Release form, composition and packing Berodual
Solution for inhalation transparent, colorless or nearly colorless, free from suspended particles, with an almost imperceptible odor. 1 ml of fenoterol hydrobromide 500 mcg ipratropium bromide anhydrous, 250 mcg. Excipients: benzalkonium chloride, disodium edetate dihydrate, sodium chloride, hydrochloric acid, purified water. Clinico-pharmacological group: bronchodilator drug.
Pharmacological action
Combined bronchodilator drug. Fenoterol hydrobromide is a selective beta2-agonists. Binding to β2-adrenoceptors, activates adenylyl cyclase via Gs-protein stimulyatorny with subsequent increase of cAMP formation, which in turn activates protein kinase A. The latter phosphorylates the target protein in the cells of smooth muscles, which in turn leads to phosphorylation of myosin light chain kinase, inhibition fosfoinozina hydrolysis and opening of calcium-activated potassium channels fast.
Thus, fenoterol, relaxes smooth muscles of the bronchi and vessels, and also prevents the development of bronchospasm due to the influence of bronhokonstriktornyh factors, such as histamine, methacholine, cold air and allergies (immediate type reaction). After taking the drug inhibited the release of mast cell inflammatory mediators.
In addition, after receiving fenoterol at high doses there is increasing mucociliary transport. Fenoterol also shows properties of a stimulator of respiration. Beta-adrenergic effect of fenoterol on cardiac activity, such as increasing the frequency and strength of heart contractions, due to the vascular action of fenoterol, stimulation of β2-adrenergic receptors of heart, and with the use of doses higher than therapeutic, the stimulation of β1-adrenergic receptors.
When receiving fenoterol at high doses the effect is observed at the level of metabolism: lipolysis, glycogenolysis, hyperglycemia, and hypokalemia (the latter is due to increased absorption of potassium of skeletal muscle).
Fenoterol (at high concentrations) inhibits the contractile activity of the uterus. There is insufficient data on the impact of fenoterol hydrobromide on metabolism in diabetes mellitus. Ipratropium bromide is a blocker of m-cholinergic receptors. Effectively eliminates bronchospasm associated with the influence of the vagus nerve decreases the secretion of glands (including bronchial). When inhaled causes bronchodilation, mostly attributed to local rather than systemic anticholinergic effects.
No negative influence on the secretion of mucus in the airways, mucociliary clearance and gas exchange. Together, fenoterol hydrobromide and ipratropium bromide in the form of metered aerosol bronchodilator effect is achieved by different mechanisms. Consequently, it is increasing and provides greater breadth of therapeutic action in bronchopulmonary diseases involving airway constriction.
To achieve therapeutic effects require a lower dose of beta-agonist, which allows an individual to choose an effective dose with little side effects.
In patients with bronchospasm associated with COPD (chronic bronchitis and emphysema) significant improvements in lung function (increase in forced expiratory volume in 1 sec / FEV 1 / and the maximum expiratory flow rate / MSV25-75% / 15% or more) notes for 15 min after inhalation of the drug, the maximum effect is achieved in 1-2 hours and lasts most of the patients up to 6 hours in 40% of patients with bronchospasm associated with asthma, showed a significant improvement in lung function (FEV1 increase of 15% or more).
Pharmacokinetics
Concentration of active components in plasma, detected after inhalation application to correlate with their therapeutic effect.
Plasma concentrations after inhalation were 500-1000 times lower than the concentrations observed after administration of equivalent doses of therapeutic effect of the drug inside. Effect of the drug after inhalation application comes quickly.
Statement
prevention and symptomatic treatment of chronic obstructive airways disease with reversible bronchospasm, such as bronchial asthma and especially chronic obstructive pulmonary disease (chronic bronchitis, emphysema).
Dosing regimen
Adults (including elderly) and adolescents over 12 years with acute lung and moderate attacks of asthma medication is prescribed in doses of 1 ml (20 drops).
In severe cases, such patients are in intensive care units, the drug is prescribed in higher doses, up to 2.5 ml (50 drops). In extreme cases it is possible to use the drug (provided medical supervision) to a maximum dose of 4 ml (80 drops).
In children aged 6-12 years with acute attacks of bronchial asthma for quick relief of symptoms is recommended to appoint a drug at a dose of 0.5-1 ml (10-20 drops), and in severe cases - up to 2 ml (40 drops), and in severe cases may use of the drug (provided medical supervision) to a maximum dose of 3 ml (60 drops).
