Berodual N, aerosol for inhalation, 200 doses, 10 ml

1 dose contains:

active substances:

fenoterol hydrobromide 50 mcg;

ipratropium bromide monohydrate 21 μg, which corresponds to the content of ipratropium bromide 20 μg.

Excipients:

absolute ethanol,

purified water,

lemon acid,

tetrafluoroethane (HFA 134a, propellant).

It contains two components of a combined bronchodilator drug., Possessing bronchodilator activity: ipratropium bromide - m-anticholinergic, and phenoterol hydrobromide - beta2-adrenergic agonist.

When inhaled, ipratropium bromide bronchodilation is mainly due to local and not systemic anticholinergic action. Ipratropium bromide is a quaternary ammonium compound. It has anticholinergic (parasympatolytic) properties.

Ipratropium inhibits vagus-mediated reflexes, counteracting the effect of acetylcholine, a neurotransmitter released from nerve endings. Anticholinergics prevent an increase in the intracellular concentration of cyclic guanosine monophosphate (cGMP) in the smooth muscles of the bronchi, which occurs when acetylcholine interacts with m-cholinergic receptors.

A significant improvement in lung function (an increase in FEV1 and the average volumetric rate of forced expiration by 15% or more) in patients with COPD with bouts of bronchospasm occurs within 15 minutes, the maximum effect is achieved after 1-2 hours and lasts in most patients up to 6 hours after administration. 40% of patients with bronchospasm associated with bronchial asthma have a significant improvement in lung function (increase in FEV1 by 15% or more).

Ipratropium bromide does not adversely affect mucus secretion in the respiratory tract, mucociliary clearance and gas exchange. Fenoterol hydrobromide has a direct sympathomimetic effect. In therapeutic doses, it selectively stimulates β2-adrenergic receptors of the bronchi. At higher doses, it has the ability to stimulate β1-adrenergic receptors. Binding to β2-adrenergic receptors activates adenylate cyclase with the participation of a stimulating Gs protein.

An increased level of cyclic AMP activates protein kinase A, which then phosphorylates the target proteins in smooth muscle cells. This, in turn, leads to phosphorylation of the myosine kinase light chain, inhibition of the hydrolysis of phosphoinositide and the opening of potassium channels activated by calcium. Fenoterol relaxes the smooth muscles of the bronchi and blood vessels and counteracts the development of bronchospastic reactions due to the effects of histamine, methacholine, cold air and allergens (immediate hypersensitivity reactions).

Immediately after administration, fenoterol blocks the release of bronchoconstrictor inflammatory mediators from mast cells. The use of phenoterol in higher doses increases mucociliary clearance.

At higher plasma phenoterol concentrations, uterine contractility is inhibited. In addition, when used in high doses, metabolic effects are observed: lipolysis, glycogenolysis, hyperglycemia and hypokalemia. Hypokalemia is mainly due to increased incorporation of potassium ions into skeletal muscle.

The beta-adrenergic effect of the drug on cardiac activity, such as an increase in heart rate and heart rate, is due to the vascular effect of fenoterol, stimulation of β2-adrenergic receptors of the heart, and when used in doses exceeding therapeutic, stimulation of β1-adrenergic receptors. As with other beta-adrenergic drugs, a prolongation of the QTc interval was observed when used in high doses.

The most commonly observed adverse effect of β2-adrenoreceptor stimulants is tremor. In contrast to exposure to smooth muscles of the bronchi, systemic effects of β2-adrenoreceptor stimulants may develop tolerance. Fenoterol prevents the development of bronchoconstriction caused by various stimuli, such as physical activity, cold air and allergens (immediate hypersensitivity reactions).

With the combined use of ipratropium bromide and fenoterol, the bronchodilating effect is achieved by exposure to various pharmacological targets. These substances complement each other, as a result, the bronchodilator effect is enhanced and a wide range of therapeutic effects is provided for bronchopulmonary diseases accompanied by constriction of the respiratory tract.

The complementary effect is such that to achieve the desired effect, a lower dose of the beta-adrenergic component is required, which facilitates the individual dosage of the drug and helps to minimize side effects.

Prevention and treatment of obstructive airways diseases with reversible bronchospasm: Chronic bronchitis, complicated or not complicated by emphysema. COPD Bronchial asthma.

Contraindicated in the first trimester of pregnancy. Existing experience has shown that ipratropium bromide and phenoterol hydrobromide do not have a negative effect during pregnancy.

However, in the II and III trimesters of pregnancy, Berodual®N should be used with caution. It is necessary to take into account the possibility of the inhibitory effect of Berodual N on the contractile activity of the uterus. Fenoterol hydrobromide is excreted in breast milk. Data confirming the allocation of ipratropium bromide with breast milk have not been obtained.

Significant effects of ipratropium on the infant, especially in the case of the use of the drug in the form of an aerosol, are unlikely. However, given the ability of many drugs to pass into breast milk.

Berodual®N should be used with caution during lactation (breastfeeding).

Children under 6 years old. I trimester of pregnancy. Hypertrophic obstructive cardiomyopathy. Tachyarrhythmia. Hypersensitivity to the components of the drug.

Hypersensitivity to atropine-like substances.

With caution: use the drug for angle-closure glaucoma, coronary insufficiency, hypertension, insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic diseases of the cardiovascular system, hyperthyroidism, pheochromocytoma, prostatic hypertrophy, obstruction of the bladder neck, in cystic fibrosis, in children over 6 years old.

Allergic reactions: rarely - skin rash, angioedema of the tongue, lips, face, urticaria, laryngospasm, laryngeal edema, anaphylactic shock.

From the side of the central nervous system: often - small tremor of skeletal muscle, nervousness; sometimes - headache, dizziness, (especially in patients with aggravating factors); in isolated cases - changes in the psyche.

