Berodual for inhalation instructions for use. Solution, aerosol Berodual: instructions for use for inhalation

  • 08.03.2022

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 opinions of doctors of specialists on the use of Berodual in their practice are presented. A big request to actively add your reviews about the drug: did the medicine help or not help get rid of the disease, what complications and side effects were observed, perhaps not declared 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. It contains two components with bronchodilator activity: ipratropium bromide - an m-anticholinergic blocker and fenoterol hydrobromide - a beta2-adrenergic agonist.

Bronchodilation with inhaled administration of ipratropium bromide is mainly due to local rather than systemic anticholinergic action.

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 mediator released from the vagus nerve endings. Anticholinergics prevent an increase in intracellular calcium concentration, which occurs due to the interaction of acetylcholine with a muscarinic receptor located on bronchial smooth muscle. Calcium release 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 pulmonary 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 adversely affect airway mucus secretion, 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 a tocolytic effect).

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 type hypersensitivity reactions). Immediately after administration, fenoterol blocks the release of mediators of inflammation and bronchial obstruction from mast cells. In addition, with the use of 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 heart rate, is due to the vascular action of fenoterol, stimulation of beta2-adrenergic receptors of the heart, and when used in doses exceeding therapeutic, stimulation of beta1-adrenergic receptors.

As with other beta-adrenergic drugs, prolongation of the QTc interval has been observed with high doses. When using fenoterol using metered-dose aerosol inhalers (PMAs), this effect was inconsistent and was noted in the case of doses exceeding the recommended ones. However, after the use of fenoterol using nebulizers (solution for inhalation in vials with a standard dose), systemic exposure may be higher than when using the drug using PDI at the recommended doses. The clinical significance of these observations has not been established.

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

With the combined use of ipratropium bromide and fenoterol, the bronchodilatory effect is achieved by acting on various pharmacological targets. These substances complement each other, as a result, the spasmolytic effect on the muscles of the bronchi is enhanced and a wide range of therapeutic action is provided for bronchopulmonary diseases accompanied by constriction of the airways. The complementary effect is such that a lower dose of the beta-adrenergic component is required to achieve the desired effect, which allows for individualized adjustment of the 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 erroneously called drops).

Aerosol for inhalation dosed Berodual H (sometimes erroneously called a spray).

Instructions for use and dosage

Solution

The dose should be selected individually. During therapy, medical supervision is required (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 with acute attacks of bronchial asthma, the drug is prescribed at a dose of 1 ml (20 drops). This dose is usually sufficient for the rapid relief of attacks of mild to moderate bronchospasm. In severe cases, for example, in patients in intensive care units, with the ineffectiveness of the drug in the doses indicated above, it may be necessary to use it 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 the case of moderate bronchospasm or as an aid in the implementation of lung ventilation, a dose is recommended, the lower level of which is 0.5 ml (10 drops).

In children aged 6-12 years with acute attacks of bronchial asthma, for quick relief of symptoms, it is recommended to prescribe the drug at 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) at a maximum dose of 3 ml (60 drops). The maximum daily dose is 4 ml.

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

In children under the age of 6 years (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): ipratropium bromide 25 mcg and fenoterol 50 mcg 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 solution for inhalation should only be used for inhalation (with a suitable nebulizer) and should not be taken orally.

Treatment should usually begin with the lowest recommended dose.

Solution for inhalation should not be diluted with distilled water.

Dilution of the solution should be carried out each time before use; the 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 solution for inhalation can be used using various commercial models of nebulizers. 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-dose aerosol (depending on the type of inhaler). In cases where wall oxygen is available, the solution is best applied at a flow rate of 6-8 l/min.

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

Spray can

The dose is set individually.

For the relief of asthma attacks, adults and children over 6 years of age are prescribed 2 inhalation doses. If there is no relief in breathing within 5 minutes, 2 more inhalation doses can be prescribed.

The patient should be informed that in case of no effect after 4 inhalation doses and the need for additional inhalations, you should immediately consult a doctor.

Dosed aerosol BerodualN in children should be used only as directed by a doctor and under the supervision of adults.

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

Rules for the use of 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, clasp the mouthpiece with your lips. The balloon must be directed upside down.

4. Taking the deepest possible breath, at the same time quickly press the bottom of the balloon 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, press the bottom of the can once before use until an aerosol cloud appears.

The balloon is designed for 200 inhalations. Then the balloon should be replaced. Although some contents may remain in the balloon, the amount of drug released during inhalation is reduced.

Since the container is opaque, the amount of the drug in the container can be determined as follows: after removing the protective cap, the container is immersed in a container filled with water. The amount of the drug is determined depending on the position of the balloon in the water.

The mouthpiece should be kept clean, if necessary, it can be washed in warm water. After using soap or detergent, the mouthpiece should be thoroughly rinsed with water.

The plastic mouthpiece is designed specifically for Berodual N metered-dose aerosol and is used for accurate dosing of the drug. The mouthpiece must not be used with other metered-dose aerosols. It is also impossible to use Berodual N metered-dose aerosol with other mouthpieces.

Side effect

  • anaphylactic reaction;
  • hypersensitivity;
  • hypokalemia;
  • nervousness;
  • excitation;
  • headache;
  • tremor;
  • dizziness;
  • glaucoma;
  • increase in intraocular pressure;
  • mydriasis;
  • blurred vision;
  • Pain in the eyes;
  • corneal edema;
  • the appearance of a halo around objects;
  • tachycardia;
  • arrhythmias;
  • atrial fibrillation;
  • myocardial ischemia;
  • increase in systolic blood pressure;
  • increase in 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 lactation

Preclinical data and human experience indicate that fenoterol or ipratropium bromide do not adversely affect pregnancy.

The possibility of an inhibitory effect of fenoterol on uterine contractility should be considered.

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

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

Fenoterol passes into breast milk. Data confirming that ipratropium bromide passes into breast milk has not been received. However, Berodual should be administered with caution to nursing mothers.

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 in the event of an unexpected rapid increase in shortness of breath (difficulty breathing), you should immediately consult a doctor.

It should be borne in mind 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, it should be remembered that anti-inflammatory therapy should be carried out or increased to control the inflammatory process of the respiratory tract and the course of the disease.

Regular use of increasing doses of drugs containing beta2-agonists, such as Berodual, to relieve bronchial obstruction can cause an uncontrolled worsening of the course of the disease. In the case of increased bronchial obstruction, a simple increase in the dose of beta2-agonists (including Berodual) more than recommended for a long time is not only not justified, but also dangerous. To prevent a life-threatening worsening of the course of the disease, consideration should be given to revising the patient's treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids.

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

Other sympathomimetic bronchodilators should be administered simultaneously 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 the nebulizer be inhaled through the mouthpiece. In the absence of a mouthpiece, a mask that fits tightly to the face should be used. Patients predisposed to the development of glaucoma should take special care to protect their eyes.

Berodual should be used with caution in patients predisposed to the development of 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 in 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 hyperreactivity.

Influence on the ability to drive vehicles and control mechanisms

Studies of the effects of the drug on the ability to drive vehicles and use mechanisms have not been conducted. However, patients should be warned that during treatment with Berodual they may experience such undesirable sensations as dizziness, tremors, eye accommodation disturbances, mydriasis and blurred vision. Therefore, care should be taken when driving or using machinery. If patients experience the above undesirable sensations, they should refrain from such potentially dangerous activities as driving a car or operating machinery.

drug interaction

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

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

Perhaps a significant weakening of the bronchodilator action of Berodual with the simultaneous use of beta-blockers.

Hypokalemia associated with the use of beta-agonists may be enhanced by the simultaneous use of xanthine derivatives, corticosteroids and diuretics. This fact should be given special attention in the treatment of patients with severe forms of obstructive airways disease.

Hypokalemia may lead to an increased risk of arrhythmias in patients receiving digoxin. In addition, hypoxia can enhance the negative effect of hypokalemia on heart rate. In such cases, it is recommended to monitor the level of potassium in the blood serum.

Beta-adrenergic agents should be used with caution in patients treated with 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 increase the effect of beta-adrenergic drugs on the cardiovascular system.

