Berodual - instructions for use, dose, side effects, contraindications

Active substanceIpratropium bromide + FenoterolIpratropium bromide + Fenoterol

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Berodual®

solution d / inhal.

Boehringer Ingelheim International GmbH Germany

Berodual® H

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Boehringer Ingelheim International GmbH Germany

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aerosol d / inhal.

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Ipraterol-native

solution d / inhal.

NATIVA, LLC Russia

Dosage form: & nbspinhalation solution

Composition:

1 ml of solution for inhalation contains:

active ingredients: 261 μg of ipratropium bromide monohydrate, based on anhydrous ipratropium bromide (250 μg) and 500 μg fenoterol hydrobromide;

auxiliary components: benzalkonium chloride, disodium edetate dihydrate, sodium chloride, hydrochloric acid 1Н, purified water.

Description:

A clear, colorless or almost colorless liquid, free from suspended particles. The smell is almost imperceptible.

Pharmacotherapeutic group:Bronchodilator combined (beta2-adrenomimetic selective + m-holinoblokator)

ATX: & nbsp

R.03.A.L.01 Fenoterol and ipratropium bromide

Pharmacodynamics:

BERODAAL® contains two components that have broncholytic activity: ipratropium bromide - m-holinoblokator, and fenoterol - β₂-adrenomimetic.

Bronchodilation in the inhalation of ipratropium bromide is mainly due to local, rather than systemic, anticholinergic action.

Ipratropium bromide is a quaternary ammonium derivative possessing anticholinergic (parasympatolytic) properties.

The drug inhibits the reflexes caused by the vagus nerve, counteracting effects of acetylcholine - a mediator released from the endings of the vagus nerve. Anticholinergic drugs prevent the increase in intracellular concentration of Ca⁺⁺, which occurs due to the interaction of acetylcholine with the muscarinic receptor located on the smooth muscles of the bronchi. Release of Ca⁺⁺ is mediated by a system of secondary mediators, which include ITF (inositol triphosphate) and DAG (diacylglycerin).

In patients with bronchospasm associated with chronic obstructive pulmonary diseases (chronic bronchitis and emphysema), a significant improvement in lung function (increase in forced expiratory volume per 1 sec (FEV₁) and peak expiratory flow rate of 15% or more) was noted within 15 minutes, the maximum effect was achieved in 1-2 hours and lasted in most patients up to 6 hours after administration.

Ipratropium bromide does not adversely affect the secretion of mucus in the respiratory tract, mucociliary clearance and gas exchange.

Fenoterol selectively stimulates β₂-adrenoceptors in a therapeutic dose. Stimulation of β₁-adrenoceptors occurs when high doses are used.

Fenoterol relaxes the smooth musculature of the bronchi and vessels and counteracts the development of bronchospastic reactions due to the influence of histamine, methacholine, cold air and allergens (immediate-type hypersensitivity reactions). Immediately after the introduction fenoterol blocks the release of mediators of inflammation and bronchoobstruction from mast cells. In addition, when fenoterol was used in doses of 0.6 mg, there was an increase in mucociliary clearance.

The β-adrenergic effect of the drug on cardiac activity, such as an increase in heart rate and strength, is due to the vascular effect of fenoterol, stimulation of β₂β-adrenoreceptors of the heart, and when doses exceeding therapeutic are used, stimulation β₁adrenoreceptors. As with the use of other β-adrenergic drugs, lengthening of the interval QT_C when using high doses. When fenoterol was used with metered-dose aerosol inhalers (DAD), this effect was unstable and was noted in the case of doses exceeding the recommended doses. However, after the use of fenoterol with nebulizers (solution for inhalation in vials with a standard dose), systemic exposure may be higher than with the use of the drug with the help of DAD in the recommended doses. The clinical significance of these observations is not established.

Most The often 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 is not clear. Tremor is the most common undesirable effect when using β-adrenergic agonists.

When these two active substances are used together, the bronchodilating effect is achieved by affecting various pharmacological targets. These substances complement each other, as a result of increased spasmolytic effect on the muscles of the bronchi and provides a large latitudetherapeutic effect with bronchopulmonary diseases, accompanied by constriction of the respiratory tract. Complementary action is such that, in order to achieve the desired effect, a lower dose of the β-adrenergic component is required, which allows individual selection of an effective dose in the practical absence of side effects. BERODUAL®. In acute bronchoconstriction, the effect of BERODUALA develops rapidly, which allows using it in acute attacks of bronchospasm.

