Ipraterol-aeronativ aeroz d/ingal doser 20mcg+50mcg/dose 200 doses
Registration Certificate Holder
NATIVA (Russia)
Dosage form
Medicine - Ipraterol-Aeronativ (Ipraterol-Aeronativ)
Description
Aerosol for inhalation dosed
in the form of a clear solution, colorless or with a slight yellowish tint.
1 dose
ipratropium bromide monohydrate 0.021 mg, which corresponds to the content of ipratropium bromide 0.02 mg fenoterol hydrobromide 0.05 mg
Excipients
: absolute ethanol - 15.3 mg, citric acid monohydrate - 0.005 mg, triethyl citrate - 0.15 mg, propellant R134a (1,1,1,2-tetrafluoroethane) - 44.47 mg.
200 doses - stainless steel cylinders (1) with a dosing valve and a spray nozzle - cardboard packs.
Indications
Prevention and symptomatic treatment of obstructive airway diseases with reversible airway obstruction, such as bronchial asthma and, especially, COPD, chronic bronchitis with or without emphysema.
Contraindications for use
Hypertrophic obstructive cardiomyopathy; tachyarrhythmia; I and III trimesters of pregnancy; children under 6 years of age (aerosol for inhalation); hypersensitivity to fenoterol and other components of the drug; hypersensitivity to atropine-like drugs.
With caution: angle-closure glaucoma, arterial hypertension, diabetes mellitus, recent myocardial infarction (within the last 3 months), heart and vascular diseases (chronic heart failure, coronary artery disease, arrhythmia, aortic stenosis, severe lesions of the cerebral and peripheral arteries), hyperthyroidism, pheochromocytoma, prostatic hyperplasia, bladder neck obstruction, cystic fibrosis, second trimester of pregnancy, lactation period, childhood and adolescence from 6 to 18 years (aerosol for inhalation).
pharmachologic effect
Combined bronchodilator drug. Contains two components with bronchodilator activity: ipratropium bromide - an m-anticholinergic blocker, and fenoterol hydrobromide - a beta2-adrenergic agonist.
Ipratropium bromide is a quaternary ammonium derivative with anticholinergic (parasympatholytic) properties. Bronchodilation with inhaled ipratropium bromide is due primarily to local rather than systemic anticholinergic effects. Ipratropium bromide inhibits reflexes caused by the vagus nerve by counteracting the effects of acetylcholine, a neurotransmitter released from the endings of the vagus nerve. Anticholinergics prevent an increase in the intracellular concentration of calcium ions, which occurs due to the interaction of acetylcholine with muscarinic receptors located on the smooth muscles of the bronchi. The release of calcium ions is mediated by a system of secondary mediators, which include inositol triphosphate and diacylglycerol. Ipratropium bromide does not have a negative effect on mucus secretion in the respiratory tract, mucociliary clearance and gas exchange.
Fenoterol selectively stimulates β2-adrenergic receptors at a therapeutic dose. Stimulation of β1-adrenergic receptors occurs when fenoterol is used in high doses. Fenoterol relaxes the smooth muscles of the bronchi and blood vessels and counteracts the development of bronchospastic reactions caused by the influence of histamine, methacholine, cold air and allergens (immediate hypersensitivity reactions). Immediately after administration, fenoterol blocks the release of mediators of inflammation and bronchial obstruction from mast cells. In addition, when using fenoterol in higher doses, an increase in mucociliary clearance was observed.
The effect of the drug on cardiac activity, such as an increase in the frequency and strength of heart contractions, is due to the vascular effect of fenoterol, stimulation of β2-adrenergic receptors of the heart, and when used in doses exceeding therapeutic doses, stimulation of β1-adrenergic receptors. As with other beta-adrenergic drugs, prolongation of the QTc interval has been observed when used in high doses.
The most common adverse effect with β-adrenergic agonists is tremor. In contrast to the effects on bronchial smooth muscle, tolerance to the systemic effects of β-adrenergic agonists may develop, but the clinical significance of this manifestation is unclear.
When ipratropium bromide and fenoterol are used together, the bronchodilator effect is achieved by acting on various pharmacological targets. These substances complement each other, as a result, the antispasmodic effect on the bronchial muscles is enhanced and a greater breadth of therapeutic action is provided for bronchopulmonary diseases accompanied by airway obstruction. 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.
