Composition and release form
| Solution for inhalation 0.1% | 1 ml |
| fenoterol hydrobromide | 1 mg |
| excipients: benzalkonium chloride; disodium edetate dihydrate; sodium chloride; 1 n. hydrochloric acid; distilled water |
in dark glass dropper bottles of 20 ml (1 ml = 20 drops); in a cardboard pack there is 1 dropper bottle.
| Dosed inhalation aerosol | 1 dose |
| fenoterol hydrobromide | 100 mcg |
| propellant: 1,1,1,2 - tetrafluoroethane (HFA 134a) | |
| excipients: citric acid anhydride; distilled water; ethanol |
in aerosol cans with a mouthpiece of 10 ml (200 doses); There is 1 cylinder in the box.
pharmachologic effect
Pharmacological action: bronchodilator.
Selectively stimulates beta2-adrenergic receptors. Relaxes the smooth muscles of the bronchi and blood vessels and counteracts the development of bronchospastic reactions caused by the influence of histamine, methacholine, cold air and allergens (immediate hypersensitivity reactions). Immediately after administration, fenoterol blocks the release of mediators of inflammation and bronchial obstruction from mast cells. In addition, when using fenoterol in higher doses, increased mucociliary clearance was noted.
The beta-adrenergic effect of the drug on cardiac activity (increased strength and heart rate) is due to the vascular effect of fenoterol, stimulation of beta2-adrenergic receptors of the heart, and when using doses exceeding therapeutic ones, stimulation of beta1-adrenergic receptors. Tremor is the most common adverse effect with beta-agonists.
The drug reduces contractile activity and myometrial tone.
Pharmacokinetics
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 swallowed. As a result, some amount of inhaled fenoterol enters the gastrointestinal tract. After inhalation of 1 dose of the drug, the degree of absorption is 17% of the administered dose. Absorption is biphasic - 30% of fenoterol hydrobromide is rapidly absorbed with a T1/2 of 11 minutes, and 70% is absorbed slowly with a T1/2 of 120 minutes.
After oral administration, about 60% of fenoterol hydrobromide is absorbed. The time to reach Cmax in blood plasma is 2 hours. Plasma protein binding is 40–55%. Metabolized in the liver. It is excreted by the kidneys and bile in the form of inactive sulfate conjugates.
When administered parenterally, fenoterol hydrobromide is excreted according to a three-phase model with T1/2 - 0.42 min, 14.3 min and 3.2 hours. The biotransformation of fenoterol hydrobromide in humans occurs exclusively through conjugation with sulfates, mainly in the intestinal wall.
Fenoterol hydrobromide can pass unchanged through the placental barrier and enter breast milk.
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.
Side effects
From the side of the central nervous system: slight tremor, nervousness; rarely - headache, dizziness, disturbance of accommodation; in isolated cases - a change in the psyche.
From the cardiovascular system: tachycardia, palpitations (especially in patients with aggravating factors); rarely (when used in high doses) - decreased blood pressure, increased systolic blood pressure, arrhythmia.
From the respiratory system: in rare cases - cough, local irritation; very rarely - paradoxical bronchospasm.
From the gastrointestinal tract: nausea, vomiting.
Allergic reactions: rarely - rash, angioedema of the tongue, lips and face, urticaria.
Other: hypokalemia, increased sweating, weakness, myalgia, convulsions, urinary retention.
Interaction
Beta-adrenergic and anticholinergic drugs, xanthine derivatives (theophylline) can enhance the bronchodilator effect. The simultaneous administration of other beta-agonists, anticholinergics entering the systemic circulation or xanthine derivatives (for example, theophylline) may lead to increased side effects.
A significant weakening of the bronchodilator effect is possible with the simultaneous administration of beta-blockers.
Simultaneous use with MAO inhibitors and tricyclic antidepressants enhances the effect of Berotek N.
Inhalation of halogenated hydrocarbon anesthetics (halothane, trichlorethylene, enflurane) may enhance the effect of Berotec N on the cardiovascular system.
During the use of Berotec N, hypokalemia may develop, which may increase with the simultaneous administration of xanthine derivatives, steroids and diuretics. This fact should be given special attention when treating patients with severe forms of obstructive airway diseases.
