Index of drugs

Prevention and treatment of symptoms of chronic obstructive airways disease with reversible bronchospasm: bronchial asthma, especially chronic bronchitis (with emphysema or without emphysema). In patients with bronchial asthma and chronic obstructive pulmonary disease (COPD) responding to corticosteroids, a concomitant use of anti-inflammatory therapy should be considered.

1 ml (20 drops) of the nebuliser solution contains 0.5 mg of fenoterol hydrobromide and 0.25 mg of ipratropium bromide monohydrate. The preparation contains benzalkonium chloride. 1 dose of spray contains 50 μg of fenoterol hydrobromide and 21 μg of anhydrous ipratropium bromide.

The product contains two active substances with bronchodilating effects: ipratropium bromide, anticholinergic activity and fenoterol hydrobromide that stimulates β-adrenergic receptors. Ipratropium bromide suppresses the vagus-driven reflexes and prevents the increase of intracellular cGMP concentration caused by the interaction of acetylcholine on muscarinic receptors in the bronchial smooth muscle. Bronchiectasis following inhalation of ipratropium bromide is mainly a result of local action and not a result of general action. Fenoterol has a spasmolytic effect on the smooth muscles of the bronchi and vessels, protecting the bronchi from contraction due to the action of histamine, metacholine, cold air and allergen (early response). Following rapid administration, mast cell secretion of inflammatory and contracting bronchial mediators is inhibited. In addition, higher doses of fenoterol have been shown to increase the efficacy of mucocutaneous airway clearance. After inhalation, approximately 16% of the dose gets into the airways, the rest is swallowed. Active substances are absorbed very quickly from the respiratory tract. Maximum plasma concentrations are reached a few minutes after inhalation. The ingested portion of fenoterol hydrobromide is metabolized mainly by coupling with sulphates. The absolute bioavailability following oral administration is low (around 1.5%). Fenoterol and its metabolites undergo rapid renal excretion. Approx. 40% of the drug is bound to plasma proteins. The absolute bioavailability of the swollen portion of ipratropium bromide is low (around 2%). T_0,5 is 1.6 hours. Approx. 40% of the clearance of the substance is renal clearance, and 60% extra-renal clearance, mainly metabolism by the liver. 4.4-13.1% of the dose administered in the form of inhalation is excreted in the urine in unchanged form. The binding of the drug to plasma proteins is minimal (less than 20%).

Hypersensitivity to fenoterol hydrobromide, atropine-like substances or any auxiliary substances of the preparation. Severe hypertrophic cardiomyopathy. Arrhythmias with accelerated cardiac function (tachyarrhythmia).

In the case of long-term use in patients with bronchial asthma and mild course of COPD, it may be more advisable to administer the preparation temporarily, in order to eliminate symptoms than its regular use; in patients with bronchial asthma and COPD responding to treatment with corticosteroids, additional administration of anti-inflammatory drugs (or increasing their dose) should be considered in order to control the inflammation in the airways and prevent the disease from getting worse. In the case of deteriorating bronchial obstruction, continuous increase in doses of β-group drugs₂- above the recommended doses and for a long time is inadvisable and risky - in this case, the treatment plan should be reconsidered, paying particular attention to the anti-inflammatory therapy of inhaled corticosteroids to prevent life-threatening worsening of the symptoms of the disease. In the case of ACUTE, rapidly increasing dyspnoea, the patient should immediately contact a physician. In patients with inadequately controlled diabetes, recent myocardial infarction and / or severe cardiac or vascular disease, hyperthyroidism, phaeochromocytoma, the formulation can only be used after careful consideration of the benefit / risk ratio, especially if doses greater than those recommended are used. Treatment with β-receptor agonists₂-adrenergic can lead to potentially dangerous hypokalemia. Caution should be exercised when using the product in patients with prostatic hyperplasia, narrowing of the bladder neck, predisposition to narrow-angle glaucoma. If an aerosol containing ipratropium bromide or ipratropium bromide enters the eye in combination with a β-receptor agonist₂ may occur: mydriasis, increased intraocular pressure, narrow-angle glaucoma, eye pain - special care should be taken to prevent the solution from reaching the eye, especially in patients with a predisposition to glaucoma. Eye pain or discomfort, blurred vision, visual halo or color vision coexisting with eye redness as a result of conjunctival congestion and corneal edema may be signs of acute narrow-angle glaucoma - if these symptoms occur, initiate treatment with eye-constricting eye drops and seek expert opinion immediately . Patients with cystic fibrosis may be more susceptible to gastrointestinal motility disorders. The preparation in the form of a nebuliser solution contains benzalkonium chloride, which can cause bronchospasm.

