Berodualom (solution)

Active material: Fenoterol, Ipratropiya bromide
When ATH: R03AK03
CCF: Bronchodilators
ICD-10 codes (testimony): J43, J44, J45
When CSF: 12.01.05
Manufacturer: BOEHRINGER INGELHEIM INTERNATIONAL GmbH (Germany)

Pharmaceutical form, composition and packaging

The solution for inhalations clear, colorless or near colorless, free of suspended particles, with an almost imperceptible odor.

Excipients: benzalkonium chloride, disodium эdetata digidrat, sodium chloride, hydrochloric acid, Purified water.

20 ml – amber glass vials (1) with tube-dropper – packs cardboard.

Pharmacological action

Combined bronchodilators. It contains two components, having bronchodilator activity: ipratropiya bromide – Mr. holinoblokator and fenoterol hydrobromide – beta₂-adrenomimetik.

When inhaled ipratropium bromide caused bronchodilation, mainly, local, instead systemic anticholinergic.

When using ipratropium bromide in patients with bronchospasm, associated with COPD (chronic bronchitis and emphysema), significant improvement in lung function (increase in FEV₁ and mean forced expiratory volume velocity on 15% and more) It noted for 15 m, maximum effect is achieved through 1-2 hours and lasted in most patients to 6 hours after injection.

In 40% patients with bronchospasm, associated with asthma, It showed a significant improvement in lung function (increase in FEV₁ on 15 % and more) during treatment with ipratropium bromide.

Ipratropium bromide has no adverse effect on mucus secretion in the airways, mucociliary clearance and gas exchange.

Fenoterol hydrobromide selectively stimulates β₂-adrenoreceptory. It relaxes bronchial smooth muscle and blood vessels and prevents the development of bronchospastic reactions, due to the influence of histamine, metaxolina, cold air and allergens (immediate hypersensitivity reactions). Immediately after administration fenoterol blocking the release of mediators of inflammation and bronchial mast cell. Besides, when applying fenoterol higher doses showed an increase mucociliary clearance.

Beta-adrenergic effect of the drug on cardiac function, such as increased heart rate and force of heart contractions, due to the action of vascular fenoterol, стимуляцией b₂-adrenoreceptors of the heart, and when used in doses, exceeding therapeutic, стимуляцией b₁-adrenoreceptorov. The most frequently observed undesirable effect of stimulants β₂-adrenoceptor is tremor.

When combined ipratropium bromide and fenoterol bronhilatiruyuschy effect is achieved by acting on different pharmacological targets. These substances are complementary, resulting in enhanced antispasmodic effect on the bronchial muscles and allow for greater breadth of therapeutic action in bronchopulmonary diseases, accompanied by constriction of the respiratory tract. Complementary actions such, that to achieve the desired effect requires a lower dose of beta-adrenergic component, allowing the individual to choose an effective dose of the substantial absence of side effects.

Pharmacokinetics

The concentrations of active components in plasma, detectable after inhalation application, correlate with their therapeutic effect.

Blood plasma concentration after inhalation are from 500-1000 times lower, concentration than, observed after administration of equivalent doses of the therapeutic effect of the drug inside. Effect of the drug after inhalation application comes quickly.

Testimony

- Prevention and symptomatic treatment of chronic obstructive airways disease with reversible bronchospasm, such as bronchial asthma and, especially, COPD (chronic bronchitis, emphysema).

Dosage regimen

In Adult (including the elderly) and older teens 12 years at acute mild to moderate asthma attacks the drug is prescribed in a dose 1 ml (20 drops).

At severe cases, such patients, are in intensive care units, the drug is prescribed at higher doses to 2.5 ml (50 drops).

IN severe cases possible use of the drug (under medical supervision) to the maximum dose 4 ml (80 drops).

In children 6-12 years at acute attacks of asthma for quick relief of symptoms it is recommended to prescribe the drug at a dose of 0.5-1 ml (10-20 drops); in severe cases – to 2 ml (40 drops); in severe cases possible use of the drug (under medical supervision) to the maximum dose 3 ml (60 drops).

To course and long-term care adult (including the elderly) and adolescents over 12 years the drug is prescribed in a dose 1-2 ml (20-40 drops) 4 times / day. The maximum daily dose – 8 ml. For children 6-12 years appoint 0.5-1 ml (10-20 drops) 4 times / day. The maximum daily dose – 4 ml.

IN moderate case of bronchospasm or as an aid in the implementation of the ventilation adult (including the elderly), adolescents over 12 years, and children aged 6-12 years recommended dose 0.5 ml (10 drops).

In children under the age of 6 years (weight less 22 kg) because, Information about use of the drug in this age group is limited, recommended next dose (only under medical supervision): 25 micrograms ipratropium bromide 50 fenoterol hydrobromide micrograms per kilogram of body weight (per dose) = 0.5 ml (10 drops) to 3 time / day.

The maximum daily dose – 1.5 ml.

Treatment should usually start with the lowest recommended dose.

Terms of use of the drug

The recommended dose should be diluted with saline to a final volume, constituent 3-4 ml, and apply (fully) via nebulizer.

Inhalation Solution should not be diluted with distilled water.

Dilution should be carried out every time before use; the remains of the diluted solution should be destroyed.

Dosing may depend on the method and type of inhalation nebulizer. The duration of inhalation can be controlled by spending diluted volume.

Solution for inhalation can be applied using various commercial models nebulizers. Where, when there is a wall-mounted oxygen, solution is best to apply at a flow rate 6-8 l / min. If necessary, this dose may be repeated at intervals, is not less than 4 no.

