Berodual solution for inhalation 20 ml
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Active ingredients
Ipratropium bromide
Release form
Solution
Composition
Fenoterol hydrobromide 500 mcg; ipratropium bromide monohydrate 261 mcg; in terms of anhydrous ipratropium bromide 250 mcg. Excipients: benzalkonium chloride, disodium edetate dihydrate, sodium chloride, hydrochloric acid 1N, purified water; dropper and screw-in polypropylene lid with the control of the first opening (1) - packs of cardboard.
Pharmacological effect
Combined bronchodilator drug. It contains two components with bronchodilator activity: ipratropium bromide - m-holinoblokator, and fenoterol hydrobromide - beta2-adrenomimetik.; Bronchodilatation with inhalation ipratropium bromide is mainly due to local, rather than systemic, anticholinergic. with anticholinergic (parasympatholytic) properties. The drug inhibits the reflexes caused by the vagus nerve, counteracting the effects of acetylcholine, a mediator released from the endings of the vagus nerve. Anticholinergics prevent an 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 ITP (inositol triphosphate) and DAG (diacylglycerol); in patients with bronchospasm associated with COPD (chronic bronchitis and pulmonary emphysema), a significant improvement in lung function (increase in forced expiratory volume after 1 s (FEV1) and peak expiratory flow rate of 15% or more) was noted for 15 minutes, the maximum effect was achieved after 1-2 hours and lasted for most patients up to 6 hours after administration. Ipratropium bromide does not adversely affect ekretsiyu mucus in the airways, mucociliary clearance and gas exchange;. fenoterol hydrobromide selectively stimulates β2-adrenergic receptors in the therapeutic dose. Stimulation of β1-adrenoreceptors 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 effect 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, when using fenoterol at a dose of 600 mcg, an increase in mucociliary clearance was observed. exceeding therapeutic, stimulation of β1-adrenoreceptors.; As with other beta-adrenergic drugs, the QTc interval was prolonged when used in high doses. When using fenoterol using metered-dose aerosol inhalers (DAIs), this effect was variable and was observed when used in 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 with DAI in recommended doses. The clinical significance of these observations has not been established.; The most commonly observed effect of β-adrenoreceptor agonists is tremor. In contrast to the effects on the smooth muscles of the bronchi, the systemic effects of β-adrenoreceptor agonists can develop tolerance. The clinical significance of this manifestation has not been elucidated. With the combined use of ipratropium bromide and fenoterol, the bronchodilator effect is achieved by acting on various pharmacological targets. These substances complement each other, as a result, the antispasmodic effect on the muscles of the bronchi is enhanced and a greater breadth of the therapeutic action in case of bronchopulmonary diseases accompanied by constriction of the respiratory tract is ensured. The complementary effect is such that to achieve the desired effect, a lower dose of the beta-adrenergic component is required, which allows you to individually select an effective dose with virtually no side effects. With acute bronchoconstriction, the effect of the drug Berodual; develops quickly, which allows its use in acute attacks of bronchospasm.
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.; The drug should be prescribed with caution in case of angle-closure glaucoma, arterial hypertension, diabetes mellitus, recent myocardial infarction (within the last 3 months), heart and vascular diseases (heart failure, CHD, heart disease, aortic stenosis , pronounced lesions of cerebral and peripheral arteries), hyperthyroidism, pheochromocytoma, prostatic hyperplasia, bladder neck obstruction, cystic fibrosis, in the second trimester during breastfeeding.
Use during pregnancy and lactation
These preclinical studies and experience in humans show that fenoterol or ipratropium bromide does not adversely affect pregnancy; the possibility of an inhibitory effect of fenoterol on the contractile activity of the uterus should be taken into account. ; It should be used with caution in the II trimester of pregnancy.; Fenoterol is excreted in breast milk. Data confirming that ipratropium bromide penetrates into breast milk has not been obtained. However, Berodual should be used with caution; to nursing mothers; clinical data on the effect of the combination of ipratropium bromide and fenoterol hydrobromide on fertility are not known.