For course and long-term treatment for adults (including elderly) and adolescents over 12 years of preparation is administered at a dose of 1-2 ml (20-40 drops) 4 times / day. The maximum daily dose - 8 ml.
Children aged 6-12 years are designated by 0.5-1 ml (10-20 drops) 4 times / day. The maximum daily dose - 4 mL. In the case of mild bronchospasm, or as an aid in the implementation of mechanical ventilation for adults (including elderly), adolescents aged 12 years and children aged 6-12 years recommended dose of 0.5 ml (10 drops).
In children under 6 years (body weight less than 22 kg) due to the fact that information about the use of the drug in this age group is limited, we recommend the use of the next dose (only provided medical supervision): 25 micrograms ipratropium bromide and 50 mcg fenoterol hydrobromide / kg body weight (per dose) = 0.5 ml (10 drops) up to 3 times per day. The maximum daily dose - 1.5 ml. Treatment should usually begin with the lowest recommended dose.
Terms of use of the drug
The recommended dose should be diluted with saline to a final volume of 3-4 mL, and apply (in full) by nebulizer. Solution for inhalation should not be diluted with distilled water. Dilution of the solution should be carried out each time before use; residues diluted solution should be destroyed.
Dosing may depend on the method of inhalation and type of nebulizer. The duration of inhalation can be controlled by spending diluted volume. Solution for inhalation can be applied using different business models nebulizers. In those cases where there are wall-mounted oxygen, the solution is best applied at a flow rate of 6.8 l / min. If necessary, the use of this dose may be repeated at intervals of not less than 4 hours
Side effect
The most common adverse effects are fine tremor of skeletal muscles, nervousness, dry mouth and changes in taste, less marked headache, dizziness, tachycardia and palpitations, especially in patients with aggravating factors.
With the respiratory system: cough, respiratory tract irritation, rarely - paradoxical bronchospasm.
From the digestive system: nausea, vomiting, gastrointestinal dysmotility (especially in patients with cystic fibrosis).
Cardio-vascular system: reduction of diastolic blood pressure, increased systolic blood pressure, arrhythmia.
On the part of the vision: When the product enters the eye - reversible accommodation disturbances, mydriasis, increased intraocular pressure (pain or discomfort in the eyeball, blurry vision, a sense of ghosting and color spots before the eyes, redness of the conjunctiva).
Allergic reactions: seldom - a skin rash, angioedema tongue, lips and face, urticaria.
Other: hypokalemia, excessive sweating, a feeling of general weakness, myalgia, muscle cramps, mental changes, urinary retention.
Contraindications
hypertrophic obstructive cardiomyopathy;
tachyarrhythmia;
Hypersensitivity to fenoterol hydrobromide, or atropinopodobnym drugs or other drug compounds.
Precautions should be prescribed drug in angle-closure glaucoma, coronary insufficiency, hypertension, diabetes, recent myocardial infarction, severe organic diseases of the heart and blood vessels, hyperthyroidism, pheochromocytoma, prostatic hyperplasia, bladder neck obstruction, cystic fibrosis, pregnancy, during breast feeding, children under the age of 6 years.
Pregnancy and lactation
Necessary to observe the usual precautions associated with the use of drugs during pregnancy, especially in the I trimester. Should take into account the possibility of inhibitory effect Berodual on contractile activity of the uterus.
Fenoterol hydrobromide passes into breast milk. Evidence that ipratropium bromide passes into breast milk is not received.
However, given that many of the drugs get into breast milk, should be prescribed with care Berodual nursing mothers.
Cautions
The patient should be informed that in the event of unexpected rapid amplification of shortness of breath should see a doctor immediately. Keep in mind that patients with asthma or mild to moderate forms of chronic obstructive pulmonary disease symptomatic treatment may be preferable to regular use. In patients with bronchial asthma or severe chronic obstructive pulmonary disease should be mindful of the need for amplification or anti-inflammatory therapy to control inflammation of the airways and the disease course.
Regular use of increasing doses of products containing beta2-adrenoceptor agonists, such as Berodual, for relief of bronchial obstruction can cause uncontrolled deterioration of the disease. In the event the bronchial obstruction simply increasing doses of beta 2-agonists (including Berodual) is greater than recommended for a long time, not only justified, but also dangerous.
To prevent life-threatening deterioration of the 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 berodual only under medical supervision.
