Беродуал®

General characteristics. Structure:

Active ingredients: 261 mkg a monohydrate bromide ipratropiya (in terms of anhydrous an ipratropiya bromide of 250 mkg), 500 mkg of Fenoterolum of hydrobromide.

Auxiliary components:  a benzalkoniya chloride, dinatrium of an edetat a dihydrate, sodium chloride, Acidum hydrochloricum 1H, water purified.

Pharmacological properties:

Pharmacodynamics. Беродуал® contains two components having broncholitic activity: an ipratropiya bromide - m-holinoblokator, and Fenoterolum - in 2-adrenomimetik.

Bronchodilatation at inhalation introduction an ipratropiya of bromide is caused, mainly, by local, but not systemic anticholinergic action.

At patients with the bronchospasm connected with chronic obstructive diseases of lungs (chronic bronchitis and emphysema of lungs), considerable improvement of function of lungs (increase in volume of the forced exhalation for 1 sec. (OFV1) and a peak expiratory rate for 15% and more) it is noted within 15 minutes, the maximum effect was reached in 1-2 hours and proceeded at most of patients till 6 o'clock after introduction.

Ipratropiya bromide does not exert negative impact on secretion of slime in respiratory tracts, mukotsiliarny clearance and gas exchange.

Fenoterolum selectively stimulates beta2-adrenoceptors in a therapeutic dose. Stimulation of beta1-adrenoceptors happens when using high doses.

Fenoterolum relaxes smooth muscles of bronchial tubes and vessels and counteracts development of the bronkhospastichesky reactions caused by influence of a histamine, metasincaline, cold air and allergens (reaction of immediate hypersensitivity). Right after introduction Fenoterolum blocks release of mediators of an inflammation and bronkhoobstruktion from mast cells. Besides, when using Fenoterolum in higher doses, strengthening of mukotsiliarny clearance was noted.

Beta and adrenergic influence of drug on cordial activity, such as increase in frequency and force of cordial reductions, is caused by vascular action of Fenoterolum, stimulation of beta2-adrenoceptors of heart, and when using the doses exceeding therapeutic, stimulation of beta1-adrenoceptors. As well as when using other beta and adrenergic drugs it was noted lengthening of an interval of OTS when using high doses. The clinical importance of this manifestation is not found out.

The tremor is the most frequent undesirable effect when using agonists of beta adrenoceptors.

At combined use of these two active agents the bronchodilatory effect is reached by impact on various pharmacological targets. The specified substances supplement each other, the spasmolytic effect on muscles of bronchial tubes as a result amplifies and the big width of therapeutic action at the bronchopulmonary diseases which are followed by a konstriktion of respiratory tracts is provided. Complementary action such is that achievement of desirable effect requires lower dose of a beta and adrenergic component that allows to pick up individually an effective dose at practical lack of side effects.

Indications to use:

Prevention and symptomatic treatment of chronic obstructive respiratory diseases with a reversible bronchospasm, such as bronchial asthma and, especially, chronic obstructive pulmonary disease (chronic obstructive bronchitis and emphysema).

Route of administration and doses:

The dose has to be selected individually. During performing therapy medical observation is required. The following doses are recommended:
At adults (including elderly people) and teenagers 12 years are more senior:

Bad attacks of bronchial asthma. At easy and moderate attacks in many cases 1 ml (20 drops) is recommended. In especially hard cases, for example at the patients who are in intensive care units at inefficiency of the doses stated above higher doses, to 2,5 ml (50 drops) can be required. The maximum dose, can reach 4,0 ml (80 drops).

Course and prolonged treatment. In need of repeated use for each introduction use 1 - 2 ml (20 - 40 drops) to 4 times a day. In case of a moderate bronchospasm or as supportive application at implementation of ventilation of the lungs the dose which lower level makes 0,5 ml (10 drops) is recommended.

At children at the age of 6-12 years. Bad attacks of bronchial asthma. In many cases for bystry stopping of symptoms 0,5 - 1 ml (10 - 20 drops) are recommended. In hard cases if the dose of 1 ml (20 drops) is inefficient, higher doses, to 2 ml (40 drops) can be required. In especially hard cases if the dose to 2,0 ml (40 drops) is inefficient, use (on condition of medical observation) the maximum dose reaching 3,0 ml (60 drops) is possible.

