Berodual solution for inhalation 0.25mg+0.5mg/ml, 20ml

Release forms and dosages

• Solution for inhalation. Available in bottles of 20 ml. It contains 400 drops of this medicine. According to medical recommendations, the bronchodilator is used in nebulizers.
• Aerosols. Produced in 10 ml. (200 doses). Prescribed as injections into the throat.

Both forms of the drug are intended for topical use; they act through the mucous membranes of the respiratory tract.

To achieve maximum effect, Berodual should be used correctly before meals or some time after meals.

The medicine is dosed as follows:

• children (after six years) - 0.5-2 ml.;
• adults - 1-2.5 ml.

The drug can be used in its pure form, but doctors usually recommend diluting it with saline in a volume of 2-4 ml.

Instructions for use BERODUAL

BERODUAL 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 organic heart or vascular disease, 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:

- patients with bronchial asthma should use BERODUAL only as needed. For patients with mild chronic obstructive pulmonary disease, symptomatic treatment may be preferable to regular use of the drug.

- Patients with steroid-responsive asthma or chronic obstructive pulmonary disease should be given or increased anti-inflammatory therapy to prevent deterioration of disease control.

Regular use of increasing doses of drugs containing beta2-agonists, such as BERODUAL, to relieve bronchial obstruction can cause uncontrolled worsening of the disease. In case of increased bronchial obstruction, a simple increase in the dose of beta2-adrenergic agonists, including BERODUAL, 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.

Other sympathomimetic bronchodilators can be prescribed simultaneously with BERODUAL only under medical supervision.

Sympathomimetics, including BERODUAL, may have effects on the cardiovascular system. There are known cases of myocardial ischemia caused by taking beta-agonists. Patients with cardiac pathology (including coronary artery disease, arrhythmias or severe heart failure) taking BERODUAL should consult a doctor if chest pain or other symptoms of cardiac pathology occur. 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.

Serious hypokalemia may occur when beta2-agonists are used.

BERODUAL should be used with caution in patients predisposed to angle-closure glaucoma or who have urinary tract obstruction (for example, prostatic hyperplasia or bladder neck obstruction).

There have been isolated cases of ophthalmological complications (mydriasis, increased intraocular pressure, angle-closure glaucoma, eye pain) when nebulized ipratropium bromide alone or in combination with an adrenergic beta2-agonist came into contact with the eyes.

For inhalation, it is recommended to use nebulizers with a mouth tip. When using a nebulizer with a mask, use an appropriately sized mask. Patients predisposed to the development of glaucoma should be especially warned about the need to protect their eyes from contact with the drug.

Eye pain or irritation, blurred vision, halos or colored patterns when the eyes are red as a result of conjunctival hyperemia or corneal edema may be signs of acute angle-closure glaucoma. If any combination of such symptoms progresses, treatment with miotic drops should be started and immediate medical attention should be sought.

People with cystic fibrosis are at increased risk of developing slowed gastrointestinal motility.

When taking BERODUAL, immediate hypersensitivity reactions may occur, such as rash, urticaria, angioedema, oropharyngeal edema, bronchospasm and anaphylaxis.

The use of BERODUAL may lead to positive results for fenoterol in tests for non-clinical use of the drug, for example, when testing athletes for doping.

BERODUAL solution for inhalation contains the preservative benzalkonium chloride and the stabilizer disodium edetate, which, when inhaled, can cause bronchospasm in sensitive patients with airway hyperactivity.

Impact on the ability to drive a car and operate machinery

Studies on the effect of the drug on the ability to drive a car and operate machinery have not been conducted.

However, patients should be warned about the possibility of such side effects during treatment with BERODUAL, such as dizziness, tremor, disturbance of accommodation, mydriasis and blurred vision. 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.

Why you can’t use inhalations or aerosol injections shortly before meals

• Eating after inhalation will remove most of the solution from the mucous membranes, that is, it will reduce the therapeutic benefit of the medicine or make the procedure completely useless.
• Food particles will absorb Berodual and it will enter the stomach, and from there into the bloodstream. This can cause unwanted reactions in the body (nausea, dizziness, palpitations, etc.).