In patients with bronchospasm associated with COPD (chronic bronchitis and emphysema), a significant improvement in lung function (increase in FEV1 and peak expiratory flow by 15% or more) was noted within 15 minutes, the maximum effect was achieved after 1-2 hours and lasted for most patients within 6 hours after administration.
Drug interactions
The simultaneous use of other beta-agonists, anticholinergic drugs and xanthine derivatives (for example, theophylline) may enhance the bronchodilator effect of the drug.
A significant weakening of the bronchodilator effect of the drug is possible with the simultaneous administration of beta-blockers.
Hypokalemia associated with the use of beta-agonists may be exacerbated by the simultaneous use of xanthine derivatives, corticosteroids and diuretics. This fact should be given special attention when treating patients with severe forms of obstructive airway diseases.
Hypokalemia may lead to an increased risk of arrhythmias in patients receiving digoxin. In addition, hypoxia may enhance the negative effects of hypokalemia on heart rate. In such cases, it is recommended to monitor serum potassium concentrations.
Beta2-agonists should be prescribed with caution to patients receiving MAO inhibitors and tricyclic antidepressants, because these drugs can enhance the effect of beta-adrenergic drugs.
The use of inhaled halogenated anesthetics, such as halothane, trichlorethylene or enflurane, may increase the cardiovascular effects of beta-adrenergic agents.
Combined use of the drug with cromoglycic acid and/or GCS increases the effectiveness of therapy.
Dosage regimen
Solution for inhalation
The dose should be selected individually, depending on the severity of the attack. Treatment is usually started at the lowest recommended dose and stopped once sufficient relief of symptoms has been achieved.
Treatment should be carried out under medical supervision (for example, in a hospital setting). Treatment at home is possible only after consultation with a doctor in cases where a fast-acting beta-adrenergic agonist at a low dose is not effective enough. An inhalation solution may be recommended to patients when an inhalation aerosol cannot be used or when higher doses are required.
In adults (including the elderly) and adolescents over 12 years of age during acute attacks of bronchospasm, depending on the severity of the attack, doses can vary from 1 ml (1 ml = 20 drops) to 2.5 ml (2.5 ml = 50 drops). In especially severe cases, it is possible to use the drug in doses reaching 4 ml (4 ml = 80 drops).
In children aged 6-12 years during 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 following dose is recommended (only under medical supervision): 0.1 ml (2 drops) per kg body weight, but not more than 0.5 ml (10 drops).
Rules for using the drug
The inhalation solution should only be used for inhalation (with a suitable nebulizer) and should not be administered orally.
The recommended dose should be diluted with 0.9% sodium chloride solution to a final volume of 3-4 ml and administered (completely) using a nebulizer.
The solution for inhalation should not be diluted with distilled water.
The solution should be diluted each time before use; Remains of the diluted solution should be destroyed.
The diluted solution should be used immediately after preparation.
The duration of inhalation can be controlled by the consumption of the diluted solution.
The inhalation solution can be used using various commercial nebulizer models. The dose reaching the lungs and the systemic dose depend on the type of nebulizer used and may be higher than the corresponding doses using a metered dose aerosol (which depends on the type of inhaler). In cases where wall oxygen is available, the solution is best used at a flow rate of 6-8 l/min.
The instructions for use, maintenance and cleaning of the nebulizer must be followed.
Aerosol for inhalation dosed
The dose is set individually.
To relieve attacks, adults and children over 6 years of age are prescribed 2 inhalation doses. If breathing relief does not occur within 5 minutes, 2 more inhalation doses can be prescribed.
The patient should be informed to immediately consult a doctor if there is no effect after 4 inhalation doses and the need for additional inhalations.
Metered-dose aerosol should be used in children only as prescribed by a doctor and under the supervision of adults.
For long-term and intermittent therapy, 1-2 inhalations are prescribed per dose, up to 8 inhalations/day (on average, 1-2 inhalations 3 times/day).
For bronchial asthma, the drug should be used only as needed.
Rules for using the drug
The patient should be instructed in the correct use of the metered dose aerosol.
Before using the metered-dose aerosol for the first time, press the bottom of the can twice.
Each time you use a metered dose aerosol, the following rules must be observed.
1. Remove the protective cap.
2. Take a slow, deep breath.
3. Holding the balloon, wrap your lips around the mouthpiece. The cylinder should be pointing upside down.
4. While inhaling as deeply as possible, simultaneously quickly press the bottom of the cylinder until 1 inhalation dose is released. Hold your breath for a few seconds, then remove the mouthpiece from your mouth and exhale slowly. Repeat steps to receive the 2nd inhalation dose.
