Buy Berotec N aerosol for inhalation 100 mcg/dose 200 doses 10 ml in pharmacies

Composition and release form

in dark glass dropper bottles of 20 ml (1 ml = 20 drops); in a cardboard pack there is 1 dropper bottle.

in aerosol cans with a mouthpiece of 10 ml (200 doses); There is 1 cylinder in the box.

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

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.

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.

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.

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.

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.

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).

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 aerosol dosed for inhalation 100 µg/dose 10 ml (200 doses) No. 1

Name

Berotek N aer.dose.d/ing.100mcg/dose in vial. 10ml (200 doses) per pack. No. 1

Description

10 ml in a metal can with a dosing valve. Spray can with instructions for use in a cardboard box

Main active ingredient

Ipratropium bromide + fenoterol

Release form

Aerosol

Dosage

20mcg+50mcg/dose

Pharmacological properties

Pharmacodynamics

BERODUAL N contains two components with bronchodilator activity: ipratropium bromide (m-anticholinergic blocker) and fenoterol hydrobromide (beta-adrenergic agonist). Ipratropium bromide is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. Preclinical studies have shown that it inhibits reflexes mediated by the vagus nerve by counteracting the effect of acetylcholine, a neurotransmitter released from this nerve. Anticholinergics prevent the increase in intracellular calcium concentration, which is caused by the interaction of acetylcholine with the muscarinic receptor of bronchial smooth muscle. The release of calcium is mediated by a system of second messengers consisting of IPG (inositol triphosphate) and DAG (diacylglycerol). Bronchodilation that occurs after inhalation of ipratropium bromide is a local and lung-specific effect that is not systemic. Fenoterol hydrobromide is a direct-acting sympathomimetic, a selective stimulator of beta2-adrenergic receptors when taken in therapeutic doses. Stimulation of beta1-adrenergic receptors occurs when the drug is used in higher doses (for example, during tocolytic therapy). Binding of beta2-adrenergic receptors activates adenylate cyclase through the stimulatory Gs protein with a subsequent increase in the formation of cAMP, which in turn activates protein kinase A. The latter phosphorylates target proteins in smooth muscle cells. This results in phosphorylation of myosin light chain kinase, inhibition of phosphoinosine hydrolysis, and opening of calcium-dependent fast potassium channels. Fenoterol hydrobromide relaxes the smooth muscles of the bronchi and blood vessels, and also prevents the development of bronchospasm caused by the effects 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 0.6 mg of fenoterol, an increase in mucociliary transport is observed. Higher plasma concentrations of the drug, achieved after oral or, more often, intravenous administration, inhibit uterine contractility. When taking high doses of the drug, effects are observed at the metabolic level: lipolysis, glycogenolysis, hyperglycemia and hypokalemia (the latter is due to increased absorption of K+ by skeletal muscles). The beta-adrenergic effects of the drug 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 beta2-adrenergic receptors of the heart, and when taking the drug in doses exceeding therapeutic doses, stimulation of beta1-adrenergic receptors. As with other beta-adrenergic agents, prolongation of the QTc interval has been reported. For fenoterol administered by metered dose inhaler, these events were discrete and occurred at doses higher than recommended. However, systemic exposure after administration of the drug using nebulizers (inhalation solution) was higher than when administering recommended doses using a metered dose inhaler. Clinical significance has not been established. The most commonly observed effect of beta-agonists is tremor. In contrast to the effects on bronchial smooth muscle, the systemic effects of beta-adrenergic agonists are associated with the development of tolerance. When these two active substances are used together, the bronchodilator effect is achieved by acting on various pharmacological targets. These substances complement each other, as a result, the antispasmodic effect on the bronchial muscles is enhanced, and a greater breadth of therapeutic action is provided for bronchopulmonary diseases accompanied by narrowing of the airways. The complementary effect is such that to achieve the desired effect, a lower dose of beta-agonist is required, which allows you to individually select an effective dose with virtually no side effects.

