Berodual ®N dosed aerosol for inhalation. Berodual n: instructions for use Berodual during pregnancy and lactation

In this article you can read the instructions for using a non-hormonal drug Berodual. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Berodual in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Berodual in the presence of existing structural analogues. Use for the treatment of dry cough attacks in bronchial asthma and chronic bronchitis in adults, children, as well as during pregnancy and lactation.

Berodual- combined bronchodilator drug. Contains two components with bronchodilator activity: ipratropium bromide - an m-anticholinergic blocker and fenoterol hydrobromide - a beta2-adrenergic agonist.

Bronchodilation with inhaled ipratropium bromide is due primarily to local rather than systemic anticholinergic effects.

Ipratropium bromide is a quaternary ammonium derivative with anticholinergic (parasympatholytic) properties. The drug inhibits reflexes caused by the vagus nerve, counteracting the effects of acetylcholine, a neurotransmitter released from the endings of the vagus nerve. Anticholinergics prevent the increase in intracellular calcium concentration, which occurs due to the interaction of acetylcholine with the muscarinic receptor located on the smooth muscles of the bronchi. The release of calcium is mediated by a system of secondary mediators, which include ITP (inositol triphosphate) and DAG (diacylglycerol).

In patients with bronchospasm associated with COPD (chronic bronchitis and emphysema), a significant improvement in lung function (increase in forced expiratory volume in 1 second (FEV1) and peak expiratory flow by 15% or more) was noted within 15 minutes, the maximum effect was achieved after 1-2 hours and continued in most patients up to 6 hours after administration.

Ipratropium bromide does not have a negative effect on mucus secretion in the respiratory tract, mucociliary clearance and gas exchange.

Fenoterol hydrobromide selectively stimulates beta2-adrenergic receptors at a therapeutic dose. Stimulation of beta1-adrenergic receptors occurs when high doses are used (for example, when prescribed for tocolytic action).

Fenoterol 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 at a dose of 600 mcg, an increase in mucociliary clearance was noted.

The beta-adrenergic effect of the drug on cardiac activity, such as an increase in heart rate and strength of heart contractions, is due to the vascular effect of fenoterol, stimulation of beta2-adrenergic receptors of the heart, and when used in doses exceeding therapeutic doses, stimulation of beta1-adrenergic receptors.

As with the use of other beta-adrenergic drugs, prolongation of the QTc interval was observed when using high doses. When fenoterol was used via metered-dose aerosol inhalers (MDIs), the effect was inconsistent and occurred at doses higher than recommended. However, following administration of fenoterol via nebulizers (inhalation solution in unit dose vials), systemic exposure may be higher than when using the drug via a MDI at recommended doses. The clinical significance of these observations has not been established.

The most commonly observed effect of beta-agonists is tremor. In contrast to the effects on bronchial smooth muscle, tolerance may develop to the systemic effects of beta-adrenergic agonists. The clinical significance of this manifestation is not clear.

When ipratropium bromide and fenoterol 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 constriction of the airways. The complementary effect is such that to achieve the desired effect, a lower dose of the beta-adrenergic component is required, which allows you to individually select an effective dose with virtually no side effects.

Indications

Prevention and symptomatic treatment of obstructive airway diseases with reversible bronchospasm:

• chronic obstructive pulmonary disease (COPD);
• bronchial asthma;
• chronic obstructive bronchitis, complicated or not complicated by emphysema.

Release forms

Solution for inhalation (sometimes mistakenly called drops).

Aerosol for inhalation dosed Berodual N (sometimes mistakenly called a spray).

Instructions for use and dosage

Solution

The dose should be selected individually. Medical supervision is required during therapy (treatment should usually begin with the lowest recommended dose). The following doses are recommended:

In adults (including the elderly) and adolescents over 12 years of age during acute attacks of bronchial asthma, the drug is prescribed in a dose of 1 ml (20 drops). This dose is usually sufficient to quickly relieve bronchospasm attacks of mild to moderate severity. In severe cases, for example, in patients in intensive care units, if the drug is ineffective at the doses indicated above, it may require its use in higher doses - up to 2.5 ml (50 drops). The maximum dose can reach 4.0 ml (80 drops). The maximum daily dose is 8 ml.

In case of moderate bronchospasm or as an adjuvant during ventilation, a dose whose lower level is 0.5 ml (10 drops) is recommended.

In children aged 6-12 years during acute attacks of bronchial asthma, for rapid relief of symptoms, it is recommended to prescribe the drug in a dose of 0.5-1 ml (10-20 drops); in severe cases - up to 2 ml (40 drops); in especially severe cases, it is possible to use the drug (subject to medical supervision) in a maximum dose of 3 ml (60 drops). The maximum daily dose is 4 ml.

In cases of moderate bronchospasm or as an aid during ventilation, the recommended dose is 0.5 ml (10 drops).

In children under 6 years of age (body weight less than 22 kg), due to the fact that information on the use of the drug in this age group is limited, the following dose is recommended (only under medical supervision): 25 mcg ipratropium bromide and 50 mcg fenoterol hydrobromide = 0.1 ml (2 drops) per kg of body weight (per dose), but not more than 0.5 ml (10 drops) (per dose). The maximum daily dose is 1.5 ml.

The inhalation solution should only be used for inhalation (with a suitable nebulizer) and should not be administered orally.

Treatment should usually begin with the lowest recommended dose.

The solution for inhalation should not be diluted with distilled water.

The solution should be diluted each time before use; Remains of the diluted solution should be destroyed.

The diluted solution should be used immediately after preparation.

The duration of inhalation can be controlled by the consumption of the diluted volume.

The inhalation solution can be used using various commercial nebulizer models. The dose reaching the lungs and the systemic dose depend on the type of nebulizer used and may be higher than the corresponding doses when using Berodual HFA and CFC metered aerosol (which depends on the type of inhaler). In cases where wall oxygen is available, the solution is best used at a flow rate of 6-8 l/min.

The instructions for use, maintenance and cleaning of the nebulizer must be followed.

Aerosol

The dose is set individually.

To relieve attacks of bronchial asthma, adults and children over 6 years of age are prescribed 2 inhalation doses. If breathing relief does not occur within 5 minutes, 2 more inhalation doses can be prescribed.

The patient should be informed that if there is no effect after 4 inhalation doses and additional inhalations are necessary, consult a doctor immediately.

Metered-dose aerosol BerodualN should be used in children only as prescribed by a doctor and under the supervision of adults.

For long-term and intermittent therapy, 1-2 inhalations are prescribed per 1 dose, up to 8 inhalations per day (on average, 1-2 inhalations 3 times a day).

Rules for using the drug

The patient should be instructed on the correct use of the metered dose aerosol.

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. Holding the balloon, wrap your lips around the mouthpiece. The cylinder should be pointing upside down.

4. While inhaling as deeply as possible, simultaneously quickly press the bottom of the cylinder until 1 inhalation dose is released. Hold your breath for a few seconds, then remove the mouthpiece from your mouth and exhale slowly. Repeat steps to receive the 2nd 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. Then the cylinder should be replaced. Although some contents may remain in the canister, the amount of drug released during inhalation is reduced.

Since the cylinder is opaque, the amount of drug in the cylinder can be determined as follows: after 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 mouthpiece should be kept clean; if necessary, it can be rinsed in warm water. After using soap or detergent, the mouthpiece should be rinsed thoroughly with water.

