Berodual solution 0.25mg + 0.5mg/ml 20ml

Berodual user manual

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Composition

1 ml of solution for inhalation has the following pharmaceutical components:
    bromide ipratropium - 0.261 mg (0.25 mg when transferring the dosage form to the dry residue);
    fenoterola hydrobromide - 0.5 mg;
    benzalkonium chloride;
    disodium edetate dihydrate;
    sodium chloride;
    1-molar hydrochloric acid;
    purified water.
Composition 1 of injection of a dosed inhalation aerosol:
    ipratropium bromide - 0.021 mg (corresponding to 0.02 mg in the mass portion of the anhydrous active substance);
    fenoterol hydrobromide - 0.05 mg;
    1,1,1,2-tetrafluoroethane (HFA 134a) as a propellant;
    anhydrous citric acid;
    ethanol;
    distilled water.

Form of issue

Transparent, colorless (or almost colorless) solution for inhalation without suspended particles and practically odorless. The pharmaceutical preparation is packed into 2 ml dropper bottles (1 ml corresponds to 20 drops). A cardboard box holds a container of medicinal liquid and an annotation to it.
Dosed aerosol for inhalations in special cylinders with a mouthpiece of 10 ml, calculated for 200 injections (1 dose equals to 1 injection). In the cardboard box, an annotation and a container containing the drug are inserted.
Berodual H is an enhanced pharmaceutical form of this drug that does not differ in operation, as it is supplied as an aerosol for inhalations and a solution for inhalations. It has its therapeutic properties accordingly, it is somewhat more effective.

pharmachologic effect

The drug group Berodual (the international name of the drug is identical to commercial) is a combination of bronchodilator drugs of inhalation type of action, that is, the active components provide active expansion of the bronchial lumen upon inhalation. The mechanism of its therapeutic effect depends on two biological active substances, which are the basis of the pharmaceutical mixture used in pulmonological hospitals.
Ipratropium bromide is an ammonium derivative that has anticholinergic properties. Bronchodilation is caused by its local action, since it is administered as fine particles by inhalation of an aspirating aerosol or solution for inhalation. Biologically active component prevents the release of acetylcholine, the main mediator of parasympathetic synapses, which is manifested in the normalization of the concentration of calcium inside the cellular structures. Thus, the action of the vagus nerve is neutralized and the lumen of the bronchus expands.
Fenoterol hydrobromide, in turn, is a stimulator of beta-adrenoreceptors, 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 application of Berodual in the course of conservative treatment of bronchopulmonary pathology.
The mechanism of biochemical influences of Fenoterol is to counteract such agents as histamine, methacholine, cold air and allergens of plant and animal nature (a particular case of inhibition of immediate-type hypersensitivity reaction). Immediately after administration in a therapeutic dose, the release of inflammatory mediators from the mast cells is blocked, which inevitably leads to relaxation of the smooth muscle of the bronchial tree and the local vascular bed. In addition, there is an increase in the productivity of mucociliary clearance.
Separately, we should note the cardiac effects of Fenoterol, since when entering the main bloodstream for a biologically active component, it becomes possible to interact with beta-adrenoceptors localized in the myocardium, respectively, the following manifestations can be observed:
    increased 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 necessary therapeutic effect by various pharmacological mechanisms, since the targets for the action of the active components are different. The complementary effects of fenoterol and ipratropium provide a reliable achievement of the desired clinical result, which is manifested in the increased spasmolytic properties of the muscular apparatus of the bronchi and their sufficient expansion to ensure the normal functioning of a healthy organism.

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 respiratory tract tissue (the rest of the drug remains on the tip of the inhaler, in the oral cavity and in the upper respiratory paths).
Therapeutic effects of ipratropium bromide develop within 15 minutes and represent an increase in forced expiration in 1 second (an important parameter in assessing the normal functioning of the respiratory system) and a peak expiratory flow rate of 15 percent. The maximum action of this biologically active ingredient is achieved already in 1-2 hours from the moment of injection, and the achieved effects remain for 6 hours.
The overall systemic bioavailability of fenoterol hydrobromide is slightly lower than that of ipratropium and is about 1.5%, however Berodual is a pharmaceutical preparation of a local nature of action, therefore the speed of therapeutic effect with an inhaled route of administration is not more clinically significant, which is not less than in the first active component of the drug.

