Berodual N 20mkg + 50mkg / dose 200dosol inhalation spray 10ml
Clinico-pharmacological group:Bronchodilator drug
pharmachologic effectCombined bronchodilator drug. It contains two components with bronchodilator activity: ipratropium bromide - m-holinoblokator, and fenoterol hydrobromide - beta2-adrenomimetic.
In case of inhalation use of ipratropium bromide, 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. 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 an average forced expiratory flow rate of 15% or more) in patients with COPD with bouts of bronchospasm occurs within 15 minutes, the maximum effect is achieved within 1-2 hours and continues 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 (an increase in FEV1 by 15% or more).
Ipratropium bromide does not adversely affect the secretion of mucus in the respiratory tract, mucociliary clearance and gas exchange.
Fenoterol hydrobromide has a direct sympathomimetic effect. At therapeutic doses, it selectively stimulates the bronchial β2-adrenoreceptors. At higher doses, it has the ability to stimulate β1-adrenoreceptors. Binding to β2-adrenoreceptors activates adenylate cyclase with the participation of a stimulating Gs protein. An increased level of cyclic AMP activates protein kinase A, which then phosphorylates target proteins in smooth muscle cells. This, in turn, leads to phosphorylation of the light chain of myosine kinase, inhibition of the hydrolysis of phosphoinositide and the 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 effect of histamine, methacholine, cold air and allergens (immediate type hypersensitivity reactions). Immediately after the appointment, fenoterol blocks the release of bronchoconstrictor mast cell inflammatory mediators. The use of fenoterol in higher doses increases mucociliary clearance.
At higher concentrations of fenoterol in plasma, 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 the increased inclusion of potassium ions in skeletal muscle.
The beta-adrenergic effect of the drug on heart activity, such as an increase in heart rate and cardiac strength, is due to the vascular action of fenoterol, stimulation of heart β2-adrenoreceptors, and when used in doses exceeding therapeutic, stimulation of β1-adrenoreceptors. As with the use of other beta-adrenergic drugs, prolonged QTc interval was observed when used in high doses.
The most frequently observed undesirable effect of β2-adrenoreceptor stimulants is a tremor. In contrast to the impact on the smooth muscles of the bronchi to the systemic effects of stimulators of β2-adrenoreceptors, tolerance may develop.
Fenoterol prevents the development of bronchoconstriction caused by various stimuli, such as exercise, cold air and allergens (immediate type hypersensitivity reactions).
With the combined use of 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 ensured 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 individual dosing of the drug and helps to minimize side effects.
PharmacokineticsData on the pharmacokinetics of the drug Berodual&№174;N not provided.
Indications for use of the drug BERODUAL HPrevention and symptomatic treatment of obstructive respiratory diseases with reversible bronchospasm:
- bronchial asthma;
- chronic bronchitis, complicated or not complicated by emphysema.
Side effectFrom the side of 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.
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, increased systolic blood pressure, arrhythmia, fibrillation, supraventricular tachycardia.
From the side of water and electrolyte balance: sometimes - severe hypokalemia.
From the side of the respiratory system: sometimes - cough, local irritation (pharyngitis); rarely, paradoxical bronchospasm.
On the part of the digestive system: often - dry mouth; sometimes nausea, vomiting; rarely - reversible violations of GI motility (constipation, diarrhea).
On the part of the organ of vision: rarely - reversible disturbance of accommodation, mydriasis, increased intraocular pressure, angle-closure glaucoma, pain in the eyeball.
Allergic reactions: rarely - skin rash, angioedema of the tongue, lips, face, urticaria, laryngism, laryngeal edema, anaphylactic shock.
Other: possible increased sweating, weakness, myalgia, seizures; rarely reversible urinary retention.
Contraindications to the use of the drug BEREDUAL N- hypertrophic obstructive cardiomyopathy;
- I trimester of pregnancy;
- children's age up to 6 years;
- hypersensitivity to the drug;
- hypersensitivity to atropin-like substances.
With care use in patients with angle-closure glaucoma, coronary artery disease, hypertension, insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic diseases of the cardiovascular system, hyperthyroidism, pheochromocytoma, prostatic hypertrophy, bladder outlet obstruction, cystic fibrosis in children over 6 years old.
Use of the drug BERODUAL N in pregnancy and lactationThe drug is contraindicated for use 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, BerodualN should be used with caution. It is necessary to consider the possibility of the inhibitory effect of Berodual H on the contractile activity of the uterus.
Fenoterol hydrobromide is excreted in breast milk. Data confirming the allocation of ipratropium bromide with breast milk, not received. A significant effect of ipratropium on the 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 penetrate into breast milk. It is necessary to appoint with caution BerodualN in the period of lactation (breastfeeding).
Application for violations of kidney functionWith caution, use the drug for obstruction of the bladder neck.
special instructionsWith prolonged use in patients with bronchial asthma or light and 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 be aware of the need for or strengthening of 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 to relieve bronchial obstruction can cause an uncontrolled deterioration in 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 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 GCS.