Pharmacokinetics

The therapeutic effect of the combination of ipratropium bromide and fenoterol hydrobromide is created by local action on the respiratory tract. Therefore, the pharmacodynamics of bronchodilation is not related to the pharmacokinetics of the active substances. After inhalation, 10-39% of the dose, depending on the dosage form, inhalation method and the device used for inhalation, is deposited in the lungs. The rest of the dose remains in the mouthpiece, mouth, and upper respiratory tract (oropharynx). The same amount of dose is deposited in the respiratory tract after inhalation of a metered dose aerosol. After inhalation of an aqueous solution through the Respimat inhaler, the amount entering the lungs was 2 times higher compared to inhalation with a metered-dose aerosol, while when inhaled through the Respimat inhaler, a much smaller amount of the active substance settles in the oropharynx. A portion of the dose that reaches the lungs quickly enters the circulatory system (within minutes). The active substance, deposited in the oropharynx, is slowly swallowed and passes through the gastrointestinal tract. Therefore, systemic exposure results from bioavailability from the lungs and gastrointestinal tract. There is no data indicating that the pharmacokinetics of both ingredients in combination differs from the pharmacokinetics of the active substances individually. Fenoterol hydrobromide The ingested portion is metabolized primarily to complex sulfate compounds. The absolute bioavailability of the drug when administered orally is low (about 1.5%). After intravenous administration of fenoterol in the urine for 24 hours, about 15% and 27% of the administered dose, respectively, are found in the free and conjugated state. After inhalation of BERODUAL N using a metered dose inhaler, about 1% of the dose is excreted as free fenoterol in the urine within 24 hours. Based on this information, the calculated total systemic bioavailability of fenoterol hydrobromide after inhalation administration is approximately 7%. The distribution of fenoterol in blood plasma after intravenous administration occurs according to a three-phase pharmacokinetic model, the final half-life is about 3 hours. In this three-phase pharmacokinetic model, the apparent volume of distribution at steady state (Vdss) is approximately 189 L (? 2.7 L/kg). About 40% of the substance binds to blood plasma proteins. Fenoterol and its metabolites do not penetrate the blood-brain barrier. The total clearance of fenoterol is 1.8 l/min, renal clearance is 0.27 l/min. Ipratropium bromide Cumulative renal excretion (0-24 hours) of ipratropium (parent compound) approaches 46% of the intravenous dose, less than 1% of the oral dose, and approximately 3-13% of the BERODUAL N dose administered by metered dose inhaler. Based on these data, the overall systemic bioavailability of ipratropium bromide for oral and inhaled administration is 2% and 7 to 28%, respectively. The ingested portion of the dose of ipratropium bromide does not have a significant systemic effect. Kinetic parameters characterizing the distribution of ipratropium were calculated based on plasma concentrations of the drug after intravenous administration. A rapid two-phase decrease in plasma concentrations is observed. The apparent volume of distribution at equilibrium (Vdss) is approximately 176 L (“2.4 L/kg). The drug minimally (less than 20%) binds to blood plasma proteins. Preclinical studies conducted on mice and dogs showed that ipratropium, being a quaternary amine; does not penetrate the blood-brain barrier. The half-life of the final elimination phase is approximately 1.6 hours. The total clearance of ipratropium is 2.3 l/min, and the renal clearance is 0.9 l/min. After intravenous administration, approximately 60% of the dose is metabolized in the liver by oxidation.

Indications for use

Prevention and treatment of shortness of breath in chronic obstructive disorders of the respiratory tract: allergic and non-allergic (endogenous) bronchial asthma, physical exertion asthma, chronic obstructive bronchitis, complicated or uncomplicated by emphysema. To prepare (“open the lungs”) and maintain aerosol therapy with corticosteroids, mucolytics, saline solutions, cromoglycic acid and antibiotics. Long-term treatment should be accompanied by appropriate anti-inflammatory therapy.

