Berodual solution Inh. + 0.25mg 0.5mg / ml 20ml

$6.50

Berodual solution Inh. + 0.25mg 0.5mg / ml 20ml

Quantity:

Description

Composition
Active substance:
1 ml of solution contains: 261 g of ipratropium bromide monohydrate, based on the anhydrous ipratropium bromide (250 mg) and 500 mg of fenoterol hydrobromide.
Excipients:
Benzalkonium chloride, disodium edetate dihydrate, sodium chloride, hydrochloric acid 1H, purified water.
Description:
Transparent colorless or nearly colorless liquid, free from suspended particles. The smell is almost imperceptible.
Product form:
Solution for inhalation 0.25 mg + 0.5 mg / ml. 20 ml in a glass amber bottle with a polyethylene dropper and a polypropylene screw cap with tamper-evident. Bottle with instructions for use placed in a cardboard box.
Contraindications
Hypertrophic obstructive cardiomyopathy, tachyarrhythmia, I, and III trimesters of pregnancy. Fenoterolu hypersensitivity to atropine or drugs or other components of the formulation.
Precautions: angle-closure glaucoma, hypertension, diabetes, recent myocardial infarction (within the last 3 months), the heart and vascular disease, such as congestive heart failure, coronary artery disease, heart disease, aortic stenosis, expressed lesion cerebral and peripheral arteries. Hyperthyroidism, pheochromocytoma, prostatic hyperplasia, bladder neck obstruction, cystic fibrosis, II of three months of pregnancy, breast-feeding.
Dosage
0.25 mg + 0.5 mg / ml
Indications
Prevention and symptomatic treatment of chronic obstructive airways disease with reversible airways obstruction such as asthma, and especially chronic obstructive pulmonary disease, chronic obstructive bronchitis with the presence of or without emphysema.
Interaction with other drugs
Prolonged simultaneous use of Flomax with other anticholinergic drugs is not recommended due to lack of data. The simultaneous use of other beta-adrenomimeticheskih agents, anticholinergics and systemic xanthine derivatives (e.g., theophylline) may increase beroduala bronchodilatory effect and lead to increased side effects. Hypokalemia associated with the use of beta agonists, can be enhanced while appointment xanthine derivatives, corticosteroids and diuretics. This fact should be given special attention in the treatment of patients with severe obstructive airways disease. Hypokalemia may increase the risk of arrhythmias in patients receiving digoxin. Additionally, hypoxia may exacerbate the negative impact of hypokalemia in the heart rhythm. In such cases, it is recommended to carry out monitoring of the level of potassium in the blood serum. It should be used with caution beta2-adrenergic agents patients receiving monoamine oxidase inhibitors, and tricyclic antidepressants, since these drugs can enhance the effect of beta-adrenergic agents. Inhalation agents for general anesthesia halogenated hydrocarbon anesthetics such as halothane, enflurane or trichlorethylene, can enhance the influence of beta-adrenergic agents to the cardiovascular system. Joint application with beroduala cromoglicic acid and / or increases the efficiency of therapy with glucocorticosteroids.
Overdose
Overdose symptoms commonly associated predominantly with the action of fenoterol. Perhaps the appearance of the symptoms associated with excessive stimulation of beta-adrenergic receptors. The most likely occurrence of tachycardia, palpitations, tremor, high blood pressure, lowering blood pressure, increasing the difference between systolic and diastolic blood pressure, angina, arrhythmias, and a sense of “tides” of blood to the face, a feeling of heaviness in the chest, increased bronchial obstruction. It is also observed metabolic acidosis and hypokalemia. Symptoms of overdose due to ipratropium bromide (such as dry mouth, accommodation disturbances) are mild and transient, due to its topical application.
Treatment: you must stop taking the drug. Should take into account monitoring data of acid-base balance of blood. Recommended that the administration of sedatives, anxiolytic drugs (tranquilizers) in severe cases – intensive care. As a specific antidote possible use of beta-blockers, preferably beta1- selective blockers. However, in patients with asthma or chronic obstructive pulmonary disease should consider the possibility of strengthening the bronchial obstruction, which may result in death, under the influence of beta – blockers and carefully select their dose.
pharmachologic effect
Pharmacological group:
Bronchodilator combined (beta2-agonists selective-holinoblokator + m).
