Berodual N - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Berodual N

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 445 rub.

Buy

Berodual N is a bronchodilator with improved bronchodilatory action with minimization of side effects due to the combination of the active ingredients of m-anticholinergic antagonist and β ₂ -adrenomimetic.

Release form and composition

Dosage form of the drug - metered dose inhalation aerosol: clear, colorless or slightly brownish or yellowish liquid, free of suspended inclusions (200 doses (10 ml) in a metal can with a mouthpiece and a dispensing valve, 1 can in a cardboard box).

1 dose of aerosol contains:

• Active substances: fenoterol hydrobromide - 50 μg, ipratropium bromide - 20 μg;
• Auxiliary components: absolute ethanol, citric acid, 1,1,1,2-tetrafluoroethane (propellant HFA 134a), purified water.

Indications for use

Symptomatic therapy and prevention of obstructive airway diseases with reversible bronchospasm:

• Bronchial asthma;
• Chronic obstructive pulmonary disease (COPD);
• Chronic bronchitis, uncomplicated or complicated by emphysema.

Contraindications

Absolute:

• Tachyarrhythmia;
• Hypertrophic obstructive cardiomyopathy;
• Pregnancy (I trimester);
• Children under 6 years old;
• Hypersensitivity to atropine-like substances;
• Hypersensitivity to any of the active or auxiliary components of the drug.

Relative (Berodual N should be used with caution under close medical supervision due to the high risk of side effects):

• Arterial hypertension;
• Hyperthyroidism;
• Hypertrophy of the prostate;
• Closed-angle glaucoma;
• Coronary insufficiency;
• Cystic fibrosis;
• Recently suffered myocardial infarction;
• Insufficiently controlled diabetes mellitus;
• Bladder neck obstruction;
• Severe organic diseases of the cardiovascular system;
• Pheochromocytoma;
• Children over 6 years of age.

Method of administration and dosage

Berodual N is used by inhalation of an aerosol dose through the mouth.

The dosage regimen and the number of inhalation doses are set individually.

In order to relieve attacks of bronchial asthma, adults and children over 6 years old inhale 2 inhalation doses. If relief of breathing does not occur within 5 minutes, it is allowed to take 2 more inhalation doses.

You should immediately consult a doctor if, after 4 inhalation doses, there is no therapeutic effect and additional inhalations are needed.

The use of a metered aerosol Berodual N in childhood is permissible only if the drug is prescribed by a doctor and adults can control the inhalation process.

For prolonged therapy with breaks for one dose, 1-2 inhalations are recommended, on average - 1-2 inhalations 3 times a day; the maximum daily dose is up to 8 inhalations.

The attending physician should instruct the patient on the correct use of the aerosol can.

Before the first use of the drug, you must double-click on the bottom of the can.

Rules for the use of metered aerosol, which should be observed with each use of the drug:

1. Remove the protective cap;
2. Exhale slowly and deeply;
3. Clasp the mouthpiece with your lips, holding the balloon upside down;
4. Inhale as deeply as possible while simultaneously quickly pressing on the bottom of the balloon until the first inhalation dose is released; hold your breath for a few seconds, then, taking out the mouthpiece from your mouth, exhale slowly (to obtain a second inhalation dose, repeat the procedure);
5. Put on a protective cap;
6. Before using the drug, after a break between inhalations of 3 days or more, press the bottom of the container once until an aerosol cloud appears.

The balloon contains 200 doses; after using them, the balloon must be replaced, even if some content remains in it, since with further inhalations the amount of the released drug decreases. Due to the fact that the container is opaque, the amount of aerosol in the container is determined by the degree of its immersion (without a cap) in a container with water.

The mouthpiece must be kept clean, it is recommended to rinse it as needed in warm water with soap or detergent, and then rinse thoroughly with clean water.

The plastic mouthpiece is specially designed for Berodual N and is necessary for accurate dosing of aerosol. It cannot be used with other metered aerosols. Also, you cannot use the metered Berodual N. aerosol with other mouthpieces.

