Berodual

Berodual is a bronchodilator drug with a combined effect. It has an inhalation form.

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Indications Berodual

It is used in the treatment of the following diseases:

• bronchial asthma of various origins (endogenous or allergic form or caused by physical exertion);
• pathology of lung tissue in the chronic stage, against the background of which bronchospastic syndrome is observed;
• chronic bronchitis, which is accompanied by obstruction of the bronchopulmonary tract;
• pulmonary emphysema;
• other pathologies of the respiratory organs (of an obstructive chronic nature), accompanied by curable obstruction of the respiratory tract;
• preventive treatment of nosological forms that affect the respiratory system;
• preparation of the lumen inside the respiratory tract before introducing corticosteroids, antibiotics or other mucolytics into them (using an aerosol).

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Release form

It is released as an inhalation solution - in dropper bottles with a capacity of 2 ml (1 ml contains 20 drops). The pack contains 1 bottle with the solution.

It is also produced as a special aerosol with metered inhalations, in canisters with a nozzle, with a capacity of 10 ml (corresponds to 200 sprays - 1 portion is equal to 1 spray). Inside the box - 1 canister with medicine.

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Pharmacodynamics

The mechanism of the drug's medicinal action is based on the effects of two bioactive components that are part of the medicinal mixture used in hospitals in pulmonology.

Ipratropium bromide is an ammonium derivative with cholinolytic action. Bronchodilation occurs as a result of local therapeutic influence, because the substance is administered in the form of finely dispersed elements - by inhaling an inhalation solution or aerosol. The bioactive element prevents the secretion of acetylcholine (this is the main conductor of parasympathetic synapses), due to which calcium levels inside cell structures are normalized. All this allows neutralizing the influence of the vagus nerve, and in addition, expanding the bronchial lumen.

Fenoterol hydrobromide activates the stimulation of β-adrenoreceptors, and the selectivity of the drug effect is determined by the quantitative factor. Small portions of the bioactive element selectively affect β2-endings, which is required when using Berodual in conservative therapy of bronchopulmonary disease.

The biochemical effect of fenoterol is based on counteraction to the following agents - methacholine with histamine, as well as cold air and allergens of animal and plant origin (a particular situation with a slowdown in the manifestation of immediate hypersensitivity). Immediately after the use of the drug in a therapeutic dosage, the release of inflammatory conductors from labrocytes is blocked, resulting in relaxation of the smooth muscles of the bronchial tract, and along with this, the local vascular bed. In addition, an increase in the activity of mucociliary clearance is observed.

Separately, it is necessary to note the effect of fenoterol on the heart, because after penetrating into the main circulatory system, the bioactive element gets the opportunity to interact with β-adrenergic receptors located inside the myocardium. This can cause the development of such symptoms:

• increased heart rate;
• progressive increase in the activity of the muscular organ;
• prolongation of QT interval indicators on ECG.

The combination of two active bronchodilators allows achieving the desired medicinal effect using different therapeutic mechanisms, because the targets for the action of the active elements are different.

The complementary effect of fenoterol with ipratropium helps to achieve the required therapeutic result, which is manifested in the form of potentiation of the spasmolytic reaction of the bronchial muscles and their expansion, necessary for the stable functioning of the body.

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Pharmacokinetics

As a result of active inhalation of the medicinal solution, the functioning of the bronchopulmonary tract improves quite quickly, even though only 10-39% of the dose taken settles in the tissues of the respiratory system (the remainder of the drug remains on the inhaler nozzle, in the mouth, and in addition inside the upper part of the respiratory tract).

The medicinal effect of ipratropium bromide develops over 15 minutes and appears as an increase in forced expiratory volume in 1 second (this is an important characteristic by which the normal function of the respiratory system is assessed), as well as the maximum speed of exhalation by 15%.

Peak values of this bioactive element are observed after 1-2 hours of spraying. The therapeutic effect of the substance is maintained for 6 hours.

The overall bioavailability of fenoterol is slightly lower than that of ipratropium - it is approximately 1.5%. However, since Berodual is a drug with a local type of action, a more significant parameter for the therapy is the speed of the drug effect after inhalation, which is approximately equal to the speed of the first active element of the drug.

Dosing and administration

Use of medication in aerosol form.

Before using the inhaler, you need to exhale slowly and deeply. Then, wrap your lips around the nozzle of the canister so that its mouthpiece is turned downwards, and the arrow is, on the contrary, upwards. Then you need to press on the bottom of the canister to release 1 portion of the drug, and then take a deep breath - this is necessary to increase the area of interaction of the bioactive elements of the drug and the structures of the respiratory tract.

After completing the procedure, you need to put a protective cap on the can.

If the medicine has not been used for the last 3 or more days, before the procedure, you must press the nozzle once until a cloud of medicinal spray appears.

Aerosol inhaler dosage sizes.

For children aged 6 years and older and adults, during an exacerbation of an attack, a dose of 2 sprays is required. If there is no improvement after 5 minutes, another 2 such inhalations must be performed. If such a treatment regimen still does not bring results, you should urgently seek help from specialists.