Pharmacological properties:
Berodual comprises two components having bronchodilating activity: ipratropium bromide – m-holinoblokator and fenoterol – beta2- adrenoagonists. Bronchodilation when inhaled ipratropium bromide caused mainly local, rather than systemic anticholinergic effects. Ipratropium bromide is a quaternary ammonium derivatives having 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 the increase in the intracellular concentration of Ca ++, which is due to interaction with muscarinic acetylcholine receptors located on smooth muscles of the bronchi. Ca ++ release mediated by the system of secondary mediators, which include ITF (inositol triphosphate) and DAG (diacylglycerol). In patients with bronchospasm associated with chronic obstructive pulmonary diseases (chronic bronchitis and emphysema), significant improvement in lung function (increase in forced expiratory volume in 1 second (FEV1), and peak expiratory flow rate at 15% or more) was observed for 15 minutes, maximal effect was achieved after 1-2 hours and lasted in most patients to 6 hours after administration. Ipratropium bromide has no adverse effect on mucus secretion in airway mucociliary clearance and gas exchange. Fenoterol selectively stimulates beta2-adrenergic receptors in the therapeutic dose. Stimulation beta1-adrenergic receptors occur when using high doses. Fenoterol relaxes the smooth muscles of bronchi and vessels and prevents the development of bronchospastic reactions, caused by histamine, methacholine, cold air and allergens (immediate hypersensitivity reaction). Immediately after administration fenoterol blocking the release of mediators of inflammation and bronchial mast cell. Furthermore, when using fenoterol at doses of 0.6 mg, it was noted enhancement of mucociliary clearance. beta -adrenergic effect of the drug on cardiac activity, such as increased frequency and severity of cardiac contractions, due to the action of vascular fenoterol, beta2-adrenergic stimulation of the heart, and at doses exceeding therapeutic, beta1- adrenoceptor stimulation. As with other beta-adrenergic drugs mentioned elongation interval QTc at high doses. When using fenoterol via aerosol metered dose inhalers (MDIs), this effect was unstable and was observed in the case of doses exceeding recommended. However, after applying fenoterol using nebulizers (for the inhalation solution in vials with standard dose) systemic exposure may be higher than when using the drug by MDI at recommended doses. The clinical significance of these observations is not established. The most frequently observed effect of beta-adrenoceptor agonists is tremor. The tolerance may develop clinical significance of this manifestation is not clear contrast to the effects on the bronchial smooth muscle, to the systemic effects of beta adrenergic receptor agonists. Tremor is the most common adverse effect when using beta adrenergic agonists. In joint use of these two active substances bronchodilatory effect is achieved by acting on different pharmacological targets. These substances complement each other, resulting in enhanced spasmolytic effect on the bronchial muscle and provides greater latitude therapeutic action in bronchopulmonary diseases involving airway constriction. The complementary action is such that to achieve the desired effect requires a lower dose of beta-adrenergic component that enables individually choose an effective dose in the substantial absence of side effects beroduala. In acute bronchoconstriction effect Flomax is developing rapidly, it can be used for acute attacks of bronchospasm.
Pregnancy and breastfeeding
These pre-clinical studies and the experience of a person show that fenoterol or ipratropium bromide does not adversely affect pregnancy. It is necessary to consider the possibility of inhibiting the effect of fenoterol on uterine activity. The drug is contraindicated in I and III trimesters (the possibility of weakening labor fenoterol). Caution is advised to use the drug in the II trimester of pregnancy. Fenoterol passes into breast milk. Data confirming that ipratropium bromide penetrates received into breast milk. But it should be used with caution in nursing mothers Flomax. Clinical data on the effect of the combination of ipratropium bromide and fenoterol hydrobromide on fertility are not known.
Conditions of supply of pharmacies
By prescription.
side effects
Many of the listed undesirable effects can be caused by anticholinergics and beta-adrenergic properties Flomax. Flomax, as well as any inhalation therapy, may cause local irritation. Adverse drug reactions were determined based on data obtained in the clinical studies and in the supervision of the pharmacological use of the drug after its registration. The most common side effects reported in clinical studies were cough, dry mouth, headache, tremor, pharyngitis, nausea, dizziness, dysphonia, tachycardia, palpitations, vomiting, increase in systolic blood pressure and nervousness.