Hypokalemia may lead to an increased risk of arrhythmias in patients receiving digoxin. In addition, hypoxia may enhance the negative effects of hypokalemia on heart rate. In such cases, it is recommended to monitor serum potassium levels.
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).
Directions for use and doses
Inhalation.
Solution for inhalation. For adults and children over 12 years old, to relieve an attack of bronchial asthma - 0.5 ml (0.5 mg - 10 drops), in severe cases - 1-1.25 ml (1-1.25 mg - 20-25 drops) , in extremely severe cases (under medical supervision) - 2 ml (2 mg - 40 drops).
Prevention of physical exertion asthma and symptomatic treatment of bronchial asthma and chronic obstructive pulmonary disease - 0.5 ml (0.5 mg - 10 drops) up to 4 times a day.
For children 6-12 years old (body weight 22-36 kg) to relieve an attack of bronchial asthma - 0.25-0.5 ml (0.25-0.5 mg - 5-10 drops), in severe cases - 1 ml ( 1 mg - 20 drops), in extremely severe cases (under medical supervision) - 1.5 ml (1.5 mg - 30 drops).
Prevention of physical exertion asthma and symptomatic treatment of bronchial asthma and other conditions with reversible narrowing of the airways - 0.5 ml (0.5 mg - 10 drops) up to 4 times a day. Children under 6 years of age (body weight less than 22 kg) (only under medical supervision) - about 50 mcg/kg per dose (0.25-1 mg - 5-20 drops) up to 3 times a day.
The recommended dose is diluted with saline immediately before use to a volume of 3–4 ml. The dose depends on the method of inhalation and the quality of the spray. If necessary, repeated inhalations are carried out at intervals of at least 4 hours.
Aerosol. Acute attack of bronchial asthma - 1 dose; if necessary, inhalation can be repeated after 5 minutes. The next prescription of the drug is possible no earlier than 3 hours later. If there is no effect and additional inhalations are required, you should immediately seek medical help at the nearest hospital.
Prevention of physical exertion asthma and symptomatic treatment of bronchial asthma and other conditions accompanied by reversible narrowing of the airways - 1-2 doses per 1 dose, but not more than 8 doses per day.
To obtain maximum effect, it is necessary to use a dosed aerosol correctly.
Before using the metered-dose aerosol for the first time, shake the can and 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 balloon and wrap your lips around the tip. The cylinder should be pointing upside down.
4. While inhaling as deeply as possible, simultaneously quickly press the bottom of the balloon until one inhalation dose is released. Hold your breath for a few seconds, then remove the tip from your mouth and exhale slowly. Repeat steps to receive the second inhalation dose.
5. Put on the protective cap.
6. If the aerosol can has not been used for more than 3 days, before use, press the bottom of the can once until a cloud of aerosol appears.
The cylinder is designed for 200 inhalations. After this, the cylinder should be replaced. Although some contents 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.
The tip should be kept clean and can be washed in warm water if necessary. After using soap or detergent, rinse the handpiece thoroughly with clean water.
Warning: The plastic mouth adapter is designed specifically for Berotec N metered-dose aerosol and serves for precise dosing of the drug. The adapter must not be used with other metered aerosols. You also cannot use metered tetrafluoroethane-containing aerosol Berotek N with any other adapters other than the adapter supplied with the cylinder.
The contents of the cylinder are under pressure. The cylinder must not be opened or exposed to temperatures above 50 °C.
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.
Overdose
Symptoms: tachycardia, palpitations, arterial hyper- or hypotension, increased pulse pressure, anginal pain, arrhythmias, flushing, tremor.
Treatment: prescription of sedatives, tranquilizers, and in severe cases, intensive care. Cardioselective beta-blockers are recommended as antidotes. However, one should remember about the possible increase in bronchial obstruction under the influence of beta-blockers and carefully select the dose for patients suffering from bronchial asthma or chronic obstructive pulmonary diseases.
Precautionary measures
Prescribed with caution for diabetes mellitus, recent myocardial infarction, severe diseases of the cardiovascular system, hyperthyroidism, pheochromocytoma.
Serious hypokalemia may occur when beta2-agonists are used.
If you experience acute, rapidly worsening dyspnea (difficulty breathing), you should consult your doctor immediately.
It should be borne in mind that the use of large doses for stopping an attack for a long time can cause an uncontrolled worsening of the disease and necessitate the need for correction of basic anti-inflammatory therapy with inhaled corticosteroids.