The plastic mouthpiece is designed specifically for Berodual N metered aerosol and serves for precise dosing of the drug. The mouthpiece should not be used with other metered dose aerosols. You also cannot use Berodual N metered-dose aerosol with other mouthpieces.

Side effect

• anaphylactic reaction;
• hypersensitivity;
• hypokalemia;
• nervousness;
• excitation;
• headache;
• tremor;
• dizziness;
• glaucoma;
• increased intraocular pressure;
• mydriasis;
• blurred vision;
• Pain in the eyes;
• corneal edema;
• the appearance of a halo around objects;
• tachycardia;
• arrhythmias;
• atrial fibrillation;
• myocardial ischemia;
• increased systolic blood pressure;
• increased diastolic blood pressure;
• cough;
• pharyngitis;
• dysphonia;
• bronchospasm;
• swelling of the pharynx;
• laryngospasm;
• dry throat;
• vomiting, nausea;
• dry mouth;
• stomatitis;
• glossitis;
• gastrointestinal motility disorders;
• diarrhea;
• constipation;
• hives;
• angioedema;
• muscle weakness;
• muscle spasm;
• urinary retention.

Contraindications

• hypertrophic obstructive cardiomyopathy;
• tachyarrhythmia;
• 1st and 3rd trimesters of pregnancy;
• hypersensitivity to fenoterol and other components of the drug;
• hypersensitivity to atropine-like drugs.

Use during pregnancy and breastfeeding

Data from preclinical studies and human experience indicate that fenoterol or ipratropium bromide do not have a negative effect during pregnancy.

The possibility of an inhibitory effect of fenoterol on uterine contractility should be taken into account.

The drug is contraindicated in the 1st and 3rd trimesters (the possibility of weakening labor by fenoterol).

The drug should be used with caution in the 2nd trimester of pregnancy.

Fenoterol passes into breast milk. There is no data confirming that ipratropium bromide passes into breast milk. However, Berodual should be prescribed to nursing mothers with caution.

Clinical data on the effect of the combination of ipratropium bromide and fenoterol hydrobromide on fertility are not known.

special instructions

The patient should be informed that if shortness of breath (difficulty breathing) suddenly increases rapidly, consult a doctor immediately.

It should be taken into account that in patients with bronchial asthma Berodual should be used only as needed. In patients with mild 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 beta2-adrenergic 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 deterioration of the disease, a review of the patient's treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids should be considered.

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

Other sympathomimetic bronchodilators should be prescribed concomitantly with Berodual only under medical supervision.

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.

Berodual should be used with caution in patients predisposed to developing acute-angle glaucoma or in patients with concomitant urinary tract obstruction (eg, prostatic hyperplasia or bladder neck obstruction).

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.

Impact 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, patients should be warned that during treatment with Berodual they may experience undesirable sensations such as dizziness, tremor, disturbances in ocular accommodation, mydriasis and blurred vision. Therefore, caution should be recommended when driving vehicles or using machinery. If patients experience the above unwanted sensations, they should refrain from potentially dangerous activities such as driving a car or operating machinery.

Drug interactions

Beta-adrenergic agonists and anticholinergics, xanthine derivatives (including theophylline) can enhance the bronchodilator effect of Berodual.

With the simultaneous use of other beta-agonists, systemic anticholinergics, xanthine derivatives (for example, theophylline), side effects may increase.

A significant weakening of the bronchodilator effect of Berodual is possible with simultaneous use of beta-blockers.

Hypokalemia associated with the use of beta-agonists may be exacerbated by the simultaneous use of xanthine derivatives, corticosteroids 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.

Beta-adrenergic agents should be prescribed with caution to patients receiving MAO inhibitors and tricyclic antidepressants, because these drugs can enhance the effect of beta-adrenergic drugs.

The use of inhaled halogenated anesthetics, such as halothane, trichlorethylene or enflurane, may enhance the cardiovascular effects of beta-adrenergic agents.

The combined use of Berodual with cromoglycic acid and/or glucocorticosteroids increases the effectiveness of therapy.

Analogues of the drug Berodual

The drug Berodual has no structural analogues for the active substance. However, there are analogues in the pharmacological group (beta-agonists in combinations):

• Biasten;
• Ditek;
• Intal plus;
• Ipramol Steri-Neb;
• Cashnol;
• Combivent;
• Combipack;
• Seretide;
• Seretide Multidisc;
• Symbicort Turbuhaler;
• Tevacombe;
• Foradil Combi.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.

Instructions for use

Active ingredients

Release form

Compound

Hydrobromide phenoterol 50 μg; oprotropy bromide monohydrate 21 μg,; which corresponds to the content of the Ipramotropy bromide 20 μg; excipients: absolute ethanol - 13.313 mg, peeled water - 0.799 mg, citric acid - 0.001 mg, tetraftoroethane (HFA 134a, propellant) - 39.070 mg.

Pharmacological effect

Combined bronchodilator drug. Contains two components with bronchodilator activity: ipratropium bromide - an m-anticholinergic blocker, and fenoterol hydrobromide - a beta2-adrenergic agonist.; Bronchodilation with inhaled ipratropium bromide is due mainly to local rather than systemic anticholinergic effects; Ipratropium bromide is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. Ipratropium bromide inhibits reflexes mediated by the vagus nerve. Anticholinergics prevent the increase in intracellular calcium concentration, which occurs due to the interaction of acetylcholine with the muscarinic receptor located on the smooth muscles of the bronchi. The release of calcium is mediated by a system of secondary mediators, which include ITP (inositol triphosphate) and DAG (diacylglycerol).; In patients with bronchospasm associated with COPD (chronic bronchitis and emphysema), a significant improvement in lung function (an increase in forced expiratory volume in 1 second (FEV1) and peak expiratory flow by 15% or more) was noted within 15 minutes, the maximum effect was achieved after 1-2 hours and lasted in most patients up to 6 hours after administration; Ipratropium bromide does not have a negative effect on mucus secretion in the respiratory tract, mucociliary clearance and gas exchange.; Fenoterol hydrobromide selectively stimulates β2-adrenergic receptors at a therapeutic dose. Stimulation of β1-adrenergic receptors occurs when used in high doses.; Fenoterol 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 at a dose of 600 mcg, an increase in mucociliary clearance was noted; The beta-adrenergic effect of the drug on cardiac activity, such as an increase in the frequency and strength of heart contractions, is due to the vascular effect of fenoterol, stimulation of β2-adrenergic receptors of the heart, and when used in doses exceeding therapeutic doses, stimulation of β1-adrenergic receptors.; As with the use of other beta-adrenergic drugs, prolongation of the QTc interval was observed when used in high doses. When fenoterol was used via metered-dose aerosol inhalers (MDIs), the effect was inconsistent and occurred at doses higher than recommended. However, following administration of fenoterol via nebulizers (inhalation solution in unit dose vials), systemic exposure may be higher than when using the drug via a MDI at recommended doses. The clinical significance of these observations has not been established.; The most commonly observed effect of β-adrenergic agonists is tremor. In contrast to the effects on bronchial smooth muscle, tolerance may develop to the systemic effects of β-adrenergic agonists. The clinical significance of this manifestation is not clear.; When ipratropium bromide and fenoterol 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 constriction of the airways. The complementary effect is such that to achieve the desired effect, a lower dose of the beta-adrenergic component is required, which allows you to individually select an effective dose with virtually no side effects.; In case of acute bronchoconstriction, the effect of the drug Berodual; H develops quickly, which makes it possible to use it in acute attacks of bronchospasm.

