Berodual® N (Ipratropium + Fenoterol) Metered Dose Inhaler, 200 doses (10 ml)
One dose of the drug contains
- Active ingredients: Ipratropium bromide monohydrate 0.021 mg (equivalent to ipratropium bromide 0.020 mg), Fenoterol hydrobromide 0.050 mg,
- Excipients : absolute ethyl alcohol, anhydrous citric acid, tetrafluoroethane (HFA 134a, propellant), purified water.
Contains two components of a combined bronchodilator drug with bronchodilator activity: ipratropium bromide – an m-anticholinergic blocker, and fenoterol hydrobromide – a beta2-adrenergic agonist.
With inhaled use of ipratropium bromide, bronchodilation is mainly due to local rather than systemic anticholinergic action. Ipratropium bromide is a quaternary ammonium compound. It has anticholinergic (parasympatholytic) properties.
Ipratropium inhibits vagus nerve reflexes by 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 (increase in FEV1 and mean forced expiratory flow rate by 15% or more) in COPD patients 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. In 40% of patients with bronchospasm associated with bronchial asthma, there is a significant improvement in lung function (increase in FEV1 by 15% or more).
Ipratropium bromide does not adversely affect airway mucus secretion, mucociliary clearance and gas exchange. Fenoterol hydrobromide has a direct sympathomimetic effect. In therapeutic doses, it selectively stimulates bronchial β2-adrenergic receptors. 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.
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 myosinkinase 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 type hypersensitivity reactions).
Immediately after administration, 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 due to 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 action 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, prolongation of the QTc interval has been observed with high doses.
The most commonly observed adverse effect of β2-adrenergic stimulants is tremor. In contrast to the effect on the smooth muscles of the bronchi, tolerance can develop to the systemic effects of β2-adrenergic stimulants. Fenoterol prevents the development of bronchoconstriction caused by various stimuli such as exercise, cold air and allergens (immediate hypersensitivity reactions).
With the combined use of ipratropium bromide and fenoterol, the bronchodilatory effect is achieved by acting on various pharmacological targets. These substances complement each other, as a result, the bronchodilator effect is enhanced and a wide range 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 dosing of the drug and helps to minimize side effects.
Prevention and treatment of obstructive airway diseases with reversible bronchospasm: Chronic bronchitis, complicated 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 adversely affect 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 received.
A significant effect of ipratropium on an infant, especially in the case of the use of the drug in the form of an aerosol, is unlikely. However, given the ability of many drugs to pass into breast milk.
Berodual®N should be prescribed with caution during lactation (breastfeeding).
Children’s age up to 6 years. 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, arterial hypertension, insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic diseases of the cardiovascular system, hyperthyroidism, pheochromocytoma, prostatic hypertrophy, bladder neck obstruction, with 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 – a small tremor of the skeletal muscles, nervousness; sometimes – headache, dizziness, (especially in patients with aggravating factors); in isolated cases – changes in the psyche.
Since the cardiovascular system: sometimes – tachycardia, palpitations (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 water and electrolyte balance: sometimes – severe hypokalemia.
From the respiratory system: sometimes – cough, local irritation (pharyngitis); rarely – paradoxical bronchospasm.
On the part of the organ of vision: rarely – reversible disturbance of accommodation, mydriasis, increased intraocular pressure, angle-closure glaucoma, pain in the eyeball.
Others: possibly increased sweating, weakness, myalgia, convulsions; rarely – reversible urinary retention.
From the digestive system: often – dry mouth; sometimes – nausea, vomiting; rarely – reversible gastrointestinal motility disorders (constipation, diarrhea).
Beta-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 N on the cardiovascular system.
With the simultaneous use of other beta-agonists entering the systemic circulation of anticholinergics or xanthine derivatives (including theophylline), side effects may increase. Perhaps a significant weakening of the bronchodilator action of Berodual N with the simultaneous appointment of beta-blockers.
With simultaneous use with MAO inhibitors and tricyclic antidepressants, there is an increase in the action of Berodual N. Against the background of the use of Berodual N, hypokalemia may develop, which can increase with simultaneous administration with xanthine derivatives, corticosteroids and diuretics.
This fact should be taken into account in the treatment of patients with severe forms of obstructive airways disease. Hypokalemia increases the risk of arrhythmias in patients receiving digoxin. In addition, during hypoxia, the negative effect of hypokalemia on the heart rate increases. In such cases, it is recommended to control the level of potassium in the blood serum.
How to take, course of administration and dosage
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 there is no relief in breathing within 5 minutes, 2 more inhalation doses can be prescribed. The patient should be informed that in case of no effect after 4 inhalation doses and the need for additional inhalations, you should immediately consult a doctor.
Dosed aerosol Berodual®N in children should be used only as directed by a doctor and under the supervision of adults. For long-term 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 correct use of the metered-dose aerosol. Before using the metered-dose aerosol for the first time, press the bottom of the can twice. Every time you use a metered-dose aerosol, the following rules must be observed: Remove the protective cap.
Take a slow, deep breath. While holding the balloon, wrap your lips around the mouthpiece. The balloon must be directed upside down. Taking the deepest possible breath, at the same time quickly press the bottom of the balloon until 1 inhalation dose is released. Hold your breath for a few seconds, then remove the mouthpiece from your mouth and exhale slowly.
Repeat steps to receive the 2nd inhalation dose. Put on the protective cap. If the aerosol can has not been used for more than 3 days, before use, press the bottom of the can once until an aerosol cloud appears. The balloon is designed for 200 inhalations. Then the balloon 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, tremor, arterial hypo- or hypertension, increased pulse blood pressure, angina pectoris, arrhythmia, hot flashes and symptoms of an overdose of ipratropium bromide: dry mouth, disturbance of accommodation – due to a wide range of therapeutic action and inhalation use, as a rule, are not very pronounced and have a transient character.
Treatment: the appointment of tranquilizers, sedatives. If necessary – intensive therapy. As a specific antidote, it is possible to use beta-blockers, preferably selective beta1-blockers. 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 be fatal.
In patients with a history of cystic fibrosis, gastrointestinal motility disorders are possible when using Berodual N. The advisability of concomitant anti-inflammatory therapy in COPD in patients with effective corticosteroids and in bronchial asthma should be considered.
With long-term use in patients with bronchial asthma or mild to moderate forms of COPD, symptomatic treatment may be preferable to regular use. With long-term use in patients with bronchial asthma or steroid-dependent forms of COPD, one should be aware of the need to conduct or enhance anti-inflammatory therapy to control the inflammatory process of the respiratory tract and the course of the disease.
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 N 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. 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 H only under medical supervision. The patient should be informed about the rules for using the inhaler. Eye pain, 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 a conjunctival or corneal injection may be signs of an acute attack of angle-closure glaucoma.
If any of the above symptoms appear, the patient should begin treatment with eye drops that cause pupillary constriction and immediately seek specialized medical attention.
Store in a place protected from light at a temperature not exceeding 25°C.
Keep out of the reach of children!
Shelf life – 3 years
Do not use after the expiry date stated on the package.
There are no reviews yet.