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 Multidisk;
  • Symbicort Turbuhaler;
  • Tevacomb;
  • Foradil Combi.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

Compound

One inhalation dose contains 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).

Pharmacotherapeutic group

Means for the treatment of obstructive respiratory diseases. Adrenergic and other drugs for the treatment of obstructive airway diseases.
ATX code: R03AL01.

Pharmacological properties

Pharmacodynamics
BERODUAL N contains two components with bronchodilator activity: ipratropium bromide (m-anticholinergic) 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 an increase in intracellular calcium concentration, which is caused by the interaction of acetylcholine with the muscarinic receptor of bronchial smooth muscle. Calcium release is mediated by a second messenger system 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 beta2-adrenergic stimulant 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 exposure to bronchoconstrictor factors such as histamine, methacholine, cold air and allergens (immediate type 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, after 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).
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 action of fenoterol on blood vessels, stimulation of beta2-adrenergic receptors of the heart, and when taking the drug in doses exceeding therapeutic, 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 phenomena were discrete and were observed at doses higher than recommended. However, systemic exposure after administration of the drug using nebulizers (solution for inhalation) was higher than with the introduction of the 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 action on bronchial smooth muscle, the systemic effects of beta-adrenergic agonists are associated with the development of tolerance.
With the combined use of these two active substances, the bronchodilator effect is achieved by acting on various pharmacological targets. These substances complement each other, as a result, the spasmolytic effect on the muscles of the bronchi is enhanced, and a wide range of therapeutic action is provided for bronchopulmonary diseases accompanied by narrowing of the airways. The complementary effect is such that a lower dose of beta-adrenergic agonist is required to achieve the desired effect, 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 active substances.
After inhalation, 10-39% of the dose, depending on the dosage form, method of inhalation and the device used for inhalation, settles in the lungs.
The rest of the dose remains in the mouthpiece, in the mouth and in the 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 that entered 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. The proportion of the dose that reached the lungs quickly enters the circulatory system (within minutes). The active substance, which has settled in the oropharynx, is slowly swallowed and passes through the gastrointestinal tract. In this regard, systemic exposure is the result of bioavailability from the lungs and gastrointestinal tract.
There are no data indicating that the pharmacokinetics of both ingredients in combination differ from the pharmacokinetics of the active substances separately.
Fenoterol hydrobromide
The ingested fraction is metabolized mainly 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 about 7%.
The distribution of fenoterol in blood plasma after intravenous administration occurs according to a three-phase pharmacokinetic model, the final elimination half-life is about 3 hours. In this three-phase pharmacokinetic model, the apparent volume of distribution at equilibrium (Vdss) is approximately 189 L (≈ 2.7 L/kg).
About 40% of the substance binds to plasma proteins. Fenoterol and its metabolites do not cross the blood-brain barrier. The total clearance of fenoterol is 1.8 l / min, renal clearance is 0.27 l / min.
Ipratropium bromide
The cumulative renal excretion (0-24 hours) of ipratropium (parent compound) approaches 46% of the intravenous dose, is less than 1% of the oral dose, and approximately 3-13% of the dose of BERODUAL N administered using a metered dose inhaler. Based on these data, the overall systemic bioavailability of ipratropium bromide for oral and inhaled use is 2% and 7 to 28%, respectively. The swallowed portion of a dose of ipratropium bromide does not have a significant systemic effect. The kinetic parameters characterizing the distribution of ipratropium are calculated based on the plasma concentrations of the drug after intravenous administration. There is a rapid two-phase decrease in plasma concentrations. The apparent volume of distribution at equilibrium (Vdss) is about 176 l ("2.4 l/kg). The drug is minimally (less than 20%) bound to 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 in the last phase of elimination is about 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, about 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, asthma of physical effort, 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.

Dosage and administration

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:
For cupping sudden spasm of the smooth muscles of the bronchi with an attack of shortness of breath, inhalation of one therapeutic dose (100 μg of fenoterol hydrobromide and 40 μg of ipratropium bromide) is recommended, which corresponds to 2 inhalation doses.
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, an additional 1-2 inhalation doses may be used. Severe dyspnoea and failure of the second therapeutic dose may indicate the need for additional doses. In these cases, patients should immediately seek medical attention.
If necessary long-term treatment metered dose inhaler BERODUAL N, the recommended dose is 1-2 inhalation doses 3-4 times a day. For the treatment of bronchial asthma, the BERODUAL H metered dose inhaler should be used only as needed. In general, the timing and dose of each administration should be adjusted according to the symptoms. It is necessary to provide at least a 3-hour interval between the administration of the drug. The daily dose should not exceed 12 inhalation doses, since higher doses usually do not have an additional therapeutic effect, but can lead to the development of potentially serious side effects.
For targeted prevention of asthma attacks physical effort or expected contact with the allergen, 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.

Instructions for use

During inhalation of the drug, the arrow on the can must be pointing straight up and the mouthpiece down, regardless of the position in which inhalation is performed. If possible, it is recommended to carry out inhalation while sitting or standing.
Before use for the first time remove the protective cap and press the bottom of the can twice.
Before each when using a metered aerosol, the following rules must be observed:
1. Remove the protective cap. (If the metered dose inhaler has not been used for more than three days, press the bottom of the can once.)
2. Breathe out slowly and deeply.
3. While holding the can, place your lips tightly around the mouthpiece. The can must be pointed upside down.
4. Taking the deepest possible breath, at the same time quickly press the bottom of the can until the inhalation dose is released. Hold your breath for a few seconds, then remove the mouthpiece from your mouth and exhale slowly. Repeat the above steps for the second inhalation.
5. Put on the protective cap.
The can is opaque, so it's impossible to see when it's empty. The bottle is designed for 200 inhalation, after which it should be replaced. Although some drug may remain in the can, the amount of drug released during inhalation may be reduced.
The amount of drug in your can can be checked as follows:
- To determine if there is liquid left in the can, shake it.
- Remove the cartridge from the plastic part of the inhaler and immerse the cartridge in
container filled with water. The amount of the drug is determined depending on the location of the can in the water.
The inhaler should be cleaned at least once a week.
It is important to keep the mouthpiece of the inhaler clean so that the drug does not accumulate in it and does not block the aerosol jet.
For cleaning, first remove the protective cap and remove the cartridge from the plastic part of the inhaler, which must then be washed with warm water until traces of the medicinal substance and / or contamination disappear.
After cleaning, the plastic part of the inhaler is shaken and air-dried. without the use of any heating devices (Fig. 4).
After drying the plastic part of the inhaler, insert a can into it and put on a protective cap.
A warning
The plastic mouthpiece is designed specifically for BERODUAL N and is designed for accurate dosing of the drug. The mouthpiece must not be used with other metered-dose aerosols. Also, you can not use BERODUAL N with any other mouthpiece, except for the one supplied with the drug.
The contents of the can are under pressure. The can must not be opened and exposed to heat above 50°C.

Side effect

Many of the side effects listed below can be attributed to the anticholinergic and beta-adrenergic properties of BERODUAL N. Like other drugs used by inhalation, BERODUAL N can 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 frequency of occurrence of side effects is indicated as: very often (≥1 / 10); often (from ≥1/100 to<1/10); нечасто (от ≥1/1000 до <1/100); редко (от ≥1/10000 до <1/1000); очень редко (<1/10000); неизвестно (не может быть установлена на основании имеющихся данных).
From the side of the immune system: rarely - anaphylactic reaction,
hypersensitivity.
Mental disorders: infrequently - nervousness; rarely - anxiety, mental disorder.
From the nervous system: infrequently - headache, tremor, dizziness; unknown - hyperactivity.
From the organ of vision: rarely - glaucoma, increased intraocular pressure, disturbance of accommodation, mydriasis, blurred vision, eye pain, corneal edema, conjunctival hyperemia, visual halos.
From the side of the cardiovascular system: infrequently - tachycardia, palpitations; rarely - arrhythmia, atrial fibrillation, supraventricular tachycardia, myocardial ischemia.
From the respiratory system: often - cough; infrequently - pharyngitis, dysphonia; rarely - bronchospasm, throat irritation, laryngeal edema, laryngospasm, paradoxical bronchospasm, dry throat.
From the gastrointestinal tract: infrequently - vomiting, nausea, dry mouth; rarely - stomatitis, glossitis, dysmotility of the gastrointestinal tract, diarrhea, constipation, swelling of the oral mucosa, heartburn.
From the skin and subcutaneous tissues: rarely - urticaria, rash, itching, angioedema, petechiae, hyperhidrosis.
From the musculoskeletal and connective tissue: rarely - muscle weakness, muscle spasms, myalgia.
From the side of the kidneys and urinary tract: rarely - urinary retention.
From laboratory and instrumental data: infrequently - increased systolic blood pressure; rarely - a decrease in diastolic blood pressure, thrombocytopenia.