Particular caution should be exercised in severe bronchial asthma, because this effect may be enhanced by the concomitant use of xanthine derivatives, glucocorticoids and diuretics. In addition, hypoxia can enhance the effect of hypokalemia on heart rhythm. In such situations, regular monitoring of serum potassium levels is recommended.
Berotek N air d/ingal doser 0.1 mg/dose 200 doses 10 ml
Registration Certificate Holder
BOEHRINGER INGELHEIM INTERNATIONAL (Germany)
Dosage form
Medicine - Berotec® N
Description
Aerosol for inhalation dosed
in the form of a transparent, colorless or light yellow or light brownish liquid, free of suspended particles.
1 inhalation dose
fenoterol hydrobromide 100 mcg
Excipients
: anhydrous citric acid - 0.001 mg, purified water - 1.04 mg, absolute ethanol - 15.597 mg, tetrafluoroethane (HFA 134a, propellant) - 35.252 mg.
10 ml (200 doses) - metal aerosol cans with a dosing valve and mouthpiece (1) - cardboard packs.
Indications
- attacks of bronchial asthma or other conditions with reversible airway obstruction (including chronic bronchitis, COPD);
- prevention of bronchial asthma attacks due to physical stress.
Contraindications for use
- hypersensitivity to fenoterol and to any of the excipients of the drug;
- tachyarrhythmia;
- hypertrophic obstructive cardiomyopathy;
- children under 4 years of age.
with caution
only after a thorough assessment of the benefit-risk ratio of treatment, especially at the maximum recommended doses in the following diseases and conditions: 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 artery disease, coronary artery disease, 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.
pharmachologic effect
Bronchodilator, selective beta2-adrenergic agonist. 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 β2-adrenergic receptor stimulant in a therapeutic dose range. Stimulation of β1-adrenergic receptors occurs when the drug is used in higher doses. Binding to 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. Protein kinase A deprives myosin of the ability to bind to actin, which causes smooth muscle relaxation.
Fenoterol relaxes bronchial and vascular smooth muscle and protects against bronchoconstrictor stimuli such as histamine, methacholine, cold air and allergens (early response). In addition, fenoterol inhibits the release of bronchoconstrictor and proinflammatory mediators from mast cells. An increase in mucociliary clearance has been demonstrated after the use of fenoterol (at a dose of 600 mcg).
Due to its stimulating effect on β1-adrenergic receptors, fenoterol can have an effect on the myocardium (especially in doses exceeding therapeutic doses), 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).
Drug interactions
With the simultaneous use of beta-adrenergic agonists, anticholinergics, xanthine derivatives (for example, theophylline), cromoglycic acid, corticosteroids, diuretics, the action and side effects of fenoterol may be enhanced.
Hypokalemia caused by β2-adrenergic agonists can be enhanced by concomitant therapy with xanthine derivatives, corticosteroids and diuretics. This should be especially taken into account in patients with severe airway obstruction.
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 β-adrenergic receptor agonists.
Inhalation anesthetics (halothane, trichlorethylene, enflurane) increase the likelihood of the effects of β-adrenergic receptor agonists (including fenoterol) on the cardiovascular system.
Dosage regimen
Adults and children over 6 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 inhalation doses and additional inhalations are required, you should immediately consult a doctor. The maximum permissible dose is 8 inhalation doses/day.
Prevention of asthma attacks due to physical stress
1-2 inhalation doses before physical activity, up to 8 inhalation doses/day.
In children aged 6 to 12 years
Berotec® N should be used only after consultation with a doctor and under adult supervision.
Children aged 4 to 6 years
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 attacks due to physical stress
1 inhalation dose before physical activity, up to 4 inhalation doses/day.
In children aged 4 to 6 years
Berotec® N should be used only after consultation with a doctor and under adult supervision.
Rules for using the drug
To achieve maximum effect, it is necessary to use a dosed aerosol correctly.
To prepare a new inhaler for use, remove the protective cap, turn the inhaler upside down and make two injections into the air (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 completely.
3. Hold the canister and tightly wrap your lips around the mouthpiece. In this case, the bottom of the inhaler faces upward.
4. While inhaling as deeply as possible, simultaneously press firmly on the bottom of the can to release the inhalation dose. 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 inhaler has not been used for more than 3 days, before use you should press the bottom of the can once.