Course and prolonged treatment. In need of repeated use use for each introduction 0,5 - 1 ml (10 - 20 drops) to 4 times a day. In cases of a moderate bronchospasm or as supportive application at implementation of ventilation of the lungs the recommended dose - 0,5 ml (10 drops).

At children 6 years are aged younger (which body weight makes less than 22 kg). Because information on use of drug in this age group is limited, use of the following dose is recommended (only on condition of medical observation): about 25 mkg an ipratropiya of bromide and 50 mkg of Fenoterolum of hydrobromide of =0,1 ml (2 drops) on body weight kg (on one dose), but no more than 0,5 ml (10 drops) (on one dose) to 3 times a day. The maximum daily dose - 1,5 ml.

Solution for inhalations should be used only for inhalations (with the suitable nebulizer) and not to apply orally.

Treatment should be begun with the smallest recommended dose usually. The recommended dose has to get divorced 0,9% chloride sodium solution up to the final volume making 3 - 4 ml and to be applied (completely) by means of the nebulizer. Beroduala® solution for inhalations should not get divorced the distilled water. Cultivation of solution has to be carried out every time before use; the remains of divorced solution should be destroyed.

Divorced solution should be used right after preparation. Dosing can depend on a method of inhalation and a type of the nebulizer. Duration of inhalation can be controlled on an expenditure of divorced volume. Beroduala® solution can be applied to inhalations with use of various commercial models of nebulizers. When there is a wall oxygen, solution is the best of all to apply at a flow rate 6 - 8 liters a minute. It is necessary to follow the application instruction, service and the cleaning of the device delivered together with the nebulizer.

Features of use:

In case of unexpected bystry strengthening of an asthma (breath difficulties) it is necessary to see a doctor immediately.

Prolonged use:
• at the patients having bronchial asthma or easy and medium-weight forms of a chronic obstructive pulmonary disease, the symptomatic treatment can be more preferable than regular use
• at patients with bronchial asthma or severe forms a chronic obstructive pulmonary disease it is necessary to remember need of carrying out or strengthening of antiinflammatory therapy for control of inflammatory process of respiratory tracts and the course of a disease.

Regular use of the increasing doses of the drugs containing beta2-adrenomimetik such as Berodual®, for stopping of bronchial obstruction can cause uncontrollable deterioration in a course of a disease. In case of strengthening of bronchial obstruction increase in a dose of beta2-agonists the, including Beroduala® more recommended for a long time not only is not justified, but also it is dangerous. For prevention of life-threatening deterioration in a course of a disease it is necessary to consider a question of review of treatment planning of the patient and adequate antiinflammatory therapy by inhalation corticosteroids. At the patients having a mucoviscidosis in the anamnesis disturbances of motility of a GIT are possible.

It is necessary to appoint other sympathomimetic bronchodilators along with Berodualom® only under medical observation.

Patients have to be instructed about the correct use of inhalation Beroduala® solution. For the prevention of hit of solution in eyes it is recommended that the solution used by means of the nebulizer was inhaled through a mouthpiece. In the absence of a mouthpiece the mask, skintight to the person, has to be used. Especially carefully the patients predisposed to development of glaucoma have to care for protection of eyes.

Pregnancy and lactation. It is necessary to consider a possibility of inhibiting Berodual's effect on a sokratitelny uterine activity. Fenoterolum hydrobromide gets into breast milk. This, confirmatory that the ipratropiya bromide gets into breast milk it is not received. However, considering that many medicines get into breast milk, it is necessary to appoint with care Berodual to nursing mothers.

Side effects:

The most frequent undesirable effects of Beroduala® is the small tremor of skeletal muscles, nervousness, dryness in a mouth; less often the headache, dizziness, tachycardia and heartbeat, especially occur at patients with risk factors.

The serious hypopotassemia can be a consequence of therapy.

At treatment of Berodualom® development of cough, irritation of respiratory tracts, pharyngitis is possible, is more rare - emergence of a paradoxical bronchospasm.

Use of Beroduala® can make tachycardia, sick, vomiting, the increased sweating, feeling of the general weakness, a mialgiya or muscular spasms. Decrease in diastolic arterial pressure, increase in systolic arterial pressure, development of arrhythmias (is in rare instances possible at use of high doses), fibrillation of auricles, supraventricular tachycardia, change of mentality.
Reversible disturbances of accommodation and glaucoma, disturbances of motility of digestive tract are sometimes noted: vomiting, a lock, diarrhea (especially at patients with a mucoviscidosis) and an ischuria.