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 of beta-agonists, may appear: flushing, delirium, headache, tachycardia, palpitations, arrhythmia, arterial hypotension up to shock, increased blood pressure, anxiety, chest pain cell, excitation, the appearance of extrasystoles and
Cases of the development of metabolic acidosis, as well as hypokalemia, have been registered with the use of fenoterol in doses exceeding those recommended, approved for indications for BERODUAL N.
Symptoms of an overdose of ipratropium bromide (such as dry mouth, disturbance of accommodation) are usually mild due to the low systemic bioavailability of inhaled ipratropium.
Therapy
Treatment with BERODUAL H should be discontinued. It is necessary to monitor the indicators of acid-base balance and blood electrolytes.
The introduction of sedatives, tranquilizers is shown; in severe cases, intensive supportive care, including hospitalization, may be required. As an antidote for fenoterol, it is possible to use beta-blockers (preferably beta-blockers); however, it is necessary to take into account the possibility of worsening bronchial patency, which requires careful selection of the dose of the drug in patients with bronchial asthma or COPD, due to the risk of provoking severe bronchospasm, which can be fatal.

Precautionary measures

In the event of a sudden rapid increase in shortness of breath (difficulty breathing), you should immediately consult a doctor.
BERODUAL N, like other inhaled drugs, can cause paradoxical bronchospasm, which can be life threatening. In the event of the development of paradoxical bronchospasm, the use of BERODUAL N should be immediately discontinued 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 agents, including BERODUAL N, effects from the cardiovascular system may occur. Rare cases of myocardial ischemia have been reported in post-marketing studies and published literature with beta-agonists. Patients with concomitant serious heart disease (for example, coronary heart disease, arrhythmias, or severe heart failure) receiving BERODUAL N should be warned about the need to consult a doctor in case of pain in the heart or other symptoms indicating worsening heart disease. It is necessary to pay attention to symptoms such as shortness of breath and chest pain, as they can be of both pulmonary and cardiac etiology.
There are isolated reports of complications from the organ of vision (for example, mydriasis, increased intraocular pressure, angle-closure glaucoma and pain in the eyes) that developed when inhaled ipratropium bromide or ipratropium bromide in combination with beta-adrenergic agonists got into the eyes.
Attention! Patients should be instructed on the correct use of BERODUAL N metered-dose aerosol. Care must be taken to prevent the drug from getting into the eyes.
Symptoms of acute angle-closure glaucoma may include pain or discomfort in the eyes, blurred vision, the appearance of a halo, colored spots before 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 during therapy with inhaled anticholinergics. This effect is reversible and disappears after treatment is stopped.
Long-term use of the drug
In patients with bronchial asthma, BERODUAL N should only be used 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 asthma or chronic obstructive pulmonary disease responding to steroid therapy, one should be aware of the need to conduct or increase anti-inflammatory therapy to control the inflammatory process of the airways and the course of the disease.
In patients with bronchial asthma, the regular use of increasing doses of drugs containing beta-adrenergic agonists, such as BERODUAL N, to relieve bronchial obstruction, can cause an uncontrolled worsening of the course of the disease.
In the case of increased bronchial obstruction, an increase in 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 a life-threatening worsening of the course 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 registered with the use of high and very high doses of inhaled beta2-agonists for a long period of time without adequate anti-inflammatory therapy. Causal relationship
not exactly established. Perhaps the inadequacy of anti-inflammatory therapy is of vital importance.
Other sympathomimetic bronchodilators should be administered simultaneously with BERODUAL H 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 at its initially low level.
An increase in blood glucose levels is possible. In this regard, it is recommended to control blood glucose levels in patients with diabetes mellitus.
After the use of 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 can lead to positive results in doping tests.

Pregnancy and lactation

Pregnancy
Data from preclinical studies, combined with existing experience with the drug in humans, did not reveal any side effects of fenoterol or ipratropium during pregnancy. However, the usual precautions should be observed when using drugs during pregnancy.
It is necessary to take into account the ability of fenoterol to have an inhibitory effect on uterine contractility. The use of beta-agonists at the end of pregnancy or in high doses can cause negative consequences 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. Data confirming the excretion of ipratropium bromide with breast milk have not been received. The appearance of ipratropium after inhalation in breast milk at a concentration that can affect the infant is unlikely. Caution should be exercised when using BERODUAL N in a woman during breastfeeding.
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 alone have not demonstrated a negative effect on fertility.

Influence on the ability to drive a car and mechanisms

Studies on the effect of the drug on the ability to drive a car and mechanisms have not been conducted.
However, patients should be warned about the possibility of such side effects during treatment with BERODUAL N as dizziness, tremor, accommodation disturbance, mydriasis and blurred vision. Therefore, it is recommended to be careful while driving and operating machinery. If patients experience the above side effects, they should avoid potentially hazardous activities such as driving and operating machinery.

Interaction with other drugs

Long-term co-administration of BERODUAL N with other anticholinergic drugs has not been studied and is therefore not recommended.
Simultaneous use of the following medicinal products/groups of medicinal products may affect the effect of BERODUAL N.
Enhance the effect and / or increase the risk of adverse reactions:
- other beta-agonists (any method of application);
- other anticholinergic drugs (any route of administration);
- xanthine derivatives (eg theophylline);
- anti-inflammatory drugs (corticosteroids);
- monoamine oxidase inhibitors;
- tricyclic antidepressants;
- halogenated hydrocarbon anesthetics (eg halothane, trichlorethylene or enflurane), since they can increase the effect 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 be taken into account in particular 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 exacerbated by hypoxia. In such cases, it is recommended to monitor the level of potassium in the blood serum.
The risk of developing an acute attack of glaucoma increases if nebulized ipratropium bromide alone or in combination with a beta-agonist gets into the eyes.

Terms of dispensing from pharmacies

By prescription.

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

Agency in Belarus
Minsk, st. V. Khoruzhey, 22-1402.
Tel.: (+375 17) 283 16 33, fax: (+375 17) 283 16 40.

Berodual (fenoterol hydrobromide + ipratropium bromide monohydrate) is a combined bronchodilator from the German pharmaceutical company BOEHRINGER INGELHEIM INTERNATIONAL, which is used for the prevention and symptomatic treatment of obstructive respiratory tract diseases (COPD, chronic obstructive bronchitis, bronchial asthma). The drug is popular with pulmonologists and has been used in most countries for more than three decades as an effective tool for expanding the bronchi. It includes a selective beta-2-agonist fenoterol hydrobromide and a substance that blocks M-cholinergic receptors - ipratropium bromide. Fenoterol helps to relax the smooth muscle "framework" of the bronchial trees and blood vessels, prevents the occurrence of bronchospasm associated with the activity of histamine, exposure to cold air and damaging antigens. It also suppresses the release of mediators of inflammatory reactions from mast cells, stimulates the transport of pathogenic agents by the mucociliary system. Ipratropium bromide stops bronchospasm caused by the influence of the vagus, suppresses the secretory activity of the bronchial glands, and causes bronchodilation. Both active ingredients of Berodual are also produced as independent preparations, but their combined use provides a pronounced combined effect due to the impact on various mechanisms and links of pathological processes. Fenoterol promotes a rapid increase in the lumen of the bronchi by stimulating beta-2-adrenergic receptors of the upper respiratory tract, while ipratropium bromide blocks the M-cholinergic receptors of the lower respiratory tract (its action develops 30 minutes after inhalation administration).