5. Put on the protective cap.
6. If the aerosol can has not been used for more than 3 days, before use, press the bottom of the can once until a cloud of aerosol appears.
The cylinder is designed for 200 inhalations. Then the cylinder should be replaced. Although some contents may remain in the canister, the amount of drug released during inhalation is reduced.
Since the balloon is opaque, the amount of drug in the balloon can be determined as follows: by removing the plastic mouthpiece from the balloon, the balloon is immersed in a container filled with water. The amount of the drug is determined depending on the position of the cylinder in the water.
You should clean your inhaler at least once a week. It is important to keep the inhaler mouthpiece clean so that drug particles do not block the release of the aerosol.
During cleaning, first remove the protective cap and remove the balloon from the inhaler. A stream of warm water is passed through the inhaler; You must ensure that the drug and/or visible dirt is removed. After cleaning, shake the inhaler and allow it to air dry without using heating devices. Once the mouthpiece is dry, insert the balloon into the inhaler and put on the protective cap.
The contents of the cylinder are under pressure. The cylinder must not be opened or exposed to temperatures above 50°C.
Side effect
The frequency of adverse reactions was determined in accordance with WHO recommendations: very often (>1/10); often (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10,000, <1/1000); very rare (<1/10,000), including isolated reports; frequency unknown (frequency cannot be calculated from available data).
From the immune system: rarely - hypersensitivity reactions, anaphylactic reactions.
Metabolism and nutrition: rarely - hypokalemia, metabolic acidosis.
Mental disorders: infrequently - nervousness; rarely - anxiety, mental disturbances.
From the nervous system: infrequently - headache, dizziness, tremor.
From the organ of vision: rarely - glaucoma, increased intraocular pressure, accommodation disturbances, mydriasis, blurred vision, eye pain, corneal edema, conjunctival hyperemia, the appearance of a halo around objects and colored spots before the eyes.
From the cardiovascular system: infrequently - tachycardia, palpitations, increased systolic blood pressure; rarely - arrhythmia, atrial fibrillation, supraventricular tachycardia, myocardial ischemia, increased diastolic blood pressure.
From the respiratory system: often - cough; infrequently - pharyngitis, dysphonia; rarely - bronchospasm, pharyngeal irritation, pharyngeal edema, laryngospasm, paradoxical bronchospasm, dry throat.
From the digestive system: infrequently - vomiting, dry mouth, nausea; rarely - stomatitis, glossitis, gastrointestinal motility disorders, constipation, diarrhea, swelling of the oral cavity.
Dermatological reactions: rarely - urticaria, skin rash, itching, angioedema, hyperhidrosis.
From the musculoskeletal system: rarely - muscle weakness, myalgia, muscle spasm.
From the urinary system: rarely - urinary retention.
special instructions
The patient should be informed that if shortness of breath (difficulty breathing) suddenly increases rapidly, consult a doctor immediately.
Paradoxical bronchospasm
The drug can cause paradoxical bronchospasm, which can be life-threatening. If paradoxical bronchospasm develops, the use of the drug should be stopped immediately and switched to alternative therapy.
Long-term use
In patients with bronchial asthma, the drug 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 remember the need to carry out or intensify 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 beta2-agonists to relieve bronchial obstruction can cause uncontrolled worsening of the disease. In case of increased bronchial obstruction, increasing the dose of beta2-agonists more than recommended for a long time is not only not justified, but also dangerous. To prevent life-threatening worsening of the disease, consideration should be given to reviewing the patient's treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids.
Other sympathomimetic bronchodilators should be co-administered with the drug only under medical supervision.
Visual disorders
The drug should be prescribed with caution to patients predisposed to the development of angle-closure glaucoma. There are isolated reports of complications from the organ of vision (for example, increased intraocular pressure, mydriasis, angle-closure glaucoma, eye pain) that developed when inhaled ipratropium bromide (or ipratropium bromide in combination with β2-adrenergic receptor agonists) entered the eyes. Symptoms of acute angle-closure glaucoma may include pain or discomfort in the eyes, blurred vision, the appearance of a halo on objects and colored spots in front of the eyes in combination with corneal edema and redness of the eyes due to conjunctival vascular injection. If any combination of these symptoms is observed, the use of eye drops that reduce intraocular pressure and immediate consultation with a specialist is indicated. Patients should be instructed on the correct use of the inhalation solution. To prevent the solution from getting into the eyes, it is recommended that the solution used with a nebulizer be inhaled through the mouthpiece. If you do not have a mouthpiece, use a mask that fits tightly to your face. Particular care should be taken to protect the eyes of patients predisposed to the development of glaucoma.
