Berodual of N

Berodual of N – broncholitic drug of the improved bronchodilatory action with minimization of side effects thanks to a combination of active ingredients of m-holinoblokatora and _{β2-адреномиметика}.

Form of release and structure

Dosage form of drug – an aerosol for inhalations dosed: transparent, colourless or slightly brownish or yellowish liquid, free from the suspended inclusions (200 doses (10 ml) in a metal barrel with a mouthpiece and the dosing valve, 1 barrel in a cardboard pack).

Contain in 1 dose of an aerosol:

• Active agents: Fenoterolum hydrobromide – 50 mkg, bromide an ipratropiya – 20 mkg;
• Auxiliary components: absolute ethanol, citric acid, 1,1,1,2-tetraftoretan (HFA 134a propellant), the purified water.

Indications to use

Symptomatic therapy and prevention of obstructive respiratory diseases with a reversible bronchospasm:

• Bronchial asthma;
• Chronic Obstructive Pulmonary Disease (COPD);
• Chronic bronchitis, uncomplicated or complicated by emphysema.

Contraindications

Absolute:

• Tachyarrhythmia;
• Hypertrophic subaortic stenosis;
• Pregnancy (I trimester);
• Children's age up to 6 years;
• Hypersensitivity to atropinopodobny substances;
• Hypersensitivity to any of active or auxiliary components of drug.

Relative (Berodual the N should be applied with care under careful medical control in view of high risk of side effects):

• Arterial hypertension;
• Hyperthyroidism;
• Prostatauxe;
• Closed-angle glaucoma;
• Coronary insufficiency;
• Mucoviscidosis;
• Recently postponed myocardial infarction;
• Insufficiently controlled diabetes mellitus;
• Obstruction of a neck of a bladder;
• Serious organic illness of cardiovascular system;
• Pheochromocytoma;
• The children's age is more senior than 6 years.

Route of administration and dosage

Berodual N apply by inhalation of a dose of an aerosol through a mouth.

The mode of dosing and quantity of inhalation doses establish individually.

For the purpose of stopping of attacks of bronchial asthma adults and children are more senior than 6 years inhale 2 inhalation doses. If for 5 minutes simplification of breath does not come, it is allowed to accept 2 more inhalation doses.

It is necessary to see immediately a doctor if after 4 inhalation doses there is no therapeutic effect and additional inhalations are necessary.

Use of the dosed aerosol Berodual of N at children's age is admissible, only if drug is appointed by the doctor and adults can check inhalation process.

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

The attending physician has to instruct the patient about the correct use of a barrel with an aerosol.

Before the first use of medicine it is necessary to make double pressing a barrel bottom.

Rules of use of the dosed aerosol which should be observed at each use of drug:

1. To remove a protective cap;
2. Slowly and deeply to exhale;
3. To clasp with lips a mouthpiece, holding a cylinder in the direction a bottom up;
4. It is the deepest to inhale, at the same time quickly pressing a cylinder bottom before release of the first inhalation dose; to hold the breath for several seconds, then, having taken out a mouthpiece from a mouth, to exhale slowly (for receiving the second inhalation dose to repeat the procedure);
5. To put on a protective cap;
6. Before use of drug after a break between inhalations in 3 days and more it is necessary to press a bottom of a cylinder once before emergence of an aerosol cloud.

The cylinder contains 200 doses, after their use the cylinder needs to be replaced even if in it there will be some contents as at further inhalations the amount of the released medicinal substance decreases. Because the cylinder is opaque, the quantity of an aerosol in a cylinder is determined by extent of its immersion (without cap) in capacity with water.

The mouthpiece needs to be kept clean, it is recommended to wash out it as required in warm water with soap or detergent then carefully to rinse with clear water.

The plastic mouthpiece is specially developed for drug Berodual by N and is necessary for exact dosing of an aerosol. It cannot be used with other dosed aerosols. Also it is impossible to use with other mouthpieces the dosed aerosol Berodual N.