The combination of these two substances in one drug provides a potentiation of the effects of each of them and a wider therapeutic range in lung diseases accompanied by obstruction of the respiratory tract. In this case, the beta-agonist is used at a lower dose, which minimizes the risk of side effects and tachyphylaxis reaction. Before using Berodual, the patient should be informed of the need for immediate medical attention in case of rapidly developing difficulty in breathing. After using the drug, immediate hypersensitivity may develop, the symptoms of which are typical allergic manifestations - urticaria, bronchospasm, edema, anaphylaxis. Berodual should not be used by competitive athletes, as Fenoterol is banned by WADA and may give a positive reaction to doping. The most common side effects that occur when taking the drug are hand tremor, increased nervousness, hyposalivation, taste disturbances, migraine headaches, dizziness, increased heart rate (especially in patients with cardiovascular pathology).

Pharmacology

Combined bronchodilator drug. It contains two components with bronchodilator activity: ipratropium bromide - an m-anticholinergic blocker, and fenoterol hydrobromide - a beta 2-adrenergic agonist.

Bronchodilation with inhaled administration of ipratropium bromide is mainly due to local rather than systemic anticholinergic action.

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 mediator released from the vagus nerve endings. Anticholinergics prevent an increase in intracellular calcium concentration, which occurs due to the interaction of acetylcholine with a muscarinic receptor located on bronchial smooth muscle. Calcium release 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 pulmonary emphysema), a significant improvement in lung function (an increase in forced expiratory volume in 1 sec (FEV 1) and peak expiratory flow by 15% or more) was noted within 15 minutes, the maximum effect reached after 1-2 hours and lasted in most patients up to 6 hours after administration.

Ipratropium bromide does not adversely affect airway mucus secretion, mucociliary clearance and gas exchange.

Fenoterol hydrobromide selectively stimulates β 2 -adrenergic receptors at a therapeutic dose. Stimulation of β 1 -adrenergic receptors occurs when high doses are used.

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 type hypersensitivity reactions). Immediately after administration, fenoterol blocks the release of mediators of inflammation and bronchial obstruction from mast cells. In addition, with the use of 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 action of fenoterol, stimulation of β 2 -adrenergic receptors of the heart, and when used in doses exceeding therapeutic, stimulation of β 1 -adrenergic receptors.

As with other beta-adrenergic drugs, prolongation of the QTc interval has been observed with high doses. When using fenoterol using metered-dose aerosol inhalers (PMAs), this effect was inconsistent and was noted when used at doses higher than recommended. However, after the use of fenoterol using nebulizers (solution for inhalation in vials with a standard dose), systemic exposure may be higher than when using the drug using PDI at the 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 the smooth muscles of the bronchi, tolerance can develop to the systemic effects of β-adrenergic agonists. The clinical significance of this manifestation has not been elucidated.

With the combined use of ipratropium bromide and fenoterol, the bronchodilatory effect is achieved by acting on various pharmacological targets. These substances complement each other, as a result, the spasmolytic effect on the muscles of the bronchi is enhanced and a wide range of therapeutic action is provided for bronchopulmonary diseases accompanied by constriction of the airways. The complementary effect is such that a lower dose of the beta-adrenergic component is required to achieve the desired effect, which allows for individualized adjustment of the effective dose with virtually no side effects.

In acute bronchoconstriction, the effect of Berodual ® develops quickly, which allows it to be used in acute attacks of bronchospasm.

Pharmacokinetics

Pharmacokinetic data not provided.

Release form

The solution for inhalation is clear, colorless or almost colorless, free from suspended particles, with an almost imperceptible odor.

Excipients: benzalkonium chloride, disodium edetate dihydrate, sodium chloride, hydrochloric acid 1N, purified water.

20 ml - dark glass dropper bottles (1) - packs of cardboard.

Dosage

Treatment should be carried out under medical supervision (for example, in a hospital setting). Home treatment is possible only after consultation with a doctor in cases where a fast-acting β-adrenergic agonist at a low dose is not effective enough. Also, an inhalation solution can be recommended to patients when an inhalation aerosol cannot be used or if higher doses are required.

The dose should be selected individually, depending on the severity of the attack. Treatment is usually started at the lowest recommended dose and discontinued after sufficient symptomatic relief has been achieved.

In adults (including the elderly) and adolescents over 12 years of age with acute attacks of bronchospasm, depending on the severity of the attack, doses can vary from 1 ml (1 ml = 20 drops) to 2.5 ml (2.5 ml = 50 drops). In especially severe cases, it is possible to use the drug in doses reaching 4 ml (4 ml = 80 drops).

In children under 6 years of age (body weight<22 кг) в связи с тем, что информация о применении препарата в этой возрастной группе ограничена, рекомендуется использование следующей дозы (только при условии медицинского наблюдения): 0.1 мл (2 капли) на кг массы тела, но не более 0.5 мл (10 капель).

Rules for the use of the drug

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

Treatment should usually begin with the lowest recommended dose.

Solution for inhalation Berodual ® should not be diluted with distilled water.

Dilution of the solution should be carried out each time before use; the 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 solution.

Solution for inhalation Berodual ® can be used using various commercial models of nebulizers. 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-dose aerosol (depending on the type of inhaler). In cases where wall oxygen is available, the solution is best applied at a flow rate of 6-8 l/min.

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

Overdose

Symptoms: overdose symptoms are usually associated mainly with the action of fenoterol (the appearance of symptoms associated with excessive stimulation of β-adrenergic receptors). The most likely occurrence is tachycardia, palpitations, tremors, an increase or decrease in blood pressure, an increase in differences between systolic and diastolic blood pressure, angina pectoris, arrhythmia, a feeling of flushing to the face, a feeling of heaviness behind the sternum, and increased bronchial obstruction. Metabolic acidosis and hypokalemia have also been observed.

Possible symptoms of overdose due to the action of ipratropium bromide (such as dry mouth, impaired eye accommodation) are mild and transient, due to the wide therapeutic range of doses of this drug and its topical application.

Treatment. It is necessary to stop taking the drug. The monitoring data of the acid-base balance of the blood should be taken into account. Recommended appointment of sedatives, anxiolytic drugs (tranquilizers), in severe cases - intensive care.

As a specific antidote, it is possible to use beta-blockers, preferably selective beta 1-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

Long-term simultaneous use of the drug Berodual ® with other anticholinergic drugs is not recommended due to lack of data.

With the simultaneous use of other beta-agonists, systemic anticholinergics, xanthine derivatives (for example, theophylline), it is possible to increase the bronchodilatory effect and increase side effects.

Perhaps a significant weakening of the bronchodilator action of Berodual with the simultaneous use of beta-blockers.

Hypokalemia associated with the use of beta-agonists may be enhanced by the simultaneous use of xanthine derivatives, corticosteroids and diuretics. This fact should be given special attention in the treatment of patients with severe forms of obstructive airways disease.

Hypokalemia may lead to an increased risk of arrhythmias in patients receiving digoxin. In addition, hypoxia can enhance the negative effect of hypokalemia on heart rate. In such cases, it is recommended to monitor the concentration of potassium in the blood serum.

Caution should be given to beta-adrenergic agonists in patients treated with MAO inhibitors and tricyclic antidepressants, tk. these drugs can enhance the effect of beta-adrenergic drugs.

The use of inhaled halogenated anesthetics, such as halothane, trichlorethylene or enflurane, may increase the effect of beta-adrenergic drugs on the cardiovascular system.

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

Side effects

Many of these adverse effects may be due to the anticholinergic and beta-adrenergic properties of Berodual. As with any inhalation therapy, the use of Berodual may cause local irritation. Adverse reactions of the drug were determined on the basis of data obtained in clinical trials and in the course of 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.

From the side of metabolism: hypokalemia.

From the nervous system and psyche: nervousness, agitation, mental disorders, headache, tremor, dizziness.

On the part of the organ of vision: glaucoma, increased intraocular pressure, accommodation disorders, mydriasis, blurred vision, eye pain, corneal edema, conjunctival hyperemia, the appearance of a halo around objects.

From the side of the cardiovascular system: tachycardia, palpitations, arrhythmias, atrial fibrillation, supraventricular tachycardia, myocardial ischemia, increased systolic blood pressure, increased diastolic blood pressure.

From the respiratory system: cough, pharyngitis, dysphonia, bronchospasm, pharynx irritation, pharyngeal edema, laryngospasm, paradoxical bronchospasm, dry throat.