Systemic effects
For diseases such as recent myocardial infarction, diabetes mellitus with inadequate glycemic control, severe organic heart and vascular diseases, hyperthyroidism, pheochromocytoma or urinary tract obstruction (for example, prostatic hyperplasia or bladder neck obstruction), the drug should be prescribed only after careful assessment of the risk/benefit ratio, especially when used in doses higher than recommended.
Effect on the cardiovascular system
In post-marketing studies, rare cases of myocardial ischemia have been reported when taking beta-adrenergic agonists. Patients with underlying serious heart disease (eg, coronary artery disease, arrhythmias, or significant heart failure) receiving the drug should be warned to seek medical attention if heart pain or other symptoms indicating worsening of heart disease occur. It is necessary to pay attention to symptoms such as shortness of breath and chest pain, because... they can be of both cardiac and pulmonary etiology.
Hypokalemia
Hypokalemia may occur when using β2-adrenergic agonists.
In athletes, the use of the drug, due to the presence of fenoterol in its composition, can lead to positive doping test results.
Excipients
The drug in the form of an inhalation aerosol contains a preservative, benzalkonium chloride, and a stabilizer, disodium edetate dihydrate. During inhalation, these components may cause bronchospasm in sensitive patients with airway hyperresponsiveness.
Impact on the ability to drive vehicles and machinery
The effect of the drug on the ability to drive vehicles and use machinery has not been specifically studied. However, patients should be informed that during treatment with the drug, the development of such undesirable effects as dizziness, tremor, impaired accommodation, mydriasis, and blurred vision is possible. Therefore, caution should be recommended when driving vehicles or using machinery. If patients experience the above unwanted sensations, they should refrain from potentially dangerous activities such as driving vehicles or operating machinery.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - With caution. Restrictions when breastfeeding - With caution.
Data from preclinical studies and experience with the use of a combination of ipratropium bromide and fenoterol show that the components of the drug do not have a negative effect during pregnancy. The possibility of an inhibitory effect of fenoterol on uterine contractility should be taken into account. The drug is contraindicated in the first and third trimesters of pregnancy (the possibility of weakening labor by fenoterol). The drug should be used with caution in the second trimester of pregnancy.
Fenoterol is excreted in breast milk. There is no data confirming that ipratropium bromide passes into breast milk. The use of the drug during breastfeeding is possible only if the potential benefit to the mother outweighs the potential risk to the child.
Use in elderly patients
Restrictions for elderly patients - No restrictions. The drug is approved for use in elderly patients
Use in children
Restrictions for children - With caution.
Aerosol for inhalation is contraindicated for use in children under 6 years of age.
The drug in the form of an inhalation aerosol should be prescribed with caution to patients aged 6 to 18 years.
Ipraterol-Aeronativ solution for inhalation 0.25 mg/ml + 0.5 mg/ml bottle 20 ml
A country
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.
Active substance
Ipratropium bromide + Fenoterol
Compound
Bottle 20 ml
Ipratropium bromide monohydrate 0.261 mg, fenoterol hydrobromide 0.5 mg per 1 ml. Excipients: sodium benzoate 0.5 mg, disodium edetate 0.5 mg, citric acid monohydrate 1.5 mg, sodium hydroxide to pH 3.2, water for up to 1 ml.