Indications

Prevention and symptomatic treatment of obstructive airway diseases with reversible bronchospasm: - COPD; - bronchial asthma; - chronic bronchitis, complicated or not complicated by emphysema.

Contraindications

Hypertrophic obstructive cardiomyopathy; - tachyarrhythmia; - I trimester of pregnancy; - children under 6 years of age; - hypersensitivity to the components of the drug; - increased sensitivity to atropine-like substances; The drug should be prescribed with caution for angle-closure glaucoma, coronary insufficiency, arterial hypertension, poorly controlled diabetes mellitus, recent myocardial infarction, severe organic diseases of the cardiovascular system, hyperthyroidism, pheochromocytoma, prostatic hypertrophy, bladder neck obstruction, cystic fibrosis, children over 6 years old.

Use during pregnancy and breastfeeding

The drug is contraindicated for use in the first trimester of pregnancy.; Current experience has shown that ipratropium bromide and fenoterol hydrobromide do not have adverse effects during pregnancy. However, in the II and III trimesters of pregnancy Berodual; N should be used with caution. It is necessary to take into account the possibility of an inhibitory effect of Berodual N on the contractile activity of the uterus.; Fenoterol hydrobromide is excreted in breast milk. There is no data confirming the excretion of ipratropium bromide in breast milk. Significant exposure of an infant to ipratropium, especially when administered as an aerosol, is unlikely. However, given the ability of many drugs to pass into breast milk, Berodual should be prescribed with caution; H during lactation (breastfeeding).

Directions for use and doses

The dose is set individually.; To relieve attacks, adults and children over 6 years of age are prescribed 2 inhalation doses. If breathing relief does not occur within 5 minutes, 2 more inhalation doses can be prescribed.; The patient should be informed to immediately consult a doctor if there is no effect after 4 inhalation doses and the need for additional inhalations.; Metered aerosol Berodual; N should be used in children only as prescribed by a doctor and under the supervision of adults.; For long-term and intermittent therapy, 1-2 inhalations are prescribed per 1 dose, up to 8 inhalations / day (on average, 1-2 inhalations 3 times / day).; For bronchial asthma, the drug should be used only as needed; Rules for using the drug; The patient should be instructed on the correct use of the metered-dose aerosol.; 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. Exhale slowly, deeply; 3. Holding the balloon, wrap your lips around the mouthpiece. The cylinder should be directed upside down.; 4. While inhaling as deeply as possible, simultaneously quickly press the bottom of the cylinder until 1 inhalation dose is released. Hold your breath for a few seconds, then remove the mouthpiece from your mouth and exhale slowly. Repeat steps to receive the 2nd inhalation dose.; 5. Put on the protective cap.; 6. If the aerosol can has not been used for more than 3 days, before use, you should press the bottom of the can once until a cloud of aerosol appears.; The cylinder is designed for 200 inhalations. Then the cylinder should be replaced. Although some contents may remain in the cylinder, the amount of drug released during inhalation is reduced.; Since the balloon is opaque, the amount of drug in the balloon can be determined as follows: - by removing the plastic mouthpiece from the balloon, the balloon 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.; Clean your inhaler at least once a week. It is important to keep the inhaler mouthpiece clean so that drug particles do not block the release of the aerosol.; When cleaning, first remove the protective cap and remove the canister from the inhaler. Run a stream of warm water through the inhaler, making sure to remove the drug and/or visible dirt. After cleaning, shake the inhaler and allow it to air dry without using heating devices.Once the mouthpiece is dry, insert the canister into the inhaler and put on the protective cap.; The plastic mouthpiece is designed specifically for Berodual metered aerosol; N and serves for precise dosing of the drug. The mouthpiece should not be used with other metered dose aerosols. You should also not use Berodual metered-dose aerosol; H with other mouthpieces.; The contents of the cylinder are under pressure.The cylinder must not be opened or exposed to temperatures above 50°C.

Side effects

Many of the listed undesirable effects may be a consequence of the anticholinergic and beta-adrenergic properties of the drug Berodual; N. Berodual; H, like any inhalation therapy, may cause local irritation. Adverse drug reactions were determined based on data obtained in clinical trials and during pharmacological surveillance of the use of the drug after its registration.; The most common side effects reported in clinical studies were cough, dry mouth, headache, tremor, pharyngitis, nausea, dizziness, dysphonia, tachycardia, palpitations, vomiting, increased systolic blood pressure and nervousness; From the immune system: anaphylactic reaction, hypersensitivity, incl. urticaria, angioedema; Metabolism: hypokalemia; Mental disorders: nervousness, agitation, mental disorders.; From the nervous system: headache, tremor, dizziness.; From the organ of vision: glaucoma, increased intraocular pressure, impaired accommodation, mydriasis, blurred vision, eye pain, corneal edema, conjunctival hyperemia, the appearance of a halo around objects.; From the heart: tachycardia, palpitations, arrhythmias, atrial fibrillation, supraventricular tachycardia, myocardial ischemia.; From the respiratory system: cough, pharyngitis, dysphonia, bronchospasm, pharyngeal irritation, pharyngeal edema, laryngospasm, paradoxical bronchospasm, dry pharynx.; From the digestive system: vomiting, nausea, dry mouth, stomatitis, glossitis, gastrointestinal motility disorders, diarrhea, constipation, swelling of the oral cavity.; From the skin and subcutaneous tissues: itching, hyperhidrosis; From the musculoskeletal system: muscle weakness, muscle spasm, myalgia.; From the urinary system: urinary retention; Laboratory and instrumental data: increased systolic blood pressure, increased diastolic blood pressure.

Overdose

Symptoms: Symptoms of overdose are usually associated primarily with the effects of fenoterol. Symptoms associated with excessive stimulation of β-adrenergic receptors may occur. The most likely occurrence is tachycardia, palpitations, tremor, arterial hypo- or hypertension, increased pulse pressure, angina pain, arrhythmia, hot flashes, metabolic acidosis, hypokalemia.; Symptoms of an overdose of ipratropium bromide, such as dry mouth, impaired eye accommodation, given the wide breadth of therapeutic action and inhalation use, are usually mild and transient in nature.; Treatment. It is necessary to stop taking the drug. Data from monitoring the acid-base balance of the blood should be taken into account. Sedatives, tranquilizers, and in severe cases intensive care are indicated; As a specific antidote, it is possible to use beta-blockers, preferably beta1-selective blockers. However, one should be aware of the possible increase in bronchial obstruction under the influence of beta-blockers and carefully select the dose for patients suffering from bronchial asthma or COPD due to the risk of severe bronchospasm, which can be fatal.