Side effects

• Central nervous system (CNS): often - nervousness, minor tremors of skeletal muscles; sometimes - dizziness, headache (mainly in patients with aggravating factors); isolated cases - changes in the psyche;
• Cardiovascular system: sometimes - a feeling of palpitations, tachycardia (mainly in patients with risk factors); rarely (when using high doses) - increased systolic blood pressure (BP), decreased diastolic blood pressure, fibrillation, arrhythmia, supraventricular tachycardia;
• Respiratory system: sometimes - local irritation (pharyngitis), cough; rarely - paradoxical bronchospasm;
• Water-electrolyte balance: sometimes - severe hypokalemia;
• Digestive system: often - a feeling of dry mouth; sometimes - nausea, vomiting; rarely - reversible pathologies of gastrointestinal motility (diarrhea, constipation);
• Organ of vision: rarely - mydriasis, reversible accommodation disorder, angle-closure glaucoma, increased intraocular pressure, pain in the eyeball;
• Allergic responses: rarely - angioedema (tongue, lips, face), skin rash, urticaria, laryngeal edema, laryngospasm, anaphylactic shock;
• Other: possible - weakness, increased sweating, convulsions, myalgia; rarely - urinary retention (reversible).

An aerosol overdose of Berodual N is mainly associated with the action of fenoterol (excessive stimulation of β-adrenergic receptors) and is accompanied by the following symptoms: tachycardia, palpitations, tremors, arterial hypo- or hypertension, increased pulse pressure, angina pectoris, arrhythmias, hot flashes, metabolic acidosis, hypokalemia.

In the second active component of the aerosol, ipratropium bromide, due to the wide range of therapeutic action and inhalation method of application, the symptoms of overdose, such as impaired accommodation of the eyes and a feeling of dry mouth, are usually mild and transient.

In order to eliminate the symptoms of an overdose, the use of the drug should be discontinued, it is also necessary to take into account the data of the acid-base balance of the blood. The administration of tranquilizers, sedatives is indicated, and in severe situations - intensive therapy.

As a specific antidote, the use of β-blockers (preferably β ₁ -selective adrenergic blockers) is allowed. However, it is important to remember about the possibility of increased bronchial obstruction under the influence of β-blockers, and carefully select the dose for patients with COPD or bronchial asthma due to the risk of severe bronchospasm, which can be fatal.

special instructions

If shortness of breath (shortness of breath) worsens unexpectedly quickly, see a doctor immediately.

Special instructions for the use of aerosol Berodual N in the following conditions / diseases:

• Hypersensitivity to the drug: after inhalation of an aerosol, an immediate hypersensitivity reaction may occur, the symptoms of which (in rare cases) are: angioedema, urticaria, rash, oropharyngeal edema, bronchospasm, anaphylactic shock;
• Hypersensitivity to auxiliary components: a stabilizer (edetate disodium dihydrate) and a preservative (benzalkonium chloride) contained in the aerosol can cause bronchospasm in sensitive patients with airway hyperresponsiveness;
• Hypokalemia: as a result of the use of β2-adrenergic receptor agonists, the concentration of potassium ions in the blood may decrease;
• Gastrointestinal tract (GIT): when using Berodual N aerosol, gastrointestinal motility may be impaired if the patient has a history of cystic fibrosis;
• Organ of vision: the drug is prescribed with caution if the patient is predisposed to the development of glaucoma. In some cases, the following complications were reported: eye pain, mydriasis, increased intraocular pressure, angle-closure glaucoma, which developed from inhalation of ipratropium bromide (or ipratropium bromide in combination with β2-adrenergic receptor agonists) in the eyes. As a result of conjunctival injection of the eye vessels, the formation of symptoms of acute angle-closure glaucoma is possible: blurred vision, discomfort or pain in the eyes, the appearance of colored spots or a halo in objects in front of the eyes, in combination with reddening of the eyes and corneal edema. For any combination of these symptoms, eye drops that reduce intraocular pressure should be used, and immediately consult a specialist. Patients with a predisposition to the development of glaucoma should be especially careful about eye protection;
• Paradoxical bronchospasm: Berodual N, like other inhaled drugs, can cause paradoxical bronchospasm that threatens life, with such a reaction, you should immediately stop using the drug and switch to alternative methods of treatment; the appointment of other sympathomimetic bronchodilators simultaneously with Berodual N aerosol is allowed only under medical supervision;
• Cardiovascular system: with concomitant therapy with Berodual N for serious cardiac pathologies (arrhythmias, ischemic heart disease, severe heart failure), it is important to remember the need to consult a doctor if pain in the heart or other symptoms indicating a deterioration in cardiac function appear. Dyspnea and chest pain should be considered, as these symptoms can be of both pulmonary and cardiac etiology. According to post-marketing studies, there have been rare cases of myocardial ischemia due to the use of β-adrenergic receptor agonists;
• Systemic effects: only after a thorough assessment of the risk / benefit ratio, especially if the required doses exceed the recommended ones, Berodual N is prescribed for the following diseases: diabetes mellitus with inadequate glycemic control, recent myocardial infarction, severe organic pathologies of the heart and blood vessels, hyperthyroidism, pheochromocytoma, obstruction of the urinary tract (eg, prostatic hyperplasia or obstruction of the bladder neck);
• Doping tests: athletes using Berodual N aerosol should take into account the likelihood of positive test results due to the presence of fenoterol in its composition.