Directions for use and doses

The dosage depends on the nature and severity of the disease. For adults and children over 6 years of age, the following doses are recommended: To relieve a sudden spasm of bronchial smooth muscles with an attack of shortness of breath, inhalation of one therapeutic dose (100 mcg of fenoterol hydrobromide and 40 mcg of ipratropium bromide), which corresponds to 2 inhalation doses, is recommended. As a rule, one inhalation dose is sufficient to provide a significant improvement in bronchial patency. If there is no noticeable improvement within 5 minutes after the first 1-2 inhalation doses, another 1-2 inhalation doses may be used. Severe dyspnea and failure of the second therapeutic dose may indicate the need for additional doses. In these cases, patients should seek medical attention immediately. If long-term treatment with the BERODUAL N metered dose inhaler is necessary, the recommended dose is 1-2 inhalation doses 3-4 times a day. For the treatment of bronchial asthma, the BERODUAL N metered dose inhaler should be used only as needed. In general, the time and dose of each administration should be adjusted according to the symptoms. It is necessary to ensure at least a 3-hour interval between drug administration. The daily dose should not exceed 12 inhalation doses, since higher doses usually do not provide additional therapeutic effect, but may lead to the development of potentially serious side effects. For targeted prevention of asthma attacks during physical exertion or when contact with an allergen is expected, it is recommended to take 2 inhalation doses of the drug 10-15 minutes before the expected physical activity/contact with the allergen. To achieve successful therapy, patients must be instructed on how to properly use the metered dose inhaler

Use during pregnancy and lactation

Pregnancy Data from preclinical studies, combined with existing experience with the drug in humans, have not revealed any side effects of fenoterol or ipratropium during pregnancy. However, normal precautions should be taken when using medications during pregnancy. It is necessary to take into account the ability of fenoterol to have a suppressive effect on uterine contractility. The use of betag-agonists at the end of pregnancy or in high doses can cause negative effects in newborns (tremor, tachycardia, fluctuations in blood glucose levels, hypokalemia). Breastfeeding period Preclinical studies have shown the ability of fenoterol to be excreted in breast milk. There is no data confirming the excretion of ipratropium bromide in breast milk. The appearance of ipratropium after inhalation administration in breast milk in a concentration that can affect the infant is unlikely. When using BERODUAL N in a woman during breastfeeding, caution should be exercised. Fertility There are no clinical data on the effect of the combination of ipratropium bromide and fenoterol hydrobromide on fertility. Preclinical studies conducted with ipratropium bromide and fenoterol hydrobromide individually did not demonstrate a negative effect on fertility.

Precautionary measures

If shortness of breath (difficulty breathing) suddenly increases rapidly, you should consult a doctor immediately. BERODUAL N, like other inhaled drugs, can cause paradoxical bronchospasm, which can be life-threatening. If paradoxical bronchospasm develops, the use of BERODUAL N should be stopped immediately and switched to alternative therapy. BERODUAL N should be used only after a careful assessment of the risk/benefit ratio, especially when using doses higher than recommended in the following diseases: diabetes mellitus with inadequate glycemic control, recent myocardial infarction, myocarditis, severe organic diseases of the heart or blood vessels (in particular, in the presence of tachycardia), hyperthyroidism, pheochromocytoma. When using sympathomimetic drugs, including BERODUAL N, effects on the cardiovascular system may occur. Post-marketing studies and published literature have reported rare cases of myocardial ischemia with beta-agonists. Patients with underlying serious heart disease (eg, coronary artery disease, arrhythmias, or severe heart failure) receiving BERODUAL N should be warned to seek medical attention if they experience heart pain or other symptoms indicating worsening of their heart disease. It is necessary to pay attention to symptoms such as shortness of breath and chest pain, as they can be of either pulmonary or cardiac etiology. There are isolated reports of complications from the organ of vision (for example, mydriasis, increased intraocular pressure, angle-closure glaucoma and eye pain) that developed when inhaled ipratropium bromide or ipratropium bromide in combination with beta-adrenergic agonists came into contact with the eyes. Attention! Patients should be instructed on the correct use of BERODUAL N metered dose aerosol. Care must be taken to prevent contact of the drug with the eyes. Symptoms of acute angle-closure glaucoma may include pain or discomfort in the eyes, blurred vision, halo, colored spots in front of the eyes, redness of the eyes due to injection of conjunctival vessels and corneal edema. If any of these symptoms appear, immediate consultation with a specialist is necessary and the use of miotic agents is indicated. In patients with a history of cystic fibrosis, gastrointestinal motility disorders may occur when treated with inhaled anticholinergic drugs. This effect is reversible and disappears after stopping treatment. Long-term use of the drug In patients with bronchial asthma, BERODUAL N should be used only as needed. In patients with mild chronic obstructive pulmonary disease, on-demand symptomatic treatment may be preferable to regular use of the drug. In patients with bronchial asthma or chronic obstructive pulmonary disease responding to steroid therapy, the need for or intensification of anti-inflammatory therapy should be remembered to control airway inflammation and the course of the disease. In patients with bronchial asthma, regular use of increasing doses of drugs containing betag-agonists, such as BERODUAL N, to relieve bronchial obstruction, can cause an uncontrolled worsening of the disease. In case of increased bronchial obstruction, increasing the dose of beta-adrenergic agonists, including BERODUAL N, more than recommended for a long time is not only not justified, but also dangerous. To prevent life-threatening worsening of the disease, consideration should be given to reviewing the patient's treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids, or adjusting the dose of anti-inflammatory therapy. An increased risk of serious complications of bronchial asthma, including fatal ones, has been reported when using high and very high doses of inhaled beta2-agonists for a long period of time without adequate anti-inflammatory therapy. The cause-and-effect relationship has not been clearly established. Inadequacy of anti-inflammatory therapy may be of vital importance. Other sympathomimetic bronchodilators should be prescribed simultaneously with BERODUAL N only under medical supervision. Potentially severe hypokalemia may occur when high doses of beta2-agonists are used. It is recommended to monitor the concentration of potassium in the blood if its level is initially low. Blood glucose levels may increase. In this regard, it is recommended to monitor blood glucose levels in patients with diabetes mellitus. After using BERODUAL N, in rare cases, immediate hypersensitivity reactions may occur: urticaria, angioedema, rash, bronchospasm; swelling of the oropharynx and allergic reactions. This medicine contains 99% ethanol (alcohol; less than 100 mg/dose). The use of BERODUAL N may lead to positive doping test results.