Because the container is not transparent, it is impossible to determine visually whether it is empty. The cylinder is designed for 200 inhalations. After using this number of doses, a small amount of solution may remain. However, the inhaler should be replaced because otherwise, you may not receive the required therapeutic dose.
The amount of drug remaining in the cylinder can be checked as follows: remove the protective cap, immerse the cylinder in a container filled with water. The contents of the cylinder can be determined depending on its position in the water (Fig. 1).
img_berotec_n_1.eps|png
Rice. 1
The inhaler should be cleaned at least once a week.
It is important to keep the inhaler mouthpiece clean so that medication does not accumulate and block the spray.
To clean, first remove the cap and remove the can from the inhaler. Rinse the inhaler body with warm water to remove any accumulated medication or visible dirt.
After cleaning, shake the inhaler and allow it to air dry without using heating devices. When the mouthpiece is dry, return the can and protective 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 should also not be used with 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.
Overdose
Symptoms:
expected symptoms are caused by excessive beta-adrenergic stimulation, incl. 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:
discontinuation of therapy with Berotec® N. Monitoring the acid-base balance and electrolyte balance. Prescription of sedatives; in severe cases, intensive symptomatic therapy. The use of beta-blockers (preferably selective beta1-blockers) is recommended as specific antidotes. In this case, 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.
Side effect
Like all other inhalation treatments, Berotec® N may cause symptoms of local irritation.
Determination of the categories of frequency of adverse reactions that may occur during treatment: very often (≥1/10), often (from ≥1/100 to <1/10), infrequently (from ≥1/1000 to <1/100), rare (from ≥1/10,000 to <1/1000), very rare (<1/10,000); frequency unknown (frequency cannot be estimated from available data).
From the immune system:
frequency unknown - hypersensitivity, urticaria.
From the side of metabolism:
Uncommon: hypokalemia, including severe hypokalemia.
From the psyche and nervous system:
often - tremor; infrequently - excitement; frequency unknown - nervousness, headache, dizziness.
From the cardiovascular system:
uncommon - arrhythmia; frequency unknown - myocardial ischemia, tachycardia, palpitations, increased systolic blood pressure, decreased diastolic blood pressure.
From the respiratory system:
often - cough; infrequently - paradoxical bronchospasm; frequency unknown - irritation of the larynx and pharynx.
From the digestive system:
infrequently - nausea, vomiting.
From the skin and subcutaneous tissues:
infrequently - itching; frequency unknown - hyperhidrosis, skin reactions, incl. rash.
From the musculoskeletal system:
frequency unknown - muscle spasm, myalgia, muscle weakness.
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 beta2-agonist therapy. Particular caution is recommended in severe bronchial asthma, since hypokalemia can be potentiated by concomitant therapy with xanthine derivatives, corticosteroids and diuretics. In addition, hypoxia may 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 to determine 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 frequency of administration of β2-adrenergic receptor agonists, incl. the drug Berotek® N, in doses exceeding the recommended ones and for a long time. Regular use of β2-adrenergic receptor agonists, incl. Berotek® N, to control the symptoms of bronchial obstruction may indicate a deterioration in disease control. In such a situation, the treatment plan and especially the adequacy of anti-inflammatory therapy should be reconsidered to prevent potentially life-threatening deterioration of disease control.
Concomitant use with sympathomimetic and anticholinergic bronchodilators
Other sympathomimetic bronchodilators should be used in combination 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 the presence of fenoterol in drug abuse studies for non-medical indications, for example, in connection with increased performance in athletes (doping).
Please note that the drug contains a small amount of ethanol (15.597 mg per dose).
Effect on the ability to drive vehicles and machinery
No studies have been conducted to study the effect of the drug on the ability to drive vehicles and machinery. However, symptoms such as dizziness have been observed in clinical studies. Therefore, it is recommended to exercise caution when driving vehicles and using machinery.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Best before date
Shelf life: 3 years.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.
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.
There are no clinical data on the effects of fenoterol on fertility. Preclinical studies of fenoterol have shown no adverse effects on fertility.
Use in children
Restrictions for children - With caution.
Contraindicated in children under 4 years of age.
Because information on the use of the drug in children 4-6 years of age is limited; treatment is carried out with caution, only under the supervision of a doctor.