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: urticaria, itching, angioedema, hyperhidrosis.

From the musculoskeletal system: muscle weakness, muscle spasm, myalgia.

From the urinary system: urinary retention.

Indications

Prevention and symptomatic treatment of chronic obstructive airway diseases with reversible airway obstruction, such as bronchial asthma and especially COPD, chronic obstructive bronchitis with or without emphysema.

Contraindications

  • hypertrophic obstructive cardiomyopathy;
  • tachyarrhythmia;
  • I and III trimesters of pregnancy;
  • hypersensitivity to fenoterol and other components of the drug;
  • hypersensitivity to atropine-like drugs.

With caution, the drug should be prescribed for angle-closure glaucoma, arterial hypertension, diabetes mellitus, recent myocardial infarction (within the last 3 months), heart and vascular diseases (heart failure, coronary artery disease, heart disease, aortic stenosis, severe lesions of cerebral and peripheral arteries) , hyperthyroidism, pheochromocytoma, prostatic hyperplasia, bladder neck obstruction, cystic fibrosis, in the second trimester of pregnancy, during breastfeeding.

Application features

Use during pregnancy and lactation

Preclinical data and human experience indicate that fenoterol or ipratropium bromide do not adversely affect pregnancy.

The possibility of an inhibitory effect of fenoterol on uterine contractility should be considered.

The drug is contraindicated in the I and III trimesters (the possibility of weakening labor activity with fenoterol).

It should be used with caution in the II trimester of pregnancy.

Fenoterol is excreted in breast milk. Data confirming that ipratropium bromide passes into breast milk has not been received. However, Berodual should be used with caution in breastfeeding mothers.

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

Application for violations of kidney function

With caution, the drug should be prescribed for obstruction of the bladder neck.

Use in children

In adolescents over 12 years of age with acute attacks of bronchospasm, depending on the severity of the attack, doses can vary from 1 ml (1 ml = 20 drops) to 2.5 ml (2.5 ml = 50 drops). In especially severe cases, it is possible to use doses up to 4 ml (4 ml = 80 drops).

In children aged 6-12 years with acute attacks of bronchial asthma, depending on the severity of the attack, the doses can vary from 0.5 ml (0.5 ml = 10 drops) to 2 ml (2 ml = 40 drops).

In children under 6 years of age (body weight<22 кг) в связи с тем, что информация о применении препарата в этой возрастной группе ограничена, рекомендуется использование следующей дозы (только при условии медицинского наблюдения): около 25 мкг ипратропия бромида и 50 мкг фенотерола гидробромида = 0.1 мл (2 капли) на кг массы тела (на одну дозу), но не более 0.5 мл (10 капель) (на одну дозу). Максимальная суточная доза - 1.5 мл.

special instructions

The patient should be informed that in the event of an unexpected rapid increase in shortness of breath (difficulty breathing), you should immediately consult a doctor.

Hypersensitivity

After the use of Berodual, immediate hypersensitivity reactions may occur, the 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. In the event of the development of paradoxical bronchospasm, the use of Berodual should be immediately discontinued and switched to alternative therapy.

Long-term use

In patients with bronchial asthma, Berodual ® should be used only as needed. In patients with mild COPD, symptomatic treatment may be preferable to regular use.

In patients with bronchial asthma, it should be remembered that anti-inflammatory therapy should be carried out or increased to control the inflammatory process of the respiratory tract and the course of the disease.

Regular use of increasing doses of drugs containing β 2 -adrenergic agonists, such as Berodual ® , to relieve bronchial obstruction can cause an uncontrolled worsening of the course of the disease. In the case of increased bronchial obstruction, an increase in the dose of β 2 -agonists, incl. Berodual, more than recommended for a long time, is not only not justified, but also dangerous. To prevent a life-threatening worsening of the course 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 administered 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 administered with caution to patients predisposed to the development of glaucoma. There are separate reports of complications from the organ of vision (for example, increased intraocular pressure, mydriasis, angle-closure glaucoma, pain in the eyes) that developed when inhaled ipratropium bromide (or ipratropium bromide in combination with β 2 -adrenergic agonists) gets into the eyes. Symptoms of acute angle-closure glaucoma may include pain or discomfort in the eyes, blurred vision, the appearance of a halo in objects and colored spots in front of the eyes, combined 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 is indicated, and immediate consultation with a specialist is 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 the nebulizer be inhaled through the mouthpiece. In the absence of a mouthpiece, a mask that fits tightly to the face should be used. Especially care should be taken to protect the eyes of patients predisposed to the development of glaucoma.

System effects

In 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 ® should be prescribed only after careful assessment of the risk/benefit ratio, especially when used at doses higher than those recommended.

Effect on the cardiovascular system

In post-marketing studies, there have been rare cases of myocardial ischemia when taking β-adrenergic agonists. Patients with concomitant serious heart disease (for example, coronary artery disease, arrhythmias or severe heart failure) receiving Berodual ® should be warned about the need to consult a doctor in case of pain in the heart 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

With the use of β 2 -adrenergic agonists, hypokalemia may occur.

In athletes, the use of Berodual, due to the presence of fenoterol in its composition, can lead to positive results in 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 hyperreactivity.

1 ml solution for inhalation has the following pharmaceutical ingredients:

  • - 0.261 mg (0.25 mg when converting the dosage form into a dry residue);
  • fenoterol hydrobromide - 0.5 mg;
  • disodium edetate dihydrate;
  • sodium chloride;
  • 1 molar hydrochloric acid;
  • purified water.

Composition 1 dosed injection inhalation aerosol:

  • ipratropium bromide - 0.021 mg (corresponds to 0.02 mg in the mass part of the anhydrous active substance);
  • fenoterol hydrobromide - 0.05 mg;
  • 1,1,1,2-tetrafluoroethane (HFA 134a) as propellant;
  • anhydrous citric acid;
  • ethanol;
  • distilled water.

Release form

Transparent, colorless (or almost colorless) solution for inhalation without suspended particles and practically odorless. The pharmaceutical preparation is packaged in 2 ml dropper bottles (1 ml corresponds to 20 drops). The cardboard box contains a container with a medicinal liquid and an annotation to it.

Metered aerosol for inhalation in special cylinders with a mouthpiece of 10 ml, designed for 200 injections (1 dose equals 1 injection). An annotation and a container with a medicinal product are enclosed in a cardboard package.

Berodual N - this is an enhanced pharmaceutical form of this drug, which does not differ in operation, as it is also supplied in the form of an aerosol for inhalation and a solution for inhalation. It renders its therapeutic properties, respectively, it is somewhat more effective.

pharmachologic effect

Berodual drug group (the international name of the drug is identical to the commercial one) - combined bronchodilator drugs of the inhalation type of action, that is, the active ingredients provide active expansion of the bronchial lumen when they are inhaled. The mechanism of its therapeutic effect depends on two biologically active substances that form the basis of the pharmaceutical mixture used in pulmonary hospitals.

Ipratropium bromide is an ammonium derivative that has anticholinergic properties. Bronchodilation is due to its local action, since it is administered in the form of fine particles by inhalation of an aspiration aerosol or inhalation solution. The biologically active component prevents the release of acetylcholine, the main mediator of parasympathetic synapses, which manifests itself in the normalization of calcium concentration within cellular structures. Thus, the action is neutralized vagus nerve and the lumen of the bronchus expands.

Fenoterol hydrobromide , in turn, is beta-adrenergic stimulant , the selectivity of the therapeutic effect of which depends on the quantitative factor. So small dosages of the biologically active component selectively act on beta2 receptors, which is expected from the use of Berodual in the course of conservative treatment of bronchopulmonary pathology.

The mechanism of the biochemical effects of Fenoterol is to counteract agents such as histamine , methacholine, cold air and allergens of plant and animal nature (a special case of inhibition of an immediate hypersensitivity reaction). Immediately after administration at a therapeutic dose, the release of inflammatory mediators from mast cells is blocked, which inevitably leads to relaxation of the smooth muscles of the bronchial tree and the local vascular bed. In addition, there is an increase in productivity mucociliary clearance .