pharmachologic effect
Combined bronchodilator drug. Contains two components with bronchodilator activity: ipratropium bromide - an m-anticholinergic blocker, and fenoterol hydrobromide - a beta2-adrenergic agonist. Ipratropium bromide is a quaternary ammonium derivative with anticholinergic (parasympatholytic) properties. Bronchodilation with inhaled ipratropium bromide is due primarily to local rather than systemic anticholinergic effects. Ipratropium bromide inhibits reflexes caused by the vagus nerve by counteracting the effects of acetylcholine, a neurotransmitter released from the endings of the vagus nerve. Anticholinergics prevent an increase in the intracellular concentration of calcium ions, which occurs due to the interaction of acetylcholine with muscarinic receptors located on the smooth muscles of the bronchi. The release of calcium ions is mediated by a system of secondary mediators, which include inositol triphosphate and diacylglycerol. Ipratropium bromide does not have a negative effect on mucus secretion in the respiratory tract, mucociliary clearance and gas exchange. Fenoterol selectively stimulates β2-adrenergic receptors in a therapeutic dose. Stimulation of β1-adrenergic receptors occurs when fenoterol is used in high doses. Fenoterol relaxes the smooth muscles of the bronchi and blood vessels and counteracts the development of bronchospastic reactions caused by the influence of histamine, methacholine, cold air and allergens (immediate hypersensitivity reactions). Immediately after administration, fenoterol blocks the release of mediators of inflammation and bronchial obstruction from mast cells. In addition, when using fenoterol in higher doses, an increase in mucociliary clearance was observed. The effect of the drug on cardiac activity, such as an increase in the frequency and strength of heart contractions, is due to the vascular effect of fenoterol, stimulation of β2-adrenergic receptors of the heart, and when used in doses exceeding therapeutic doses, stimulation of β1-adrenergic receptors. As with other beta-adrenergic drugs, prolongation of the QTc interval has been observed when used in high doses. The most common adverse effect with β-adrenergic agonists is tremor. In contrast to the effect on bronchial smooth muscle, tolerance to the systemic effect of β-adrenergic receptor agonists may develop, but the clinical significance of this manifestation is not clear. When ipratropium bromide and fenoterol are used together, the bronchodilator effect is achieved by acting on various pharmacological targets. These substances complement each other, as a result, the antispasmodic effect on the bronchial muscles is enhanced and a greater breadth of therapeutic action is provided for bronchopulmonary diseases accompanied by airway obstruction. 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. In patients with bronchospasm associated with COPD (chronic bronchitis and emphysema), a significant improvement in lung function (increase in FEV1 and peak expiratory flow by 15% or more) was noted within 15 minutes, the maximum effect was achieved after 1-2 hours and lasted for most patients within 6 hours after administration.
Indications for use
Prevention and symptomatic treatment of obstructive airway diseases with reversible airway obstruction, such as bronchial asthma and, especially, COPD, chronic bronchitis with or without emphysema.
Mode of application
Solution for inhalation The dose should be selected individually, depending on the severity of the attack. Treatment is usually started at the lowest recommended dose and stopped once sufficient relief of symptoms has been achieved. Treatment should be carried out under medical supervision (for example, in a hospital setting). Treatment at home is possible only after consultation with a doctor in cases where a fast-acting β-adrenergic receptor agonist in a low dose is not effective enough. An inhalation solution may be recommended to patients when an inhalation aerosol cannot be used or when higher doses are required. In adults (including the elderly) and adolescents over 12 years of age during acute attacks of bronchospasm, depending on the severity of the attack, doses can vary from 1 ml (1 ml = 20 drops) to 2.5 ml (2.5 ml = 50 drops). In especially severe cases, it is possible to use the drug in doses reaching 4 ml (4 ml = 80 drops). In children aged 6-12 years during 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) Rules for use of the drug The solution for inhalation should be used only for inhalation (with a suitable nebulizer) and not administered orally. The recommended dose should be diluted with 0.9% sodium chloride solution to a final volume of 3-4 ml, and apply (entirely) using a nebulizer. The solution for inhalation should not be diluted with distilled water. The solution should be diluted each time before use; the remaining diluted solution should be destroyed. The diluted solution should be used immediately after preparation. The duration of inhalation can be controlled by the consumption of the diluted solution. The inhalation solution can be administered 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 doses using a metered dose aerosol (which depends on the type of inhaler). There is wall oxygen, the solution is best used at a flow rate of 6-8 l/min. The instructions for use, maintenance and cleaning of the nebulizer must be followed. Aerosol for inhalation dosed The dose is set individually. To relieve attacks, adults and children over 6 years of age