Solution for inhalation transparent, colorless or nearly colorless, free from suspended particles, with an almost imperceptible odor. 1 ml of fenoterol hydrobromide 500 mcg ipratropium bromide anhydrous, 250 mcg. Excipients: benzalkonium chloride, disodium edetate dihydrate, sodium chloride, hydrochloric acid, purified water. Clinico-pharmacological group: bronchodilator drug.
Pharmacological action
Combined bronchodilator drug. Fenoterol hydrobromide is a selective beta2-agonists. Binding to β2-adrenoceptors, activates adenylyl cyclase via Gs-protein stimulyatorny with subsequent increase of cAMP formation, which in turn activates protein kinase A. The latter phosphorylates the target protein in the cells of smooth muscles, which in turn leads to phosphorylation of myosin light chain kinase, inhibition fosfoinozina hydrolysis and opening of calcium-activated potassium channels fast.
Thus, fenoterol, relaxes smooth muscles of the bronchi and vessels, and also prevents the development of bronchospasm due to the influence of bronhokonstriktornyh factors, such as histamine, methacholine, cold air and allergies (immediate type reaction). After taking the drug inhibited the release of mast cell inflammatory mediators.
In addition, after receiving fenoterol at high doses there is increasing mucociliary transport. Fenoterol also shows properties of a stimulator of respiration. Beta-adrenergic effect of fenoterol on cardiac activity, such as increasing the frequency and strength of heart contractions, due to the vascular action of fenoterol, stimulation of β2-adrenergic receptors of heart, and with the use of doses higher than therapeutic, the stimulation of β1-adrenergic receptors.
When receiving fenoterol at high doses the effect is observed at the level of metabolism: lipolysis, glycogenolysis, hyperglycemia, and hypokalemia (the latter is due to increased absorption of potassium of skeletal muscle).
Fenoterol (at high concentrations) inhibits the contractile activity of the uterus. There is insufficient data on the impact of fenoterol hydrobromide on metabolism in diabetes mellitus. Ipratropium bromide is a blocker of m-cholinergic receptors. Effectively eliminates bronchospasm associated with the influence of the vagus nerve decreases the secretion of glands (including bronchial). When inhaled causes bronchodilation, mostly attributed to local rather than systemic anticholinergic effects.
No negative influence on the secretion of mucus in the airways, mucociliary clearance and gas exchange. Together, fenoterol hydrobromide and ipratropium bromide in the form of metered aerosol bronchodilator effect is achieved by different mechanisms. Consequently, it is increasing and provides greater breadth of therapeutic action in bronchopulmonary diseases involving airway constriction.
To achieve therapeutic effects require a lower dose of beta-agonist, which allows an individual to choose an effective dose with little side effects.
In patients with bronchospasm associated with COPD (chronic bronchitis and emphysema) significant improvements in lung function (increase in forced expiratory volume in 1 sec / FEV 1 / and the maximum expiratory flow rate / MSV25-75% / 15% or more) notes for 15 min after inhalation of the drug, the maximum effect is achieved in 1-2 hours and lasts most of the patients up to 6 hours in 40% of patients with bronchospasm associated with asthma, showed a significant improvement in lung function (FEV1 increase of 15% or more).
Pharmacokinetics
Concentration of active components in plasma, detected after inhalation application to correlate with their therapeutic effect.
Plasma concentrations after inhalation were 500-1000 times lower than the concentrations observed after administration of equivalent doses of therapeutic effect of the drug inside. Effect of the drug after inhalation application comes quickly.
Statement
prevention and symptomatic treatment of chronic obstructive airways disease with reversible bronchospasm, such as bronchial asthma and especially chronic obstructive pulmonary disease (chronic bronchitis, emphysema).
Dosing regimen
Adults (including elderly) and adolescents over 12 years with acute lung and moderate attacks of asthma medication is prescribed in doses of 1 ml (20 drops).
In severe cases, such patients are in intensive care units, the drug is prescribed in higher doses, up to 2.5 ml (50 drops). In extreme cases it is possible to use the drug (provided medical supervision) to a maximum dose of 4 ml (80 drops).
In children aged 6-12 years with acute attacks of bronchial asthma for quick relief of symptoms is recommended to appoint a drug at a dose of 0.5-1 ml (10-20 drops), and in severe cases - up to 2 ml (40 drops), and in severe cases may use of the drug (provided medical supervision) to a maximum dose of 3 ml (60 drops).