Indications:

Prevention and symptomatic treatment of chronic obstructive airway diseases with reversible bronchospasm, such as bronchial asthma and, especially, chronic obstructive pulmonary disease (chronic obstructive bronchitis and emphysema).

Contraindications:

Hypersensitivity to fenoterol or atropine-like drugs or other components of this drug.

Hypertrophic obstructive cardiomyopathy, tachyarrhythmia, II and III trimesters of pregnancy.

Carefully:Closed-angle glaucoma, arterial hypertension, diabetes mellitus, recently suffered myocardial infarction (within the last 3 months),cardiac and vascular diseases such as chronic heart failure, ischemic heart disease, heart disease, aortic stenosis, severe cerebral and peripheral arteries, hyperthyroidism, pheochromocytoma, prostatic hyperplasia, bladder neck obstruction, cystic fibrosis, second trimester of pregnancy, breastfeeding.

Pregnancy and lactation:

Pre-clinical data and experience with human use show that fenoterol or ipratropium bromide do not have a negative effect in pregnancy.

Consider the possibility of the inhibitory effect of fenoterol on contractile activity of the uterus. The drug is contraindicated in the I and III trimesters (the possibility of weakening the labor of fenoterol). It should be used with caution in the II trimester of pregnancy.

Fenoterol penetrates into breast milk. Data confirming that ipratropium bromide penetrates into breast milk not received. However, care should be taken to administer Berodual® nursing mothers.

Clinical evidence of the effect of combination of ipratropium bromide and fenoterol hydrobromide on fertility is unknown.

Dosing and Administration:

Treatment should be conducted under medical supervision (for example, in conditions hospital). Treatment at home is possible only after consulting a doctor in cases where a high-speed, low-dose β-agonist is not effective enough. Also, the inhalation solution can be recommended to patients in the case where the aerosol for inhalation can not be used or if higher doses are required.

The dose should be selected individually, depending on the severity of the attack. Treatment should usually start at the lowest recommended dose and stop after a sufficient reduction in symptoms has been achieved.

The following doses are recommended:

In adults (including the elderly) and adolescents over 12 years of age

Acute attacks of bronchospasm

Depending on the severity of the attack, the doses may vary from 1 ml (1 ml = 20 drops) to 2.5 ml (2.5 ml = 50 drops). In especially severe cases, the use of doses up to 4 ml (4 ml = 80 drops) is possible.

Children aged 6-12 years

Acute attacks of bronchial asthma

Depending on the severity of the attack, the doses may vary from 0.5 ml (0.5 ml = 10 drops) to 2 ml (2 ml = 40 drops).

In children younger than 6 years of age (body weight less than 22 kg):

Due to the fact that information about the use of the drug in this age group is limited, it is recommended to use the following dose (only under medical observation condition): 0.1 ml (2 drops) per kg of body weight, but not more than 0.5 ml (10 drops)

The solution for inhalation should be used only for inhalations (with a suitable nebulizer) and do not apply orallyabout.

Treatment should usually begin with the lowest recommended dose. The recommended dose should be diluted with 0.9% sodium chloride solution to a final volume of 3-4 ml, and be applied (completely) with a nebulizer.

The solution of BERODAALA® for inhalations should not be diluted with distilled water. Dilution of the solution should be carried out every time before use; the remnants 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 expenditure of diluted solution.

The solution of BERODAALA® for inhalations can be used with various commercial models of nebulizers. The dose reaching the lungs and the system dose depend on the type of nebulizer used and may be higher than the corresponding dose when using the BERODAALA metered aerosol HFA and CFC (which depends on the type of inhaler). In those cases where there is a wall oxygen, the solution is best used at a flow rate of 6-8 liters per minute.

Follow instructions for the use, maintenance and cleaning of the nebulizer.

Side effects:

Many of these unwanted effects may be a consequence of the anticholinergic and beta-adrenergic properties of BERODUALA®. BERDUAL®, like any inhalation therapy, can cause local irritation. Adverse reactions of the drug were determined on the basis of data obtained in clinical studies and during pharmacological supervision of the use of the drug after its registration.

The most common side effects reported in clinical trials were coughing, dry mouth, headache, tremor, pharyngitis, nausea, dizziness, dysphonia, tachycardia, palpitations, vomiting, increased systolic blood pressure, and nervousness.

Infringements from immune systems

anaphylactic reaction hypersensitivity.

Violations from hand metabolism and nutrition

hypokalemia.

Disorders of the psyche

- nervous excitement mental disorders.

