Berodual N aerosol for inhalation 10 ml 200 doses
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Active ingredients
Ipratropium bromide + Fenoterol
Release form
Spray
Composition
Fenoterol hydrobromide 50 mcg; ipratropium bromide monohydrate 21 mcg,; which corresponds to ipratropium bromide 20 mcg; Auxiliary substances: absolute ethanol - 13.313 mg, purified water - 0.799 mg, citric acid - 0.001 mg, tetrafluoroethane (HFA 134a, propellant) - 39.070 mg.
Pharmacological effect
Combined bronchodilator drug. It contains two components with bronchodilator activity: ipratropium bromide - m-holinoblokator, and fenoterol hydrobromide - beta2-adrenomimetic .; Bronchodilatation with inhalation ipratropium bromide is mainly due to local rather than systemic anticholinergic effects .; Ipratropium bromide is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. Ipratropium bromide inhibits reflexes mediated by 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 per 1 second (FEV1) and peak expiratory flow rate by 15% or more) was observed within 15 min, the maximum effect was achieved 1-2 h and continued in most patients until 6 h after injection .; Ipratropium bromide does not adversely affect the secretion of mucus in the respiratory tract, mucociliary clearance and gas exchange .; Fenoterol hydrobromide selectively stimulates β2-adrenoreceptors in a therapeutic dose. Stimulation of β1-adrenoreceptors occurs when 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 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 in a dose of 600 mcg, an increase in mucociliary clearance was noted .; The beta-adrenergic effect of the drug on heart activity, such as an increase in the frequency and strength of heart contractions, is due to the vascular action of fenoterol, stimulation of heart β2-adrenoreceptors, and when used in doses exceeding therapeutic, stimulation of β1-adrenergic receptors .; As with other beta-adrenergic drugs, the QTc interval was lengthened when used in high doses. When using fenoterol using metered-dose aerosol inhalers (DAIs), this effect was variable and was observed when doses higher than recommended were used. 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 in order to achieve the desired effect a lower dose of the beta-adrenergic component is required, which allows an individual to choose an effective dose with practically no side effects .; In acute bronchoconstriction, the effect of the drug Berodual; H develops quickly, which allows its use in acute attacks of bronchospasm.
Indications
Prevention and symptomatic treatment of obstructive respiratory diseases with reversible bronchospasm: - COPD; - bronchial asthma; - chronic bronchitis, complicated or not complicated by emphysema.
Contraindications
- hypertrophic obstructive cardiomyopathy; - tachyarrhythmia; - I trimester of pregnancy; - children's age up to 6 years; - hypersensitivity to the drug; - hypersensitivity to atropine-like substances .; Precautions should be prescribed in case of angle-closure glaucoma, coronary insufficiency, hypertension, inadequately controlled diabetes mellitus, recent myocardial infarction, severe organic diseases of the cardiovascular system, hyperthyroidism, pheochromocytoma, hypertrophy of the prostate gland, and obstruction of an obstructive artery and arterial obstruction. children over 6 years old.
Use during pregnancy and lactation
The drug is contraindicated for use in the first trimester of pregnancy .; Existing experience has shown that ipratropium bromide and fenoterol hydrobromide do not adversely affect pregnancy. However, in the second and third trimesters of pregnancy, Berodual; H should be used with caution. It is necessary to consider the possibility of inhibitory action of Berodual H on the contractile activity of the uterus .; Fenoterol hydrobromide is excreted in breast milk. Data confirming the allocation of ipratropium bromide with breast milk, not received. A significant effect of ipratropium on the infant, especially in the case of the use of the drug in the form of an aerosol, is unlikely. Nevertheless, given the ability of many drugs to penetrate into breast milk, Berodual should be prescribed with caution; H in the period of lactation (breastfeeding).