are prescribed 2 inhalation doses. If breathing relief does not occur within 5 minutes, 2 more inhalation doses can be prescribed. The patient should be informed to immediately consult a doctor if there is no effect after 4 inhalation doses and the need for additional inhalations. Metered-dose aerosol should be used in children only as prescribed by a doctor and under the supervision of adults. For long-term and intermittent therapy, 1-2 inhalations are prescribed per dose, up to 8 inhalations/day (on average, 1-2 inhalations 3 times/day). For bronchial asthma, the drug should be used only as needed. Rules for using the drug The patient should be instructed on the correct use of the metered-dose aerosol. Before using the metered-dose aerosol for the first time, press the bottom of the can twice. Each time you use a metered dose aerosol, the following rules must be observed. 1. Remove the protective cap. 2. Take a slow, deep breath. 3. Holding the balloon, wrap your lips around the mouthpiece. The cylinder should be pointing upside down. 4. While inhaling as deeply as possible, simultaneously quickly press the bottom of the cylinder until 1 inhalation dose is released. Hold your breath for a few seconds, then remove the mouthpiece from your mouth and exhale slowly. Repeat steps to receive the 2nd inhalation dose. 5. Put on the protective cap. 6. If the aerosol can has not been used for more than 3 days, before use, press the bottom of the can once until a cloud of aerosol appears. The cylinder is designed for 200 inhalations. Then the cylinder should be replaced. Although some contents may remain in the canister, the amount of drug released during inhalation is reduced. Since the balloon is opaque, the amount of drug in the balloon can be determined as follows: by removing the plastic mouthpiece from the balloon, the balloon is immersed in a container filled with water. The amount of the drug is determined depending on the position of the cylinder in the water. You should clean your inhaler at least once a week. It is important to keep the inhaler mouthpiece clean so that drug particles do not block the release of the aerosol. During cleaning, first remove the protective cap and remove the balloon from the inhaler. A stream of warm water is passed through the inhaler; You must ensure that the drug and/or visible dirt is removed. After cleaning, shake the inhaler and allow it to air dry without using heating devices. Once the mouthpiece is dry, insert the balloon into the inhaler and put on the protective cap. The contents of the cylinder are under pressure. The cylinder must not be opened or exposed to temperatures above 50°C.
Interaction
The simultaneous use of other beta-agonists, anticholinergic drugs and xanthine derivatives (for example, theophylline) may enhance the bronchodilator effect of the drug. A significant weakening of the bronchodilator effect of the drug is possible with the simultaneous administration of beta-blockers. Hypokalemia associated with the use of beta-agonists may be exacerbated by the simultaneous use of xanthine derivatives, corticosteroids and diuretics. This fact should be given special attention when treating patients with severe forms of obstructive airway diseases. Hypokalemia may lead to an increased risk of arrhythmias in patients receiving digoxin. In addition, hypoxia may enhance the negative effects of hypokalemia on heart rate. In such cases, it is recommended to monitor serum potassium concentrations. Beta2-agonists should be prescribed with caution to patients receiving MAO inhibitors and tricyclic antidepressants, because these drugs can enhance the effect of beta-adrenergic drugs. The use of inhaled halogenated anesthetics, such as halothane, trichlorethylene or enflurane, may increase the cardiovascular effects of beta-adrenergic agents. Combined use of the drug with cromoglycic acid and/or GCS increases the effectiveness of therapy.
Side effect
The frequency of adverse reactions was determined in accordance with WHO recommendations: very often (>1/10); often (>1/100, 1/1000, 1/10,000, From the immune system: rarely - hypersensitivity reactions, anaphylactic reactions. From metabolism and nutrition: rarely - hypokalemia, metabolic acidosis. Mental disorders: - infrequently - nervousness ; - rarely - anxiety, mental disorders. From the nervous system: infrequently - headache, dizziness, tremor. From the organ of vision: rarely - glaucoma, increased intraocular pressure, accommodation disturbances, mydriasis, blurred vision, pain in the eyes, swelling cornea, conjunctival hyperemia, the appearance of a halo around objects and colored spots before the eyes. From the cardiovascular system: - infrequently - tachycardia, palpitations, increased systolic blood pressure; - rarely - arrhythmia, atrial fibrillation, supraventricular tachycardia, myocardial ischemia, increased diastolic Blood pressure: From the respiratory system: - often - cough; - infrequently - pharyngitis, dysphonia; - rarely - bronchospasm, pharyngeal irritation, pharyngeal edema, laryngospasm, paradoxical bronchospasm, dry throat. From the digestive system: - infrequently - vomiting, dry mouth, nausea; - rarely - stomatitis, glossitis, gastrointestinal motility disorders, constipation, diarrhea, swelling of the oral cavity. Dermatological reactions: rarely - urticaria, skin rash, itching, angioedema, hyperhidrosis. From the musculoskeletal system: rarely - muscle weakness, myalgia, muscle spasm. From the urinary system: rarely - urinary retention.