Indications for use

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

Contraindications

    hereditary or acquired intolerance of the constituent components of the pharmaceutical preparation;
    disturbance of the rhythm of cardiac activity by the type of tachyarrhythmia;
    hypertrophic obstructive cardiomyopathy;
    the first trimester of pregnancy;
    prenatal period of fetus intrauterine production;
    hypersensitivity to the active ingredients or excipients that make up the drug.
The appointment of a pharmaceutical product against the background of the following pathological conditions necessarily requires the observance of measures of increased caution (for example, the passage of a conservative course in a specialized pulmonological hospital):
    angle-closure glaucoma;
    heart failure;
    arterial hypertension;
    cardiac ischemia;
    diabetes;
    myocardial infarction in the anamnesis for the last three months;
    marked damage to the cerebral and peripheral bloodstream;
    hyperthyroidism;
    obstruction of the neck of the bladder (a special organogenic character);
    pheochromocytoma or other hormone-dependent neoplasms;
    benign prostatic hyperplasia;
    cystic fibrosis.

Side effects

The adverse effects of using a pharmaceutical preparation are associated with extremely high biochemical activity of the active ingredients of the inhalation drug, as 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 frequently observed side effects from the whole wide list of adverse effects are dryness in the oral cavity, headache and dizziness, intentional tremor, cough, pharyngitis, nausea, tachycardia, abnormalities in sound formation, subjective palpitation, vomiting, nervousness and increased systolic blood pressure .

Other side effects:

    On the part of the cardiovascular system: arrhythmias, atrial fibrillation, supraventricular tachycardia, myocardial ischemia, increased diastolic blood pressure.
    The visual organs can respond to the administration of a pharmaceutical as follows: increased intraocular pressure, disruption of the accommodation process, mydriasis, glaucoma development, pain, corneal edema, blurred vision, conjunctival hyperemia, the appearance of a slight aura around objects.
    Respiratory tract: dysphonia, bronchospastic syndrome, irritation of the pharynx followed by edema, laryngospasm, paradoxical bronchospasm.
    From the side of the immune system: anaphylactic manifestations, hypersensitivity reaction.
    The nervous system and mental health can also be affected by inhalation mixtures: excitation, mental disturbance, nervousness, trembling of the upper limbs when performing conscious movement (especially expressed in small coordinated motor acts).
    On the part of metabolic processes: a decrease in potassium blood.
    The digestive system: stomatitis, glossitis, disorders of adequate peristalsis of the gastrointestinal tract, diarrhea or constipation, edema of the oral cavity.
    From the skin and subcutaneous tissue: itching, urticaria, local angioedema, hyperhidrosis.
    From the urinary system: the delay in the physiological duration of the act of urination.

Instructions for use Berodual (Method and dosage)

Before you carry out self-contained inhalations with a pharmaceutical product, you should carefully read the recommendations for the correct use of aerosol Berodual, which are usually represented as follows:
    The spray is in a can with a protective cap, which must be removed before use. If the drug has not been in use for the last 3 days, then before using it actively, it is necessary to press the valve once, until an aerosol for inhalation appears in the form of a small cloud.
    Make a deep and slow exhalation.
    Cover the inhaler with the lips for its tip so that the arrow on the spray can is turned upward, and the mouthpiece down.
    Simultaneously, press on the bottom of the container, releasing 1-dimensional dose of the drug, and deeply inhale "full breast" 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.
Inhaler Berodual: dosage of an aerosol form of a pharmaceutical preparation
Adults and children over 6 years of age during an acute attack - 2 inhalations. If no relief occurs within 5 minutes, two more inhalation doses are prescribed. With further ineffectiveness of this treatment tactic, urgent medical attention must be sought. With prolonged conservative sanitation - 1-2 inhalations 3 times a day, but that in total there were no more than 8 manipulations during one day.