Efficiency. Professionalism. Mercy

Doctors quickly arrived at the scene and found out that a 10-year-old boy had developed acute laryngotracheitis: he was troubled by difficulty breathing, hoarseness and a barking cough. Inhalations before the ambulance arrived brought relief to the child. Doctors continued to provide care to the boy until he arrived at the hospital: to reduce swelling of the larynx and vocal cords, the patient was inhaled with hormones through a nebulizer. ⠀ According to emergency medical services doctor Maria Kolyasnikova, the upper respiratory tract of a child is much shorter and narrower than that of an adult, therefore, during acute respiratory viral infections, the inflammatory process of the mucous membrane of the larynx and trachea proceeds rapidly and can cause a dangerous condition. Swelling and spasm lead to the development of stenosis - partial or complete narrowing of the lumen of the larynx, preventing normal breathing. ⠀ So that parents can assess the severity of stenosis (narrowing of the airways), the symptoms of the disease are divided into four categories: ⠀

• 1st degree (compensated stenosis): consciousness is clear, a barking cough occurs periodically, hoarseness is noted;
• 2nd degree (subcompensated stenosis): the child is excited, breathing - with the participation of auxiliary muscles, retraction of the compliant areas of the chest, flaring of the wings of the nose; hoarse voice;
• 3rd degree (decompensated stenosis): the child is excited or inhibited, consciousness is confused, breathing is with the participation of auxiliary muscles, retraction of the compliant areas of the chest, flaring of the wings of the nose; the skin and mucous membranes are pale, the hands, feet, lips, tip of the nose are bluish in color;
• 4th degree (asphyxia): there is no consciousness, there may be convulsions; breathing is frequent, shallow, the skin is cyanotic (blue); a rare pulse as a terrible symptom of impending cardiac arrest.

⠀ If an attack occurs, the doctor advises parents not to panic, but to urgently call an ambulance and begin providing first aid. ⠀ What needs to be done before the doctors arrive: ⠀

• calm down everyone who is near the child; distract the child in any way: give a phone, tablet, book or turn on a favorite cartoon;⠀
• ventilate the room, humidify the air in any way possible (humidifier, wet towels, sheets, go into the bathroom, turn on warm water and breathe);⠀
• warm, plentiful drink;
• if body t is high, give the child an antipyretic;⠀
• if the nose is stuffy, apply vasoconstrictor drops;
• inhalation with a glucocorticoid (if the child is not afraid of the noise of the nebulizer) - if the drug is available in the home medicine cabinet on the recommendation of the attending physician;

⠀ What you should not do, and what medications you should definitely not use: ⠀

• antibiotics (indicated only if there is a concomitant bacterial infection, such as otitis media, but even in this case they should not be used without consulting a specialist);
• antiviral (with the exception of influenza, but even in this case it should not be used without consulting a specialist);
• antihistamines and antispasmodics;
• bronchodilators for inhalation (dilate the bronchi, do not relieve laryngeal edema);
• spray antiseptics into the throat (may increase stenosis);
• drip and inhale drugs with naphazoline (toxic);
• mucolytics (lead to increased mucus secretion and blockage of the lumen of the larynx).

In total, over the past weekend, from September 25 to 26, ambulance doctors and paramedics provided assistance to 1,086 residents of the regional capital and Tyumen region. 595 calls were received in emergency form, the rest were urgent. 545 patients were delivered to hospitals.

During this period, dispatchers sent 1,897 calls to clinics around the clock; in all cases, the patients’ condition did not pose a threat to life: increased blood pressure or temperature, lower back pain, etc.

Doctors from the operational department advised 635 people on issues of self-help and mutual assistance in situations that did not require a medical team to visit.

Author: Irina Berdyugina, press service of the State Budgetary Healthcare Institution "Emergency Medical Care Station". Photo by the author.

Taking into account individual characteristics

• In case of stomach hypersensitivity to drugs or gastritis, it is better to take Berodual after meals.
• If strict adherence to a diet is necessary, it is best to develop a regimen of inhalation or aerosol treatment and constantly use Berodual after meals. Because inhalations on an empty stomach are not recommended for people with dosed nutrition and disorders of the digestive system, they can aggravate existing chronic diseases.
• Berodual before meals (one hour) can be used by patients without gastrointestinal pathologies. Inhalations are also carried out in this mode for children with a severe cough to avoid the manifestation of the gag reflex.