It should be noted separately cardiac effects , since when it enters the main bloodstream for a biologically active component, it becomes possible to interact with beta-adrenergic receptors localized in the myocardium, respectively, the following manifestations can be observed:

  • increase in heart rate;
  • progressive increase in the strength of the muscular organ;
  • prolongation of the QT interval on the electrocardiogram.

The combined use of two active bronchodilators makes it possible to realize the desired therapeutic effect by various pharmacological mechanisms, since the targets for the action of the active components differ. Complementary Influence fenoterol and ipratropium ensures reliable achievement of the desired clinical result, which is manifested in the strengthening of the antispasmodic properties of the muscular apparatus of the bronchi and their sufficient expansion to ensure the normal functioning of a healthy body.

Pharmacodynamics and pharmacokinetics

With active inhalation of the drug solution, the improvement in the functioning of the bronchopulmonary system occurs in a short time, even if only 10-39% of the entire dose settles in the tissues of the respiratory tract (the rest of the drug remains on the inhaler tip, in the oral cavity and in the upper respiratory tract). ways).

Therapeutic effects ipratropium bromide develop within 15 minutes and represent an increase in forced expiratory flow in 1 second (an important parameter for assessing the normal functioning of the respiratory system) and peak expiratory flow by 15 percent. The maximum effect of this biologically active component is achieved within 1-2 hours from the moment of injection, and the achieved effects persist for 6 hours.

Total systemic bioavailability fenoterol hydrobromide somewhat lower than ipratropium and is about 1.5%, however, Berodual is a pharmaceutical preparation of a local nature of action, therefore, the rate of therapeutic effect during the inhalation route of administration, which is no less than that of the first active component of the drug, is more clinically significant.

Indications for use

  • of various origins (allergic and endogenous, physical stress asthma);
  • chronic disease of the lung tissue, accompanying bronchospastic syndrome;
  • chronic with impaired patency of the bronchopulmonary tract;
  • emphysema ;
  • other chronic obstructive diseases of the respiratory system with reversible airway obstruction;
  • preventive sanitation nosological units affecting the respiratory system;
  • preparatory measures for the lumen of the respiratory tract before aerosol administration , corticosteroids or other mucolytic drugs.

Contraindications

  • hereditary or acquired intolerance to the constituent components of a pharmaceutical product;
  • type tachyarrhythmias ;
  • hypertrophic obstructive cardiomyopathy ;
  • first trimester of pregnancy;
  • prenatal period of intrauterine gestation;
  • hypersensitivity to the active or excipients that make up the drug.

Prescribing a pharmaceutical preparation against the background of the following pathological conditions necessarily requires compliance with measures of increased caution (for example, taking a conservative course in a specialized pulmonary hospital):

  • closed-angle ;
  • heart failure ;
  • coronary artery disease;
  • history within the last three months;
  • severe damage to the cerebral and peripheral bloodstream;
  • obstruction of the neck of the bladder (of a special organogenic nature);
  • pheochromocytoma or other hormone-dependent neoplasms;
  • benign hyperplasia prostate;
  • cystic fibrosis .

Side effects

The adverse effects of using a pharmaceutical preparation are associated with an extremely high biochemical activity of the active components of the inhaled medicinal product, since they have anticholinergic and beta-adrenergic properties . Also, the use of Berodual can cause local irritation, which is typical for any kind of inhalation therapy.

The most commonly observed side effects from the entire wide list of adverse effects are dry mouth, and , intentional , cough, nausea, violations of the function of sound formation, subjective feeling of heartbeat, vomiting, nervousness and an increase in systolic .

Other side effects:

  • From the organs of cardio-vascular system: , fibrillation atrial, supraventricular , myocardial, increased diastolic blood pressure.
  • organs of vision can respond to the administration of a pharmaceutical preparation in the following ways: increased intraocular pressure, violation of the process of accommodation , mydriasis , development, pain, corneal edema, blurred vision, conjunctival hyperemia, the appearance of a mild halo around objects.
  • Respiratory tract: dysphonia, bronchospastic syndrome , irritation of the pharynx with its subsequent edema, laryngospasm, paradoxical bronchospasm.
  • From the side immune system: anaphylactic manifestations, reaction hypersensitivity .
  • Nervous system and mental health inhalation mixtures may also be adversely affected: excitation , mental disorder, nervousness , trembling of the upper limbs when performing a conscious movement (especially pronounced with small coordinated motor acts).
  • From the side metabolic processes: decrease in blood potassium.
  • Digestive system: stomatitis , disorders of adequate peristalsis of the gastrointestinal tract, or , swelling of the oral cavity.
  • From the side skin and subcutaneous tissue: , , local , hyperhidrosis .
  • From the side urinary system: delay in the physiological duration of the act of urination.

Application instruction of Berodual (Way and dosage)

Aerosol Berodual, instructions for use

Before conducting independent inhalations with a pharmaceutical preparation, you should carefully read the recommendations for the correct use of the Berodual aerosol, which are usually presented as follows:

  • The spray is in a can with a protective cap, which must be removed before use. If the drug has not been used for the last 3 days, then before its active use, it is necessary to press the valve 1 time until an aerosol for inhalation appears in the form of a small cloud.
  • Take a deep and slow breath.
  • Place your lips around the inhaler by its tip so that the arrow on the medicine bottle is turned up and the mouthpiece is down.
  • Simultaneously press the bottom of the container, releasing 1 measured dose of the drug, and inhale deeply " full chest» to increase the area of ​​interaction of biologically active components and structures of the respiratory system.
  • After use, put back the protective cap, returning the cylinder to its original position.

Berodual inhaler: dosage of the aerosol form of a pharmaceutical preparation

Adults and children over 6 years of age during an acute attack - 2 inhalations. If relief does not occur within 5 minutes, then 2 more inhalation doses are prescribed. With further ineffectiveness of this treatment tactic, it is urgent to seek qualified medical help. At long-term conservative rehabilitation - 1-2 inhalations 3 times a day, but so that in total there are no more than 8 manipulations within one day.

Berodual solution for inhalation, instructions for use

A pharmaceutical product in this form of release requires special medical equipment for proper use, which is called nebulizer . This is an apparatus through which Berodual (or another drug) is sprayed into a fine cloud. In this form, the drug enters almost unhindered even into poorly ventilated areas bronchopulmonary system, and the dosage for a nebulizer is much lower than for a traditional inhaler, because the “miracle of technology” has especially taken root in pulmonological hospitals and is now widely used for the rehabilitation of respiratory diseases.

Before using the drug directly, you should definitely find out how to dilute for inhalation correctly, since the effectiveness of the impact and the completeness of the implementation of the therapeutic possibilities of the active components of Berodual depend on this stage. Typically used as a solvent isotonic sodium chloride solution with a concentration of 0.9%, because it is closest to the composition of the aqueous portion of plasma (in no case should distilled water be used to dilute a pharmaceutical preparation, this threatens with adverse consequences). How to dilute with saline - add liquids up to 3-4 ml to the recommended dose.

General schemes of conservative treatment with a solution for inhalation

Adults and children over 12 years of age to eliminate acute attacks - 20-80 drops (1-4 ml) 4 times, and for a long-term course - 1-2 ml (20-40 drops) up to 4 times a day. With a moderately developing bronchospastic syndrome to facilitate ventilation of the bronchopulmonary system - 0.5 ml (10 drops).

In pediatric practice for children from 6 to 12 years old - 0.5-1 ml (10-20) drops to counteract an attack (in severe clinical course, the dosage may increase to 2-3 ml, which corresponds to 40-60 drops). With prolonged therapy, for example, with an allergic cough - 0.5-1 ml (10-20 drops) 4 times a day.

In the younger age category of patients under 6 years of age and weighing less than 22 kg, the dosage of the pharmaceutical preparation is calculated individually, based on the following need for a therapeutic course - 25 μg of Ipratropium and 50 μg of Fenoterol per 1 kg of body weight (total amount of the drug up to 0.5 ml) up to 3 times a day.

Instructions for use Berodual N

The practical operation of this pharmaceutical form of the drug does not differ from the previously invented Berodual. An enhanced version is also available in the form of an aerosol in special containers for active inhalation and a solution for inhalation through a nebulizer or other similar medical equipment. As for dosages, you should separately visit a qualified pulmonologist and find out this issue on an individual basis, since at the moment there are no general protocols for conservative sanitation with Berodual N.