Interaction with other drugs

Long-term simultaneous use of the drug Berodual; N with other anticholinergic drugs is not recommended due to lack of data.; Beta-adrenergic agonists and anticholinergics, xanthine derivatives (including theophylline) can enhance the bronchodilator effect of the drug Berodual; N.; With the simultaneous use of other beta-agonists, anticholinergics entering the systemic circulation or xanthine derivatives (including theophylline), increased side effects may occur; There may be a significant weakening of the bronchodilator effect of the drug Berodual; H with simultaneous prescription of beta-blockers.; Hypokalemia associated with the use of beta-agonists can be enhanced by the simultaneous administration of xanthine derivatives, corticosteroids and diuretics. This 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 the concentration of potassium in the blood serum.; Beta-agonists should be prescribed with caution to patients receiving MAO inhibitors and tricyclic antidepressants, because these drugs can enhance the effect of beta-adrenergic drugs.; Inhalation anesthetics containing halogenated hydrocarbons (including halothane, trichlorethylene, enflurane) may increase the adverse effects of beta-adrenergic drugs on the cardiovascular system.

special instructions

If shortness of breath (difficulty breathing) suddenly increases rapidly, you should consult a doctor immediately; Hypersensitivity; After using the drug Berodual; N immediate hypersensitivity reactions may occur, signs of which in rare cases may include urticaria, angioedema, rash, bronchospasm, oropharyngeal edema, anaphylactic shock.; Paradoxical bronchospasm; Berodual; N, like other inhaled drugs, can cause paradoxical bronchospasm, which can be life-threatening. In case of development of paradoxical bronchospasm, use of the drug Berodual; N should be stopped immediately and switched to alternative therapy.; Long-term use; In patients with bronchial asthma Berodual; H should be used only as needed. In patients with mild COPD, 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 beta2-adrenergic agonists, such as Berodual; H, to relieve bronchial obstruction may cause uncontrolled worsening of the disease. In case of increased bronchial obstruction, increase the dose of beta2-agonists, incl. drug 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.; Other sympathomimetic bronchodilators should be prescribed simultaneously with Berodual; N only under medical supervision.; Gastrointestinal disorders; In patients with a history of cystic fibrosis, gastrointestinal motility disorders are possible.; Violations of the organ of vision; Berodual; N should be prescribed with caution to patients predisposed to the development of angle-closure 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; N. 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 you do not have a mouthpiece, use a mask that fits tightly to your face. Particular care should be taken to protect the eyes of patients predisposed to the development of glaucoma.; 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; N should be prescribed only after a careful assessment of the risk/benefit ratio, especially in doses higher than recommended.; Effect on the cardiovascular system; In post-marketing studies, rare cases of myocardial ischemia were reported when taking beta-adrenergic agonists. Patients with concomitant serious heart diseases (for example, coronary artery disease, arrhythmias or severe heart failure) receiving Berodual; N, you should be warned to consult a doctor if you experience heart pain or other symptoms indicating worsening heart disease. It is necessary to pay attention to symptoms such as shortness of breath and chest pain, because... they can be of both cardiac and pulmonary etiology.; Hypokalemia; When using β2-adrenergic receptor agonists, hypokalemia may occur.; In athletes, the use of the drug Berodual; H, 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.; Effect on the ability to drive vehicles and operate machinery; The effect of the drug on the ability to drive vehicles and use machinery has not been specifically studied. However, patients should be advised that during treatment with Berodual; It is possible to develop such undesirable phenomena as dizziness, tremor, disturbance of accommodation, mydriasis, blurred vision. Therefore, caution should be recommended when driving vehicles or using machinery. If patients experience the above unwanted sensations, they should refrain from potentially dangerous activities such as driving vehicles or operating machinery.

Instructions

on the use of a medicinal product for medical use

BERODUAL N

Registration number: P N013312/01

Tradename: BERODUAL N

International nonproprietary name or generic name: Ipratropium bromide + Fenoterol

Dosage form: Aerosol for inhalation dosed

Compound:

1 inhalation dose contains the active ingredient: ipratropium bromide monohydrate 0.021 mg (21 mcg), which corresponds to ipratropium bromide 0.020 mg (20 mcg), fenoterol hydrobromide 0.050 mg (50 mcg)

Excipients: absolute ethanol 13.313 mg, purified water 0.799 mg, citric acid 0.001 mg, tetrafluoroethane (HFA134a, propellant) 39.070 mg

Description: Clear, colorless or slightly yellowish or slightly brownish liquid, free of suspended particles.

Pharmacotherapeutic group: bronchodilator (m-anticholinergic + beta2-adrenergic agonist)

ATX code: R03AK03

Pharmacological properties:

Berodual contains two components with bronchodilator activity: ipratropium bromide - an m-anticholinergic blocker, and fenoterol - a β 2 -adrenergic agonist. Bronchodilation following inhaled ipratropium bromide is due primarily to local rather than systemic anticholinergic effects.

Ipratropium bromide is a quaternary ammonium derivative with anticholinergic (parasympatholytic) properties. Ipratropium bromide inhibits reflexes caused by the vagus nerve. Anticholinergics prevent the increase in intracellular Ca++ concentration, which occurs due to the interaction of acetylcholine with the muscarinic receptor located on the smooth muscles of the bronchi. The release of Ca++ is mediated by a system of secondary mediators, which include ITP (inositol triphosphate) and DAG (diacylglycerol). In patients with bronchospasm associated with chronic obstructive pulmonary diseases (chronic bronchitis and emphysema), a significant improvement in lung function (an increase in forced expiratory volume in 1 second (FEV 1) and peak expiratory flow by 15% or more) was noted within 15 minutes , the maximum effect was achieved after 1-2 hours and lasted in most patients up to 6 hours after administration.

Ipratropium bromide does not have a negative effect on mucus secretion in the respiratory tract, mucociliary clearance and gas exchange.

Fenoterol selectively stimulates β2-adrenergic receptors at a therapeutic dose. Stimulation of β 1 -adrenergic receptors occurs when high doses are used (for example, when prescribed for tocolytic action).

Fenoterol relaxes the smooth muscles of the bronchi and blood vessels, 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 doses of 0.6 mg, an increase in mucociliary clearance was noted. The β-adrenergic effect of the drug on cardiac activity, such as an increase in the frequency and strength of heart contractions, is due to the vascular effect of fenoterol, stimulation of β2-adrenergic receptors of the heart, and when using doses exceeding therapeutic doses, stimulation of β1-adrenergic receptors. As with the use of other β-adrenergic drugs, prolongation of the QT interval was observed when using high doses. When fenoterol was used via metered-dose aerosol inhalers (MDIs), the effect was inconsistent and occurred at doses higher than recommended. However, following administration of fenoterol via nebulizers (inhalation solution in unit dose vials), systemic exposure may be higher than when using the drug via a MDI at recommended doses. The clinical significance of these observations has not been established. The most commonly observed effect of beta-agonists is tremor. In contrast to the effects on bronchial smooth muscle, tolerance may develop to the systemic effects of beta-adrenergic agonists; the clinical significance of this manifestation is unclear. Tremor is the most common adverse effect with β-adrenergic agonists.

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 constriction of the airways. The complementary effect is such that to achieve the desired effect, a lower dose of the β-adrenergic component is required, which allows you to individually select an effective dose with virtually no side effects.

Indications

Prevention and symptomatic treatment of obstructive airway diseases with reversible airway obstruction: chronic obstructive pulmonary disease, bronchial asthma, chronic bronchitis, complicated or uncomplicated by emphysema.

Contraindications

Hypertrophic obstructive cardiomyopathy, tachyarrhythmia; hypersensitivity to fenoterol hydrobromide, atropine-like substances or any other components of the drug, first trimester of pregnancy, children under 6 years of age.

Carefully

closed-angle glaucoma, coronary insufficiency, arterial hypertension, poorly controlled diabetes mellitus, recent myocardial infarction, severe organic diseases of the heart and blood vessels, hyperthyroidism, pheochromocytoma, prostatic hypertrophy, bladder neck obstruction, cystic fibrosis, childhood.