All recommendations given in the article are designed for a course of treatment with this bronchodilator. In emergency cases, with severe bronchospasm, the drug is used in adults and children despite the diet, since prolonged tension and an active inflammatory process in the bronchi can cause swelling and serious breathing problems.

With moderate bronchospasm, but a strong and persistent cough in a child or adult, maintain a minimum interval between food and inhalation, i.e. After eating food, Berodual can be used 15-20 minutes later .

Berodual®

If shortness of breath (difficulty breathing) suddenly increases rapidly, you should consult a doctor immediately.

Hypersensitivity

After using BERODUAL®, immediate hypersensitivity reactions may occur, signs of which, in rare cases, may be: urticaria, angioedema, rash, bronchospasm, oropharyngeal edema, anaphylactic shock.

Paradoxical bronchospasm

BERODUAL®, like other inhaled drugs, can cause paradoxical bronchospasm, which can be life-threatening. If paradoxical bronchospasm develops, the use of BERODUAL® should be stopped immediately and switched to alternative therapy

Long-term use

— in patients suffering from bronchial asthma, BERODUAL® should be used only as needed;

- in patients with mild forms of chronic obstructive pulmonary disease, symptomatic treatment may be preferable to regular use;

- in patients with bronchial asthma, one should remember the need to carry out or intensify anti-inflammatory therapy to control the inflammatory process of the respiratory tract and the course of the disease.

Regular use of increasing doses of drugs containing β2-adrenergic agonists, such as BERODUAL®, to relieve bronchial obstruction can cause uncontrolled worsening of the disease. In case of increased bronchial obstruction, increasing the dose of β2-agonists, including BERODUAL®, 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.

Other sympathomimetic bronchodilators should be prescribed simultaneously with BERODUAL® only under medical supervision.

Gastrointestinal disorders

In patients with a history of cystic fibrosis, gastrointestinal motility disorders are possible.

BERODUAL® should be used with caution in patients predisposed to acute-angle glaucoma. There are isolated reports of complications from the organ of vision (for example, increased intraocular pressure, mydriasis, angle-closure glaucoma, eye pain) that developed when inhaled ipratropium bromide (or ipratropium bromide in combination with β2-adrenergic receptor agonists) entered the eyes. Symptoms of acute angle-closure glaucoma may include pain or discomfort in the eyes, blurred vision, the appearance of a halo on objects and colored spots in front of the eyes in combination with corneal edema and redness of the eyes due to conjunctival vascular injection.

If any combination of these symptoms develops, the use of eye drops that reduce intraocular pressure and immediate consultation with a specialist are indicated.

Patients should be instructed on the correct use of BERODUAL® inhalation solution. To prevent the solution from getting into the eyes, it is recommended that the solution used with a nebulizer be inhaled through the mouthpiece. If there is no mouthpiece, a mask that fits tightly to the face should be used. Patients predisposed to developing glaucoma should take special care to protect their eyes.

Systemic effects

For the following diseases: recent myocardial infarction, diabetes mellitus with inadequate glycemic control, severe organic diseases of the heart and blood vessels, hyperthyroidism, pheochromocytoma or urinary tract obstruction (for example, prostatic hyperplasia or bladder neck obstruction), BERODUAL® should be used only after careful risk/benefit assessments, especially when using doses higher than recommended.

Effect on the cardiovascular system

In post-marketing studies, rare cases of myocardial ischemia have been reported when taking beta-agonists. Patients with concomitant serious heart disease (for example, coronary heart disease, arrhythmias or severe heart failure) receiving BERODUAL® should be warned to consult a doctor if they develop heart pain or other symptoms indicating worsening of heart disease. It is necessary to pay attention to symptoms such as shortness of breath and chest pain, as they can be of both cardiac and pulmonary etiology.

Hypokalemia

When using β2-agonists, hypokalemia may occur (see section "Overdose").

In athletes, the use of BERODUAL® due to the presence of fenoterol in its composition can lead to positive results of doping tests.

The drug contains a preservative, benzalkonium chloride, and a stabilizer, disodium edetate dihydrate. During inhalation, these components may cause bronchospasm in sensitive patients with airway hyperresponsiveness.

Berodual N dosed aerosol for inhalation 20 µg+50 µg/dose 10 ml (200 doses) No. 1

Name

Berodual N aer.dose.d/ing.20mcg+50mcg/dose in 10ml vial (200doses) in 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.