Preclinical data and available clinical data did not provide evidence of adverse effects of fenoterol or ipratropium during pregnancy. It should be taken into account that the preparation inhibits the uterine contractile function. The preparation in the form of a solution for nebulization should not be used during pregnancy, especially in the first trimester, unless the expected benefit outweighs the risk to the fetus. When using the spray formulation during pregnancy, caution should be exercised, especially in the first trimester. Fenoterol bromide is excreted in human milk; it is not known whether ipratropium bromide is excreted in human milk. Caution should be exercised when using the product during breastfeeding.

Common: increased nervous excitability, dry mouth, pain and dizziness, skeletal muscle tremors. There may also be palpitations, increased heart rate. Transient adverse reactions in the form of gastrointestinal motility disorders (eg vomiting, constipation, diarrhea) and urinary retention and hypersensitivity reactions, such as skin rash, angioneurotic edema of the tongue, lips and face, urticaria, laryngeal spasm, and anaphylactic reactions have also been reported. Adverse reactions associated with the eye may occur (including accommodation disorders and glaucoma). The use of β-receptor agonists₂ It can cause potentially dangerous hypokalemia. In addition, you may experience: nausea, vomiting, excessive sweating, weakness and painful muscle cramps. Reductions in diastolic blood pressure or increased systolic blood pressure were also observed. Cardiac arrhythmias may occur (especially at higher doses), atrial fibrillation and supraventricular tachycardia. Single cases of changes in the psyche following inhalation therapy with β-receptor agonists have been described. As with other inhalation aerosols, coughing, local irritation (such as pharyngitis, throat irritation), bronchospasm caused by inhalation may occur.

Inhalation. Dosage should be adjusted to the individual needs of the patient.Solution for nebulization. Adults and adolescents over 14 years old. Acute attacks of bronchial asthma: 1 ml (20 drops) is usually sufficient to achieve immediate resolution of mild to moderate symptoms; in severe cases, doses up to 2.5 ml may be necessary. In particularly severe cases, doses up to 4 ml can be administered under the doctor's control. Periodic and long-term therapy: 1-2 ml of solution for every application up to 4 times a day. In the case of moderate bronchoconstriction or artificial ventilation, lower doses of up to 0.5 ml are recommended. Children 6-14 years old. Acute attacks of bronchial asthma: 0.5-1 ml is usually a dose sufficient for immediate relief of symptoms; in severe cases, doses up to 2 ml may be necessary. In particularly severe cases, doses up to 3 ml can be given under the doctor's supervision. Periodic and long-term treatment: 0.5-1 ml for every application up to 4 times a day. In the case of moderate bronchoconstriction or artificial ventilation, lower doses of up to 0.5 ml are recommended. Children under 6 years of age (less than 22 kg): approx. 25 μg ipratropium bromide and 50 μg fenoterol hydrobromide per kg body weight. for a dose.Up to 0.5 ml up to 3 times a day. The solution should be administered using pneumatic nebulizers. Treatment should start with the lowest recommended dose. The recommended dose should be diluted with 0.9% NaCl with a volume of 3-4 ml (before each use) and inhaled until the solution is completely consumed. The diluted solution should be used immediately after preparation. Do not dilute the preparation with distilled water. The dosage may depend on the inhalation method and the type of nebulizer. The time of inhalation can be adjusted by the volume of the solution. If necessary, inhalation of the dose may be repeated at intervals of at least 4 hours. If an aerobic wall installation is available, a flow rate of 6-8 l / min should be used.aerosol. Adults and children over 6 years. Acute attacks of bronchial asthma: 2 sprays are in many cases a sufficient dose to immediately remove symptoms; in severe cases in which no significant improvement in breathing has been achieved after 5 min, an additional 2 atomization can be used. If the asthma attack persists after 4 sprays, you may need to use more sprays. Then the patient should immediately contact the doctor or the nearest hospital. Periodic and long-term treatment: 1 or 2 sprays at a time, up to 8 sprays a day (average of 1 or 2 sprays 3 times a day).