Pregnancy and lactation

Current clinical experience has shown that fenoterol and ipratropium bromide do not have a negative effect on pregnancy. However, normal precautions should be taken when using these drugs during pregnancy, especially during the first trimester. The inhibitory effect of BERODUAL on uterine contractility should be taken into account.

Fenoterol hydrobromide may pass into breast milk. No such data have been obtained for ipratropium. Significant exposure of an infant to ipratropium, especially when administered as an aerosol, is unlikely. However, given the ability of many drugs to pass into breast milk, caution should be exercised when prescribing BERODUAL to breastfeeding women.

Directions for use and doses

The dose should be selected individually. Unless otherwise recommended by a physician, the following doses are recommended: Adults and children over 6 years of age: Treatment of seizures

In most cases, two inhalation doses of the aerosol are sufficient to relieve symptoms. If breathing relief does not occur within 5 minutes, you can use an additional 2 inhalation doses.

If there is no effect after four inhalation doses and additional inhalations are required, seek medical attention without delay. Intermittent and long-term therapy:

1-2 inhalations per dose, up to 8 inhalations per day (on average 1-2 inhalations 3 times a day). For bronchial asthma, the drug should be used only as needed

Metered-dose aerosol BERODUAL N should be used in children only as prescribed by a doctor and under the supervision of adults.

Mode of application:

Patients should be instructed on the correct use of the metered dose aerosol.

Before using the metered-dose aerosol for the first time, remove the protective cap and press the valve twice. Before each use of the metered-dose aerosol, shake the can and press the aerosol valve 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 inhaler as shown in Fig. 1 and tightly wrap your lips around the mouthpiece. The cylinder should be directed with the bottom and the arrow pointing upward.

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 mouthpiece 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 three days, before use, press the bottom of the can once until a cloud of aerosol appears.

Because the container is opaque, it is impossible to determine whether the container is empty. The cylinder is designed for 200 inhalations. After using this number of doses, a small amount of solution may remain in the container. However, the container should be replaced, as otherwise you may not receive the required therapeutic dose.

The amount of drug remaining in the container can be checked as follows.

Shake the container, this will show whether there is any liquid left in it. Another way. Remove the plastic mouthpiece from the container and place the container in a container of water. The contents of a container can be determined by its position in the water (see Figure 2).

Clean your inhaler at least once a week.

When cleaning, first remove the protective cap and remove the canister from the inhaler. Run a stream of warm water through the inhaler, making sure to remove the drug and/or visible dirt.

After cleaning, shake the inhaler and allow it to air dry without using heat. Once the mouthpiece is dry, insert the canister into the inhaler and put on the protective cap.

WARNING: The plastic mouthpiece is designed specifically for the BERODUAL N metered aerosol and serves for precise dosing of the drug. The mouthpiece should not be used with other metered dose aerosols. Also, you cannot use BERODUAL N aerosol with any adapters other than the mouthpiece supplied with the can.

The contents of the cylinder are under pressure. The cylinder must not be opened or exposed to temperatures above 50° C.

Side effect

Many of the listed undesirable effects may be a consequence of the anticholinergic and beta-adrenergic properties of BERODUAL N. BERODUAL N, like any inhalation therapy, may cause local irritation. Adverse reactions to the drug were determined based on data obtained in clinical trials and during pharmacological surveillance of the use of the drug after its registration.

The most common side effects reported in clinical studies were cough, dry mouth, headache, tremor, pharyngitis, nausea, dizziness, dysphonia, tachycardia, palpitations, vomiting, increased systolic blood pressure and nervousness.

Immune system disorders

• anaphylactic reaction
• hypersensitivity

Metabolic and nutritional disorders

• hypokalemia

Mental disorders

• nervousness
• excitation
• mental disorders

Nervous system disorders

• headache
• tremor
• dizziness

Visual disorders

• glaucoma
• increased intraocular pressure
• disturbances of accommodation
• mydriasis
• blurred vision
• Pain in the eyes

• corneal edema
• conjunctival hyperemia
• the appearance of a halo around objects

Heart disorders

• tachycardia
• heartbeat
• arrhythmias
• atrial fibrillation
• supraventricular tachycardia
• myocardial ischemia

Respiratory, thoracic and mediastinal disorders

• cough
• pharyngitis
• dysphonia
• bronchospasm
• throat irritation
• swelling of the pharynx
• laryngospasm
• paradoxical bronchospasm
• dry throat

Gastrointestinal disorders

• vomit
• nausea
• dry mouth
• stomatitis
• glossitis
• gastrointestinal motility disorders
• diarrhea
• constipation
• swelling of the mouth

Changes in the skin and subcutaneous tissues

• hives
• angioedema

• hyperhidrosis

Musculoskeletal and connective tissue disorders

• muscle weakness
• muscle spasm
• myalgia

Renal and urinary tract disorders

• urinary retention

Laboratory and instrumental data

• increased systolic blood pressure
• increased diastolic blood pressure

Special instructions:

In case of sudden onset and rapid progression of shortness of breath (difficulty breathing), you should immediately consult a doctor.

Long-term use:

• in patients suffering from bronchial asthma, BERODUAL N should be used only as needed. In patients with mild forms of chronic obstructive pulmonary disease, symptomatic treatment given as needed (depending on the presence of symptoms) may be preferable to regular treatment.
• in patients with bronchial asthma, one should remember the need to carry out or intensify anti-inflammatory therapy to control the inflammatory process in the airways and the course of the disease.

Regular use of increasing doses of drugs containing beta2-adrenergic receptor agonists, such as BERODUAL N, 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 receptor 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, a review of the patient's treatment plan and adequate anti-inflammatory therapy with inhaled glucocorticosteroids should be considered.

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

In case of poorly controlled diabetes mellitus, recent myocardial infarction, severe organic heart or vascular disease, hyperthyroidism, pheochromocytosis, BERODUAL N should be used only after a careful assessment of the risk/benefit ratio, especially if doses exceeding the recommended ones are used.

When using sympathomimetic drugs, including BERODUAL N, side effects on the cardiovascular system may be observed. Post-marketing and literature data contain reports of rare cases of myocardial ischemia associated with the use of beta-adrenergic 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 the assessment of symptoms such as shortness of breath and chest pain, as they can be of either pulmonary or cardiac origin.

Potentially serious hypokalemia may be a consequence of beta2-agonist therapy.

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

There are isolated reports of ophthalmological complications (including mydriasis, increased intraocular pressure, angle-closure glaucoma, eye pain) that developed when inhaled ipratropium bromide (or ipratropium bromide in combination with beta2-adrenergic receptor agonists) came into contact with the eyes.

In this regard, patients should be instructed on the correct use of the drug BERODUAL N.

Precautions must be taken to prevent the drug from getting into the eyes.

Symptoms of acute acute-angle glaucoma may include pain or discomfort in the eyes, blurred vision, the appearance of halos on objects and colored spots in front of the eyes, combined with redness of the eyes due to conjunctival vascular injection and corneal edema. 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 with cystic fibrosis may be more prone to gastrointestinal motility disorders.

Immediate hypersensitivity reactions may occur following use of BERODUAL N, as indicated by rare cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal edema and anaphylaxis.

The use of BERODUL N may lead to positive test results for substance abuse for non-medical reasons (due to the presence of fenoterol).

