Berodual N, inhalation aerosol, 200 doses, 10ml

Composition

1 dose contains:

active ingredients:

fenoterol hydrobromide 50 mcg;

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

excipients:

absolute ethanol,

purified water,

citric acid,

tetrafluoroethane (HFA 134a, propellant).

Pharmacological action

It contains two components of a combined bronchodilator with bronchodilator activity: ipratropium bromide-m-holinoblokator, and fenoterol hydrobromide-beta 2-adrenomimetic.

When ipratropium bromide is inhaled, bronchodilation is mainly due to local, rather than systemic, anticholinergic effects. Ipratropium bromide is a quaternary ammonium compound. It has anticholinergic (parasympatholytic) properties.

Ipratropium inhibits reflexes mediated by the vagus nerve, counteracting the effect of acetylcholine, a neurotransmitter released from nerve endings. Anticholinergic agents 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.

Significant improvement in lung function (increased FEV 1 and average forced expiratory volume rate by 15% or more) in patients with COPD with bronchospasm attacks occurs within 15 minutes, the maximum effect is achieved in 1-2 hours and lasts in most patients up to 6 hours after use. In 40% of patients with bronchospasm associated with bronchial asthma, there is a significant improvement in lung function (an increase in FEV 1 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 the beta2-adrenergic receptors of the bronchi. In higher doses, it has the ability to stimulate beta-1-adrenergic receptors. Binding to β2-adrenergic receptors activates adenylate cyclase with the participation of the stimulating Gs protein.

Elevated levels of cyclic AMP activate protein kinase A, which then phosphorylates target proteins in smooth muscle cells. This, in turn, leads to phosphorylation of the myosin kinase light chain, inhibition of phosphoinositide hydrolysis, and opening of calcium-activated potassium channels. Fenoterol relaxes the smooth muscles of the bronchi and blood vessels and counteracts the development of bronchospastic reactions caused by the influence of histamine, methacholine, cold air and allergens (immediate hypersensitivity reactions).

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

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

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 beta-2-adrenergic receptors of the heart, and when used in doses exceeding therapeutic ones, stimulation of beta-1-adrenergic receptors. As with other beta-adrenergic drugs, prolongation of the QT interval was observed when used in high doses.

The most frequently observed adverse effect of beta-2-adrenergic stimulants is tremor. In contrast to the effect on the smooth muscles of the bronchi, tolerance may develop to the systemic effects of beta-2-adrenergic stimulators. Fenoterol prevents the development of bronchoconstriction caused by various stimuli, such as exercise, cold air, and allergens (immediate hypersensitivity reactions).

When combined with ipratropium bromide and fenoterol, the bronchodilator effect is achieved by acting on various pharmacological targets. These substances complement each other, as a result, the bronchodilator effect is enhanced and a greater breadth of therapeutic action is provided for bronchopulmonary diseases accompanied by airway constriction.

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

Indications

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

Use during pregnancy and lactation

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

However, in the second and third trimesters of pregnancy, Berodual®H should be used with caution. It is necessary to take into account the possibility of an inhibitory effect of Berodual H on the contractile activity of the uterus. Fenoterol hydrobromide is excreted in breast milk. There are no data confirming the excretion of ipratropium bromide in breast milk.

A significant effect of ipratropium on an infant, especially in the case of using the drug in the form of an aerosol, is unlikely. However, given the ability of many medications to pass into breast milk.

Berodual ® H should be prescribed with caution during lactation (breastfeeding).

Contraindications

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

Hypersensitivity to atropine-like substances.

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

Side effects

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

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

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

From the side of the water-electrolyte balance: sometimes-pronounced hypokalemia.

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

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

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

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

Interaction

of Beta-adrenomimetics and anticholinergics, xanthine derivatives (including theophylline) may enhance the bronchodilator effect of Berodual N.

Inhalation anesthesia products containing halogenated hydrocarbons (including halothane, trichloroethylene, and enflurane) can enhance the effect of Berodual H on the cardiovascular system.

