Berodual - instructions for use, reviews, analogs and forms of release (solution or drops for inhalation, aerosol or spray H) is not a hormonal drug for the treatment of bronchial asthma and chronic bronchitis in adults, children and pregnancy

In this article, you can read the instructions for the use of non-hormonal drug Berodual. Comments of visitors of the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Berodual in their practice are presented. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Berodual with available structural analogues.Use for treatment of attacks of dry cough with bronchial asthma and chronic bronchitis in adults, children, as well as during pregnancy and breast-feeding.

Berodual Combined bronchodilator. Contains two components that have broncholytic activity: ipratropium bromide-m-cholinoblocker and fenoterol hydrobromide-beta2-adrenomimetic.

Bronchodilation in the inhalation of ipratropium bromide is mainly due to local, rather than systemic, anticholinergic action.

Ipratropium bromide is a quaternary ammonium derivative possessing anticholinergic (parasympatolytic) properties. The drug inhibits the reflexes caused by the vagus nerve, counteracting the effects of acetylcholine - a mediator released from the ends of the vagus nerve. Anticholinergic drugs prevent the increase in intracellular calcium concentration, which occurs due to the interaction of acetylcholine with the muscarinic receptor located on the smooth muscles of the bronchi. Calcium release is mediated by a system of secondary mediators, including ITF (inositol triphosphate) and DAG (diacylglycerin).

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

Ipratropium bromide does not adversely affect the secretion of mucus in the respiratory tract, mucociliary clearance and gas exchange.

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

Fenoterol relaxes the smooth musculature of the bronchi and vessels and counteracts the development of bronchospastic reactions due to the influence of histamine, methacholine, cold air and allergens (immediate-type hypersensitivity reactions). Immediately after administration, fenoterol blocks the release of inflammatory mediators and bronchial obstruction from mast cells. In addition, with the use of fenoterol in a dose of 600 mcg, there was an increase in mucociliary clearance.

Beta-adrenergic effect of the drug on cardiac activity, such as increased heart rate and heart rate, is due to the vascular effect of fenoterol, stimulation of beta2-adrenergic receptors of the heart, and when used in doses exceeding therapeutic, stimulation of beta1-adrenergic receptors.

As with the use of other beta-adrenergic drugs, the QTc interval was prolonged when high doses were used. When fenoterol was used with metered-dose aerosol inhalers (DAD), this effect was unstable and was noted in the case of doses exceeding the recommended doses. However, after the use of fenoterol with nebulizers (solution for inhalation in vials with a standard dose), systemic exposure may be higher than with the use of the drug with the help of DAD in the recommended doses. The clinical significance of these observations is not established.

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

In the joint application of ipratropium bromide and fenoterol bronchodilator effect is achieved by affecting various pharmacological targets. These substances complement each other, as a result of increased spasmolytic effect on the muscles of the bronchi and provides a great breadth of therapeutic effect for bronchopulmonary diseases, accompanied by constriction of the airways. Complementary action is such that, in order to achieve the desired effect, a lower dose of the beta-adrenergic component is required, which allows individual selection of an effective dose in the practical absence of side effects.

Indications

Prophylaxis and symptomatic treatment of obstructive airways diseases with reversible bronchospasm:

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

Forms of release

Solution for inhalation (sometimes mistakenly called drops).

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

Instructions for use and dosage

Solution

The dose should be selected individually. During the therapy, medical supervision is required (treatment should usually start at the lowest recommended dose). The following doses are recommended:

In adults (including the elderly) and adolescents over 12 years with acute attacks of bronchial asthma, the drug is prescribed in a dose of 1 ml (20 drops). This dose is usually sufficient for rapid relief of attacks of bronchospasm of mild and moderate severity. In severe cases, for example, in patients in intensive care units, if the drug is ineffective at the doses indicated above, it may be necessary to use it at 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 ventilation, a dose of 0.5 ml (10 drops) is recommended.

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

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

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

Terms of use

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

Treatment should usually begin with the lowest recommended dose.

The recommended dose should be diluted with physiological saline to a final volume of 3-4 ml, and applied (completely) with a nebulizer.

Solution for inhalation should not be diluted with distilled water.

Dilution of the solution should be carried out every time before use; the remnants 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 expenditure of diluted volume.

A solution for inhalation can be used using various commercial models of nebulizers. The dose reaching the lungs and the system dose depend on the type of nebulizer used and may be higher than the corresponding doses using Berodual's HFA and CFC metered aerosol (depending on the type of inhaler). In those cases where there is wall oxygen, the solution is best used at a flow rate of 6-8 l / min.

Follow instructions for the use, maintenance and cleaning of the nebulizer.

Aerosol

The dose is set individually.