If long-term conservative treatment is carried out, 1-2 inhalation procedures are performed three times a day. It should be taken into account that the total number of inhalations per day should not exceed 8 times.

Use of inhalation solution of drugs.

This dosage form of the drug requires the use of special medical instruments - such a device as a nebulizer. This device allows you to spray medicinal solutions in the form of a finely dispersed cloud.

Before starting to use the solution, it is necessary to find out the correct scheme for diluting the inhalation substance, because it is this factor that determines the effectiveness of the effect and the completeness of the implementation of the medicinal capabilities of the active elements of the drug.

Usually, 0.9% saline solution of sodium chloride is used for dilution, because its composition is as close as possible to the composition of the aqueous plasma dosage. It is strictly forbidden to use distilled water for dilution, because it can cause serious complications. It is necessary to add up to 3-4 ml of saline solution to the recommended portion of the drug.

General therapeutic regimens for conservative treatment with inhalation solution.

For adolescents over 12 years of age and adults to relieve acute attacks, use 20-80 drops (1-4 ml of solution) four times a day. If therapy has been going on for a long time, 20-40 drops (1-2 ml of solution) up to 4 times a day are required. To treat moderate bronchospastic syndrome, to facilitate the ventilation of the bronchopulmonary tract, 10 drops of the substance (0.5 ml of solution) should be administered.

Children aged 6-12 years are prescribed 10-20 drops of the drug (0.5-1 ml of solution) to prevent an attack. If a severe form of the disease is noted, the portion size can be increased to 40-60 drops (2-3 ml of solution). In the case of a long course of treatment (for example, eliminating an allergic cough), 10-20 drops of the drug (0.5-1 ml of solution) are prescribed four times a day.

For children under 6 years of age, weighing less than 22 kg, it is necessary to select dose sizes individually, taking into account the parameters proposed by the treatment course - 25 mcg/kg ipratropium and 50 mcg/kg fenoterol (the total portion size is no more than 0.5 ml), taken up to 3 times a day.

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Use Berodual during pregnancy

No reliable tests have been performed regarding the ability of the active ingredients to in any way affect a pregnant woman or fetus, but preclinical results of the use of fenoterol with ipratropium indicate that the bioactive substances do not have a negative effect on the physiological processes occurring inside the female body.

It is prohibited to use Berodual only in the 1st and 3rd trimesters, because fenoterol has a slowing effect on the uterine muscles. Accordingly, this component of the drug can slow down labor or create conditions for artificial hypotension - this fact can negatively affect the early stage of ontogenesis.

There is clinical evidence that the substance fenoterol can pass into breast milk during lactation. However, there is no such information about ipratropium. In this regard, nursing mothers should be prescribed the drug only in exceptional cases and with great caution.

Contraindications

Among the contraindications:

• hypersensitivity to a drug (acquired or hereditary);
• problems with the rhythm of cardiac function (similar to tachyarrhythmia);
• obstructive form of cardiomyopathy of hypertrophic nature;
• hypersensitivity to active and additional elements that are part of the drug.

With increased precautions (for example, it is recommended to undergo a course of conservative therapy at a specialized pulmonology hospital), it is necessary to prescribe the drug if a person has the following painful conditions:

• closed-angle glaucoma;
• heart failure;
• elevated blood pressure;
• IHD;
• diabetes mellitus;
• a history of myocardial infarction that occurred within the last 3 months;
• severe damage to peripheral and cerebral blood flow;
• thyrotoxicosis;
• obstruction in the area of the bladder neck (having a special organogenic form);
• pheochromocytoma or other tumors whose formation depends on hormones;
• benign form of prostatic hyperplasia;
• cystic fibrosis.

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Side effects Berodual

Side effects of the drug are related to the fact that its active ingredients have extremely high biochemical activity – due to the fact that they have cholinolytic and β-adrenergic effects. In addition, the use of the drug can lead to local irritation (this effect can occur with any method of inhalation).

Often, the use of the drug causes such side effects as headaches, dry mouth, intentional tremors, dizziness, pharyngitis with cough, tachycardia, and in addition vomiting, disturbance of the sound-forming function, nausea, subjective sensation of strong heartbeat or feeling of nervousness, as well as an increase in systolic blood pressure.

Other adverse reactions:

• dysfunction of the cardiovascular system: various arrhythmias (including atrial fibrillation), myocardial ischemia, supraventricular tachycardia, increased diastolic blood pressure;
• lesions affecting the visual organs: increased intraocular pressure, accommodation disorder, glaucoma, swelling in the cornea, mydriasis, pain, visual blurring, the appearance of a faint halo around objects visible to the eye and conjunctival hyperemia;
• disorders of the respiratory system: laryngospasm, dysphonia, irritation in the pharynx, which then develops into swelling, bronchospastic syndrome, and in addition, paradoxical spasm of the bronchi;
• immune manifestations: signs of hypersensitivity, as well as anaphylactic symptoms;
• mental disorders and dysfunctions of the nervous system: a feeling of nervousness or excitement, mental disorders and hand tremors when performing conscious movements (this symptom is especially noticeable when performing small coordinated movements);
• problems with metabolic processes: decreased potassium levels in the blood;
• digestive disorders: glossitis, constipation, stomatitis, diarrhea, swelling in the mouth, as well as dysfunction of the gastrointestinal tract peristalsis;
• lesions of subcutaneous tissues and skin: the appearance of urticaria, local Quincke's edema, as well as itching and increased sweating;
• disorders affecting the urinary system: urinary retention.