Dosage and administration
Treatment should be carried out under medical supervision (for example, in a hospital). Home treatment is possible only after consulting a doctor in those cases when a fast-acting β-adrenoreceptor agonist at a low dose is not sufficiently effective. Also, the solution for inhalation can be recommended to patients in the case when the inhalation aerosol cannot be used or, if necessary, to be applied in higher doses.; The dose should be selected individually, depending on the severity of the attack.Treatment usually starts with the lowest recommended dose and stops after a sufficient reduction of symptoms is achieved. The following doses are recommended: 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 vary from 1 ml 1 ml = 20 drops) to 2.5 ml (2.5 ml = 50 drops). In severe cases, it is possible to use the drug in 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, 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 kg) due to the fact that information on the use of the drug in this age group is limited, the use of the next dose is recommended ( Only under the condition of medical supervision): 0.1 ml (2 drops) per kg of body weight, but not more than 0.5 ml (10 drops); Rights la drug use; The solution for inhalation should be used only for inhalation (with a suitable nebulizer) and not orally.; Treatment should usually begin with the lowest recommended dose.; The recommended dose should be diluted with 0.9% sodium chloride solution to a final volume of 3-4 ml, and apply (completely) using a nebulizer.; Solution for inhalation Berodual; do not dilute with distilled water.; Dilution of the solution should be done each 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 spending the diluted solution.; Berodual inhalation solution; 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 dose when using a metered dose of Berodual HFA and CFC aerosol (which depends on the type of inhaler). In cases where there is wall oxygen, the solution is best used at a flow rate of 6-8 l / min. You must follow the instructions for use, maintenance and cleaning of the nebulizer.
Side effects
Many of the undesirable effects listed can be due to the anticholinergic and beta-adrenergic properties of Berodual. As with any inhalation therapy, the use of Berodual can cause local irritation.Adverse drug reactions were determined on the basis of data obtained in clinical studies and during pharmacological supervision over the use of the drug after its registration. The most frequent 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. On the immune system: an anaphylactic reaction, hypersensitivity.; On the part of substances: hypokalemia. From the nervous system and psyche: nervousness, agitation, mental disorders, headache, tremor, dizziness.; From the organ of vision: glaucoma, increased intraocular pressure, disturbance of accommodation, mydriasis, blurred vision, eye pain , corneal edema, conjunctival hyperemia, appearance of a halo around objects. destructive blood pressure, increased diastolic blood pressure. From the respiratory system: cough, pharyngitis, dysphonia, bronchospasm, pharynx irritation, pharyngeal edema, laryngospasm, paradoxical bronchospasm, dry throat. , glossitis, gastrointestinal motility disorders, diarrhea, constipation, swelling of the oral cavity. On the side of the skin and subcutaneous tissues: urticaria, pruritus, angioedema, hyperhidrosis. side urinary with STEM: urinary retention.
Overdose
Symptoms: Overdose symptoms are usually associated primarily with the action of fenoterol (the appearance of symptoms associated with excessive stimulation of β-adrenoreceptors). The most likely occurrence of tachycardia, palpitations, tremor, increase or decrease in blood pressure, increase the differences between systolic and diastolic blood pressure, angina pectoris, arrhythmias, feelings of blood flushes, a feeling of heaviness behind the sternum, increased bronchoobstruction. Metabolic acidosis and hypokalemia were also observed.; Possible overdose symptoms due to ipratropium bromide (such as dry mouth, disturbed accommodation of the eyes) are mild and transient, due to the wide therapeutic range of doses of this drug and its local use. Treatment .You must stop taking the drug. Blood pressure monitoring data should be taken into account. It is recommended the appointment of sedatives, anxiolytic drugs (tranquilizers), in severe cases - intensive therapy.; As a specific antidote, beta-blockers may be used, preferably selective beta-blockers. However, you 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 danger of severe bronchospasm, which can be fatal.