Side effects

• Central Nervous System (CNS): often – nervousness, a small tremor of skeletal muscles; sometimes – dizziness, a headache (it is preferential at patients with the burdening factors); isolated cases – changes of mentality;
• Cardiovascular system: sometimes – a heart consciousness, tachycardia (it is preferential at patients with risk factors); seldom (when using high doses) – increase in the systolic arterial pressure (AP), decrease in the diastolic ABP, fibrillation, arrhythmia, supraventricular tachycardia;
• Respiratory system: sometimes – local irritation (pharyngitis), cough; seldom – a paradoxical bronchospasm;
• Water and electrolytic balance: sometimes – the expressed hypopotassemia;
• Alimentary system: often – feeling of dryness in a mouth; sometimes – nausea, vomiting; seldom – reversible pathologies of motility of digestive tract (diarrhea, a lock);
• Organ of sight: seldom – a mydriasis, reversible disturbance of accommodation, closed-angle glaucoma, increase in intraocular pressure, pain in an eyeglobe;
• Allergic answers: seldom – a Quincke's disease (language, lips, a face), skin rash, a small tortoiseshell, throat hypostasis, a laryngospasm, an acute anaphylaxis;
• Another: are possible – weakness, strengthening of sweating, a spasm, a mialgiya; seldom – an ischuria (reversible).

The overdose by Berodual's aerosol of N is preferential connected with action of Fenoterolum (excess stimulation of β-adrenoceptors)))))))))) and is followed by the following symptoms: tachycardia, heartbeat, a tremor, arterial hypo - or hypertensia, increase in pulse pressure, stenokardichesky pains, arrhythmias, inflows, a metabolic acidosis, a hypopotassemia.

At the second operating aerosol component – a bromide ipratropiya, owing to the big range of medical action and an inhalation route of administration, overdose symptoms, such as disturbance of accommodation of eyes and feeling of dryness in a mouth, as a rule, low-expressed and passing.

For the purpose of elimination of symptoms of overdose it is necessary to stop drug use, it is also necessary to consider data of analyses of acid-base balance of blood. Reception of tranquilizers, sedative drugs, and in difficult situations – an intensive care is shown.

As a specific antidote use of β-adrenoblockers (((((((((is allowed (preferably _{β1-селективных} adrenoblockers). However it is important to remember a possibility of strengthening of bronchial obstruction under the influence of β-adrenoblockers, and to carefully select a dose for patients with HOBL or bronchial asthma in connection with risk of a heavy bronchospasm which can become the reason of a lethal outcome.

Special instructions

At unexpectedly bystry strengthening of an asthma (breath difficulty) it is necessary to see a doctor at once.

Special instructions on use of an aerosol Berodual of N at the following states / diseases:

• Hypersensitivity to drug: after inhalation of an aerosol emergence of reaction of immediate hypersensitivity which symptoms (in rare instances) are is possible: Quincke's disease, small tortoiseshell, rash, stomatopharynx hypostasis, bronchospasm, acute anaphylaxis;
• Hypersensitivity to auxiliary components: contained in an aerosol the stabilizer (a dihydrate эдетат dinatrium) and preservative (chloride a benzalkoniya) with hyperreactivity of respiratory tracts can cause a bronchospasm in sensitive patients;
• Hypopotassemia: as a result of use of agonists β2-адренорецепторов concentration of potassium ions in blood can go down;
• Digestive Tract (DT): when using an aerosol Berodual of N can be broken motility of a GIT if at the anamnesis the patient has data on a mucoviscidosis;
• Organ of sight: with care appoint drug at predisposition of the patient to development of glaucoma. It was in some cases reported about the following complications: eye pain, a mydriasis, increase in intraocular pressure, closed-angle glaucoma which developed from hit in eyes inhalation a bromide ipratropiya (or a bromide ipratropiya in a complex with agonists β2-адренорецепторов). As a result of a conjunctival injection of vessels of an eye formation of symptoms of acute closed-angle glaucoma is possible: sight misting, discomfort or eye pain, emergence before eyes of color spots or an aura in objects in combination with reddening of eyes and hypostasis of a cornea. At any combination of these symptoms it is necessary to apply the eye drops reducing intraocular pressure and to consult immediately at the specialist. Patients with predisposition to development of glaucoma should care for protection of eyes especially carefully;
• Paradoxical bronchospasm: Berodual of N, as well as other inhalation medicines, can be the cause of a paradoxical bronchospasm, life-threatening, at such reaction it is necessary to stop use of drug at once and to pass to alternative methods of treatment; appointment along with an aerosol Berodual the N of other sympathomimetic bronchodilators is allowed only under medical control;
• Cardiovascular system: at the serious cardiac pathologies accompanying therapy Berodualy N (arrhythmias, coronary heart disease, the expressed heart failure) it is important to remember need of the address to the doctor at emergence of the heartaches or other symptoms indicating deterioration in cordial function. It is necessary to pay attention to an asthma and a stethalgia as these symptoms can be both a pulmonary, and cordial etiology. According to post-market researches exceptional cases of ischemia of a myocardium owing to reception of β-adrenoceptors of agonists were celebrated;;;;;;;;;;
• System effects: only after careful assessment of a ratio risk/advantage, especially if necessary doses exceed recommended, Berodual N appoint at the following diseases: a diabetes mellitus with inadequate glycemic control, recently postponed myocardial infarction, hard proceeding organic pathologies of heart and vessels, a hyperthyroidism, a pheochromocytoma, obstructions of urethral ways (for example, a hyperplasia of a prostate or obstruction of a neck of a bladder);
• Doping tests: the athletes using an aerosol Berodual of N have to consider probability of positive takes of tests because of existence in its structure of Fenoterolum.

Special instructions at prolonged use of an aerosol Berodual of N:

• Bronchial asthma, lungs and HOBL medium-weight forms: symptomatic therapy which can be more efficient than regular use is recommended;
• Bronchial asthma or steroid - the HOBL dependent forms: it is necessary to carry out or strengthen antiinflammatory therapy to control disease and to remove an inflammation of respiratory tracts.

In case of systematic use of the drugs containing β2-агонисты including Berodual of N, in the increasing doses for stopping of bronchial obstruction perhaps uncontrollable deterioration in a course of a disease. When strengthening bronchial obstruction usual increase in a dose β2-агонистов, including Berodual of N which is recommended for a long course of therapy not only is not justified, but also it is dangerous. For the purpose of prevention of life-threatening deterioration in a course of a disease Berodual of N on adequate antiinflammatory therapy with inhalation glucocorticosteroids is required to consider a question of change of treatment planning with replacement of use of an aerosol.

Medicinal interaction

• Anticholinergic drugs: it is not recommended to apply along with Berodualy N long time in a type of lack of data on interaction;
• β-adrenoblockers:::::::::: can weaken broncholitic action of an aerosol considerably;
• Other β-adrenomimetik coming to a system blood stream, anticholinergics or ksantinovy derivatives (including theophylline): strengthening of side effects is probable; strengthening of broncholitic action of Berodual of N is also possible;
• The halogenated inhalation anesthetics (including trichloroethylene, a halothane, энфлуран): can strengthen adverse influence of β-adrenergic funds for cardiovascular system;
• Glucocorticosteroids, ksantinovy derivatives and diuretics: strengthening of the hypopotassemia connected using β-adrenomimetik therefore at therapy of severe forms of obstructive respiratory diseases it is recommended to control potassium concentration in blood is possible;
• Digoxin: the hypopotassemia connected using β-adrenomimetik can increase risk of emergence of arrhythmias and strengthen negative action on a cordial rhythm (it is necessary to carry out monitoring of potassium concentration in blood serum);
• Tricyclic antidepressants and monoamine oxidase inhibitors: appoint with care as β-adrenomimetik are capable to strengthen action of β-adrenergic means.

Terms and storage conditions

To store in the dry, dark place unavailable to children, at a temperature not above 25 °C. The aerosol is in a cylinder under pressure. A cylinder it is impossible to heat above 50 °C and to open.

Period of validity – 3 years.