For course and long-term treatment for adults (including elderly) and adolescents over 12 years of preparation is administered at a dose of 1-2 ml (20-40 drops) 4 times / day. The maximum daily dose - 8 ml.
Children aged 6-12 years are designated by 0.5-1 ml (10-20 drops) 4 times / day. The maximum daily dose - 4 mL. In the case of mild bronchospasm, or as an aid in the implementation of mechanical ventilation for adults (including elderly), adolescents aged 12 years and children aged 6-12 years recommended dose of 0.5 ml (10 drops).
In children under 6 years (body weight less than 22 kg) due to the fact that information about the use of the drug in this age group is limited, we recommend the use of the next dose (only provided medical supervision): 25 micrograms ipratropium bromide and 50 mcg fenoterol hydrobromide / kg body weight (per dose) = 0.5 ml (10 drops) up to 3 times per day. The maximum daily dose - 1.5 ml. Treatment should usually begin with the lowest recommended dose.
Terms of use of the drug
The recommended dose should be diluted with saline to a final volume of 3-4 mL, and apply (in full) by nebulizer. Solution for inhalation should not be diluted with distilled water. Dilution of the solution should be carried out each time before use; residues diluted solution should be destroyed.
Dosing may depend on the method of inhalation and type of nebulizer. The duration of inhalation can be controlled by spending diluted volume. Solution for inhalation can be applied using different business models nebulizers. In those cases where there are wall-mounted oxygen, the solution is best applied at a flow rate of 6.8 l / min. If necessary, the use of this dose may be repeated at intervals of not less than 4 hours
Side effect
The most common adverse effects are fine tremor of skeletal muscles, nervousness, dry mouth and changes in taste, less marked headache, dizziness, tachycardia and palpitations, especially in patients with aggravating factors.
With the respiratory system: cough, respiratory tract irritation, rarely - paradoxical bronchospasm.
From the digestive system: nausea, vomiting, gastrointestinal dysmotility (especially in patients with cystic fibrosis).
Cardio-vascular system: reduction of diastolic blood pressure, increased systolic blood pressure, arrhythmia.
On the part of the vision: When the product enters the eye - reversible accommodation disturbances, mydriasis, increased intraocular pressure (pain or discomfort in the eyeball, blurry vision, a sense of ghosting and color spots before the eyes, redness of the conjunctiva).
Allergic reactions: seldom - a skin rash, angioedema tongue, lips and face, urticaria.
Other: hypokalemia, excessive sweating, a feeling of general weakness, myalgia, muscle cramps, mental changes, urinary retention.
Contraindications
hypertrophic obstructive cardiomyopathy;
tachyarrhythmia;
Hypersensitivity to fenoterol hydrobromide, or atropinopodobnym drugs or other drug compounds.
Precautions should be prescribed drug in angle-closure glaucoma, coronary insufficiency, hypertension, diabetes, recent myocardial infarction, severe organic diseases of the heart and blood vessels, hyperthyroidism, pheochromocytoma, prostatic hyperplasia, bladder neck obstruction, cystic fibrosis, pregnancy, during breast feeding, children under the age of 6 years.
Pregnancy and lactation
Necessary to observe the usual precautions associated with the use of drugs during pregnancy, especially in the I trimester. Should take into account the possibility of inhibitory effect Berodual on contractile activity of the uterus.
Fenoterol hydrobromide passes into breast milk. Evidence that ipratropium bromide passes into breast milk is not received.
However, given that many of the drugs get into breast milk, should be prescribed with care Berodual nursing mothers.
Cautions
The patient should be informed that in the event of unexpected rapid amplification of shortness of breath should see a doctor immediately. Keep in mind that patients with asthma or mild to moderate forms of chronic obstructive pulmonary disease symptomatic treatment may be preferable to regular use. In patients with bronchial asthma or severe chronic obstructive pulmonary disease should be mindful of the need for amplification or anti-inflammatory therapy to control inflammation of the airways and the disease course.
Regular use of increasing doses of products containing beta2-adrenoceptor agonists, such as Berodual, for relief of bronchial obstruction can cause uncontrolled deterioration of the disease. In the event the bronchial obstruction simply increasing doses of beta 2-agonists (including Berodual) is greater than recommended for a long time, not only justified, but also dangerous.
To prevent life-threatening deterioration of the 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 berodual only under medical supervision.
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