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

Overdose

Symptoms

Symptoms of overdose are usually associated primarily with the effects of fenoterol. Symptoms associated with excessive stimulation of beta-adrenergic receptors may occur. The most likely occurrence is tachycardia, palpitations, tremor, arterial hypertension or arterial hypotension, increased pulse pressure, angina pain, arrhythmias and hot flashes, and metabolic acidosis. Symptoms of an overdose of ipratropium bromide (such as dry mouth, impaired eye accommodation), given the wide breadth of the therapeutic effect of the drug and the local method of administration, are usually mild and transient.

Treatment

Sedatives and tranquilizers are indicated, and in severe cases, intensive care. As a specific antidote, it is possible to use beta-blockers, preferably beta1-selective blockers. However, one should be aware of 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 disease, due to the risk of severe bronchospasm, which can be fatal.

Interaction with other drugs

Beta-adrenergic and anticholinergic drugs, xanthine derivatives (for example, theophylline) can enhance the bronchodilator effect of BERODULA N. The simultaneous administration of other beta-adrenergic agonists that enter the systemic circulation of anticholinergic drugs or xanthine derivatives (for example, theophylline) may lead to increased side effects.

A significant weakening of the bronchodilator effect of BERODUAL N is possible with the simultaneous administration of beta-blockers.

Hypokalemia associated with the use of beta-agonists can be enhanced by the simultaneous administration of xanthine derivatives, glucocorticosteroids and diuretics. This should be given special attention when treating patients with severe forms of obstructive airway disease.

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 concentrations.

Beta-adrenergic agents should be prescribed with caution to patients receiving monoamine oxidase inhibitors and tricyclic antidepressants, as these drugs can enhance the effect of beta-adrenergic agents. Inhalation of halogenated hydrocarbon anesthetics, such as halothane, trichlorethylene or enflurane, may increase the adverse cardiovascular effects of beta-adrenergic agents.

Effects on the ability to drive vehicles and use machinery

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

However, patients should be advised that during treatment with BERODUAL N they may experience undesirable sensations such as dizziness, tremor, disturbances in ocular accommodation, mydriasis and blurred vision. Therefore, caution should be recommended when driving vehicles or using machinery. If patients experience the above unwanted sensations, they should refrain from potentially dangerous activities such as driving a car or operating machinery.

Release form:

Aerosol for inhalation dosed 20 mcg+50 mcg/dose - 200 doses

10 ml in a metal can with a dosing valve and a mouthpiece with a protective cap. The can with instructions for use is placed in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25°C. Keep out of the reach of children.

Best before date

Do not use the drug after the expiration date.

Conditions for dispensing from pharmacies

By doctor's prescription

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG", Germany, 55216 Ingelheim am Rhein, Bingerstrasse 173

You can obtain additional information about the drug, as well as send your complaints and information about adverse events to the following address in Russia

Boehringer Ingelheim LLC

125171, Moscow, Leningradskoe shosse, 16A, building 3

Tel/Fax: 8 800 700 99 93

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Expiration date from date of manufacture

Product description

Aerosol for inhalation dosed in the form of a clear, colorless or slightly yellowish or slightly brownish liquid, free of suspended particles.

pharmachologic effect

Combined bronchodilator drug. Contains two components with bronchodilator activity: ipratropium bromide - an m-anticholinergic blocker, and fenoterol hydrobromide - a beta2-adrenergic agonist.
Bronchodilation with inhaled ipratropium bromide is due primarily to local rather than systemic anticholinergic effects.
Ipratropium bromide is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. Ipratropium bromide inhibits reflexes mediated by the vagus nerve. Anticholinergics prevent the increase in intracellular calcium concentration, which occurs due to the interaction of acetylcholine with the muscarinic receptor located on the smooth muscles of the bronchi. The release of calcium is mediated by a system of secondary mediators, which include ITP (inositol triphosphate) and DAG (diacylglycerol).
In patients with bronchospasm associated with COPD (chronic bronchitis and emphysema), a significant improvement in lung function (an increase in forced expiratory volume in 1 second (FEV1) and peak expiratory flow by 15% or more) was noted within 15 minutes, the maximum effect was achieved after 1-2 hours and continued in most patients up to 6 hours after administration.
Ipratropium bromide does not have a negative effect on mucus secretion in the respiratory tract, mucociliary clearance and gas exchange.
Fenoterol hydrobromide selectively stimulates β2-adrenergic receptors at a therapeutic dose. Stimulation of β1-adrenergic receptors occurs when used in high doses.
Fenoterol 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 at a dose of 600 mcg, an increase in mucociliary clearance was noted.
The beta-adrenergic effect of the drug on cardiac activity, such as an increase in the frequency and strength of heart contractions, is due to the vascular effect of fenoterol, stimulation of β2-adrenergic receptors of the heart, and when used in doses exceeding therapeutic doses, stimulation of β1-adrenergic receptors.
As with the use of other beta-adrenergic drugs, prolongation of the QTc interval was observed when used in high doses. When fenoterol was used via metered-dose aerosol inhalers (MDIs), the effect was inconsistent and occurred at doses higher than recommended. However, following administration of fenoterol via nebulizers (inhalation solution in unit dose vials), systemic exposure may be higher than when using the drug via a MDI at recommended doses. The clinical significance of these observations has not been established.
The most commonly observed effect of β-adrenergic agonists is tremor. In contrast to the effects on bronchial smooth muscle, tolerance may develop to the systemic effects of β-adrenergic agonists. The clinical significance of this manifestation is unclear.
When ipratropium bromide and fenoterol 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 constriction of the airways. The complementary effect is such that to achieve the desired effect, a lower dose of the beta-adrenergic component is required, which allows you to individually select an effective dose with virtually no side effects.
In acute bronchoconstriction, the effect of the drug Berodual® N develops quickly, which allows its use in acute attacks of bronchospasm.

Indications for use

Prevention and symptomatic treatment of obstructive airway diseases with reversible bronchospasm:
- COPD;
- bronchial asthma;
- chronic bronchitis, complicated or not complicated by emphysema.

Use during pregnancy and lactation

The drug is contraindicated for use in the first trimester of pregnancy.
Current experience has shown that ipratropium bromide and fenoterol hydrobromide do not have adverse effects during pregnancy. However, in the second and third trimesters of pregnancy, Berodual® N should be used with caution. It is necessary to take into account the possibility of an inhibitory effect of Berodual N on the contractile activity of the uterus.
Fenoterol hydrobromide is excreted in breast milk. There is no data confirming the excretion of ipratropium bromide in breast milk. Significant exposure of an infant to ipratropium, especially when administered as an aerosol, is unlikely. However, given the ability of many drugs to pass into breast milk, Berodual® N should be prescribed with caution during lactation (breastfeeding).