Mortar Berodual for Inhalation, instructions for use

Pharmaceutical preparation in this form of release requires special medical equipment for proper use, which is called a nebulizer. This is the device by which Berodual (or other medicinal product) is sprayed into a fine-dispersed cloud. In this form, the drug almost freely enters even weakly ventilated areas of the bronchopulmonary system, and the dosage for the nebulizer is less than that for the traditional inhaler, because "the miracle of technology" has especially taken root in pulmonary hospitals and is now universally applied for the sanitation of respiratory diseases.
Before direct use of the drug, it is necessary to know how to dilute for inhalations correctly, since this depends on the effectiveness of the effect and the completeness of the therapeutic possibilities of the active components of Berodual. As a rule, an isotonic solution of sodium chloride with a concentration of 0.9% is used as the solvent, because it is the most approximate to the composition of the aqueous portion of the plasma (in no case can distilled water be used to dilute the pharmaceutical preparation, this may lead to unfavorable consequences). How to grow with saline solution - add liquid to 3-4 ml to the recommended dose.

General schemes of conservative treatment with a solution for inhalation

Adults and children over 12 years for the elimination of acute attacks - 20-80 drops (1-4 ml) 4 times, and with prolonged flow - 1-2 ml (20-40 drops) up to 4 times a day. With 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 - 0.5-1 ml (10-20) drops to counteract the attack (in severe clinical course, the dosage can 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 group of patients up to 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 Ipratropium and 50 μg Fenoterol per 1 kg body weight (total drug up to 0.5 ml) 3 times a day.

Instructions for use Berodual H

The practical operation of this pharmaceutical form of the drug is no different from the one previously invented by Berodual. The amplified variation is also supplied in the form of an aerosol in special cylinders for active inhalation and a solution for inhalation by means of a nebulizer or other similar medical equipment. As for dosages, it is necessary to visit a qualified specialist pulmonologist separately and find out this issue individually, since at the moment there are no general protocols for conservative sanation with Berodual N.

Overdose

When a pharmaceutical is used in clinical practice, a pathological condition such as an overdose of active active components can be observed, which is usually associated with excessive stimulation of beta-adrenergic receptors. In this case, the most likely symptoms of intoxication 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 the bronchial obstructive pathological process;
    increasing the difference between systolic and diastolic blood pressure;
    angina pectoris and symptoms accompanying it (for example, a feeling of heaviness behind the sternum);
    hyperemia of the skin of the face and accompanying sensation of fever;
    metabolic acidosis.
Also, an overdose can be caused by excessive intake of ipratropium bromide into the body, however, in this case it is weakly expressed and has a transitory character. This is due to the breadth of therapeutic use of this component in pharmacy. In such a case, dryness in the mouth or a violation of the accommodation capacity of the organs of vision may be observed.
As a specific pharmacological antidote, it is possible to use selective beta 1-blockers. Possessing the opposite mechanism of therapeutic action, these drugs will help get rid of the 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 type of pharmacological action, there is a possibility of developing bronchial blockage, which can be avoided only by careful selection of an accurate dosage.
Also, as a therapeutic measure, sedatives, tranquilizers (when the symptoms are expressed too violently) are used. In case of severe overdose syndrome, intensive conservative sanation should be performed immediately with the use of all possible medications that can adequately help the patient.

Terms of sale

To buy Berodual online you don't need a prescription.

Storage conditions

Like inhalation solution, Berodual aerosol should be stored in a place inaccessible to children of the younger category at a temperature of no higher than 30 degrees Celsius.
Shelf life - 5 years.

special instructions

Berodual - hormonal or not?

Bronchial asthma is a polyethological 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 complicated from a medical point of view. Quite often in the treatment of asthmatic conditions or in clinically severe cases, pharmaceutical preparations based on human natural hormones are used. Since among the indications for Berodual's use there is bronchial asthma, in ordinary people without medical education a quite logical question arises: "Berodual is 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 substance is an amine derivative with anticholinergic properties, and the second active component of the drug is a non-selective beta-adrenomimetic. Based on this, it can be stated with certainty that Berodual is not a hormonal drug and, according to its mechanism of action, can not affect the hormonal balance in the body.

Which is better: Berodual or Ventolin?