Disturbances from the nervous system

- headache;

- tremor, dizziness.

Disturbances on the part of the organ of sight

- glaucoma;

- increased intraocular pressure;

- violation of accommodation;

- mydriasis;

- blurred vision;

- Pain in the eyes;

corneal edema;

- hyperemia conjunctiva;

- the appearance of a halo around objects.

Heart Disease

- tachycardia;

- palpitation;

- arrhythmia;

- atrial fibrillation;

supraventricular tachycardia;

myocardial ischemia.

Violations from hand respiratory organs, thorax and mediastinum

- cough;

pharyngitis;

- dysphonia;

- bronchospasm;

- Throat irritation;

swelling of the pharynx;

- laryngospasm;

- Paradoxical bronchospasm;

dryness of pharynx.

Disorders from the gastrointestinal tract

- vomiting;

- nausea;

- dry mouth;

- stomatitis;

- glossitis;

- violations of motility of the gastrointestinal tract;

- diarrhea;

- constipation;

- edema of the mouth.

Changes in the skin and subcutaneous tissues

- hives;

- itching;

- angioedema;

- Hyperhidrosis.

Musculoskeletal disorders and connective tissue disorders

- Muscle weakness;

- muscle spasm;

- myalgia.

Violations from hand kidney and urinary tract

- retention of urine.

Laboratory and instrumental data

- Increased diastolic blood pressure.

Overdose:

Overdose Symptoms are usually associated primarily with the action of fenoterol. There may be symptoms associated with excessive stimulation of β-adrenergic receptors. The most likely appearance of tachycardia, palpitation, tremor, increased blood pressure, lowering blood pressure, increasing the difference between systolic and diastolic blood pressure, angina pectoris, arrhythmia and the feeling of "tides" of blood to the face, a feeling of heaviness behind the sternum, increased bronchial obstruction. Metabolic acidosis and hypokalemia were also observed. Possible overdosage symptoms caused by ipratropium bromide (such as dry mouth, accommodation disorders) are weak and transient, which is due to its local application.

Treatment. It is necessary to stop taking the drug. It should take into account the monitoring of the acid-base balance of blood. It is recommended the appointment of sedatives, anxiolytic drugs (tranquilizers),in severe cases - intensive therapy.

As a specific antidote, it is possible to use β-blockers, preferable to selective β₁adrenoblockers. However, patients with bronchial asthma or chronic obstructive pulmonary disease should consider the possibility of strengthening bronchial obstruction, which can lead to death, under the influence of β-blockers and carefully select their dose.

Interaction:

Long-term simultaneous use of BERODAALA® with other anticholinergic drugs is not recommended in the absence of data.

Simultaneous use of other β-adrenomimetic drugs, systemic anticholinergics and xanthine derivatives (for example, theophylline) can increase the bronchodilator effect of BORODAALA® and lead to an increase in side effects.

It is possible to significantly weaken the bronchodilator action of BERODAALA® with the simultaneous administration of β-blockers.

Hypokalemia associated with the use of β-adrenomimetics can be enhanced by the simultaneous administration of xanthine derivatives, corticosteroids and diuretics.This fact should be given special attention in the treatment of patients with severe forms of obstructive airway disease.

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 potassium level in the blood serum.

It should be used with caution β₂-adrenergic agents for patients receiving monoamine oxidase inhibitors and tricyclic antidepressants, since these drugs are able to enhance the action of β-adrenergic agents.

Inhalations of agents for general anesthesia of halogenated hydrocarbon anesthetics, for example halothane, trichlorethylene or enflurane, can enhance the effect of β-adrenergic agents on the cardiovascular system.

The combined use of BERODUALA® with cromoglycic acid and / or glucocorticosteroids increases the effectiveness of therapy.

Special instructions:

In case of sudden rapid increase in dyspnoea (difficulty breathing) should immediately consult a doctor.

Hypersensitivity

After application of BERDUALA®, immediate hypersensitivity reactions may occur which, in rare cases, may include: urticaria, angioedema, rash, bronchospasm, edema of the oropharynx, anaphylactic shock.

Paradoxical bronchospasm

BERDUAL®, like other inhaled drugs, can cause paradoxical bronchospasm, which can endanger life. In the case of paradoxical bronchospasm, the use of BERODUALA® should be stopped immediately and switched to alternative therapy

Long-term use

- in patients suffering from bronchial asthma, BERODUAL® should be used only as needed;

- in patients with mild forms of chronic obstructive pulmonary disease, symptomatic treatment may be preferable to regular use;

- Patients with bronchial asthma should be aware of the need to conduct or enhance anti-inflammatory therapy to control the inflammatory process of the airways and the course of the disease.

