BERODUAL N AEROSOL 10 ML BOTTLE

Active ingredient

Berodual N metered dose inhalation:
1 dose contains 50 mcg fenoterol hydrobromide, ipratropium bromide 21 mcg;
Excipients: propellant: 1,1,1,2-tetrafluoroethane (HFA 134a), anhydrous citric acid, ethanol, distilled water;
10 ml (200 doses) in an aerosol can with a metering valve.

Berodual solution for inhalation:
1 ml of solution contains fenoterol hydrobromide 500 mcg, ipratropium anhydrous bromide 250 mcg;
Excipients: benzalkonium chloride, disodium edetate dihydrate, sodium chloride, 1N hydrochloric acid, purified water;
20 ml in a bottle with a stopper dropper.

Mechanism of action

Berodual - combined bronchodilator drug.

Fenoterol hydrobromide is a selective beta2-adrenergic agonist.
Fenoterol relaxes the smooth muscles of the bronchi and blood vessels, and also prevents the development of bronchospasm due to the effects of bronchoconstrictor factors such as histamine, methacholine, cold air and allergens (immediate type reaction). After taking the drug, the release of inflammatory mediators from mast cells is inhibited. In addition, after taking fenoterol in high doses, there is an increase in mucociliary transport.
Fenoterol also exhibits respiratory stimulant properties.
The beta-adrenergic effect of fenoterol on cardiac activity, such as an increase in the frequency and strength of heart contractions, is due to the vascular action of fenoterol, stimulation of beta2-adrenoreceptors of the heart, and when using doses exceeding therapeutic, stimulation of beta1-adrenoreceptors.
When taking fenoterol in high doses, effects are observed at the metabolic level: lipolysis, glycogenolysis, hyperglycemia, and hypokalemia (the latter is due to increased potassium uptake by skeletal muscle). Fenoterol (in high concentrations) inhibits the contractile activity of the uterus.

Ipratropium bromide is a blocker of m-cholinergic receptors. Effectively eliminates bronchospasm associated with the influence of the vagus nerve, reduces the secretion of glands (including bronchial). When administered by inhalation, it causes bronchodilation, mainly due to local, rather than systemic anticholinergic effects. It does not adversely affect the secretion of mucus in the respiratory tract, mucociliary clearance and gas exchange.

With the joint use of fenoterol hydrobromide and ipratropium bromide in the form of a metered aerosol, the bronchodilator effect is achieved through various mechanisms. As a consequence, it is enhanced and provides a large breadth of therapeutic action in case of bronchopulmonary diseases accompanied by constriction of the respiratory tract.To achieve a therapeutic effect, a lower dose of a beta-agonist is required, which allows an individual to select an effective dose with virtually no side effects.

In patients with bronchospasm associated with COPD (chronic bronchitis and emphysema of the lungs), a significant improvement in lung function (an increase in forced expiratory volume in 1 sec / FEV1 / and maximum expiratory flow / MSV25-75% / 15% or more) 15 minutes after inhalation of the drug, the maximum effect is achieved after 1-2 hours and lasts up to 6 hours in most patients.
In 40% of patients with bronchospasm associated with bronchial asthma, there is a significant improvement in lung function (an increase in FEV1 by 15% or more).

Indications and usage

Prevention and symptomatic treatment of chronic obstructive respiratory diseases with reversible bronchospasm: bronchial asthma; chronic obstructive bronchitis, whether or not complicated by emphysema.

Contraindications

Hypertrophic obstructive cardiomyopathy; tachyarrhythmia; Hypersensitivity to fenoterol hydrobromide or atropine-like drugs or other components of the drug.

Carefully the drug should be prescribed for angle-closure glaucoma, coronary insufficiency, arterial hypertension, diabetes mellitus, recent myocardial infarction, severe organic heart and vascular diseases, hyperthyroidism, pheochromocytoma, prostatic hyperplasia,bladder neck obstruction, cystic fibrosis, pregnancy, during breastfeeding, in children under 6 years of age.

Dosage and administration

Dose set individually. Treatment should begin with the lowest recommended dose.
Berodual N
For the relief of asthma attacks, 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 that if there is no effect after 4 inhalation doses and additional inhalations are required, consult a doctor immediately.
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 adults and adolescents over 12 years old with acute lung and moderately pronounced attacks of bronchial asthma, the drug is prescribed in a dose of 1 ml (20 drops).
In severe cases, the drug is prescribed in higher doses up to 2.5 ml (50 drops).
In severe cases, it is possible to use the drug (subject to medical supervision) in a maximum dose of 4 ml (80 drops).

In children aged 6-12 years with acute attacks of asthma for rapid relief of symptoms, it is recommended to prescribe the drug in a dose of 0.5-1 ml (10-20 drops); in severe cases, up to 2 ml (40 drops); in severe cases, it is possible to use the drug (subject to medical supervision) in a maximum dose of 3 ml (60 drops).

For course and long-term treatment in adults (including the elderly) and adolescents over 12 years old, the drug is prescribed in a dose of 1-2 ml (20-40 drops) 4 times / day. The maximum daily dose is 8 ml. Children aged 6-12 years appoint 0.5-1 ml (10-20 drops) 4 times / day. The maximum daily dose is 4 ml.

In the case of moderate bronchospasm or as an aid in the implementation of ventilation, adults, adolescents over 12 years of age and children aged 6-12 years, a dose of 0.5 ml (10 drops) is recommended.

In children younger than 6 years old (body weight less than 22 kg), use is recommended (only under medical supervision): 25 mcg ipratropium bromide and 50 mcg fenoterol hydrobromide per kg body weight (per dose) = 0.5 ml (10 drops) to 3 times / day The maximum daily dose is 1.5 ml.

Adverse reactions

The most frequent undesirable effects are small tremor of skeletal muscles, nervousness, dry mouth and a change in taste; headaches, dizziness, tachycardia and palpitations are less common, especially in patients with aggravating factors.
Respiratory: cough, irritation of the respiratory tract; rarely, paradoxical bronchospasm.
From the digestive system: nausea, vomiting, gastrointestinal motility disorders (especially in patients with cystic fibrosis).
Cardiovascular: decrease in diastolic blood pressure, increased systolic blood pressure, arrhythmias.
Special senses: when the drug gets into the eyes - reversible disturbance of accommodation, mydriasis, increased intraocular pressure (pain or discomfort in the eyeball, blurred vision, sensation of aura or color spots before eyes, conjunctival hyperemia).
Allergic reactions: rarely - skin rash, angioedema of the tongue, lips and face, urticaria.
Other: hypokalemia, increased sweating, feeling of general weakness, myalgia, muscle cramps, mental changes, urinary retention.

Special notes

With prolonged use in patients with bronchial asthma or light and moderate forms of COPD, symptomatic treatment is preferable to regular use.
With long-term use in patients with bronchial asthma should be borne in mind the need for or enhance anti-inflammatory therapy to control the inflammatory process of the respiratory tract and the course of the disease.

Regular use of Berodual in increasing doses to relieve bronchial obstruction can cause an uncontrolled deterioration in the course of the disease. In the case of increased bronchial obstruction, simply increasing the dose of Berodual 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 at the same time as Berodual only under medical supervision.
In patients with indications of a history of cystic fibrosis, gastrointestinal motility disorders are possible with Berodual.
Caution is advised to prescribe Berodual to patients receiving MAO inhibitors and tricyclic antidepressants.
It is recommended that the solution used with a nebulizer is breathed 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 prone to the development of glaucoma.

Store in a dark place at a temperature not exceeding 30 ° C.

Berodual n