Ventolin is a pharmaceutical drug that belongs to selective beta2-adrenomimetics, the therapeutic effect of which is to actively expand the bronchial lumen and facilitate ventilation of the pulmonary parenchyma. As a rule, this drug is prescribed for prevention and conservative management of spasmodic contraction, which develops in contact with the allergen in the pathogenesis of bronchial asthma.
Berodual, in its turn, contains fenoterol, which, like Ventolin, has a stimulating effect on this type of bronchial tree receptor. 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, because this pharmaceutical preparation by the majority of qualified pulmonologists is considered better, and its use is more rational.

Salbutamol or Berodual - which is better?

Salbutamol is a medicinal product that has been described since time immemorial in the medical literature. According to its chemical structure and its therapeutic effect, it is a non-selective beta-adrenoceptor stimulant that spreads its biochemical effects on both the respiratory system and the heart. The active substance of the same name is uniquely stronger in the effects than phenoterol, 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 consequences of passing a conservative course of respiratory system sanation. It should also be noted a faster onset of relief when treating a nosological unit, such as chronic bronchitis, which is also very indicative.
Based on the above facts, it can be recognized that Berodual is better in the treatment of sluggish diseases of the respiratory tract with possible or already onset obstructive processes, but Salbutamol should be chosen for the sanation of bronchial asthma, as it is not only the recommendations for maintaining this nosological unit, but the official protocols for pulmonologists and pediatricians.

Berodual to children

The drug is actively used in pediatric practice from the youngest age for several reasons. First of all, of course, one should take into account the therapeutic effectiveness of the drug, when inhalation is carried out for the child in connection with chronic obstructive diseases of the respiratory system. Complex ipratropium bromide and Fenoterol allow not only to expand the bronchial lumen, but also greatly facilitate the ventilation of the lung parenchyma. The dosage of the nebulizer to children can be found in the item with the instruction for use, which will also be useful to parents who prefer the aerosol form of the pharmaceutical preparation.
Separately it is worth noting that the pharmaceutical preparation can be used not only for nosological units, the pathogenesis of which is inextricably linked with spasmodic narrowing of the bronchi, but also with dry cough, because the active ingredients improve mucociliary clearance, which stimulates regulatory and immune processes. Thus, the problem of a slow idiopathic dry cough is eliminated.
The most coughing young cough is unequivocally, the so-called "barking" cough that develops with laryngitis in children. This disease, affecting the upper respiratory tract, is especially dangerous, because the pathological process in the larynx is associated with a risk of developing an acute form of laryngitis and false croup. Therefore, if a given nosological unit is detected, the dosage for inhalation to children is slightly higher than that prescribed for chronic obstructive diseases of the respiratory system.

Berodual during pregnancy and lactation

There were no reliable studies on the ability of the active components to influence the fetus and the mother in any way during pregnancy, but the preclinical practice of using Fenoterol and Ipratropium of the past years indicates that biologically active substances do not have a negative effect on the physiological processes occurring in the body women.
It is not recommended to use the pharmaceutical preparation only in the I and III trimesters, since Fenoterol has a retarding effect in relation to the muscular apparatus of the uterus. Accordingly, this component Berodual is able to slow down the labor activity or give conditions for artificial hypotension, which can also adversely affect the early stages of ontogeny.
It has been clinically proven that Fenoterol is capable of penetrating into breast milk during lactation, but there is no such data on ipratropium, therefore it is recommended that young mothers who breastfeed themselves should use Berodual only with increased precautions.

Reviews about Berodual

Reviews about Berodual for inhalations confirm the clinical and theoretical studies of the biologically active components of the pharmaceutical preparation, since they are overwhelmingly colored with positive emotions. Aerosol and nebulizer are convenient in daily operation and do not require additional medical knowledge or special professional skills.
The doctors' comments on this medicine praise the combined approach to expanding the lumen of the bronchial tree, which is carried out by Berodual, because the active ingredients combine two different mechanisms for the development of bronchodilation, which makes it possible to effectively combat pathological conditions in the respiratory tract even in the most complicated clinical cases.
Reviews about Berodual for children do not differ from those for the adult category of patients. Of course, the parents of their recovered children are more active in recommending the use of the pharmaceutical in conservative treatment, as they saw with their own eyes how inhalation with Berodual facilitates pulmonary respiration and greatly improves the quality of life for children, even the youngest.