Berotec N aerosol

Clinicopharmacological group

Broncholytic drug - beta₂-adrenergic agonist

Dosage form, composition and packaging

Metered aerosol for inhalation in the form of a transparent, colorless or slightly yellowish or slightly brownish liquid, free from suspended particles.

Berotec N Pharmacological action

Broncholytic drug, a selective β₂-adrenergic receptor stimulant.

In case of using the drug in higher doses the stimulation of β₁-adrenergic receptors occurs (such as in case of prescription for tocolytic therapy). The binding of β₂-adrenergic receptors activates adenylate cyclase through a stimulatory G_S-protein with a consequent increase in the formation of cAMP, which activates protein kinase A, the latter deprives myosin of the ability to connect to actin, preventing smooth muscle contraction and promoting broncholytic effect and elimination of bronchospasm.

Furthermore, fenoterol inhibits the release of mediators of inflammation from mast cells, thereby exerting a protective effect against the influence of such bronchoconstrictors as histamine, methacholine, cold air and allergens. Administration of fenoterol in the dose of 600 mcg increases the activity of ciliated bronchial epithelium and accelerates the mucociliary transport.

Due to the stimulating effect on the β-adrenergic receptors, fenoterol may have effects on the myocardium (especially in doses exceeding therapeutic ones), causing increased frequency and strength of cardiac contractions.

Fenoterol prevents and quickly relieves bronchospasm of varying origin. The onset of action after inhalation is in 5 min, max - 30-90 min, duration - 3-5 hours.

Berotec N Overdose

Symptoms: tachycardia, palpitations, tremor, decreased/increased blood pressure, increased pulse pressure, anginal pain, arrhythmias and face hyperemia.

Treatment: administration of sedatives, tranquilizers, in severe cases - intensive symptomatic therapy.

Beta-blockers are recommended as specific antidotes (preferably selective beta₁-adrenergic blockers). However, one should consider the possibility of exacerbation of bronchial obstruction and carefully adjust the dose of these drugs in patients with bronchial asthma.

Berotec N interactions

Beta-adrenergic agonists and anticholinergics, xanthine derivatives (including theophylline) cromoglicic acid, corticosteroids and diuretics may increase the effects and side effects of fenoterol.

The significant weakening of bronchodilator action of fenoterol is possible in case of simultaneous use of beta-blockers.

Berotec N should be used with caution in patients receiving monoamine oxidase inhibitors and tricyclic antidepressants, since these drugs can increase the effects of fenoterol.

The products for inhalation anesthesia containing halogenated hydrocarbons (including halothane, trichlorethylene, enflurane) may increase the effect of fenoterol on the cardiovascular system (arrhythmias may develop). The simultaneous appointment of broncholytics with a similar mechanism of action results in additive effects and overdose phenomena.

Berotec N in Pregnancy and lactation

The results of pre-clinical studies in combination with available clinical experience with the drug did not reveal any adverse effect of the drug on pregnancy. However, during pregnancy (especially in the I trimester), the drug should be used with caution and only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

It is necessary to consider the possibility of the inhibitory effect of fenoterol on the contractile activity of the uterus.

Preclinical studies have shown that fenoterol is excreted in breast milk. Safety of the drug during lactation has not been studied. In the period of lactation the use of the drug is possible only if the potential benefit to the mother outweighs the potential risk to the infant.

Berotec N Side effects

Immune system: hypersensitivity.

Metabolism: hypokalemia.

Nervous system: agitation, nervousness, tremors, headache, dizziness.

Cardiovascular system: myocardial ischemia, arrhythmia, tachycardia, palpitations, increased systolic blood pressure, decreased diastolic blood pressure.

Respiratory system: paradoxical bronchospasm, irritation of the larynx and pharynx.

Digestive system: nausea, vomiting.

Skin and subcutaneous tissues: hyperhidrosis, skin reactions such as rash, itching, urticaria.

Musculoskeletal system: muscle spasm, myalgia, muscle weakness.

Storage time and conditions

The drug should be stored out of children’s reach at a temperature not exceeding 25°C. Shelf life - 3 years.

The content of the container is pressurized. The container must not be opened or exposed to heat above 50°C.

Berotec N Indications

• asthma attacks or other states with reversible airway obstruction (including chronic bronchitis, COPD);
• prevention of asthma attacks of physical effort.

Berotec N Contraindications

• tachyarrhythmia;
• hypertrophic obstructive cardiomyopathy;
• children under 4 years of age;
• hypersensitivity to fenoterol and other drug components.

The drug should be prescribed with caution in case of hyperthyroidism, arterial hypotension, arterial hypertension, intestinal atony, hypokalemia, diabetes, recent myocardial infarction (within the last 3 months), diseases of the heart and blood vessels, such as chronic heart failure, ischemic heart disease, coronary artery disease, structural heart defects (including aortic stenosis), pronounced diseases of cerebral and peripheral arteries, pheochromocytoma.

Since information on the use of the drug in children under 6 years of age is limited, treatment is carried out with caution, only under medical supervision.

Berotec N Cautions

During the first use of the metered Berotec N aerosol patients may note that the new spray has a slightly different taste compared to the same aerosol containing freon. Patients should be warned about this in the transition from Berotec N, containing freon, to Berotec N, not containing freon. Patients need to know that Berotec N, containing freon, and Berotec N, not containing freon, are completely interchangeable, and the taste change has no impact on efficacy and safety of the drug.

Other sympathomimetic bronchodilators may be used together with Berotec N only under medical supervision. In case of acute, rapidly increasing dyspnea (shortness of breath) one should consult a doctor immediately.

Long-term use:

• rapid relief of bronchial asthma attacks may be preferable to regular use of the drug (symptomatic treatment);
• patients should be screened to identify the need for additional or more intensive anti-inflammatory therapy (e.g. inhaled corticosteroids) to control airway inflammation and to prevent long-term exacerbations of asthma.

In the event of exacerbation of bronchial obstruction it is unacceptable and may even be risky to increase the frequency of administration of β₂-adrenergic receptor agonists contained in such drugs as metered Berotec N aerosol for inhalation, in excess of recommended doses. In this situation, one should review the treatment plan and, especially, the appropriateness of anti-inflammatory therapy.

During the treatment with β2-adrenergic receptor agonists one may develop severe hypokalemia. Particular caution should be exercised in cases of severe bronchial asthma, as this effect may be enhanced by concomitant use of xanthine derivatives, corticosteroids and diuretics. In case of hypoxia the negative impact of hypokalemia on cardiac rhythm may be increased. In such situations, we recommend regular monitoring of the concentration of potassium in the blood serum.

In rare cases, myocardial ischemia associated with β2-adrenergic receptor agonist was observed.

Hypokalemia in patients receiving digoxin increases sensitivity to cardiac glycosides and can cause cardiac arrhythmia.

Effects on the ability to drive and use machines

The effect of the drug on the patient's ability to perform work that requires high level of attention and rapid psychomotor reactions has not been established.

Berotec N Application in children

It is contraindicated for children under 4 years of age.

Since information on the use of the drug in children of 4-6 years of age is limited, treatment is carried out with caution, only under medical supervision.