Berodual H aerosol 20mcg + 50mcg 10ml 200doses

Berodual H instruction for use

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Composition

    1 dose contains:
    Active substances: fenoterola hydrobromide 50 mcg; ipratropium bromide monohydrate 21 μg, which corresponds to ipratropium bromide content of 20 μg.
    Excipients: ethanol absolute, purified water, citric acid, tetrafluoroethane (HFA 134a, propellant).
Packaging
Bottle 10 ml.

pharmachologic effect

Combined bronchodilator. Contains two components that have broncholytic activity: ipratropium bromide-m-cholinoblocker, and fenoterol hydrobromide-beta2-adrenomimetic.
In inhaled use of ipratropium bromide, bronchodilation is mainly due to local, rather than systemic, anticholinergic action.
Ipratropium bromide is a quaternary ammonium compound. Has anticholinergic (parasympatolytic) properties. Ipratropium inhibits reflexes mediated by the vagus nerve, counteracting the effect of acetylcholine, a neurotransmitter released from nerve endings. Anticholinergic drugs prevent the increase in the intracellular concentration of cyclic guanosine monophosphate (cGMP) in the smooth muscles of the bronchi, arising from the interaction of acetylcholine with m-cholinergic receptors.
Significant improvement in lung function (increase in FEV1 and mean volume rate of forced expiration by 15% and more) in COPD patients 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 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. In therapeutic doses, he selectively stimulates β2-adrenergic receptors of the bronchi. In higher doses, it has the ability to stimulate β1-adrenergic receptors. Binding to β2-adrenoceptors activates adenylate cyclase with the participation of a stimulating Gs-protein. An elevated 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 myosinkinase light chain, inhibition of hydrolysis of phosphoinositide and the discovery of calcium-activated potassium channels.
Fenoterol relaxes the smooth musculature of the bronchi and vessels and counteracts the development of bronchospastic reactions due to the influence of histamine, methacholine, cold air and allergens (immediate-type hypersensitivity reactions). Immediately after administration, fenoterol blocks the release of bronchoconstrictor mediators of inflammation 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 caused, mainly, by increased inclusion of potassium ions in skeletal muscles.
Beta-adrenergic effect of the drug on cardiac activity, such as increased 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, the stimulation of β1-adrenergic receptors. As with the use of other beta-adrenergic drugs, there was an increase in the QTc interval when applied at high doses.
The most commonly observed undesirable effect of β2-adrenoreceptor stimulants is tremor. In contrast to the effect on the smooth muscles of the bronchi, the systemic effects of β2-adrenoreceptor stimulants can develop tolerance.
Fenoterol prevents the development of bronchoconstriction caused by various stimuli, such as physical activity, cold air and allergens (immediate-type hypersensitivity reactions).
In the joint application of ipratropium bromide and fenoterol bronchodilator effect is achieved by affecting various pharmacological targets. These substances complement each other, as a result of increased bronchodilator effect and provides a great breadth of therapeutic effect for bronchopulmonary diseases, accompanied by constriction of the airways. Complementary action is such that, in order to achieve the desired effect, a lower dose of beta-adrenergic component is required, which facilitates individual dosing of the drug and helps minimize side effects.

Berodual H, indications for use

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

Contraindications for Berodual H

    Hypertrophic obstructive cardiomyopathy.
    Tachyarrhythmia.
    I trimester of pregnancy.
    Children under 6 years.
    Hypersensitivity to the components of the drug.
    Hypersensitivity to atropine-like substances.
With caution: use the drug with closed-angle glaucoma, coronary insufficiency, arterial hypertension, insufficiently controlled diabetes mellitus, recently transferred myocardial infarction, severe organic diseases of the cardiovascular system, hyperthyroidism, pheochromocytoma, prostatic hypertrophy, bladder neck obstruction, cystic fibrosis, children over 6 years.

Dosing and Administration

The dose is set individually.
For relief of asthma attacks, adults and children over 6 years of age are prescribed 2 inhalation doses. If no breathing is achieved within 5 minutes, another 2 inhalation doses may be prescribed.
The patient should be informed that in the absence of effect after 4 inhalation doses and the need for additional inhalations, the doctor should be consulted immediately.
Dosirovannym aerosol Berodual in children should be used only on the prescription of a doctor and under the supervision of adults.
For long-term and intermittent therapy, 1-2 inhalations are prescribed for 1 intake, up to 8 inhalations / day (on average, 1-2 inhalations 3 times / day).

Terms of use

The patient should be instructed about the correct use of the metered aerosol. Before using the metered aerosol for the first time, press the bottom of the canister twice.
Each time using a metered aerosol, the following rules must be observed:
Remove the protective cap.
    Make a slow, deep exhalation.
    Holding the balloon, grasp the mouthpiece with your lips. The cylinder should be pointed upside down.
    Drawing the deepest breath, simultaneously quickly press the bottom of the cylinder until the release of 1 inhalation dose. Hold the breath for a few seconds, then take the mouthpiece out of the mouth and exhale slowly. Repeat the procedure to obtain the 2nd inhalation dose.
    Put the protective cap on.
    If the aerosol canister has not been used for more than 3 days, it is advisable to press the bottom of the cylinder once before applying the aerosol cloud.
The cylinder is designed for 200 inhalations. Then the cylinder should be replaced. Despite the fact that some contents may remain in the container, the amount of drug released by inhalation decreases.