Terms of sale
The drug is available with a prescription.
Contacts for inquiries
BERINGER INGELHEIM INTERNATIONAL GmbH (Germany)
Boehringer Ingelheim LLC
125171 Moscow Leningradskoe highway 16A, building 3 Tel. Fax
special instructions
When using the new form of Berotec N metered-dose aerosol for the first time, patients may note that the taste of the new drug is somewhat different from the previous dosage form containing freon. When switching from one form to another, patients should be warned about a possible change in taste sensations. It should also be communicated that these drugs are interchangeable and that taste properties are not relevant to the safety and effectiveness of the new drug.
Other sympathomimetic bronchodilators should be prescribed concomitantly with Berotec N only under medical supervision.
BEROTEK N (aerosol)
gained momentum and by the age of 20, every spring I already suffered quite severely from spring hay fever.
The most unpleasant time of the year for me was spring, when the birch buds began to “gather dust” and throw their pollen into the air. For several years in the winter I took a course of injections for allergies, it became easier, but still the allergy did not disappear. At the age of 25, I gave birth to my first child and, to my great regret, I passed on this allergy to him. From the age of one, as soon as I stopped breastfeeding him, he began to develop diathesis, but now, when he is already an adult and he himself is 25 years old, he has exactly the same spring hay fever as I do, plus intolerance to chicken eggs (and many products, including cakes and baked goods, that contain eggs). Well, my allergy gradually began to progress. Previously, the reaction was only in the spring to the pollen of trees and grasses, then the allergy appeared to fruits (in all likelihood, they are treated with something so that they are better transported and stored later), but at the same time I can eat many fruits abroad and cannot eat those that are not which I buy in Moscow... The reaction to pollen is standard: my eyes itch (and then I use Cromohexal), my nose runs, I sneeze (this year I started using Nazaval and felt tremendous relief! This remedy is a real salvation from pollen allergies). When eating fruit, my throat feels sore and itchy, my nose is stuffy. Then I just take something antihistamine like “Cetirizine.”
Well, a couple of years ago I developed a new form of allergy: I began to choke. Moreover, such an allergy most often manifests itself to spices and seasonings, but recently I noticed that it also occurs to some flavorings that are used in baking. This form of allergy became simply deadly for me: you never know, after which an attack of suffocation may begin. It becomes difficult to breathe, the air passes through with a whistle. I took breathing tests for bronchial asthma - fortunately, it was not confirmed. This form of allergy - for now! - can be treated with the same antihistamines, but sometimes you have to take 2 tablets at once.
Well, since I don’t know when, why and how severe this form of suffocation will be, the allergist advised me to buy and always carry an inhalation aerosol with me. This can be an aerosol "Berodual" or "Berotek", they are, in principle, identical in form of action.
I bought myself Berotec because this medicine at that time was cheaper than Berodual.
Two years ago it cost 299 rubles, but now the price has risen quite a bit and costs about 330-350 rubles.
This drug is produced in Germany.
This small inhaler is located inside a cardboard package. Before use, remove the blue protective cap, shake the can, and place the tip down. Then you need to take a deep breath, wrap your lips around the tip and start on the can.
The instructions for using the inhaler are described in great detail. By the way, it is so huge that it could be printed in the form of a brochure. I was not able to photograph the entire sheet on one side...
Indications for use “classical”: * bronchial asthma * chronic bronchitis * any form of disease in which a person begins to choke
Children under 4 years of age are not allowed to use the aerosol.
The instructions also describe in detail and even show a picture of how to use the aerosol.
The canister is designed for 200 inhalations and the instructions show how, by immersing it in water, you can check how full or empty the canister is. Very convenient, by the way.
Like any “serious” drug, “Berotek” contains possible side effects in its instructions.
Luckily, I only used this inhaler a couple of times when I felt like the antihistamine wasn't working and I was finding it increasingly difficult to breathe. I can say that the medicine worked almost instantly, making breathing easier and calming me and my husband. Now I always carry this aerosol (as well as allergy pills) with me, because I don’t know what could cause such an allergic reaction (last time it was from cheesecake with caramel, before that from mussels in curry sauce, and also before that, from smoked sausages “Okraina”).
I would like to take this opportunity to wish you all good health. And only for you, but also for your family, loved ones, and most importantly - for the kids!
