of BEROTEK N may result in positive test results for fenoterol in drug abuse studies for non-medical indications, such as performance enhancement in athletes (doping).
Please note that the drug contains a small amount of ethanol (15.597 mg per dose).