Overdose

When using a pharmaceutical preparation in clinical practice, such a pathological condition as an overdose of active active ingredients can be observed, which, as a rule, is associated with excessive stimulation of beta-adrenergic receptors. In this case, the most likely symptoms are the following:

  • subjective sensation of heartbeat and tachycardia confirmed by hardware methods;
  • increase or decrease in blood pressure (depending on individual predisposition);
  • strengthening of broncho-obstructive pathological process;
  • an increase in the difference between systolic and diastolic blood pressure;
  • and the symptoms that accompany it (for example, a feeling of heaviness behind the sternum);
  • hyperemia skin of the face and the accompanying sensation of heat;
  • metabolic .

Also, an overdose may be due to excessive intake of ipratropium bromide , however, in this case, it is weakly expressed and has a transient (passing) character. This is due to the breadth of the therapeutic application of this component in pharmacy. In this case, there may be dry mouth or accommodative disorder organs of vision.

As a specific pharmacological antidote, it is possible to use selective beta1-blockers . Possessing the opposite mechanism of therapeutic action, these drugs will help get rid of a pathological condition that threatens the life and well-being of the patient. But in patients with chronic obstructive pulmonary disease and bronchial asthma, under the influence of biologically active components of this nature of the pharmacological action, there is a possibility of developing bronchial blockage, which can only be avoided by careful selection of the exact dosage.

Also, as a therapeutic measure, the introduction is used sedatives , tranquilizers (when the symptoms are too violent). In the case of a severe overdose syndrome, intensive conservative sanitation should be immediately carried out using all possible drugs that can adequately help the patient.

Terms of sale

The medicine belongs to list B, therefore, when purchasing it, the pharmacist must present a certified document from the attending physician, which confirms the appointment of Berodual by a qualified specialist. Of course, no one will require a prescription in Latin at the pharmacy, but you must have the official form with you.

Storage conditions

Like a solution for inhalation, Berodual aerosol should be stored out of the reach of children of the younger category at a temperature not exceeding 30 degrees Celsius.

Shelf life

special instructions

Berodual - hormonal or not?

Bronchial asthma - This is a polyetiological disease, one of the factors of which are allergic disorders and sensitization of the body, therefore the conservative treatment of this respiratory pathology is so difficult from a medical point of view. Very common in therapy asthmatic conditions or in clinically severe cases, pharmaceutical preparations based on natural human hormones are used. Since bronchial asthma is present among the indications for the use of Berodual, a completely logical question arises for ordinary people without a medical education: “Is Berodual a hormonal drug or not?”.

The solution to this problem lies in the chemical composition of the drug, which is represented by ipratropium bromide and Fenoterol hydrobromide. The first active ingredient is an amine derivative with anticholinergic properties, and the second active ingredient of the drug is a non-selective beta-agonist. Based on this, it can be confidently stated that Berodual is not a hormonal drug and, according to its mechanism of action, it cannot affect the hormonal balance in the body.

Berodual's analogs

Coincidence in the ATX code of the 4th level:

Berodual's analogues are medicines that have a similar or identical ATC code, which marks absolutely all pharmaceutical products on the official market, or Berodual's INN (international non-proprietary name). Analogues for inhalation in pharmacy kiosks are usually cheaper, because the price factor of choosing a drug is sometimes one of the most important, especially in the conservative treatment of chronic, sluggish diseases. Bronchodilators of various nature, which can be replaced by Berodual, are the following list: Beroteks , , Duolin , Salbroxol , .

Which is better: Berodual or Pulmicort?

- a synthetic hormonal drug, which is a glucocorticosteroid for inhalation use. That is, the active component of the drug in its chemical structure is identical to the structure of biological substances produced by the adrenal glands. The mechanism of therapeutic action lies in the direct influence on cellular elements in order to regulate metabolic processes and cycles in the formation of new substances.

The effectiveness of local use of Pulmicort is 15 times higher than that of , since synthetic active ingredients have a higher chemical affinity for glucocorticosteroid receptors, therefore the drug is the drug of choice in the treatment of bronchial asthma in clinically advanced cases (or when the pathological process cannot be stopped by other, safer conservative means).

Therefore, it is extremely difficult to compare Berodual and Pulmicort. Medical researchers have not reached a consensus on this issue and regularly publish "new" arguments in favor of a particular pharmaceutical drug. More experienced doctors have found the only true and very acceptable option, which is the use of Pulmicort and Berodual together, in combination therapy diseases of the respiratory system. Thus, the therapeutic effects of two strong pharmaceuticals are combined, which makes it possible to eliminate even the most clinically severe attacks of bronchial asthma or chronic obstructive pulmonary disease.

Dosage for inhalation Berodual and Pulmicort is selected individually for each patient in empirical ways, starting from the minimum limit of the therapeutic range of pharmaceuticals (for Berodual - 0.5 ml, and for Pulmicort - 0.25 mg for one inhalation).

Which is better: Berodual or Ventolin?

It is a pharmaceutical preparation that belongs to selective beta2-agonists , the therapeutic effect of which is to actively expand the bronchial lumen and facilitate ventilation of the lung parenchyma. As a rule, this drug is prescribed for the prevention and conservative relief of spastic contraction that develops upon contact with an allergen in the pathogenesis of bronchial asthma.

Berodual, in turn, contains fenoterol , which, like Ventolin, has a stimulating effect on this type of bronchial tree receptors. However, this is not the only biologically active component of Berodual, due to which the indications for its use are much wider than those of Ventolin, therefore this pharmaceutical preparation is considered better by most qualified pulmonologists, and its use is more rational.

Berotek or Berodual - which is better?

Like Ventolin, it belongs to the group of pharmaceutical beta2-adrenergic agonists , that is, the active component of the drug, like the previous drug, selectively affects the bronchi, which manifests itself in the relaxation of the smooth muscles of the airways, and the expansion of their lumen. Thus, the appointment of Berotek as a symptomatic therapy for bronchial asthma is quite justified, but Berodual covers a wider range of action, and the therapeutic effect develops faster, therefore it is not necessary to talk about comparing drugs separately.

Salbutamol or Berodual - which is better?

Salbutamol - a drug that has been described since time immemorial in the medical literature. According to its chemical structure and therapeutic effect, it is non-selective beta-adrenergic stimulant , spreading its biochemical influences both on the respiratory system and on the heart. The active ingredient of the same name in a pharmaceutical product is clearly stronger in its effects than fenoterol , therefore, Salbutamol is included in the protocol for the treatment of bronchial asthma.

But when comparing it with Berodual, one should not forget about ipratropium , the use of which is associated with fewer side effects and adverse effects of a conservative course of sanitation of the respiratory system. It should also be noted a faster onset of relief in the treatment of such a nosological unit, such as, for example, Chronical bronchitis , which is also very revealing.

Based on the facts presented, it can be recognized that Berodual is better in the treatment of sluggish respiratory tract diseases with possible or already occurring obstructive processes, but for sanitation bronchial asthma you should choose Salbutamol, because this is not just the recommendations for maintaining this nosological unit, but also the official protocols for pulmonologists and pediatricians.

Berodual for children

The drug is actively used in pediatric practice. from a very young age for several reasons. First of all, of course, the therapeutic efficacy of the drug should be taken into account when inhalations are given to a child for chronic obstructive diseases of the respiratory system. The complex of ipratropium bromide and Fenoterol allows not only to expand the bronchial lumen, but also to a large extent facilitate ventilation of the lung parenchyma . The dosage of the nebulizer for children can be found in the instructions for use, which will also be useful to parents who prefer the aerosol form of the pharmaceutical preparation.

Separately, it should be noted that a pharmaceutical preparation can be used not only for nosological units, the pathogenesis of which is inextricably linked with spasmodic constriction of the bronchi , but also with a dry cough, because the active ingredients improve mucociliary clearance, which has a stimulating effect on regulatory and immune processes. Thus, the problem of sluggish idiopathic dry cough is eliminated.