special instructions

If shortness of breath (difficulty breathing) suddenly increases rapidly, you should consult a doctor immediately.
Hypersensitivity
After using the drug Berodual® N, immediate hypersensitivity reactions may occur, signs of which in rare cases may include urticaria, angioedema, rash, bronchospasm, oropharyngeal edema, anaphylactic shock.
Paradoxical bronchospasm
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.
Long-term use
In patients with bronchial asthma, Berodual® N should be used only as needed. In patients with mild COPD, 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 beta2-adrenergic agonists, such as Berodual® N, to relieve bronchial obstruction can cause uncontrolled worsening of the disease. In case of increased bronchial obstruction, increase the dose of beta2-agonists, incl. taking 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.
Other sympathomimetic bronchodilators should be prescribed simultaneously with Berodual® N only under medical supervision.
Gastrointestinal disorders
In patients with a history of cystic fibrosis, gastrointestinal motility disorders are possible.
Visual disorders
Berodual® N should be prescribed with caution to patients predisposed to the development of angle-closure 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® N 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 you do not have a mouthpiece, use a mask that fits tightly to your face. Particular care should be taken to protect the eyes of patients predisposed to the development of glaucoma.
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, with prostatic hyperplasia or bladder neck obstruction), Berodual® N should be prescribed only after careful assessment of the risk/benefit ratio, especially at doses higher than recommended.
Effect on the cardiovascular system
In post-marketing studies, rare cases of myocardial ischemia have been reported when taking beta-adrenergic agonists. Patients with concomitant serious heart disease (for example, coronary artery disease, arrhythmias or severe heart failure) receiving Berodual® N 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, because... they can be of both cardiac and pulmonary etiology.
Hypokalemia
Hypokalemia may occur when using β2-adrenergic agonists.
In athletes, the use of the drug Berodual® N, 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.
Impact on the ability to drive vehicles and operate machinery
The effect of the drug on the ability to drive vehicles and use machinery has not been specifically studied. However, patients should be informed that during treatment with Berodual® N, adverse events such as dizziness, tremor, impaired accommodation, mydriasis, and blurred vision may develop. Therefore, caution should be recommended when driving vehicles or using machinery. If patients experience the above unwanted sensations, they should refrain from potentially dangerous activities such as driving vehicles or operating machinery.

With caution (Precautions)

Use the drug with caution in cases of bladder neck obstruction.
Contraindicated in children under 6 years of age.
The drug should be used with caution in children over 6 years of age.

Contraindications

Hypertrophic obstructive cardiomyopathy;
- tachyarrhythmia;
- I trimester of pregnancy;
- children under 6 years of age;
- hypersensitivity to the components of the drug;
- increased sensitivity to atropine-like substances.
The drug should be prescribed with caution for angle-closure glaucoma, coronary insufficiency, arterial hypertension, poorly controlled diabetes mellitus, recent myocardial infarction, severe organic diseases of the cardiovascular system, hyperthyroidism, pheochromocytoma, prostatic hypertrophy, bladder neck obstruction, cystic fibrosis, children over 6 years old.

Directions for use and doses

The dose is set individually.
To relieve attacks, adults and children over 6 years of age are prescribed 2 inhalation doses. If breathing relief does not occur within 5 minutes, 2 more inhalation doses can be prescribed.
The patient should be informed to immediately consult a doctor if there is no effect after 4 inhalation doses and the need for additional inhalations.
Metered-dose aerosol Berodual® N should be used in children only as prescribed by a doctor and under the supervision of adults.
For long-term and intermittent therapy, 1-2 inhalations are prescribed per dose, up to 8 inhalations/day (on average, 1-2 inhalations 3 times/day).
For bronchial asthma, the drug should be used only as needed.
Rules for using the drug
The patient should be instructed in the correct use of the metered dose aerosol.
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. Holding the balloon, wrap your lips around the mouthpiece. The cylinder should be pointing upside down.
4. While inhaling as deeply as possible, simultaneously quickly press the bottom of the cylinder until 1 inhalation dose is released. Hold your breath for a few seconds, then remove the mouthpiece from your mouth and exhale slowly. Repeat steps to receive the 2nd 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. Then the cylinder should be replaced. Although some contents may remain in the canister, the amount of drug released during inhalation is reduced.
Since the balloon is opaque, the amount of drug in the balloon can be determined as follows:
- having removed the plastic mouthpiece from the cylinder, 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.
img_berodual_n_1.eps|png
Fig 1.
Clean your inhaler at least once a week. It is important to keep the inhaler mouthpiece clean so that drug particles do not block the release of the aerosol.
When cleaning, first remove the protective cap and remove the canister from the inhaler. Run a stream of warm water through the inhaler to ensure that the drug and/or visible dirt is removed. After cleaning, shake the inhaler and allow it to air dry without using heat. Once the mouthpiece is dry, insert the canister into the inhaler and put on the protective cap.
The plastic mouthpiece is designed specifically for Berodual® N metered aerosol and serves for precise dosing of the drug. The mouthpiece should not be used with other metered dose aerosols. You also cannot use Berodual® N metered-dose aerosol with other mouthpieces.
The contents of the cylinder are under pressure.The cylinder must not be opened or exposed to temperatures above 50°C.

Overdose

Symptoms: Symptoms of overdose are usually associated primarily with the effects of fenoterol. Symptoms associated with excessive stimulation of β-adrenergic receptors may occur. The most likely occurrence is tachycardia, palpitations, tremor, arterial hypo- or hypertension, increased pulse pressure, angina pain, arrhythmia, hot flashes, metabolic acidosis, hypokalemia.
Symptoms of an overdose of ipratropium bromide, such as dry mouth, impaired eye accommodation, given the wide breadth of therapeutic action and inhalation use, are usually mild and transient.
Treatment. It is necessary to stop taking the drug. Data from monitoring the acid-base balance of the blood should be taken into account. Sedatives and tranquilizers are indicated, and in severe cases, intensive care.
As a specific antidote, it is possible to use beta-blockers, preferably beta1-selective blockers. However, one should be aware of the possible increase in bronchial obstruction under the influence of beta-blockers and carefully select the dose for patients suffering from bronchial asthma or COPD due to the risk of severe bronchospasm, which can be fatal.

Side effect

Many of the listed undesirable effects may be a consequence of the anticholinergic and beta-adrenergic properties of the drug Berodual® N. Berodual® N, like any inhalation therapy, can cause local irritation. Adverse reactions to the drug were determined based on data obtained in clinical trials and during pharmacological surveillance of the use of the drug after its registration.
The most common side effects reported in clinical studies were cough, dry mouth, headache, tremor, pharyngitis, nausea, dizziness, dysphonia, tachycardia, palpitations, vomiting, increased systolic blood pressure and nervousness.
From the immune system: anaphylactic reaction, hypersensitivity, incl. urticaria, angioedema.
Metabolism: hypokalemia.
Mental disorders: nervousness, agitation, mental disorders.
From the nervous system: headache, tremor, dizziness.
From the organ of vision: glaucoma, increased intraocular pressure, impaired accommodation, mydriasis, blurred vision, eye pain, corneal edema, conjunctival hyperemia, the appearance of a halo around objects.
From the heart: tachycardia, palpitations, arrhythmias, atrial fibrillation, supraventricular tachycardia, myocardial ischemia.
From the respiratory system: cough, pharyngitis, dysphonia, bronchospasm, pharyngeal irritation, pharyngeal edema, laryngospasm, paradoxical bronchospasm, dry pharynx.
From the digestive system: vomiting, nausea, dry mouth, stomatitis, glossitis, gastrointestinal motility disorders, diarrhea, constipation, swelling of the oral cavity.
From the skin and subcutaneous tissues: itching, hyperhidrosis.
From the musculoskeletal system: muscle weakness, muscle spasm, myalgia.
From the urinary system: urinary retention.
Laboratory and instrumental data: increased systolic blood pressure, increased diastolic blood pressure.