The patient should be informed that in case of sudden development and rapid progression of shortness of breath, you should consult a doctor.
Other sympathomimetic bronchodilators should be prescribed 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 appearance of a halo or colored spots before the eyes, in combination 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. When these symptoms occur in any combination, the patient should begin treatment with eye drops causing pupil constriction and immediately seek specialized medical care.
In patients with indications of a history of cystic fibrosis, gastrointestinal motility disorders are possible when using Berodual N.
The appropriateness of concomitant anti-inflammatory therapy in patients with COPD in patients with GCS and in bronchial asthma should be considered.
OverdoseSymptoms are associated primarily with the action of fenoterol hydrobromide and are due to excessive stimulation of β-adrenoreceptors: tachycardia, palpitations, tremor, arterial hypo- or hypertension, increased pulse blood pressure, angina, arrhythmia, flushing, metabolic acidosis.
Symptoms of an overdose of ipratropium bromide: dry mouth, disturbed accommodation - due to the large breadth of therapeutic action and inhalation use, as a rule, are poorly expressed and have a transient nature.
Treatment: the appointment of sedatives, tranquilizers. If necessary, intensive therapy. As a specific antidote, beta-blockers may be used, preferably selective beta-blockers. However, you 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 danger of severe bronchospasm, which can be fatal.
Drug interactionBeta adrenomimetics and anticholinergics, xanthine derivatives (including theophylline) can enhance the bronchodilator effect of Berodual N.
With the simultaneous use of other beta-adrenergic agonists, anticholinergics or xanthine derivatives entering the systemic circulation (includingtheophylline) may increase side effects.
Perhaps a significant weakening of the bronchodilator action of Berodual H with the simultaneous appointment of beta-blockers.
With simultaneous use with MAO inhibitors and tricyclic antidepressants, an increase in the action of Berodual N. is noted.
Against the background of the use of Berodual H, the development of hypokalemia is possible, which can be intensified with simultaneous administration with xanthine derivatives, GCS and diuretics. This fact should be taken into account when treating patients with severe obstructive respiratory diseases.
Hypokalemia increases the risk of arrhythmias in patients receiving digoxin. In addition, during hypoxia, the negative effect of hypokalemia on the heart rhythm is enhanced. In such cases, it is recommended to monitor the level of potassium in the serum.
Means for inhalation anesthesia containing halogenated hydrocarbons (including halothane, trichlorethylene, enflurane) can enhance the effect of Berodual H on the cardiovascular system.
It is a drug. Consultation with a doctor is required.
CompositionDosed inhalation aerosol as a clear, colorless or slightly yellowish, or slightly brownish liquid, free from suspended particles.
- fenoterol hydrobromide 50 &№181;g
- ipratropium bromide monohydrate 21 &№181;g, which corresponds to the content of ipratropium bromide 20 &№181;g
Excipients: absolute ethanol, purified water, citric acid, tetrafluoroethane (HFA 134a, propellant).
Mode of applicationDose set individually.
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 the need for additional inhalations, you should immediately consult a doctor.
Dosed aerosol Berodual&№174;N in children should be used only on prescription and under the supervision of adults.
For long-term and intermittent therapy, 1-2 inhalations are prescribed per administration, up to 8 inhalations / (on average, 1-2 inhalations 3).
The patient should be instructed in the proper use of the metered-dose aerosol.
Before using the metered aerosol for the first time, double-click on the bottom of the can.
Each time you use a metered aerosol, you must observe the following rules:
1. Remove the protective cap.
2. Make a slow, deep breath.
3. Holding the balloon, clasp the mouthpiece with your lips. The cylinder must face upside down.
4. Making the maximum deep breath, at the same time quickly press the bottom of the balloon until the release of 1 inhalation dose. Hold your breath for a few seconds, then take the mouthpiece out of your mouth and exhale slowly. Repeat steps to obtain the 2nd inhalation dose.
5. Put on the protective cap.
6. If the aerosol canister has not been used for more than 3 days, before applying, press the bottom of the bottle once until the aerosol cloud appears.
The balloon is designed for 200 inhalations. Then the cylinder should be replaced. Although some contents may remain in the bottle, the amount of drug released during inhalation is reduced.
Since the balloon is opaque, the amount of the drug in the balloon can be determined as follows: removing the protective cap, the balloon is immersed in a container filled with water. The amount of the drug is determined depending on the position of the cylinder in the water.
The mouthpiece should be kept clean, if necessary it can be washed in warm water. After using soap or detergent, rinse the mouthpiece thoroughly with water.
The plastic mouthpiece is designed specifically for Berodual&№174;H metered-dose aerosol and is used for precise dosing of the drug. The mouthpiece should not be used with other metered aerosols. It is also impossible to use the dosed aerodol Berodual&№174;N with other mouthpieces.
Pharmacy sales terms
The drug is available on prescription.
Terms and conditions of storage
The drug should be stored out of reach of children at a temperature not exceeding 25 &№176; C.
The contents of the container is under pressure. The cylinder must not be opened and subjected to heating above 50 &№176; C.