Disorders of immune system: anaphylactic reaction, hypersensitivity
Violations by the Metabolism and nutrition: hypokalaemia
Mental disorders: anxiety, agitation, mental disorders
Disorders of the nervous system: headache, tremor, dizziness,
Violations by the organ of vision: glaucoma, increased intraocular pressure, accommodation disturbances, mydriasis, blurred vision, eye pain, corneal edema, hyperemia, conjunctival, ghosting around objects
Violations of the heart: tachycardia, palpitations, arrhythmia, atrial fibrillation, supraventricular tachycardia, myocardial ischemia
Violations by the respiratory, thoracic and mediastinal disorders: cough, sore throat, hoarseness, bronchospasm, throat irritation, swelling of the throat, laryngospasm, bronchospasm paradoxical, throat dryness
Disorders of the gastrointestinal tract: vomiting, nausea, dry mouth, stomatitis, glossitis, motility disorders of the gastrointestinal tract, diarrhea, constipation, swelling of the mouth
Changes in the skin and subcutaneous tissue disorders: urticaria, pruritus, angioedema, rash
Musculoskeletal disorders and connective tissue disorders: muscle weakness, muscle spasms, myalgia
Violations of the kidneys and urinary tract: urinary retention,
Laboratory and instrumental data: systolic blood pressure, diastolic blood pressure increase.
special instructions
In the event of an unexpected rapid amplification of dyspnea (difficulty breathing) should immediately consult a doctor.
Hypersensitivity: After application beroduala may arise immediate hypersensitivity reaction, which features, in rare cases, may be: urticaria, angioedema, skin rashes, bronchospasm, oropharyngeal edema, anaphylactic shock.
Paradoxical bronchospasm: Flomax, like other inhaled drugs can cause paradoxical bronchospasm that may be life-threatening. In the case of paradoxical bronchospasm use Flomax should be discontinued immediately and switch to an alternative therapy
Long-term use: Patients suffering from bronchial asthma Flomax should be used only as needed. Patients with mild chronic obstructive pulmonary disease, symptomatic treatment may be preferable to regular use; in patients with bronchial asthma patients should be aware of the need for strengthening or anti-inflammatory therapy to control airway inflammation and the disease process. Regular use of increasing doses of drugs containing beta2- adrenoceptor agonists such as berodual, for the relief of bronchial obstruction can cause uncontrolled degradation of the disease course. In the event the bronchial obstruction, increasing the dose of beta2-agonists, including Flomax longer recommended for a long time not only justified, but also dangerous. To prevent life-threatening deterioration of disease should consider reviewing the patient’s treatment plan, and adequate anti-inflammatory therapy with inhaled corticosteroids. Other sympathomimetic bronchodilators should be administered simultaneously with berodualom only under medical supervision.
Disorders of the gastrointestinal tract: in patients with a history of cystic fibrosis, gastrointestinal motility disorders are possible. Flomax should be used with caution in patients predisposed to acute glaucoma. Known individual reports of complications from organ of vision (such as increased intraocular pressure, mydriasis, angle-closure glaucoma, eye pain) developed by ingestion of inhaled ipratropium bromide (ipratropium bromide or in combination with agonists of the beta 2-adrenergic receptors) in the eye. Symptoms of acute angle-closure glaucoma can be a pain or discomfort in the eyes, blurred vision, ghosting in objects and colored spots before his eyes in combination with corneal edema and redness of the eyes due to conjunctival vascular injection. If any composition develops these symptoms showing application of eye drops, the intraocular pressure-lowering and immediately consult a specialist. Patients should be instructed on the proper use of inhalation solution Flomax. To prevent ingress of solution in the eye is recommended that the solution used via nebulizer inhaled through a mouthpiece. In the absence of a mouthpiece must be used to close fitting face mask. Particular care should take care of the protection of the eye, patients predisposed to the development of glaucoma.
Systemic effects: In the following diseases: recent myocardial infarction, diabetes mellitus with inadequate glycemic control, hard protekayuschix organicheskix zabolevaniyax heart and blood vessels, hyperthyroidism, pheochromocytoma or obstruction of the urinary tract (such as prostatic hyperplasia or bladder outlet obstruction) beroduala should only apply after careful assessment of the risk / benefit ratio, especially when used in excess of recommended doses.