Interaction with other drugs
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-adrenergic mimetics, anticholinergics of systemic action, xanthine derivatives (for example, theophylline), it is possible to enhance the bronchodilator action and enhance side effects. beta adrenergic blockers.; Hypokalemia associated with the use of beta adrenergic mimetics can be enhanced by simultaneous the use of xanthine derivatives, corticosteroids and diuretics. This fact should be given special attention when treating patients with severe obstructive respiratory diseases. 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 concentration of potassium in the blood serum.; Be careful to prescribe beta2-adrenomimetics to patients who received MAO inhibitors and tricyclic antidepressants, since these drugs can enhance the effect of beta-adrenergic agents.; The use of inhaled halogenated anesthetics, such as halothane, trichlorethylene or enflurane, can enhance the effect of beta-adrenergic drugs on the cardiovascular system.; Combined use of Berodual with cromoglycic acid and / or GCS increases efficiency therapy.
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; Immediate hypersensitivity reactions may occur after the use of Berodual, which in rare cases can be urticaria, angioedema, rash, bronchospasm , oropharyngeal edema, anaphylactic shock.; Paradoxical bronchospasm; Berodual ;, like other inhalation drugs, can cause paradoxical bronchospasm, which can It is life threatening. In the case of the development of paradoxical bronchospasm, the use of Berodual should be immediately stopped and switched to alternative therapy.; Long-term use; In patients with 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, one should be aware of the need to conduct or enhance anti-inflammatory therapy to control the inflammatory process of the respiratory tract and the course of the disease. Regular use of increasing doses of drugs containing β2-adrenomimetics , such as Berodual ;, for relief of bronchial obstruction may cause an uncontrolled deterioration in the course of the disease. In the case of increased bronchial obstruction, an increase in the dose of β2-agonists, incl. Berodual, more than recommended for a long time is not only not justified, but also dangerous. To prevent a life-threatening deterioration in the course of the disease, consideration should be given to revising the patient’s treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids. Other sympathomimetic bronchodilators should be given at the same time as Berodual only under medical supervision. Disorders from the gastrointestinal tract cystic fibrosis, possible gastrointestinal dysmotility. Violations of the organ of vision; Berodual; should be prescribed with caution to patients prone to the development of angle-closure 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 the inhalation ipratropium bromide (or ipratropium bromide combined with β2-adrenoreceptor agonists) hit the eyes.Symptoms of acute angle-closure glaucoma can be pain or discomfort in the eyes, blurred vision, the appearance of aureole in objects and colored spots before the eyes, combined with corneal edema and redness of the eye, due to conjunctival vascular injection. If any composition of these symptoms develops, the use of eye drops, which reduce intraocular pressure, and the immediate consultation of a specialist are indicated. Patients should be instructed about the correct use of inhalation solution Berodual ;. To prevent the solution from getting into the eyes, it is recommended that the solution used with a nebulizer be inhaled through the mouthpiece. In the absence of a mouthpiece, a mask should be used tightly to the face. Particular care should be taken to protect the eyes of patients prone to the development of glaucoma. Systemic 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 obstruction for example, prostatic hyperplasia or bladder neck obstruction) Berodual; should be prescribed only after a thorough assessment of the risk / benefit ratio, especially when used at doses higher than recommended.; Effect on the cardiovascular system; In post-marketing studies, there have been rare cases of myocardial ischemia when taking β-adrenoreceptor 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 see a doctor if heart pain or other symptoms appear that indicate worsening heart disease. It is necessary to pay attention to symptoms such as shortness of breath and chest pain, because they can be both cardiac and pulmonary etiology.; Hypokalemia; When using β2-adrenoreceptor agonists, hypokalemia can occur.; Athletes have Berodual, due to the presence of fenoterol in its composition, it can lead to positive results of doping tests.; The drug contains preservative, benzalkoniya chloride, and the stabilizer - disodium edetate dihydrate.During inhalation, these components can cause bronchospasm in sensitive patients with airway hyperresponsiveness; Effects on ability to drive vehicles and control mechanisms; Effects of the drug on ability to control vehicles and use mechanisms are not specifically studied. However, patients need to be informed that during treatment with the drug Berodual; possible development of such adverse events as dizziness, tremor, disturbance of accommodation, mydriasis, blurred vision. Therefore, caution should be recommended when driving or using machinery. If patients experience the above undesirable sensations, one should refrain from such potentially dangerous actions as driving a vehicle or controlling machinery.