Regular use of increasing doses of drugs containing β₂-adrenomimetics, such as BEROUDAL®, for the relief of bronchial obstruction can cause an uncontrolled deterioration in the course of the disease. In the case of increased bronchial obstruction, an increase in the dose of β₂agonists, including BERODUALA®, more recommended for a long time not only is not justified, but also dangerous. To prevent a life-threatening deterioration in the course 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 administered concomitantly with BERODUALOM ® only under medical supervision.

Disorders from the gastrointestinal tract

Patients with a history of cystic fibrosis may have GI motility disorders.

BERODUAL® should be used with caution in patients predisposed to acute angular glaucoma. There are some reports of complications from the side of the eye (for example, increased intraocular pressure, mydriasis, occlusive glaucoma, eye pain) developed when inhaled ipratropium bromide (or ipratropium bromide in combination with agonists β₂adrenoreceptors) into the eyes.Symptoms of acute closed-angle glaucoma may be pain or discomfort in the eyes, blurred vision, the appearance of a halo in subjects and color spots in front of the eyes in combination with corneal edema and red eyes, due to conjunctival vascular injection.

If any composition of these symptoms develops, the use of eye drops that reduce intraocular pressure and immediate consultation of a specialist is indicated.

Patients should be instructed about the correct use of the BERODAALA® inhalation solution. To prevent the solution from entering the eyes, it is recommended that the solution used by the nebulizer be inhaled through the mouthpiece. In the absence of the mouthpiece, a face mask that fits snugly should be used. Especially careful to protect the eyes of patients who are predisposed to the development of glaucoma.

System Effects

With the following diseases: recently transferred myocardial infarction, diabetes mellitus with inadequate glycemic control, severe organic diseases of the heart and blood vessels, hyperthyroidism, pheochromocytoma or obstruction of the urethra (for example, with prostatic hyperplasiaor bladder neck obstruction), BERDUAL® should only be used after a thorough assessment of the risk / benefit, especially if doses exceeding the recommended levels are used.

Influence on the cardiovascular system

In postmarketing studies, rare cases of myocardial ischemia with β-agonists were noted. Patients with concomitant serious heart disease (eg, coronary heart disease, arrhythmias or severe heart failure) receiving BERDUALA® should be warned of the need to see a doctor if there is a heart trouble or other symptoms indicating a worsening of heart disease. It is necessary to pay attention to such symptoms as dyspnea and chest pain, since they can be both cardiac and pulmonary etiology.

Hypokalemia

When applying β₂agonists may experience hypokalemia (see the section "Overdose").

In athletes application of BERODUALA® due to the presence of phenoterol in its composition can lead to positive results of doping tests.

The drug contains a preservative, benzalkonium chloride, and the stabilizer is disodium edetate dihydrate.During inhalation, these components can cause bronchospasm in sensitive patients with airways hyperreactivity.

Effect on the ability to drive transp. cf. and fur:

Studies of the effects of the drug on the ability to the management of vehicles and the use of mechanisms was not carried out.

However, patients need to be informed that during treatment with BERODUALOM, they may experience such undesirable sensations as dizziness, tremors, eye disorders, mydriasis and blurred vision. Therefore, care should be taken when driving vehicles or using mechanisms. If patients experience the above undesirable feelings, refrain from such potentially dangerous actions as driving a motor vehicle or control mechanisms.

Form release / dosage:Solution for inhalation, 0.25 mg + 0.5 mg / ml.

Packaging:

To 20 ml in a glass bottle of amber color with a polyethylene dropper and a screwed polypropylene cover with the control of the first opening.

The bottle with instructions for use is placed in a cardboard box.

Storage conditions:At a temperature not higher than 30 ° C, do not freeze.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N015914 / 01

Date of registration:24.07.2009

Expiration Date:Unlimited

The owner of the registration certificate:Boehringer Ingelheim International GmbHBoehringer Ingelheim International GmbH Germany

Manufacturer: & nbsp

INSTITUTO de ANGELI, S.r.L. Italy

Representation: & nbspBERINGER INGELCHAIM INTERNATIONAL GmbH BERINGER INGELCHAIM INTERNATIONAL GmbH Germany

Information update date: & nbsp23.01.2017

Illustrated instructions

Instructions

Berodual® (Berodual®)