Expiration date: 01/2025

Composition and form of release:

Solution for inhalation 1 ml

ipratropia bromide 0, 261 mg

(which corresponds to 0, 25 mg of ipratropium bromide anhydrous)

phenoterol hydrobromide 0, 5 mg

in dropper bottles of 20 ml (1 ml = 20 drops) in a box 1 bottle.

Aerosol inhalation dosed 1 dose

ipratropia bromide 0, 021 mg

(which corresponds to 0, 02 mg of ipratropium bromide anhydrous)

phenoterol hydrobromide 0, 05 mg

propellant: 1, 1, 1, 2-Tetrafluoroethane (HFA 134a)

excipients: citric acid anhydrous distilled water ethanol

in aerosol cans with a mouthpiece of 10 ml (200 doses) in a box 1 balloon.

Pharmacological action:

Berodual contains two components that have broncholytic activity: ipratropium bromide-m-holinoblokator, and phenoterol hydrobromide-beta2-adrenomimetic. These active components complement each other, resulting in increased spasmolytic effect on the muscles of the bronchi.

Bronchodilation with inhalation administration of ipratropium bromide is mainly due to local, rather than systemic anticholinergic action.

In patients with bronchospasm associated with chronic obstructive pulmonary diseases (chronic bronchitis and emphysema), a significant improvement in lung function (an increase in forced expiratory volume for 1 s (FEV1) and the average volume rate of forced expiration by 15% or more) is observed after 15 minutes, the maximum effect is achieved after 1-2 hours and continues in most patients up to 6 hours.

Ipratropia bromide does not adversely affect mucus secretion in the respiratory tract, mucociliary clearance and gas exchange.

Phenoterol hydrobromide selectively stimulates beta2-adrenergic receptors.

Phenoterol relaxes the smooth muscles of the bronchi and blood vessels and counteracts the development of bronchospastic reactions due to the influence of histamine, metacholine, cold air and allergens (immediate hypersensitivity reactions). Phenoterol blocks the release of inflammatory mediators and bronchial obstruction from mast cells, and also increases mucociliary clearance.

The beta-adrenergic effect of the drug on cardiac activity (increase in strength and heart rate) is due to the vascular action of phenoterol, stimulation of beta2-adrenergic receptors of the heart, and when using doses exceeding therapeutic ones, stimulation of beta1 — adrenergic receptors. Tremor is the most frequent undesirable effect when using beta agonists.

When these two active substances are used together in the form of a dosed aerosol, the bronchodilating effect is achieved by affecting various pharmacological targets. The complementary effect is such that a lower dose of the beta - adrenergic component is required to achieve the desired effect, which allows you to individually select an effective dose with virtually no side effects.

Indications:

Prevention and symptomatic treatment of chronic obstructive respiratory diseases with reversible bronchospasm: bronchial asthma, chronic obstructive bronchitis, complicated or uncomplicated emphysema.

Contraindications:

Hypersensitivity, hypertrophic obstructive cardiomyopathy, tachyarrhythmia, pregnancy (I trimester).

Use during pregnancy and lactation:

Contraindicated in the first trimester of pregnancy. Use with caution when breastfeeding.

It is necessary to consider the possibility of an inhibitory effect of Berodual H on the contractile activity of the uterus.

Side effect:

From the Central nervous system: small tremor, nervousness rarely-headache, dizziness, violation of accommodation in isolated cases-changes in the psyche.

From the cardiovascular system: tachycardia, palpitations (especially in patients with aggravating factors) rarely (when used in high doses) - a decrease in DBP, increased sad, arrhythmia.

From the respiratory system: in rare cases — cough, local irritation very rarely-paradoxical bronchospasm.

From the digestive tract: nausea, vomiting.

Allergic reactions: rarely-rash, angioedema of the tongue, lips and face, urticaria.

Other: hypokalemia, increased sweating, weakness, myalgia, convulsions, urinary retention.

There are reports of undesirable effects from the eyes (see "precautions").

Drug interaction:

Beta-adrenergic and anticholinergic agents, xanthine derivatives (theophylline) can enhance the bronchodilator effect. The simultaneous administration of other beta-adrenomimetics that enter the systemic bloodstream of anticholinergic agents or xanthine derivatives (for example, theophylline) may lead to increased side effects.

There may be a significant weakening of the bronchodilator effect with the simultaneous appointment of beta-blockers.

Simultaneous use with MAO inhibitors and tricyclic antidepressants increases the effect of Berodual H.

Inhalation of halogenated hydrocarbon anesthetics (halotane, trichloroethylene, enflurane) can enhance the effect of Berodual H on the cardiovascular system.

Against the background of the use of Berodual H, hypokalemia may develop, which may increase with the simultaneous appointment of xanthine derivatives, steroids and diuretics. This fact should be given special attention in the treatment of patients with severe forms of obstructive respiratory diseases.

Hypokalemia may lead to an increased risk of arrhythmias in patients receiving digoxin. In addition, hypoxia can increase the negative effect of hypokalemia on the heart rate. In such cases, it is recommended to monitor the level of potassium in the blood serum.

Dosage and administration:

Inhalation.