Compound

1 inhalation dose

Interaction with other drugs

Long-term simultaneous use of Berodual® N with other anticholinergic drugs is not recommended due to the lack of data.
Beta-adrenergic agonists and anticholinergics, xanthine derivatives (including theophylline) can enhance the bronchodilator effect of Berodual® N.
With the simultaneous use of other beta-agonists, anticholinergics entering the systemic circulation or xanthine derivatives (including theophylline), side effects may increase.
A significant weakening of the bronchodilator effect of Berodual® N is possible with simultaneous administration of beta-blockers.
Hypokalemia associated with the use of beta-agonists can be enhanced by the simultaneous administration of xanthine derivatives, corticosteroids and diuretics. This should be given special attention when treating patients with severe forms of obstructive airway disease.
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 concentrations.
Beta-agonists should be prescribed with caution to patients receiving MAO inhibitors and tricyclic antidepressants, because these drugs can enhance the effect of beta-adrenergic drugs.
Inhalation anesthetics containing halogenated hydrocarbons (including halothane, trichlorethylene, enflurane) may increase the adverse effects of beta-adrenergic drugs on the cardiovascular system.

Release form

Aerosol for inhalation dosed in the form of a clear, colorless or slightly yellowish or slightly brownish liquid, free of suspended particles.
1 inhalation dose
fenoterol hydrobromide 50 mcg
ipratropium bromide monohydrate 21 mcg,
which corresponds to the content of ipratropium bromide 20 mcg
Excipients: absolute ethanol - 13.313 mg, purified water - 0.799 mg, citric acid - 0.001 mg, tetrafluoroethane (HFA 134a, propellant) - 39.070 mg.
10 ml (200 doses) - metal cans with a dosing valve and mouthpiece (1) - cardboard packs.

For respiratory diseases, experts regularly prescribe Berodual aerosol for inhalation. This medicine effectively eliminates bronchodilator spasms, helps relieve cough, and helps with asthmatic attacks. Due to its convenient dosage and method of delivery - an aerosol - the drug helps even with advanced cases and reaches hard-to-reach places. Let's tell you more about this medicine.

Effect of the drug Berodual N on the body

The inhaler delivers a dosed dose of medications. The wide spray nozzle directs the stream towards the respiratory organs, reaching the lower respiratory tract. The drug can also be given to children, this is especially true for those who suffer from asthma.

The action of Berodual is as follows: in case of excessive physical exertion, in contact with an allergen or in extreme cold, when an asthmatic’s inhalation process slows down, a dose of an aerosol will relieve this spasm, allowing the lungs to work widely, with a normal frequency of inhalations and exhalations. Berodual produces the first relief effect within 15 minutes.

Then the drug is active for two hours, then the residual effect of the inhaler remains for 6 hours, but repeated use is required. You can use the spray on a regular basis according to your schedule, and you can also use the spray in moments of urgent need at the onset of an asthma attack.

Why do experts prescribe this inhaler, its advantages over analogues:

• long-lasting effect – up to 6 hours;
• low dose spray;
• elimination of bronchospasm in just 15 minutes;
• In addition to quick results, there are also long-term, therapeutic ones aimed at chronic diseases.

Indications for use

Aerosol for inhalation Berodual N should be prescribed for pathologies that have symptoms of bronchospasm. If the organ begins to shrink and ceases to perform its function, then the lungs are not completely filled with oxygen, cannot complete the breathing cycle, and the patient may suffocate. So Berodual N is prescribed as a treatment for acute or chronic illnesses:

• asthma;
• COPD;
• bronchitis with or without emphysema.

Pulmonologists also recommend injections for preventive purposes. The drug can be used in different dosages on the recommendation of a specialist, depending on the severity of the disease, exacerbation or remission of the disease, as well as according to the age of the patient. Berodual can be used by both adults and children over 6 years old - but with caution.

Advice from a doctor: “Since the drug has a number of contraindications and side effects, patients can take it only as prescribed by the treating pulmonologist or therapist, in a strictly prescribed dose.”

Directions for use and dosage for inhalation

The release form of Berodual N is a spray. This, as well as the serious condition of the patient, determines the severity of using the drug - sometimes due to respiratory spasm, the patient may have difficulty accepting the inhalation dose. Instructions for use of the treatment:

• when using for the first time, you need to press the bottom of the bottle 2-3 times;
• remove the protective cap - it is designed to protect against children;
• if you are doing the procedure not for yourself, but for a child over 6 years old, then you need to explain the inhalation technology - you need to make it deep and slow;
• turn the bottle over and point the mouthpiece into your mouth, wrapping your lips tightly around it;
• the tongue should be left calm so that it does not block the path of the aerosol stream;
• take a breath and press on the bottom of the bottle - this is one dose, or injection;
• do not exhale for 2-3 seconds, and then slowly exhale.

This is the cycle of taking the drug Berodual N. Usually the dose is two injections. If this is not enough to relieve severe bronchospasm or an asthma attack, then the procedure should be repeated four times. 4 is the maximum dosage for inhalation doses; if this number of injections does not help, then you should consult your doctor or call an ambulance to stop the attack.

Dosage for children and adults

Buy and use Berodual N only as prescribed by your doctor, as it is a very potent drug with a high level of danger if you use it for other purposes or do not take the correct dose.

• single dose to prevent spasm – 2 dosed injections;
• in difficult situations, when bronchospasm does not subside, you can do up to 4 presses.

Such measures are taken to relieve asthma symptoms. If the drug is used for complex long-term treatment, then only 1 inhalation dose can be prescribed.

The number of uses for attacks is as needed, and as a treatment for chronic respiratory disease - up to 8 times a day.

For adults, the aerosol should be used in the same proportions as for children. There are no special restrictions - only contraindications for health reasons and personal intolerance.

During pregnancy

Fenoterol and ipratropium, the active substances of Berodual N, do not have a negative effect on the fetus. However, they have a number of possible consequences and complications, including uterine contractions. This, as well as insufficient clinical trials on pregnant women due to unethicality and danger, is the basis for the ban in the first trimester.

The gynecologist advises: “For the first 3-4 months of pregnancy, a woman should, if possible, stop taking the drug Berodual N. During the subsequent period of gestation, the aerosol should be used only in cases where the risk of negative effects of bronchospasm is higher than the possible complications associated with taking fenoterol and ipratropium."

The instructions for use indicate that pregnant women, as well as children over 6 years of age, should take the drug with caution and only after consultation with a pulmonologist and gynecologist, with their approval.

Effects of active substances:

• increased contractility of the uterine muscles;
• possibility of penetration into breast milk;
• the effect on fertility has not yet been studied - there have been no clinical trials.

Duration and features of treatment

The duration of the course is determined solely by the attending physician. In case of long-term illnesses, in the presence of seizures, the aerosol should be used only when necessary to prevent spasms and to improve breathing.

Some diseases may increase symptoms with long-term use of Berodual N - bronchial obstruction will worsen. In this case, it is worth significantly reducing the dosage or stopping the use altogether.

Side effects and contraindications

Possible consequences:

• itching, redness, urticaria - an allergic reaction to the components;
• paradoxical bronchospasm - when the spasm only increases after using the drug;
• problems with gastrointestinal motility;
• possible vision pathologies – recorded in patients with glaucoma and other abnormalities;
• myocardial ischemia and other cardiovascular diseases;
• hypokalemia;
• dizziness;
• tremor of the limbs.

The drug should not be used:

• with personal intolerance to ingredients;
• tachyarrhythmias;
• cardiomyopathy;
• children under 6 years old;
• pregnant women in the first months of gestation.

Prescribe Berodual with caution if the patient:

• glaucoma;
• heart failure;
• diabetes;
• cystic fibrosis;
• arterial hypertension and others.

Summarizing

Berodual N is an excellent remedy for patients suffering from respiratory diseases. But the use of the drug is possible only after consultation with a doctor. Be careful when using.