Special instructions for long-term use of aerosol Berodual N:

• Bronchial asthma, mild and moderate forms of COPD: symptomatic therapy is recommended, which may be more effective than regular use;
• Bronchial asthma or steroid-dependent forms of COPD: it is necessary to conduct or intensify anti-inflammatory therapy to control the course of the disease and relieve inflammation of the airways.

In the case of the systematic use of preparations containing β2-agonists, including Berodual N, in increasing doses to relieve bronchial obstruction, an uncontrolled worsening of the course of the disease is possible. With increased bronchial obstruction, the usual increase in the dose of β2-agonists, including Berodual N, which is recommended for a long course of therapy, is not only unjustified, but also dangerous. In order to prevent a life-threatening worsening of the course of the disease, it is necessary to consider changing the treatment plan with replacing the use of Berodual N aerosol with adequate anti-inflammatory therapy with inhaled glucocorticosteroids.

Drug interactions

• Anticholinergic drugs: it is not recommended to use simultaneously with Berodual N for a long time due to the lack of data on the interaction;
• β-blockers: can significantly weaken the bronchodilator effect of the aerosol;
• Other β-adrenergic agonists entering the systemic circulation, anticholinergics or xanthine derivatives (including theophylline): likely increased side effects; it is also possible to enhance the bronchodilator action of Berodual N;
• Halogenated inhalation anesthetics (including trichlorethylene, halothane, enflurane): may increase the adverse effect of β-adrenergic drugs on the cardiovascular system;
• Glucocorticosteroids, xanthine derivatives and diuretics: it is possible to increase hypokalemia associated with the use of β-adrenergic agonists, therefore, when treating severe forms of obstructive respiratory diseases, it is recommended to control the concentration of potassium in the blood;
• Digoxin: hypokalemia associated with the use of β-adrenergic agonists may increase the risk of arrhythmias and increase the negative effect on the heart rate (the concentration of potassium in the blood serum should be monitored);
• Tricyclic antidepressants and monoamine oxidase inhibitors: Prescribe with caution, since β-adrenergic agonists can enhance the effect of β-adrenergic drugs.

Analogs

The analogues of Berodual N are: Berodual, Ipraterol-Nativ, Ipraterol-Aeronativ.

Terms and conditions of storage

Store in a dry, dark place out of reach of children, at a temperature not exceeding 25 ° C. The aerosol in the can is under pressure. The cylinder must not be heated above 50 ° C and must not be opened.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Berodual N: prices in online pharmacies

Drug name Price Pharmacy

Berodual N 20 μg + 0.5 mg / dose aerosol for inhalation metered dose 10 ml 1 pc. 445 RUB Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!