For relief of asthma attacks, adults and children over 6 years of age are prescribed 2 inhalation doses. If no breathing is achieved within 5 minutes, another 2 inhalation doses may be prescribed.

The patient should be informed that in the absence of effect after 4 inhalation doses and the need for additional inhalations, the doctor should be consulted immediately.

Dosirovannoe aerosol Berodualn in children should be used only on the prescription of 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).

Terms of use

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

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

Each time using a metered aerosol, the following rules must be observed:

1. Remove the protective cap.

2. Make a slow, deep exhalation.

3. Holding the balloon, grasp the mouthpiece with your lips. The cylinder should be pointed upside down.

4. While making the deepest inhalation, simultaneously quickly press the bottom of the cylinder until the release of 1 inhalation dose. Hold the breath for a few seconds, then take the mouthpiece out of the mouth and exhale slowly. Repeat the procedure to obtain the 2nd inhalation dose.

5.Put the protective cap on.

6. If the aerosol canister has not been used for more than 3 days, it is advisable to press the bottom of the cylinder once before applying the aerosol cloud.

The cylinder is designed for 200 inhalations. Then the cylinder should be replaced. Despite the fact that some contents may remain in the container, the amount of drug released by inhalation decreases.

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

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

The plastic mouthpiece is specially designed for aerated dosing Berodual H and serves for accurate dosing of the drug. The mouthpiece should not be used with other metered aerosols. You can not also use Berodual H dosed aerosol with other mouthpieces.

Side effect

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

Contraindications

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

Application in pregnancy and lactation

Pre-clinical data and experience with human use show that fenoterol or ipratropium bromide does not adversely affect pregnancy.

Consider the possibility of the inhibitory effect of fenoterol on contractile activity of the uterus.

The drug is contraindicated in 1 and 3 trimesters (the possibility of weakening the birth of phenoterol).

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

Fenoterol penetrates into breast milk. Data confirming that ipratropium bromide penetrates into breast milk is not obtained. However, caution should be used to appoint Berodual to nursing mothers.

Clinical evidence of the effect of combination of ipratropium bromide and fenoterol hydrobromide on fertility is not known.

special instructions

The patient should be informed that in case of sudden rapid increase of dyspnea (difficulty breathing), 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 forms of chronic obstructive pulmonary disease, symptomatic treatment may be preferable to regular use.

Patients with bronchial asthma should be aware of the need to conduct or enhance anti-inflammatory therapy to control the inflammatory process of the airways and the course of the disease.

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

Patients with a history of cystic fibrosis may have GI motility disorders.

Other sympathomimetic bronchodilators should be administered simultaneously with Berodual only under medical supervision.

Patients should be instructed about the proper use of the inhalation solution of Berodual. To prevent the solution from entering the eyes, it is recommended that the solution used by the nebulizer be inhaled through the mouthpiece. In the absence of the mouthpiece, a face mask that fits snugly should be used.Especially careful to protect the eyes of patients who are predisposed to the development of glaucoma.

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

In athletes, the use of Berodual in connection with the presence of fenoterol in its composition can lead to positive results of doping tests.

The drug contains a preservative - benzalkonium chloride and a stabilizer - disodium edetate dihydrate. During inhalation, these components can cause bronchospasm in sensitive patients with airways hyperreactivity.

Impact on the ability to drive vehicles and manage mechanisms

Studies of the effects of the drug on the ability to drive vehicles and the use of mechanisms were not carried out. However, patients should be warned that during treatment with Berodual they may experience such undesirable sensations as dizziness, tremors, eye disorders, mydriasis and blurred vision.Therefore, care should be taken when driving vehicles or using mechanisms. If patients experience the above-mentioned undesirable feelings, one should refrain from such potentially dangerous actions as driving a car or controlling machinery.

Drug Interactions

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

With the simultaneous use of other beta-adrenomimetics, anticholinergic systemic agents, xanthine derivatives (eg, theophylline), there may be an increase in side effects.

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

Hypokalemia associated with the use of beta-adrenomimetics can 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 airway disease.

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

Caution should be used to administer beta-adrenergic agents to patients receiving MAO inhibitors and tricyclic antidepressants, these drugs can enhance the action of beta-adrenergic drugs.

The use of inhaled halogenated anesthetics, for example, halothane, trichlorethylene or enflurane, can enhance the effect of beta-adrenergic agents 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

Berodual does not have structural analogs for the active substance. However, there are analogues for the pharmacological group (beta-adrenomimetics in combinations):

• Biasten;
• Ditek;
• Intal plus;
• Iprimol Steri-Neb;
• Cough;
• Combination;
• Kombipack;
• Seretid;
• Seredid Multidisk;
• Symbicort Turbuhaler;
• Tevakomb;
• Foradyl Combi.

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