Berodual is used for prevention and...
Berodual is used for prevention and symptomatic treatment of obstructive airways diseases with reversible bronchospasm: chronic bronchitis, complicated or not complicated by emphysema, bronchial asthma.
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Dosage form, composition and packaging
Metered aerosol for inhalation in the form of a transparent, colorless or slightly yellowish or slightly brownish liquid, free from suspended particles.
ipratropium bromide monohydrate
which corresponds to the content of ipratropium bromide
Combined broncholytic drug. It contains two components having bronchodilator activity: ipratropium bromide - M-cholinoblocker, and fenoterol hydrobromide - beta2-adrenergic agonist.
In case of inhalation use of ipratropium bromide the bronchodilation is mainly due to local rather than systemic anticholinergic effects.
Ipratropium bromide is a quaternary ammonium compound. It has anticholinergic (parasympatholytic) properties. Ipratropium slows reflexes mediated by the vagus nerve, counteracting the effect of acetylcholine - a neuromediator released from nerve endings. Anticholinergics prevent the increase in intracellular concentration of cyclic guanosine monophosphate (cGMP) in the smooth muscles of the bronchi caused by interaction of acetylcholine with M-cholinoreceptors.
Berodual N aerosol interactions
Beta-adrenergic agonists and anticholinergics, xanthine derivatives (including theophylline) may enhance the bronchodilatory effect of Berodual N.
In case of simultaneous use of other beta-adrenergic agonists, anticholinergics entering the systemic circulation or xanthine derivatives (including theophylline) side effects may be increased.
The significant reduction of bronchodilator effect of Berodual N is possible in case of simultaneous administration of beta-blockers.
In case of simultaneous administration with MAO inhibitors and tricyclic antidepressants the increased effect of Berodual N is observed.
During the use Berodual N hypokalemia may develop, which can be increased in case of simultaneous use of xanthine derivatives, cortical hormones and diuretics. This fact should be taken into account when treating patients with severe forms of obstructive airways diseases.
Hypokalemia increases the risk of arrhythmias in patients receiving digoxin. In addition, in case of hypoxia the negative impact of hypokalemia on cardiac rhythm is increased. In such cases it is advisable to monitor the level of potassium in the blood serum.
The products for inhalation anesthesia containing halogenated hydrocarbons (including halothane, trichlorethylene, enflurane), may increase the effect of Berodual N on the cardiovascular system.
Berodual N aerosol in Pregnancy and lactation
The drug is contraindicated in the I trimester of pregnancy.
Existing experience has shown that ipratropium bromide and fenoterol hydrobromide do not adversely affect pregnancy. However, in the II and III trimester of pregnancy Berodual N should be used with caution. It is necessary to consider the possibility of the inhibitory effect of Berodual N on the contractile activity of the uterus.
Fenoterol hydrobromide is excreted in breast milk. Data supporting the excretion of ipratropium bromide in breast milk have not been obtained. Significant impact of ipratropium on the infant is unlikely, particularly when the drug is used in aerosol form. Nevertheless, given the ability of many drugs to excrete in breast milk, Berodual N should be used with caution during lactation (breastfeeding).
Berodual N Side effects
CNS: often - a fine tremor of skeletal muscles, nervousness; sometimes - headache, dizziness (especially in patients with confounding factors); in isolated cases - mental changes.
Cardio-vascular system: sometimes - tachycardia, palpitations (especially in patients with risk factors); rarely (when used in high doses) - decrease in diastolic blood pressure, increase in systolic blood pressure, arrhythmia, atrial fibrillation, supraventricular tachycardia.
Water-electrolyte balance: sometimes - severe hypokalemia.
Respiratory system: sometimes - cough, local irritation (pharyngitis); rarely - paradoxical bronchospasm.
Digestive system: often - dry mouth; sometimes - nausea, vomiting; rarely - reversible gastrointestinal dysmotility (constipation, diarrhea).
Organs 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, laryngospasm, laryngeal edema, anaphylactic shock.
Miscellaneous: possible increased sweating, weakness, myalgia, muscle cramps; rarely - reversible urinary retention.
Storage time and conditions
The drug should be stored out of children’s reach at a temperature not exceeding 25°C. Shelf life - 3 years.
The content of the container is pressurized. The container must not be opened or exposed to heat above 50°C.
Berodual N Indications
Prevention and symptomatic treatment of obstructive airways diseases with reversible bronchospasm:
Berodual N Contraindications
- hypersensitivity to atropine-like substances.
The drug is used with caution in patients with angle-closure glaucoma, coronary insufficiency, arterial hypertension, inadequately 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 of age.
In case of long-term use in patients with bronchial asthma or mild and moderate COPD forms the symptomatic treatment may be preferable to regular use.
In case of long-term use in patients with bronchial asthma or hormon-dependent COPD forms one should be aware of the need for conducting or enhancement of anti-inflammatory therapy to control inflammation of the airways and the disease.
Regular use of Berodual N in increasing doses for relief of bronchial obstruction can cause uncontrolled worsening of the disease. In the event of bronchial obstruction simple Berodual N dose increase in dose over the recommended one for a long time is not only unjustified, but also dangerous. To prevent life-threatening exacerbation of the disease one should consider reviewing the patient's treatment plan and an appropriate anti-inflammatory therapy with inhaled cortical hormones.
The patient should be informed that in case of a sudden onset and rapid progression of shortness of breath they should seek medical help.
Other sympathomimetic bronchodilators should be administered simultaneously with Berodual N only under medical supervision.
The patient should be informed about the rules of use of the inhaler.
Eye pain, blurred vision, seeing halos or color spots before the eyes, combined with redness of the eyes in the form of conjunctival or corneal injection may be signs of an acute attack of angle-closure glaucoma. In case of appearance of the abovementioned symptoms in any combination, the patient should begin treatment with eye drops, causing constriction of the pupil, and immediately seek specialized medical care.
Patients with a history of cystic fibrosis may have gastrointestinal dysmotility during the application of Berodual N.
One should consider the feasibility of concomitant anti-inflammatory therapy in COPD patients in whom cortical hormones are effective, and in bronchial asthma patients.
In case of renal impairment
The drug should be used with caution in patients with bladder outlet obstruction.
It is contraindicated for children under 6 years of age.
The drug should be used with caution in children over 6 years of age.