Contraindications
Hypertrophic obstructive cardiomyopathy;
tachyarrhythmia; I and III trimesters of pregnancy; children under 6 years of age (aerosol for inhalation); hypersensitivity to fenoterol and other components of the drug; hypersensitivity to atropine-like drugs. With caution: angle-closure glaucoma, arterial hypertension, diabetes mellitus, recent myocardial infarction (within the last 3 months), heart and vascular diseases (chronic heart failure, coronary artery disease, arrhythmia, aortic stenosis, severe lesions of the cerebral and peripheral arteries), hyperthyroidism, pheochromocytoma, prostatic hyperplasia, bladder neck obstruction, cystic fibrosis, second trimester of pregnancy, lactation period, childhood and adolescence from 6 to 18 years (aerosol for inhalation). Use during pregnancy and lactation Data from preclinical studies and experience with the combination of ipratropium bromide and fenoterol show that the components of the drug do not have a negative effect during pregnancy. The possibility of an inhibitory effect of fenoterol on uterine contractility should be taken into account. The drug is contraindicated in the first and third trimesters of pregnancy (the possibility of weakening labor by fenoterol). The drug should be used with caution in the second trimester of pregnancy. Fenoterol is excreted in breast milk. There is no data confirming that ipratropium bromide passes into breast milk. The use of the drug during breastfeeding is possible only if the potential benefit to the mother outweighs the potential risk to the child.
special instructions
The patient should be informed that if shortness of breath (difficulty breathing) suddenly increases rapidly, consult a doctor immediately. Paradoxical bronchospasm The drug can cause paradoxical bronchospasm, which can be life-threatening. If paradoxical bronchospasm develops, the use of the drug should be stopped immediately and switched to alternative therapy. Long-term use In patients with bronchial asthma, the drug 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 remember the need to carry out or intensify 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 beta2-agonists to relieve bronchial obstruction can cause uncontrolled worsening of the disease. In case of increased bronchial obstruction, increasing the dose of beta2-agonists more than recommended for a long time is not only not justified, but also dangerous. To prevent life-threatening worsening of the disease, consideration should be given to reviewing the patient's treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids. Other sympathomimetic bronchodilators should be co-administered with the drug only under medical supervision. Visual disorders The drug should be prescribed with caution to patients predisposed to the development of angle-closure glaucoma. There are isolated reports of complications from the organ of vision (for example, increased intraocular pressure, mydriasis, angle-closure glaucoma, eye pain) that developed when inhaled ipratropium bromide (or ipratropium bromide in combination with β2-adrenergic receptor agonists) entered the eyes. Symptoms of acute angle-closure glaucoma may include pain or discomfort in the eyes, blurred vision, the appearance of a halo on objects and colored spots in front of the eyes in combination with corneal edema and redness of the eyes due to conjunctival vascular injection. If any combination of these symptoms is observed, the use of eye drops that reduce intraocular pressure and immediate consultation with a specialist is indicated. Patients should be instructed on the correct use of the inhalation solution. To prevent the solution from getting into the eyes, it is recommended that the solution used with a nebulizer be inhaled through the mouthpiece. If you do not have a mouthpiece, use a mask that fits tightly to your face. Particular care should be taken to protect the eyes of patients predisposed to the development of glaucoma. Systemic effects In diseases such as recent myocardial infarction, diabetes mellitus with inadequate glycemic control, severe organic heart and vascular diseases, hyperthyroidism, pheochromocytoma or urinary tract obstruction (for example, prostatic hyperplasia or bladder neck obstruction), the drug should be prescribe only after a careful assessment of the risk/benefit ratio, especially when used in doses higher than recommended. Effect on the cardiovascular system In post-marketing studies, rare cases of myocardial ischemia have been reported when taking beta-adrenergic agonists. Patients with underlying serious heart disease (eg, coronary artery disease, arrhythmias, or significant heart failure) receiving the drug should be warned to seek medical attention if heart pain or other symptoms indicating worsening of heart disease occur. It is necessary to pay attention to symptoms such as shortness of breath and chest pain, because... they can be of both cardiac and pulmonary etiology. Hypokalemia Hypokalemia may occur when using β2-adrenergic receptor agonists. In athletes, the use of the drug, due to the presence of fenoterol in its composition, can lead to positive doping test results. Excipients The drug in the form of an aerosol for inhalation contains a preservative, benzalkonium chloride, and a stabilizer - disodium edetate dihydrate. During inhalation, these components may cause bronchospasm in sensitive patients with airway hyperresponsiveness. Effect on the ability to drive vehicles and use machines The effect of the drug on the ability to drive vehicles and use machines has not been specifically studied. However, patients should be informed that during treatment with the drug, the development of such undesirable effects as dizziness, tremor, impaired accommodation, mydriasis, and blurred vision is possible. Therefore, caution should be recommended when driving vehicles or using machinery. If patients experience the above unwanted sensations, they should refrain from potentially dangerous activities such as driving vehicles or operating machinery.