Application in pregnancy and lactation

The drug is contraindicated in the first trimester of pregnancy.
Existing experience has shown that ipratropium bromide and fenoterol hydrobromide do not have a negative effect in pregnancy. However, in the II and III trimesters of pregnancy, Berodual H should be used with caution. It is necessary to take into account the possibility of the inhibitory action of Berodual H on the contractile activity of the uterus.
Fenoterol hydrobromide is excreted in breast milk. Data confirming the isolation of ipratropium bromide with breast milk is not obtained. The significant effect of ipratropium on an infant, especially if the drug is applied in the form of an aerosol, is unlikely. However, given the ability of many medications to penetrate into breast milk. Caution should be used to administer Berodual H during lactation (breastfeeding).

Side effects of Berodual H

From the side of the central nervous system: often - a small 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, a feeling of palpitations (especially in patients with risk factors); rarely (when used in high doses) - reduced diastolic blood pressure, increased systolic blood pressure, arrhythmia, fibrillation, supraventricular tachycardia.
From the side of water-electrolyte balance: sometimes - pronounced hypokalemia.
On the part of the respiratory system: sometimes - cough, local irritation (pharyngitis); rarely - a paradoxical bronchospasm.
From the digestive system: often - dry mouth; sometimes - nausea, vomiting; rarely - reversible motor disorders of the digestive tract (constipation, diarrhea).
From the side of the organ of vision: rarely - reversible disruption of accommodation, mydriasis, increased intraocular pressure, angle-closure glaucoma, pain in the eyeball.
Allergic reactions: rarely - skin rash, angioedema, tongue, lips, face, urticaria, laryngospasm, laryngeal edema, anaphylactic shock.
Other: there may be increased sweating, weakness, myalgia, convulsions; rarely - reversible retention of urine.

special instructions

With prolonged use in patients suffering from 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 the need to conduct or enhance anti-inflammatory therapy to control the inflammatory process of the airways and the course of the disease.
Regular use of Berodual H in increasing doses for relief of bronchial obstruction can cause 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 reviewing the patient's treatment plan and about adequate anti-inflammatory therapy with inhaled glucocorticosteroids.
The patient should be informed that in case of sudden development and rapid progression of dyspnea, it is necessary to consult a doctor.
Other sympathomimetic bronchodilators should be administered simultaneously with Berodual N only under medical supervision.
The patient should be informed of the rules for using the inhaler.
Pain in the eye, blurred vision, sensation of the appearance 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 closed-angle glaucoma. If any of these symptoms occur, in any combination, the patient should begin treatment with eye drops causing a narrowing of the pupil, and immediately seek specialized medical care.
Patients with a history of mucoviscidosis may have gastrointestinal motility disorders with Berodual N.
One should consider the advisability of concomitant anti-inflammatory therapy in COPD in patients who have SCS, and in bronchial asthma.

Drug Interactions

Beta-adrenomimetics and anticholinergics, xanthine derivatives (including theophylline) can enhance the bronchodilator effect of Berodual N.
With the simultaneous use of other beta-adrenomimetics entering the systemic circulation of anticholinergic agents or xanthine derivatives (including theophylline), there may be an increase in side effects.
Perhaps a significant weakening of the bronchodilator action of Berodual N with concomitant administration of beta-blockers.
With simultaneous use with MAO inhibitors and tricyclic antidepressants, the effect of Berodual N.
Against the background of the application of Berodual H, hypokalemia may develop, which can be intensified by simultaneous administration with xanthine derivatives, GCS and diuretics. This fact should be taken into account in the treatment of patients with severe forms of obstructive airway disease.
Hypokalemia increases the risk of arrhythmias in patients receiving digoxin. In addition, hypoxia increases the negative effect of hypokalemia on the heart rhythm. In such cases it is recommended to monitor the potassium level in the blood serum.
Means for inhalation anesthesia, containing halogenated hydrocarbons (including halothane, trichlorethylene, enflurane), can enhance the action of Berodual H on the cardiovascular system.

Overdose

Symptoms are mainly associated with the action of fenoterol hydrobromide and are caused by excessive stimulation of β-adrenergic receptors: tachycardia, palpitation, tremor, arterial hypo- or hypertension, increase in pulse BP, angina pectoris, arrhythmia, hot flashes.
Symptoms of an overdose of ipratropium bromide: dry mouth, disruption of accommodation - due to the wide breadth of the therapeutic effect and inhalation use, are usually not very pronounced and transient.
Treatment: the appointment of sedatives, tranquilizers. If necessary, intensive therapy. As a specific antidote, it is possible to use beta-blockers, preferably selective beta-1 blockers. However, one should remember about the possible strengthening of 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.

Storage conditions

Keep out of reach of children at a temperature of no higher than 25 ° C.
The contents of the cylinder are under pressure. The cylinder should not be opened and subjected to heating above 50 ° C.
Shelf life - 3 years.

Terms of sell

To buy Berodual H you don't need a prescription.