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Overdose

The use of the drug may cause intoxication with its active ingredients, which occurs due to excessive stimulation of β-adrenergic receptor activity. In this case, an overdose usually manifests itself with the following symptoms:

• a subjective feeling of increased heartbeat, as well as tachycardia diagnosed with the help of special devices;
• increase or decrease in blood pressure values (this depends on the patient’s personal predisposition);
• potentiation of the broncho-obstructive pathogenic process;
• an increase in the difference between diastolic and systolic blood pressure values;
• angina pectoris along with the symptoms observed against its background (for example, a feeling of heaviness in the area behind the breastbone);
• skin hyperemia in the facial area and a feeling of heat that appears against its background;
• non-respiratory acidosis.

In addition, poisoning can develop due to an excessively large amount of ipratropium bromide entering the body, but the strength of its expression is quite low and has a transient nature. With such an overdose, a disorder of visual accommodation or dryness of the oral mucosa is noted.

Selective β1-adrenoblockers can be used as a specific medicinal antidote. Having the opposite mechanism of therapeutic action, these drugs are able to eliminate the pathology that poses a danger to the life and health of the victim. At the same time, people with chronic pulmonary obstruction or bronchial asthma under the influence of bioactive elements with a similar type of therapeutic effect have a risk of developing bronchial obstruction. Such a violation can be avoided by carefully selecting the required portion.

In addition, such treatment procedures as the administration of tranquilizers (in case of extremely intense symptoms) and sedatives are carried out. In case of severe intoxication, urgent conservative intensive sanitation is necessary, during which any medications are used that can provide the required assistance to the victim.

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Interactions with other drugs

Regular combined use of Berodual and other anticholinergic drugs has not been studied, therefore such a combination is not recommended.

The combined use of the drugs/categories of medicines described below may affect the effectiveness of the drug.

Potentiation of properties or increase in the likelihood of side effects:

• other β-adrenergic agents (any route of administration);
• other anticholinergic drugs (any method of use);
• xanthine derivatives (eg, theophylline);
• anti-inflammatory medications (such as corticosteroids);
• MAOI;
• tricyclics;
• anesthetics with halogenated hydrocarbons (including trichloroethylene, halothane, and enflurane). They can especially potentiate the effect on the cardiovascular system.

A weakening of the therapeutic effect of the drug is observed with combined use with β-blockers.

Other possible interactions.

Hypokalemia, which occurs due to the use of β-adrenomimetics, may be potentiated when combined with corticosteroids, xanthine derivatives and diuretics. This factor must be taken into account during therapy in people with severe forms of respiratory tract obstruction.

Hypokalemia may increase the risk of arrhythmia in individuals taking digoxin. However, hypoxia may potentiate the negative effects of hypokalemia on heart rhythm. Therefore, with such treatment, it is necessary to constantly monitor potassium levels in the blood.

The risk of developing an acute glaucoma attack increases if ipratropium spray gets into the eye area, as well as when used in combination with β2-adrenergic receptors.

At the same time, the use of Berodual may lead to a weakening of the antidiabetic properties of hypoglycemic drugs. But this can only be expected when using large doses, often used for systemic administration (tablets or infusions/injections).

If the therapy involves the use of inhalation anesthetics, it is necessary to take into account that fenoterol should be administered at least 6 hours before the start of the anesthesia.

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Storage conditions

Berodual aerosol and inhalation solution should be kept in a place out of reach of small children. Temperature indicators – maximum 30°C.

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Shelf life

Berodual can be used for 5 years from the date of release of the drug.

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Reviews

Berodual receives mostly positive reviews about its therapeutic effect - this is also confirmed by theoretical and clinical tests, which checked the effectiveness of the drug's bioactive elements. The nebulizer or aerosol is very convenient and easy to use, which allows you to use them without having specific medical skills and knowledge.

Doctors speak positively about the combined effect of the drug, which helps to expand the bronchial lumen, since the active elements of Berodual combine 2 different mechanisms of influence on the development of bronchodilation. This is what allows the drug to successfully combat diseases affecting the respiratory tract, even in the most complex forms of the disease.

Reviews regarding the use of the drug in children are similar to those for adult patients. Often, parents very actively recommend using this drug during conservative therapy, because they have already become familiar with its properties and noticed that inhalations significantly facilitate breathing processes in the lungs, which significantly improves the health of even the smallest children.