Dosage and administration
Dose set individually .; For relief of seizures, adults and children over 6 years old are prescribed 2 inhalation doses. If breathing is not relieved within 5 minutes, another 2 inhalation doses can be given .; The patient should be informed of immediate treatment to the doctor if there is no effect after 4 inhalation doses and the need for additional inhalations .; The dosed aerosol Berodual; H in children should be used only on prescription and under the supervision of adults .; For long-term and intermittent therapy, 1-2 inhalations are prescribed per administration, up to 8 inhalations / day (on average,1-2 inhalations 3 times / day; In bronchial asthma, the drug should be used only as needed. Rules of use of the drug; The patient should be instructed on the proper use of metered aerosol .; Before using the metered aerosol for the first time, double-click on the bottom of the can .; Each time you use a metered aerosol, you must observe the following rules .; 1. Remove the protective cap .; 2. Make a slow, deep breath. 3. Holding the balloon, clasp the mouthpiece with your lips. The cylinder must face upside down .; 4. Making the maximum deep breath, at the same time quickly press the bottom of the balloon until the release of 1 inhalation dose. Hold your breath for a few seconds, then take the mouthpiece out of your mouth and exhale slowly. Repeat steps to obtain the 2nd inhalation dose .; 5. Put on the protective cap .; 6. If the aerosol canister has not been used for more than 3 days, before applying, press the bottom of the bottle once until the aerosol cloud appears; The balloon is designed for 200 inhalations. Then the cylinder should be replaced. Although some contents may remain in the bottle, the amount of drug released during inhalation decreases .; Since the balloon is opaque, the amount of the drug in the balloon can be determined as follows: - 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 .; Clean the inhaler at least once a week. It is important to keep the mouthpiece of the inhaler clean so that the drug particles do not block the release of the aerosol .; During cleaning, first remove the protective cap and remove the balloon from the inhaler. Pass a jet of warm water through the inhaler, make sure to remove the drug and / or visible dirt. After cleaning, shake the inhaler and allow it to air dry without using heating devices. Once the mouthpiece has dried, insert the balloon into the inhaler and put on a protective cap .; The plastic mouthpiece is designed specifically for Berodual metered-dose aerosol; H and serves for accurate dosing of the drug. The mouthpiece should not be used with other metered aerosols.It is also impossible to use the dosed aerodol Berodual; H with other mouthpieces .; The contents of the container are under pressure. The container should not be opened and subjected to heating above 50 ° C.
Side effects
Many of these adverse effects can be due to the anticholinergic and beta adrenergic properties of the drug Berodual; N. Berodual; H, like any inhalation therapy, 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 common 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 part of the immune system: anaphylactic reaction, hypersensitivity, including urticaria, angioedema .; Metabolism: hypokalemia .; Mental disorders: nervousness, agitation, mental disorders .; From the nervous system: headache, tremor, dizziness .; On the part of the organ of vision: glaucoma, increased intraocular pressure, disturbance of accommodation, mydriasis, blurred vision, eye pain, corneal edema, conjunctival hyperemia, appearance of aureole around objects .; Cardiac disorders: tachycardia, palpitations, arrhythmias, atrial fibrillation, supraventricular tachycardia, myocardial ischemia .; On the part of the respiratory system: cough, pharyngitis, dysphonia, bronchospasm, pharynx irritation, pharyngeal edema, laryngospasm, paradoxical bronchospasm, pharyngeal dryness .; On the part of the digestive system: vomiting, nausea, dry mouth, stomatitis, glossitis, gastrointestinal motility disorders, diarrhea, constipation, swelling of the oral cavity .; From the skin and subcutaneous tissues: itching, hyperhidrosis .; On the part of the musculoskeletal system: muscle weakness, muscle spasm, myalgia .; On the part of the urinary system: urinary retention .; Laboratory and instrumental data: increase systolic blood pressure, increase diastolic blood pressure.