From the cardiovascular system: sometimes - tachycardia, palpitations (especially in patients with risk factors); rarely (when used in high doses) - a decrease in diastolic blood pressure, increased systolic blood pressure, arrhythmia, fibrillation, supraventricular tachycardia.

From the water-electrolyte balance: sometimes - severe hypokalemia.

From the side of the respiratory system: sometimes - cough, local irritation (pharyngitis); rarely - paradoxical bronchospasm.

From the side of the organ of vision: rarely - reversible disturbance of accommodation, mydriasis, increased intraocular pressure, angle-closure glaucoma, pain in the eyeball.

Other: increased sweating, weakness, myalgia, cramps; rarely, reversible urinary retention.

From the digestive system: often - dry mouth; sometimes - nausea, vomiting; rarely, reversible gastrointestinal motility (constipation, diarrhea).

Beta-adrenergic agonists and anticholinergics, xanthine derivatives (including theophylline) can enhance the bronchodilator effect of Berodual N.

Means for inhalation anesthesia containing halogenated hydrocarbons (including halothane, trichlorethylene, enflurane) can enhance the effect of Berodual H on the cardiovascular system.

With the simultaneous use of other beta-adrenergic agonists entering the systemic circulation of anticholinergics or xanthine derivatives (including theophylline), side effects may intensify. Perhaps a significant weakening of the bronchodilator effect of Berodual N with the simultaneous appointment of beta-blockers.

With the simultaneous use of MAO inhibitors and tricyclic antidepressants, an increase in the action of Berodual N is noted. With the use of Berodual N, hypokalemia may develop, which can be enhanced with the simultaneous administration of xanthine derivatives, GCS and diuretics.

This fact should be considered when treating patients with severe obstructive airway diseases. Hypokalemia increases the risk of arrhythmias in patients receiving digoxin. In addition, with hypoxia, the negative effect of hypokalemia on the heart rate is enhanced. In such cases, it is recommended that serum potassium levels be monitored.

The dose is set individually., But for the relief of asthma attacks, adults and children over 6 years of age are prescribed 2 inhalation doses. If breathing relief does not occur within 5 minutes, another 2 inhalation doses may be prescribed. The patient should be informed that if there is no effect after 4 inhalation doses and the need for additional inhalations, you should immediately consult a doctor.

Berodual® N metered-dose aerosol in children should be used only as directed by a doctor and under the supervision of adults. For prolonged and intermittent therapy, 1-2 inhalations are prescribed for 1 dose, up to 8 inhalations / day (on average, 1-2 inhalations 3 times / day). Rules for the use of the drug The patient should be instructed on the proper use of metered-dose aerosol. Before using metered-dose aerosol for the first time, double-click on the bottom of the spray can. Each time you use a metered-dose aerosol, the following rules must be observed: Remove the protective cap.

Take a slow, deep exhale. Holding the balloon, grasp the mouthpiece with your lips. The cylinder should be directed upside down. Taking the deepest breath possible, simultaneously quickly press the bottom of the container until 1 inhaled dose is released. Hold your breath for a few seconds, then remove the mouthpiece from your mouth and slowly exhale.

Repeat for the 2nd inhalation dose. To put on a protective cap. If the aerosol can has not been used for more than 3 days, before use it is necessary to press once on the bottom of the can until an aerosol cloud appears. The balloon is designed for 200 inhalations. Then the cylinder should be replaced. Although some contents may remain in the balloon, the amount of drug released during inhalation is reduced.

Symptoms: fenoterol hydrobromide and are caused by excessive stimulation of β-adrenergic receptors: tachycardia, palpitations, tremors, arterial hypo- or hypertension, increased pulse blood pressure, angina pectoris, arrhythmias, hot flashes and overdose symptoms ipratropium bromide: dry mouth, communication problems the great breadth of therapeutic action and inhalation use, as a rule, are not very pronounced and have a transient character.

Treatment: prescription of tranquilizers, sedatives. If necessary, intensive care. As a specific antidote, beta-blockers, preferably selective beta-1 blockers, may be used. However, one should remember about the possible increase in bronchial obstruction under the influence of beta-blockers and carefully select the dose for patients suffering from bronchial asthma or COPD, due to the danger of severe bronchospasm, which can lead to death.

In patients with a history of cystic fibrosis, gastrointestinal motility disorders with Berodual N.

With prolonged use in patients with bronchial asthma or mild to moderate forms of COPD, symptomatic treatment may be preferable to regular use. With prolonged use in patients with bronchial asthma or steroid-dependent forms of COPD, one should remember about the need to conduct or strengthen anti-inflammatory therapy to control the inflammatory process of the respiratory tract and the course of the disease.

The regular use of Berodual N in increasing doses for the relief of bronchial obstruction can cause an uncontrolled worsening of the course of the disease. In the case of increased bronchial obstruction, a simple increase in the dose of Berodual H more than recommended for a long time is not only not justified, but also dangerous.

To prevent a life-threatening worsening of the course of the disease, consideration should be given to revising the patient's treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids. The patient should be informed that in case of sudden development and rapid progression of shortness of breath, it is necessary to consult a doctor.

Other sympathomimetic bronchodilators should be prescribed simultaneously with Berodual N only under medical supervision. The patient should be informed about the rules for using the inhaler. Pain in the eye, blurred vision, a sensation of a halo or colored spots in front of the eyes, combined with redness of the eye in the form of conjunctival or corneal injection can be signs of an acute attack of angle-closure glaucoma.

If these symptoms appear in any combination, the patient should begin treatment with eye drops that cause the pupil to narrow, and immediately seek specialized medical help.

Aerosol for metered-dose inhalation.