Concomitant use of other beta-adrenomimetics, systemic anticholinergic agents or xanthine derivatives (including theophylline) may increase side effects. It is possible to significantly weaken the bronchodilator effect of Berodual H with simultaneous use of beta-blockers.

When used concomitantly with MAO inhibitors and tricyclic antidepressants, the effect of Berodual H is enhanced. Against the background of the use of Berodual H, hypokalemia may develop, which may increase with simultaneous use with xanthine derivatives, corticosteroids and diuretics.

This fact should be taken into account in the treatment of patients with severe obstructive airway diseases. Hypokalemia increases the risk of arrhythmias in patients receiving digoxin. In addition, hypoxia increases the negative impact of hypokalemia on the heart rate. In such cases, it is recommended to monitor the level of potassium in the blood serum.

How to take it, course of use and dosage

The dose is set individually, but to stop attacks of bronchial asthma, adults and children over 6 years of age are prescribed 2 inhaled doses. If there is no relief of breathing within 5 minutes, you can prescribe 2 more inhaled doses. The patient should be informed that if there is no effect after 4 inhaled doses and additional inhalations are required, you should immediately consult a doctor.

Metered-dose aerosol Berodual®H in children should only be used as prescribed by a doctor and under adult supervision.For long-term and intermittent therapy,1-2 inhalations are prescribed for 1 reception, up to 8 inhalations/day (on average,1-2 inhalations 3 times/day). Instructions for use of the drug The patient should be instructed on the correct use of the metered-dose aerosol. Before using the metered-dose spray for the first time, double-tap the bottom of the can. Each time you use a metered-dose aerosol, you must follow the following rules:: Remove the protective cap.

Take a slow, deep breath out. While holding the balloon, wrap your lips around the mouthpiece. The balloon must be pointed upside down. While inhaling as deeply as possible, quickly press the bottom of the cylinder until 1 inhaled dose is released. Hold your breath for a few seconds, then remove the mouthpiece from your mouth and exhale slowly.

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

Overdose

Symptoms: fenoterol hydrobromide and are caused by excessive stimulation of beta-adrenergic receptors: tachycardia, palpitation, tremor, arterial hypo – or hypertension, increased pulse blood pressure, angina pectoris, arrhythmia, hot flashes and symptoms of overdose ipratropia bromide: dry mouth, accommodation disorders-due to the large breadth of therapeutic action and inhalation use, as a rule, are poorly expressed and have a transient character.

Treatment: use of tranquilizers, sedatives. If necessary – intensive care. Beta-blockers, preferably selective beta-1 blockers, may be used as a specific antidote. However, one should be aware of 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 risk of severe bronchospasm, which can lead to death.

Special instructions

In patients with a history of cystic fibrosis, gastrointestinal motility disorders may occur when using Berodual N. The expediency of concomitant anti-inflammatory therapy for COPD in patients with effective corticosteroids and bronchial asthma should be considered.

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

Regular use of Berodual H in increasing doses to relieve bronchial obstruction may cause uncontrolled deterioration of the course of the disease. In the case of increased bronchial obstruction, simply increasing the dose of Berodual H beyond the recommended dose 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 reviewing 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 administered simultaneously with Berodual and only under medical supervision. The patient should be informed about the rules for using the inhaler. Pain in the eye, blurred vision, a feeling 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 start treatment with eye drops that cause pupil constriction, and immediately seek specialized medical attention.

Form of production

Metered-dose aerosol for inhalation.

Storage conditions

Keep out of reach of children at a temperature not exceeding 25°C. The contents of the cylinder are under pressure. The cylinder must not be opened or exposed to heat above 50°C.

Shelf life

3 years

Active ingredient

Ipratropium bromide, Fenoterol

Conditions of release from pharmacies

By prescription

Dosage form

aerosol for inhalation

Purpose

Children as prescribed by a doctor, Pregnant women as prescribed by a doctor, Adults as prescribed by a doctor, Children over 6 years of age, Nursing mothers as prescribed by a doctor

Indications

Bronchospasm, Bronchitis, Chronic Obstructive pulmonary disease, Bronchial asthma