Overdose
Symptoms: Overdose symptoms are usually associated primarily with the effect of fenoterol. Possible symptoms associated with excessive stimulation of β-adrenergic receptors. The most likely occurrence of tachycardia, palpitations, tremor, arterial hypo-or hypertension, increased pulse pressure, angina pain, arrhythmias, hot flashes, metabolic acidosis, hypokalemia .; Symptoms of an overdose of ipratropium bromide, such as dry mouth, disturbed accommodation of the eyes, given the greater breadth of therapeutic action and inhalation use, as a rule, are poorly expressed and have a transient character .; Treatment. You must stop taking the drug. Blood pressure monitoring data should be taken into account. Sedatives, tranquilizers, and in severe cases, intensive therapy are shown .; Beta-blockers, preferably beta1-selective blockers, may be used as a specific antidote. 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; H with other anticholinergic drugs is not recommended due to lack of data .; Beta adrenomimetics and anticholinergics, xanthine derivatives (including theophylline) can enhance the bronchodilator effect of the drug Berodual; N .; With the simultaneous use of other beta-adrenomimetics, anticholinergic agents or xanthine derivatives (including theophylline) entering the systemic circulation may increase side effects .; Perhaps a significant weakening of the bronchodilator effect of the drug Berodual; H while the simultaneous appointment of beta-blockers .; Hypokalemia associated with the use of beta adrenomimetics can be enhanced by the simultaneous appointment of xanthine derivatives, GCS and diuretics. This 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 .; Beta adrenomimetics should be carefully prescribed to patients who received MAO inhibitors and tricyclic antidepressants, since these drugs can enhance the effect of beta-adrenergic agents .; Means for inhalation anesthesia containing halogenated hydrocarbons (including halothane, trichlorethylene, enflurane) may increase the adverse effect of beta-adrenergic drugs on the cardiovascular system.
special instructions
In the case of an unexpected rapid increase in shortness of breath (difficulty breathing), consult a doctor without delay .; Hypersensitivity; After the use of the drug Berodual; H may cause immediate hypersensitivity reactions, symptoms in which in rare cases can be urticaria, angioedema, rash, bronchospasm, oropharyngeal edema, anaphylactic shock .; Paradoxical bronchospasm; Berodual; H, like other inhaled drugs, can cause paradoxical bronchospasm, which can be life threatening. In the case of the development of paradoxical bronchospasm, the use of the drug Berodual; H should be stopped immediately and switch to alternative therapy .; Long-term use; In patients with bronchial asthma, Berodual; H should be used only as needed. In patients with a mild COPD, symptomatic treatment may be preferable to regular use. Patients with asthma 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 beta2-adrenomimetics, such as Berodual; H, for the 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 beta2-agonists, incl. Berodual; H, 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 administered simultaneously with the drug Berodual; H only under medical supervision .; Violations of the gastrointestinal tract; In patients with a history of cystic fibrosis,possible motor impairment of the digestive tract .; Violations of the organ of vision; Berodual; H should be administered 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 in the correct use of the inhalation solution Berodual; N. 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 who are prone to developing 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 urethral obstruction (for example, prostatic hyperplasia or bladder neck obstruction). H should be prescribed only after a thorough assessment of the risk / benefit ratio, especially at doses higher than the recommended ones .; Effect on the cardiovascular system; In postmarketing studies, there were rare cases of myocardial ischemia when taking β-adrenoreceptor agonists. Patients with concomitant serious heart disease (eg, coronary artery disease, arrhythmias, or severe heart failure) receiving Berodual; H, you should be warned about the need to go to a doctor if you have pain in the heart or other symptoms that indicate worsening heart disease. It is necessary to pay attention to symptoms such as shortness of breath and chest pain, becausethey can be of both cardiac and pulmonary etiology .; Hypokalemia; When using β2-adrenoreceptor agonists, hypokalemia may occur .; In athletes, the use of the drug Berodual; H, due to the presence of fenoterol in its composition, can lead to positive results of doping tests; The drug contains a preservative, benzalkonium chloride, and a stabilizer, disodium edetate dihydrate. During inhalation, these components can cause bronchospasm in sensitive patients with airway hyperresponsiveness .; The effect on the ability to drive vehicles and control mechanisms; The influence of the drug on the ability to drive vehicles and use mechanisms was not specifically studied. However, patients need to be informed that during treatment with the drug Berodual; H may develop such adverse events as dizziness, tremor, accommodation disturbance, 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.