Interaction with other drugs

Long-term co-administration of BERODUAL N with other anticholinergic drugs has not been studied and is therefore not recommended. The simultaneous use of the following drugs/groups of drugs may affect the action of BERODUAL N. They enhance the effect and/or increase the risk of adverse reactions: other beta-adrenergic agonists (any method of administration); other anticholinergic drugs (any route of administration); xanthine derivatives (for example, theophylline); anti-inflammatory drugs (corticosteroids); monoamine oxidase inhibitors; tricyclic antidepressants; halogenated hydrocarbon anesthetics (for example, halothane, trichlorethylene or enflurane), because they may increase the effects on the cardiovascular system. Reduces the effectiveness of BERODUAL N: simultaneous use of beta-blockers. Other possible reactions: Hypokalemia caused by the use of a beta2-agonist can be enhanced by the simultaneous use of xanthine derivatives, glucocorticosteroids and diuretics. This should especially be taken into account when treating patients with severe forms of obstructive airway disease. Hypokalemia may lead to an increased risk of arrhythmias in patients taking digoxin. In addition, the negative effect of hypokalemia on heart rate can be enhanced by hypoxia. In such cases, it is recommended to monitor serum potassium levels. The risk of developing an acute attack of glaucoma increases if nebulized ipratropium bromide alone or in combination with a betag agonist comes into contact with the eye.

Contraindications

BERODUAL N is contraindicated in patients with known hypersensitivity to fenoterol hydrobromide and/or ipratropium bromide, atropine-like substances, or any of the excipients. BERODUAL N is also contraindicated in patients with hypertrophic obstructive cardiomyopathy and tachyarrhythmia. Overdose Symptoms Depending on the degree of overdose, the following side effects, typical for betag-agonists, may occur: a feeling of a rush of blood to the face, delirium, headache, tachycardia, palpitations, arrhythmia, arterial hypotension up to shock, increased blood pressure, anxiety, pain in the chest, agitation, possible appearance of extrasystoles and There have been cases of the development of metabolic acidosis, as well as hypokalemia, when using fenoterol in doses exceeding the recommended ones approved for indications for BERODUAL N. Symptoms of an overdose of ipratropium bromide (such as dry mouth, impaired accommodation) are usually weakly expressed due to the low systemic bioavailability of inhaled ipratropium. Therapy Treatment with BERODUAL N should be discontinued. It is necessary to monitor acid-base balance and blood electrolytes. The administration of sedatives and tranquilizers is indicated; in severe cases, intensive supportive care, including hospitalization, may be required. Beta-blockers (preferably beta-blockers) can be used as an antidote for fenoterol; however, it is necessary to take into account the possibility of deterioration of bronchial obstruction, which requires careful selection of the dose of the drug in patients suffering from bronchial asthma or COPD, due to the risk of provoking severe bronchospasm, which can be fatal.