Side effect

The most common adverse effects They are fine tremor of skeletal muscles, nervousness, dry mouth and taste change; less marked headache, dizziness, tachycardia and palpitations, especially in patients with aggravating factors.

The respiratory system: cough, respiratory tract irritation; rarely – paradoxical bronchospasm.

From the digestive system: nausea, vomiting, gastrointestinal dysmotility (especially in patients with cystic fibrosis).

Cardio-vascular system: rarely – decrease in diastolic blood pressure, increase in systolic blood pressure, Arrhythmia.

On the part of the organ of vision: in contact with the eyes – reversible damage accommodation, midriaz, increased intraocular pressure (pain or discomfort in the eyeball, blurred vision, feeling of ghosting or color spots before my eyes, conjunctival hyperemia).

Allergic reactions: rarely – skin rash, angioedema language, lips and face, hives.

Other: kaliopenia, increased perspiration, feeling of general weakness, mialgii, muscle cramps, mental changes, urinary retention.

Contraindications

- Gipertroficheskaya obstruktivnaya cardiomyopathy;

- Dryness;

- Hypersensitivity to the drug;

- Hypersensitivity to the drug atropine.

FROM caution should be prescribed the drug for angle-closure glaucoma, coronary insufficiency, hypertension, diabetes, recent myocardial infarction, severe organic heart disease and vascular, gipertireoze, pheochromocytoma, prostatic hyperplasia, bladder outlet obstruction, mukovystsydoze, pregnancy, during breastfeeding, children under the age of 6 years.

Pregnancy and lactation

Observe the usual precautions, associated with the use of medications during pregnancy, especially in the I trimester.

Keep in mind the possibility of an inhibitory effect of Berodual^® on the contractile activity of the uterus.

Fenoterol hydrobromide is excreted in breast milk. Data, confirmatory, that ipratropium bromide is excreted in breast milk is not obtained. However, given the, that many drugs penetrate the breast milk, It should be used with caution Flomax^® during breastfeeding.

Cautions

The patient should be informed, that in the event of an unexpected rapid amplification of dyspnea should seek medical advice immediately.

It should be taken into account, In patients with asthma or mild and moderate chronic obstructive pulmonary disease symptomatic treatment may be preferable to regular use.

In patients with asthma or severe chronic obstructive pulmonary disease should be aware of the need for strengthening or anti-inflammatory therapy to control inflammation of the airways and the disease.

Regular use of increasing doses of drugs, containing beta₂-adrenomimetiki, such as Flomax^®, for the relief of bronchial obstruction can cause an uncontrolled deterioration of the disease. In the case of amplification of bronchial obstruction simply increasing doses of beta₂-adrenomimetikov (incl. Beroduala^®) more than the recommended for a long time, not only justified, but also dangerous. To prevent life-threatening deterioration of disease should consider reviewing the patient's treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids.

Other sympathomimetic bronchodilators should be administered simultaneously with Berodual^® only under medical supervision.

Patients should be instructed on the correct use of the inhalation solution Berodual^®. Care should be exercised to prevent contact with eyes.

Recommended, to a solution of, used with a nebulizer, He inhales through a mouthpiece. In the absence of a mouthpiece should be used to the tight face mask. Particular care should be concerned about the protection of the patient's eye, predisposed to the development of glaucoma.

Shortly before giving birth should stop taking the drug because of the possibility of weakening of labor under the influence of fenoterol.

Overdose

Symptoms: Overdose symptoms are usually associated primarily with the effect of fenoterol (symptoms, associated with excessive stimulation of β-adrenergic receptors). The most likely to occur tachycardia, heartbeat, tremor fingers, arterïalnoy hypo- or hypertension, increasing the difference between systolic and diastolic blood pressure, arrythmia, angina, arrhythmia and feelings flares, Gain bronchoobstruction.

Possible overdose symptoms, due to the action of ipratropium bromide (such as dry mouth, ccomodation eyes), They are mild and have a transient, due to the wide range of therapeutic doses of the drug and its topical application.

Treatment: we recommend the use of sedatives, trankvilizatorov; in severe cases – intensive therapy.

As a specific antidote is possible to use β-adrenergic blocker, preferably selective beta₁-adrenoblokatorov. However, in patients with asthma or chronic obstructive pulmonary disease should consider increasing bronchial obstruction under the influence of beta-blockers and their dose of carefully selected.

Drug Interactions

Beta-agonists and anticholinergics, xanthine derivatives (incl. theophylline) can enhance the effect of bronchodilator Berodual^®.

With simultaneous use of other beta-agonists, anticholinergics systemic effects, xanthine derivatives (eg, teofillina) may increase the side effects.

Perhaps the significant weakening of bronchodilator action Berodual^® while the use of beta-blockers.

Kaliopenia, associated with beta-agonists, It can be amplified using simultaneous xanthine derivatives, steroids and diuretics. This fact should be given special attention in the treatment of patients with severe obstructive airways disease.

Hypokalemia may increase the risk of arrhythmias in patients, receiving digoxin. Besides, Hypoxia can exacerbate the negative impact of hypokalemia on cardiac rhythm. In such cases it is advisable to carry out monitoring of the level of potassium in the blood serum.

It should be used with caution in the beta-adrenergic agents to patients, Gets MAO inhibitors and tricyclic antidepressants, tk. These drugs can increase the effects of beta-adrenergic agents.

The use of halogenated inhalation anesthetics, eg, halothane, trichlorethylene and enflurane, may enhance the effect of beta-adrenergic agents to the cardiovascular system.

The combined use of Berodual^® kromoglitsievoy with acid and / or corticosteroids increases the effectiveness of treatment.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at or above 30 ° C; Do not freeze. Shelf life – 5 years.