The most frightening cough for young parents is definitely the so-called "barking" cough , which develops with in children. This disease, which affects the upper respiratory tract, is especially dangerous, because the pathological process in the larynx is associated with the risk of developing an acute form of laryngitis and false croup. Therefore, when this nosological unit is detected, the dosage for inhalation for children is slightly higher than prescribed for chronic obstructive diseases of the respiratory system.

Berodual during pregnancy and lactation

Reliable studies on the ability of the active ingredients in one way or another to influence the body of the fetus and mother during pregnancy have not been conducted, however, the preclinical practice of using Fenoterol and Ipratropium of past years indicates that biologically active substances do not adversely affect the physiological processes occurring in the body women.

It is not recommended to use a pharmaceutical preparation only in the 1st and 3rd trimesters , since Fenoterol has an inhibitory effect on the muscular apparatus of the uterus. Accordingly, this component of Berodual is able to slow down labor activity or give conditions for artificial hypotension, which may also adversely affect the early stages of ontogenesis.

It has been clinically proven that Fenoterol is able to penetrate into breast milk in the process, however, there are no such data on ipratropium, because young mothers, breastfeeding , the appointment of Berodual is recommended only with increased precautions.

In case of problems with the respiratory tract, self-medication is unacceptable - you must immediately contact a specialist. The patient cannot always make a diagnosis and prescribe treatment for himself, especially in the case of the respiratory system, when the focus of the disease itself is hidden from the eyes. In case of improper treatment, complications can be very severe. But even if the drug is prescribed to you by a specialist, you must carefully read the instructions for use and possible side effects in order to avoid unpleasant consequences.

Release form and composition

Before taking the medicine prescribed for you, you need to carefully study the composition of the drug. This is done in order to prevent possible allergies to certain components.

Fenoterol. First of all, it relieves tension that occurs in the muscles of the respiratory system, relieves spasm of the larynx, relaxing the trachea and bronchi. Fenoterol also reduces the reflex stimulus that provokes coughing.


Ipratropium bromide. The main purpose of this substance is to relieve the spasm that causes the cough reflex. Ipratropium bromide successfully fights bronchitis, expands bronchial flows, making breathing easier.

In addition to active substances, the following excipients may be present in the medicine:

  • lemon acid;
  • ethanol;
  • distilled water.

Berodual is produced in certain forms:

Vials for inhalation. This type is convenient for using berodual in a nebulizer. Most often used in the treatment of children by pediatricians, since the dosage can be easily changed, depending on the condition of the patient.

Spray can. This pocket form is very convenient for those who are constantly on the go, who do not have time for lengthy procedures, those who are constantly at work. After all, a nebulizer requires a certain concentration. However, it is better to use an aerosol for patients older than six years.

Indications for use in adults

Berodual for inhalation for adults is a unique and multifunctional drug. It is used in many respiratory ailments.

  • all types of cough;
  • preventive measures, long-term therapy and emergency care for asthma;
  • tracheitis;
  • bronchitis;
  • pneumonia;
  • chronic lung disease;
  • sarcoidosis;
  • early stages of tuberculosis;
  • cystic fibrosis;
  • emphysema.

It is mandatory to consult with a specialist who must prescribe an examination before prescribing the drug. In the vast majority of cases, berodual in a nebulizer is prescribed to a person when the introduction of the drug into the respiratory tract is otherwise impossible. When you urgently need to remove an attack (asthma, cough,), inhalation becomes an indispensable tool.

Method of application and dosage for inhalation in aerosol

Berodual as a medicine is quite simple to use, but before use, you must carefully read the instructions for use, as this drug has its own nuances. Berodual should not be taken with an ordinary steam inhaler. Taking the medicine in this way will not only not alleviate the condition, but will also cause a negative reaction:

  • burn of the mucous membrane;
  • coughing fits;
  • sharp pain in the throat.

Instructions for using inhalation aerosol

  1. Shake the can once and carefully remove the protective cap.
  2. Take a long deep exhalation, forcing the air out of the lungs as much as possible.
  3. Turn the bottle upside down so that the mouthpiece is on the bottom.
  4. Press your lips firmly against the mouthpiece, take a deep breath and press on the aerosol
  5. After getting the medicine inside, hold your breath for 2-5 seconds.
  6. Repeat if necessary.

Usually 2 doses per day are prescribed, with a severe attack, 4 doses may be used. If after this the attack was not stopped, you should immediately consult a doctor.

Breeding berodual with saline

First of all, it should be noted that it is not permissible to dilute berodual with ordinary or even distilled water. To do this, you need a solution of sodium chloride 0.9%. Proportions are prescribed by the attending physician. The usual prescribed dose of the drug is diluted with sodium chloride to a volume of three to four ml, then mixed thoroughly. Dilution of berodual with saline is necessary in order to reduce the concentration of the drug.

Combination with other drugs

Before using berodual, consultation is necessary, since this medicine is not compatible with many drugs and substances:

  • antidepressants;
  • bronchodilators;
  • halothane;
  • glucocorticosteroids;
  • digoxin;
  • theophylline;
  • trichlorethylene;
  • enflurane.

How to do inhalation in a nebulizer

A nebulizer is a device with which it is quite easy to inhale. It is easy to use, from the pluses there is a constant effect of the drug on the body for the required time. The purchase of such equipment will require certain investments, but it will serve you for several years. The main thing is not to forget to take care of him. Rinse after use, disinfect, store in a secluded place, away from children.

Follow a certain algorithm when using a nebulizer:

  1. Disinfection of the mask of the inhalation device, rinsing of the medicine container, preparation of equipment.
  2. Filling the container with the required amount of berodual.
  3. Dilute the drug with saline;
  4. Carrying out the procedure through a nebulizer until the solution is completely used up.

The dosage of the drug for inhalation in a nebulizer depends on the specifics of the disease and the age of the patient. The number of drops in general should not be more than forty, for small children no more than twenty.

How many minutes to do inhalation

Inhalation in a nebulizer should be done regularly. Follow the instructions prescribed by your doctor. The procedure for a patient under 12 years old is allowed to be done for five minutes. An adult can be inhaled for up to seven minutes. Medicine diluted with saline must be disposed of after use.

How many days

Adults and children do it systematically during the time prescribed by the attending physician. The usual course of therapy for moderate diseases (bronchitis, various types of cough) lasts five days. If the disease is more severe, the course can be extended up to ten days (asthma, emphysema, severe pneumonia).

Side effects and various contraindications

With the correct use of berodual, compliance with dosages and proportions, it does not have strong side effects. However, it has contraindications:

  • allergic reaction to the composition of the drug;
  • pregnancy;
  • hypertension;
  • glaucoma, blindness;
  • epilepsy;
  • cardiomyopathy;
  • psycho-emotional instability;
  • pathology of the heart and blood vessels;
  • tachymetry.

Most often, side effects occur due to the patient's neglect of the doctor's recommendations. If you do something wrong, you may experience:

  • difficulty urinating;
  • dizziness and fainting;
  • diarrhea
  • swelling of the tongue, dry mouth;
  • arrhythmia;
  • increased heart rate;
  • increased nervous excitability;
  • coughing fit;
  • metabolic problems;
  • rash.

This is not the whole list of possible side effects, since the body of each person is individual. Therefore, you need to be careful when choosing medicines.

Knowing the characteristics of the drug helps to avoid unpleasant consequences. In no case do not take the medicine inside, this often leads to serious violations.


When inhaling, a special order is observed:

  • you can not eat before and after inhalation for 40 minutes;
  • after the procedure, you should not go out;
  • during the inhalation process, you can not make sudden movements;
  • you need to breathe deeply and slowly.

Analogues

Since berodual is not suitable for everyone, there are analogues that can replace this medicine. Here are some of them:

  • Lazolvan.

The first in the list of analogues, sometimes it is even prescribed together with berodual, as a complex therapy. It resembles berodual in its properties, but it is not recommended for children under 18 years of age. The main property is expectorant.

  • Ambrobene.

It is a milder remedy compared to berodual. It is used at a fairly early age, it is safe to take it during pregnancy. Helps relieve spasms, get rid of sputum. One of the most popular and affordable mucolytic agents.

Terms and conditions of storage

You can use the solution for inhalation for five years. Carefully read the production date on the packaging and do not use after the expiration date. Storage conditions - room temperature not higher than 30 C. Keep away from children!