Influence on the cardiovascular system: in the post-marketing studies are rare occurrences of myocardial ischemia when taking beta-agonists. Patients with underlying severe heart disease (eg ischemic heart disease, arrhythmia or severe heart failure) receiving Flomax should be warned about the need to see a doctor in case of pain in the heart or other symptoms suggestive of worsening heart disease. It is necessary to pay attention to symptoms such as shortness of breath and chest pain, as they may be both cardiac and pulmonary etiology.
Hypokalemia: When using beta2-agonists may occur hypokalemia (see “Overdose”.) For athletes beroduala application due to the presence in its composition of fenoterol may result in positive test results for doping. The preparation comprises a preservative, benzalkonium chloride, and the stabilizer – disodium edetate dihydrate. During inhalation, these components can cause bronchospasm in susceptible patients with airway hyperresponsiveness.
Influence on the ability to road management and use of mechanisms
Исследований влияний препарата на способность к управлению автотранспортом и использованию механизмов не проводилось. Однако пациентам нужно сообщать, что во время лечения БЕРОДУАЛОМ они могут испытывать такие нежелательные ощущения, как головокружение, тремор, нарушения аккомодации глаз, мидриаз и затуманивание зрения. Поэтому следует рекомендовать соблюдение осторожности во время управления автотранспортом или использования механизмов. Если пациенты испытывают указанные выше нежелательные ощущения, следует воздерживаться от таких потенциально опасных действий, как вождение автомашины или управление механизмами.
Storage conditions
При температуре не выше 30 С, не замораживать. Keep out of the reach of children!.
Dosing and Administration
Лечение должно проводиться под медицинским наблюдением (например, в условиях стационара). Лечение в домашних условиях возможно только после консультации с врачом в тех случаях, когда быстродействующий бета-агонист в низкой дозе недостаточно эффективен. Так же раствор для ингаляций может быть рекомендован пациентам, в случае, когда аэрозоль для ингаляций не может использоваться или при необходимости применения более высоких доз. Доза должна подбираться индивидуально, в зависимости от остроты приступа. Лечение обычно должно начинаться с наименьшей рекомендуемой дозы и прекращаться после того как достигнуто достаточное уменьшение симптомов.
Рекомендуются следующие дозы:
У взрослых (включая пожилых людей) и подростков старше 12 лет
Острые приступы бронхоспазма: в зависимости от тяжести приступа дозы могут варьировать от 1 мл (1 мл = 20 капель) до 2,5 мл (2,5 мл = 50 капель). В особо тяжелых случаях возможно применение доз, достигающих 4 мл (4 мл = 80 капель)
У детей в возрасте 6-12 лет
Острые приступы бронхиальной астмы: в зависимости от тяжести приступа дозы могут варьировать от 0,5 мл (0,5 мл = 10 капель) до 2 мл (2 мл = 40 капель).
У детей в возрасте младше 6 лет (масса тела которых составляет менее 22 кг):
В связи с тем, что информация о применении препарата в этой возрастной группе ограничена, рекомендуется использование следующей дозы (только при условии медицинского наблюдения): 0,1 мл (2 капли) на кг массы тела, но не более 0,5 мл (10 капель) Раствор для ингаляций следует использовать только для ингаляций (с подходящим небулайзером) и не применять перорально.
Лечение следует обычно начинать с наименьшей рекомендуемой дозы. Рекомендуемая доза должна разводиться 0,9 % раствором натрия хлорида до конечного объема, составляющего 3 – 4 мл, и применяться (полностью) с помощью небулайзера. Раствор БЕРОДУАЛА для ингаляций не должен разводиться дистиллированной водой. Разведение раствора должно осуществляться каждый раз перед применением; остатки разведенного раствора следует уничтожать. Разведенный раствор следует использовать сразу после приготовления. Длительность ингаляции может контролироваться по расходованию разведенного раствора. Раствор БЕРОДУАЛА для ингаляций может применяться с использованием различных коммерческих моделей небулайзеров. Доза, достигающая легких, и системная доза зависят от типа используемого небулайзера и могут быть выше, чем соответствующие дозы при использовании дозированного аэрозоля БЕРОДУАЛА HFA и CFC (что зависит от типа ингалятора). В тех случаях, когда имеется настенный кислород, раствор лучше всего применять при скорости потока 6 – 8 литров в минуту. Необходимо следовать инструкции по применению, обслуживанию и чистке небулайзера.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Behringer

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