At hit of Beroduala® in eyes - a mydriasis, increase in intraocular pressure, glaucoma, pain in an eyeglobe.

Pain in an eyeglobe or the discomfort, indistinct sight, feeling of emergence of an aura or color spots before eyes, in combination with a hyperemia of a conjunctiva and corneal hypostasis can be symptoms of acute glaucoma. It is necessary to use the drops narrowing a pupil and to address immediately the oculist.

Skin reactions or allergic reactions, such as skin rash, Quincke's disease of language, lips and the person, small tortoiseshell, bronchospasm, laryngospasm and anaphylactic reactions are in rare instances possible.

Interaction with other medicines:

Simultaneous use of others beta адреномиметических means, anticholinergic drugs of systemic action and ksantinovy derivatives (for example, theophylline) can increase bronchodilatory action of Beroduala® and lead to strengthening of side effects.

Perhaps considerable weakening of bronchodilatory action of Beroduala® at co-administration of beta adrenoblockers.

The hypopotassemia connected using р-adrenomimetik can be strengthened by co-administration of ksantinovy derivatives, corticosteroids and diuretics. This fact should pay special attention at treatment of patients with severe forms of obstructive respiratory diseases.

The hypopotassemia can lead to increase in risk of developing of arrhythmias at the patients receiving digoxin. Besides, the hypoxia can strengthen a negative impact of a hypopotassemia on a cordial rhythm. In similar cases it is recommended to carry out monitoring of level of potassium in blood serum.

It is necessary to appoint with care beta2-adrenergic means to the patients receiving inhibitors of a monoaminooxidase and tricyclic antidepressants as these drugs are capable to strengthen action of beta and adrenergic means.

Inhalations of means for the general anesthesia of the halogenated hydrocarbon anesthetics, for example, of a halothane, a trikhloroetilena or an enflurana, can strengthen influence of beta and adrenergic funds for cardiovascular system.

Combined use of Beroduala® with kromoglitsiyevy acid and/or glucocorticosteroids increases efficiency of therapy.

Contraindications:

Hypertrophic subaortic stenosis, tachyarrhythmia, I and III trimesters of pregnancy. Hypersensitivity to Fenoterolum or atropinopodobny drugs or other components of this drug.

With care: closed-angle glaucoma, arterial hypertension, a diabetes mellitus, recently postponed myocardial infarction (within the last 3 months), a heart disease and vessels, such as chronic heart failure, coronary heart disease, heart disease, aortal stenosis, expressed damages of cerebral and peripheral arteries. Hyperthyroidism, pheochromocytoma, prostate hyperplasia, obstruction of a neck of a bladder, mucoviscidosis, II trimester of pregnancy, breastfeeding.

Overdose:

Symptoms of overdose are usually connected preferential with action of Fenoterolum. Emergence of the symptoms connected with excess stimulation р-adrenoceptors is possible. Emergence of tachycardia, heartbeat, a tremor, increase in arterial pressure, lowering of arterial pressure, increase in distinction between systolic and diastolic arterial pressure, stenocardias, arrhythmias and feelings of "inflows" of blood to the person, feeling of weight behind a breast, strengthening of a bronkhoobstruktion is the most probable.

The possible symptoms of overdose caused an ipratropiya by bromide (such as dryness in a mouth, accommodation disturbances), are expressed poorly and tranzitorna that is explained by its topical administration.

Treatment. Purpose of sedatives, anxiolytic medicines (tranquilizers), in hard cases - an intensive care is recommended.

As a specific antidote use of r-adrenoblockers is possible, it is more preferable than the selection beta1-adrenoblockers. However at patients with bronchial asthma or a chronic obstructive pulmonary disease it is necessary to consider a possibility of strengthening of bronchial obstruction which can lead to a lethal outcome, under influence р - adrenoblockers and carefully to select their dose.

Storage conditions:

List B. At a temperature not above 30 °C not to freeze. To store in the place, unavailable to children! Period of validity of 5 years. Not to use drug after expiry date.

Issue conditions:

According to the recipe

Packaging:

Solution for inhalations of 0,25 mg + 0,5 mg/ml. On 20 ml in a glass bottle of amber color with a polyethylene dropper and the screwing-up polypropylene cover with control of the first opening. The bottle with the application instruction is placed in a cardboard pack.