Storage conditions
Room temperature
Dispensing conditions in pharmacies
On prescription
IPRATEROL
Treatment with IPRATEROL, solution for inhalation should be started and carried out under medical supervision, for example in a hospital. Treatment at home may be prescribed in exceptional cases (severe symptoms or experienced patients taking high doses). Use should be discontinued when sufficient relief of symptoms is achieved.
The contents of the bottle should be used within 6 months after opening.
Adults and children over 12 years of age:
To treat an attack of bronchial obstruction, depending on the severity of the attack, it is recommended to use from 1 ml (24 drops) to 2.5 ml (60 drops), followed by dilution with saline to a volume of 3-4 ml.
In extremely severe cases, it is possible to use up to 4.0 ml (100 drops), followed by dilution with saline to a volume of 3-4 ml.
To prevent asthma attacks from physical exertion or when contact with an allergen is expected, it is recommended to use 0.1-0.2 ml (2-3 drops) 10-15 minutes before physical activity/contact, followed by dilution with 2-3 ml of saline.
Children from 6 to 12 years old:
To treat an attack of bronchial obstruction, depending on the severity of the attack, it is recommended to use from 0.5 ml (12 drops) to 2.0 ml (48 drops), followed by dilution with saline to a volume of 3-4 ml.
To prevent asthma attacks from physical exertion or when contact with allergens is expected, it is recommended to use 0.1-0.2 ml (2-3 drops) 10-15 minutes before physical activity/contact, followed by dilution with 2-3 ml of saline.
Children under 6 years old:
Due to the limited information on the use of the drug in this age group, treatment is carried out only under the supervision of a physician, prescribing the drug at the lowest dose of 0.1 ml (2 drops) per kg of body weight, up to a maximum of 0.5 ml (12 drops), with subsequent dilution with physiological solution to a volume of 3-4 ml. The recommended dose should be diluted with physiological saline solution to a final volume of 3-4 ml and administered by inhalation using a nebulizer until the solution runs out; inhalation will last about 6-7 minutes. The solution can also be used without dilution. The solution must be prepared each time before use; any remains must be destroyed.
The dosage may also depend on the method of administration of the drug and the characteristics of the nebulizer. When using particles with a size of 5 microns, a dose reduction is possible. The duration of inhalation can also be adjusted by the volume of dilution. The solution can be administered using a wide range of nebulizers. If oxygen tents are used, the recommended flow rate is 6-8 L/min.
If necessary, inhalation can be repeated at intervals of at least 4 hours.
Not recommended for use in children under 6 years of age
- Unscrew the plastic cap.
- Place the number of drops recommended by your doctor into the nebulizer chamber.
- If directed by a doctor or pharmacist, add the prescribed amount of 0.9% sodium chloride to the nebulizer chamber and add this solution using a syringe.
4) Slowly rotate the nebulizer chamber to mix the liquids and attach the nebulizer to the mouthpiece or face mask, then connect the nebulizer to the air pump or oxygen source. 5) Start therapy. Sit up straight in a comfortable position. Breathe calmly and deeply through the mask or mouthpiece until steam stops forming in the nebulizer chamber. This usually takes up to 10-15 minutes. It is important to select a mask to prevent steam from getting into your eyes.6) Follow the instructions supplied with the nebulizer and air pump to ensure proper cleaning and maintenance of the equipment. Keep the nebulizer, nebulizer chamber, and face mask clean to minimize microbial contamination.7) Store the medicinal product at a temperature not exceeding 25°C. You must remember: · IPRATEROL inhalation solution is prescribed to treat your specific condition. Do not give this medicine to other people. · Do not take any other medicines without a doctor's prescription. Tell your doctor, dentist or pharmacist that you are taking IPRATEROL, inhalation solution. The solution should be used with a nebulizer. Do not inject or take the solution orally. · Do not allow steam from the nebulizer to get into your eyes. Patients with glaucoma should use a mouthpiece or goggles to prevent vapors from entering the eyes. · Keep medications away from children. Overdose: In case of overdose, consult a doctor or the nearest emergency room (do not drive yourself). Take the labeled bottle of medication with you. Missed dose: If you miss a dose, do not worry. Take your next dose on your regular schedule. Do not double the dose.