Solution for inhalation. Adults and children over 12 years of age to stop attacks — 20-80 drops (1-4 ml). With long-term therapy-1-2 ml (20-40 drops) up to 4 times a day. In cases of moderate bronchospasm or the need for auxiliary ventilation-0, 5 ml (10 drops). Children 6-12 years of age to stop attacks-0, 5-1 ml (10-20 drops) once, with severe attacks — 2-3 ml (40-60 drops), with long — term therapy — 0, 5-1 ml (10-20 drops) 4 times a day, with moderate bronchospasm-0, 5 ml (10 drops). Children under 6 years of age (body weight less than 22 kg) (only under medical supervision) at the rate of 25 mcg of ipratropium bromide and 50 mcg of phenoterol hydrobromide per 1 kg of body weight, up to 0, 5 ml (10 drops) up to 3 times a day.

The recommended dose immediately before use is diluted with saline solution to a volume of 3-4 ml and inhaled through a nebulizer for 6-7 minutes, until the solution is completely consumed. Berodual solution for inhalation should not be diluted with distilled water. The solution should be diluted immediately before use, and the remaining diluted solution should be destroyed after inhalation.

The dose depends on the inhalation mode and the technical characteristics of the nebulizer. The duration of inhalation can be controlled through the volume of the diluted solution.

Berodual solution for inhalation can be used using various commercially available inhalation units. If there is a centralized stationary supply of oxygen, the solution is best administered at a rate of 6-8 l/min. If necessary, repeated inhalations are performed at intervals of at least 4 hours.

Aerosol. Adults and children over 6 years of age are prescribed 2 inhalation doses. If within 5 minutes there is no relief of breathing, you can assign another 2 inhalation doses. If 4 inhalations are ineffective, you should immediately seek medical help.

For long-term and intermittent therapy-1-2 doses 3 times a day (up to 8 inhalations per day).

To get the maximum effect, it is necessary to correctly use the dosed aerosol.

Before using the metered aerosol, shake the container for the first time and press the bottom of the container twice.

Each time you use a metered-dose aerosol, the following rules must be observed:

1. Remove the protective cap.

2. Take a slow, deep breath.

3. while Holding the balloon, wrap your lips around the tip. The balloon should be directed bottom up.

4. Taking the deepest possible breath, simultaneously quickly press the bottom of the balloon until one inhalation dose is released. Hold your breath for a few seconds, then remove the tip from your mouth and slowly exhale. Repeat the steps to get a second inhalation dose.

5. Put on the protective cap.

6. If the aerosol can has not been used for more than 3 days, press the bottom of the container once before use until the aerosol cloud appears.

The balloon is designed for 200 inhalations. After that, the balloon should be replaced. Although a certain amount of content may remain in the balloon, the amount of medication released during inhalation may be reduced.

The balloon is opaque, so the amount of the drug in the balloon can only be determined in the following way: 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 balloon in the water.

The tip should be kept clean and can be washed in warm water if necessary. After using soap or detergent, wash the tip thoroughly with clean water.

Warning: the plastic mouth adapter is designed specifically for berodual h dosed aerosol and is used for precise dosing of the drug. The adapter should not be used with other metered-dose aerosols. Do not use metered-dose Tetrafluoroethane-containing aerosol Berodual H with any other adapters other than the adapter supplied with the balloon.

The contents of the cylinder are under pressure. The cylinder must not be opened and subjected to heat above 50 °C.

Overdose:

Symptoms: tachycardia, palpitations, arterial Hyper - or hypotension, increased pulse pressure, anginal pain, arrhythmias, flushes of blood to the face, tremor.

Treatment: administration of sedatives, tranquilizers, in severe cases — intensive therapy. Cardioselective beta-blockers are recommended as antidotes. 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 chronic obstructive pulmonary diseases.

Precautions:

Be wary appoint diabetes, recent myocardial infarction, severe diseases of the cardiovascular system, hyperthyroidism, pheochromocytoma (required regular monitoring of potassium level in the blood), prostatic hypertrophy, obstruction of the urinary tract in patients predisposed to narrow-angle glaucoma.

In case of sudden appearance and rapid progression of shortness of breath (shortness of breath), you should immediately consult a doctor.

Prolonged use:

• in patients suffering from bronchial asthma or mild to moderate forms of chronic obstructive pulmonary disease, symptomatic treatment may be preferable to regular use
• in patients with bronchial asthma or steroid-dependent forms of chronic obstructive pulmonary diseases, it should be remembered that anti-inflammatory therapy should be carried out or strengthened to control the inflammatory process of the respiratory tract and the course of the disease.

There are reports of individual cases of eye complications (mydriasis, increased intraocular pressure, angle-closure glaucoma, pain in the eyeball) that occurred when an aerosol of ipratropium bromide or its combination with beta2-agonists got into the eyes.

Patients should be instructed in detail about the rules for using the berodual N metered-dose aerosol inhaler.

Pain in the eye, blurred vision, a feeling 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 may be signs of an acute attack of angle-closure glaucoma. If these symptoms appear in any combination, you should start treatment with eye drops that cause pupil constriction and immediately seek specialized medical help.

Patients with a history of cystic fibrosis may have gastrointestinal motility disorders.

It should be borne in mind that the use of large doses for the relief of an attack for a long time may cause an uncontrolled deterioration in the course of the disease and necessitate the correction of basic anti-inflammatory therapy. Due to the oppressive effect on labor, the use is discontinued shortly before delivery. Avoid contact with eyes.

Special instruction:

At the first application of a new form of metered-dose aerosol Berodual H, patients may note that the taste of the new drug is slightly different from the previous dosage form containing freon. When switching from one form to another, patients should be warned about possible changes in taste sensations. It should also be reported that these drugs are interchangeable and that the taste properties are not relevant to the safety and effectiveness of the new drug.