Compound

One inhalation dose contains the active ingredients: ipratropium bromide monohydrate 21 mcg (0.021 mg), which corresponds to 20 mcg (0.020 mg) of ipratropium bromide, and fenoterol hydrobromide 50 mcg (0.050 mg); excipients: anhydrous citric acid, purified water, absolute ethanol, tetrafluoroethane (HFA 134a).

Overdose

Symptoms Depending on the degree of overdose, the following side effects typical of betag-adrenergic agonists may occur: a feeling of a rush of blood to the face, delirium, headache, tachycardia, a feeling of palpitations, arrhythmia, arterial hypotension up to shock, increased blood pressure, anxiety, pain in chest, agitation, possible appearance of extrasystoles and There have been cases of the development of metabolic acidosis, as well as hypokalemia, when using fenoterol in doses exceeding the recommended ones approved for indications for BERODUAL N. Symptoms of an overdose of ipratropium bromide (such as dry mouth, impaired accommodation) are usually mild due to the low systemic bioavailability of inhaled ipratropium. Therapy Treatment with BERODUAL N should be discontinued. It is necessary to monitor acid-base balance and blood electrolytes. The administration of sedatives and tranquilizers is indicated; in severe cases, intensive supportive care, including hospitalization, may be required. Beta-blockers (preferably beta-blockers) can be used as an antidote for fenoterol; however, it is necessary to take into account the possibility of deterioration of bronchial obstruction, which requires careful selection of the dose of the drug in patients suffering from bronchial asthma or COPD, due to the risk of provoking severe bronchospasm, which can be fatal.

Side effect

Many of the following side effects can be attributed to the anticholinergic and beta-adrenergic properties of BERODUAL N. Like other drugs used by inhalation, BERODUAL N may cause symptoms of local irritation. The most commonly reported side effects include: cough, dry mouth, headache, tremor, pharyngitis, nausea, dizziness, dysphonia, tachycardia, palpitations, vomiting, increased systolic blood pressure and nervousness. The incidence of side effects is indicated as: very often (? 1/10); often (from ?1/100 to

Storage conditions

Store in a place protected from direct sunlight at temperatures below 25°C. Do not expose to high temperatures or freeze. Keep out of the reach of children.

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.

BEROTEK N AEROSOL FOR INHALATION 100MCG/DOSE 200DOSES FL 10ML

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 β2-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 the case of increased bronchial obstruction, it is unacceptable and may be risky to increase the dosage of β2-adrenergic agonists, such as BEROTEK N, beyond the recommended doses and over a long period of time. The use of increased doses of β2-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.

Impact 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).

Effect of the drug on the ability to drive vehicles and operate machinery

No studies have been conducted on the effects of the drug on the ability to drive vehicles and use machinery.

However, symptoms such as dizziness have been observed in clinical studies. Therefore, it is recommended to exercise caution when driving or using machinery.

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 100 mcg 200 doses (Behringer)

Adults and adolescents over 12 years of age 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, you can repeat the inhalation. If there is no effect after 2 inhalations and additional inhalations are required, you should immediately consult a doctor. Prevention of exercise asthma 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 obstruction of the airways. In most cases, 1 inhalation dose is sufficient to relieve bronchospasm; if breathing relief does not occur within 5 minutes, you can repeat the inhalation. If there is no effect after 2 inhalations, and additional inhalations are required, you should immediately seek medical help. Prevention of exercise asthma 1-2 inhalation doses before physical activity, up to 8 inhalations/ days. Children from 4 to 6 years old. Due to limited experience in children under 6 years of age, the drug should be used only as prescribed by a doctor and under adult supervision. Attacks of bronchial asthma and other conditions accompanied by reversible obstruction of the airways. To relieve bronchospasm, 1 dose is sufficient. inhalation dose. If there is no effect, you should immediately seek medical help. Prevention of exercise asthma 1 inhalation dose before physical activity, up to 4 inhalations/day. Rules for using the drug To achieve the maximum effect, you must use the metered-dose aerosol correctly. Before using the metered-dose aerosol for the first time, press twice to the bottom of the can. Each time when using a metered aerosol, the following rules must be observed. The can 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 inhaler should be rinsed at least once a week. It is important to keep the inhaler mouthpiece clean to ensure that medication does not accumulate and block the nebulization. For cleaning, first remove the dust cap and remove the container from the inhaler. Rinse the inhaler with warm water to remove any accumulated medication and/or visible dust. After cleaning, shake the inhaler and allow it to air dry without using heating devices. When the mouthpiece is dry, return the container and dust cap to its place. The plastic mouthpiece is designed specifically for Berotec® N metered-dose 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.

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

Directions for use and doses

Doses for adults and adolescents over 12 years of age
Attacks of bronchial asthma and other conditions accompanied by reversible airway obstruction

In most cases, one inhalation dose is sufficient to relieve bronchospasm; If breathing relief does not occur within 5 minutes, inhalation can be repeated.

If there is no effect after two inhalations and additional inhalations are required, you should immediately seek medical help at the nearest hospital. Prevention of asthma by physical effort

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

Doses for children from 6 to 12 years

Attacks of bronchial asthma and other conditions accompanied by reversible airway obstruction

In most cases, one inhalation dose is sufficient to relieve bronchospasm; If breathing relief does not occur within 5 minutes, inhalation can be repeated.

If there is no effect after two inhalations and additional inhalations are required, you should immediately seek medical help at the nearest hospital. Prevention of asthma by physical effort

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

Doses for children from 4 to 6 years

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, one inhalation dose is sufficient.

If there is no effect, you should immediately seek medical help at the nearest hospital.

Prevention of asthma by physical effort

1 inhalation dose before physical activity, up to 4 inhalations per day.

Mode of application

To achieve maximum effect, it is necessary to use a dosed aerosol correctly.

Before using metered dose aerosol for the first time, press the bottom of the can twice.

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

1. Remove the protective cap.

2. Exhale slowly and completely.

3. Hold the can as shown in Fig. 1 and tightly wrap your lips around the tip. In this case, the arrow and the bottom of the inhaler are facing upward.

4. While inhaling as deeply as possible, simultaneously quickly press the bottom of the can until the inhalation dose is released. Hold your breath for a few seconds, then remove the mouthpiece from your mouth and exhale slowly.

If repeated inhalation is required, repeat the same steps (steps 2-4).

5. Put on the protective cap.

6. If the aerosol can has not been used for more than three days, press the bottom of the can once before use.

The cylinder is designed for 200 inhalations. After this, the cylinder should be replaced. Although some drug may remain in the canister, the amount of drug released during inhalation may be reduced. The cylinder is opaque, so the amount of drug in the cylinder can only be determined in the following way: by removing the protective cap, the cylinder is immersed in a container filled with water. The amount of the drug is determined depending on the position of the cylinder in the water (see Fig. 2).

The inhaler should be washed at least once a week.

It is important to keep the mouthpiece of your inhaler clean so that medication does not accumulate and block the spray.

To clean, first remove the dust cap and remove the container from the inhaler. Rinse the inhaler with warm water to remove any accumulated medication and/or visible dust (see Figure 3).

After cleaning, shake the inhaler and allow it to air dry without using heating devices. When the mouthpiece is dry, return the container and dust cap to their place (see Fig. 4).

WARNING: The plastic mouthpiece is designed specifically for Berotek® N and is used for precise dosing of the drug. The mouthpiece should not be used with other metered dose aerosols. Also, Berotec® N should not be used with any adapters other than the mouthpiece supplied with the drug.

The contents of the cylinder are under pressure. The container must not be opened or heated above 50°C.