Berotec N, inhalation aerosol 100 µg/dose, 200 doses

Composition

Active ingredient:

fenoterol hydrobromide – 100 mcg.

Auxiliary substances:

citric acid anhydrous-0.001 mg,

absolute ethanol-15.597 mg,

purified water-1.04 mg,

1,1,1,2-tetrafluoroethane (HFA 134a, propellant) – 35.252 mg

Pharmacological action

Berotek N is a bronchodilator.

Selectively stimulates beta_-2-adrenergic receptors. Relaxes the smooth muscles of the bronchi and blood vessels and counteracts the development of bronchospastic reactions caused by the influence of histamine, methacholine, cold air and allergens (immediate hypersensitivity reactions). Immediately after use, fenoterol blocks the release of inflammatory mediators and bronchial obstruction from mast cells. In addition, when using fenoterol in higher doses, there was an increase in mucociliary clearance.

The beta-adrenergic effect of the drug on cardiac activity (increased strength and heart rate) is due to the vascular effect of fenoterol, stimulation of beta_-2— adrenergic receptors of the heart, and when using doses exceeding therapeutic ones, stimulation of beta_-1-adrenergic receptors. Tremor is the most common adverse effect when using beta-agonists.

The drug reduces the contractile activity and tone of the myometrium.

Pharmacodynamics

Fenoterol prevents and quickly stops bronchospasm of various origins. The onset of action after inhalation is 5 minutes, maximum-30-90 minutes, duration-3-6 hours.

Pharmacokinetics

Depending on the method of inhalation and the inhalation system used, about 10-30% of the Active ingredient released from the aerosol preparation after inhalation reaches the lower respiratory tract, and the rest is deposited in the upper respiratory tract and swallowed. As a result, a certain amount of inhaled fenoterol enters the gastrointestinal tract. After inhalation of 1 dose of the drug, the degree of absorption is 17% of the administered dose. Absorption is two-phase — 30% of fenoterol hydrobromide is rapidly absorbed at T_1/2 11 min, and 70% is absorbed slowly at T_1/2 120 min.

After oral use, about 60% of fenoterol hydrobromide is absorbed. The time to reach_cmax of blood plasma is 2 hours. Binding to plasma proteins is 40-55%. It is metabolized in the liver. It is excreted by the kidneys and bile in the form of inactive sulfate conjugates.

When parenteral use of fenoterol hydrobromide is eliminated, respectively, in a three-phase model with T_1/2-0.42 min,14.3 min and 3.2 h. Biotransformation of fenoterol hydrobromide in humans proceeds exclusively by conjugation with sulfates mainly in the intestinal wall.

Fenoterol hydrobromide can pass unchanged through the placental barrier and enter breast milk.

Indications

Prevention and relief of bronchospasm in bronchial asthma, chronic obstructive bronchitis, and emphysema.

Prevention of asthma by physical effort.

Symptomatic treatment of bronchial asthma and chronic obstructive pulmonary disease.

Contraindications

Hypersensitivity, hypertrophic obstructive cardiomyopathy, tachyarrhythmias, heart disease, aortic stenosis, decompensated diabetes mellitus, thyrotoxicosis, glaucoma, threatened abortion, pregnancy (I trimester).

Side effects

Immune system disorders: hypersensitivity.

From the side of metabolism: hypokalemia.

Nervous system disorders: agitation, nervousness, tremor, headache, dizziness.

From the cardiovascular system: myocardial ischemia, arrhythmia, tachycardia, palpitation, increased systolic blood pressure, decreased diastolic blood pressure.

From the respiratory system: paradoxical bronchospasm, irritation of the larynx and pharynx.

From the digestive system: nausea, vomiting.

Skin and subcutaneous tissue disorders: hyperhidrosis, skin reactions such as rash, pruritus, urticaria.

Musculoskeletal disorders: muscle spasms, myalgia, muscle weakness.

Interaction

Beta-adrenomimetics and anticholinergics, xanthine derivatives (including theophylline), Cromoglicic acid, corticosteroids and diuretics may increase the effect and side effects of fenoterol. It is possible to significantly weaken the bronchodilator effect of fenoterol with the simultaneous use of beta-blockers.

Berotek®should be prescribed with caution Use in patients receiving MAO inhibitors and tricyclic antidepressants, as these drugs can enhance the effect of fenoterol.

Means for inhalation anesthesia containing halogenated hydrocarbons (including halothane, trichloroethylene, enflurane) can increase the effect of fenoterol on the cardiovascular system (arrhythmias may develop). Simultaneous use of bronchodilators with a similar mechanism of action leads to an additive effect and overdose phenomena.

How to take, course of use and dosage

Adults and adolescents over 12 years of age

Asthma attacks and other conditions associated with reversible airway obstruction

In most cases,1 inhaled dose is sufficient to stop bronchospasm; if there is no relief of breathing within 5 minutes, you can repeat the inhalation.

If the effect is absent after 2 inhalations, and additional inhalations are required, you should immediately consult a doctor.

Prevention of physical exertion asthma

1-2 inhaled doses before physical exertion, up to 8 inhalations/day.

Children from 6 to 12 years old

Asthma attacks and other conditions associated with reversible airway obstruction

In most cases,1 inhaled dose is sufficient to stop bronchospasm; if there is no relief of breathing within 5 minutes, you can repeat the inhalation.

If the effect is absent after 2 inhalations, and additional inhalations are required, you should immediately seek medical attention.

Prevention of physical exertion asthma

1-2 inhaled doses before physical exertion, up to 8 inhalations/day.

Children from 4 to 6 years old

Due to the limited experience of use in children under 6 years of age, the drug should only be used as prescribed by a doctor and under adult supervision.

Asthma attacks and other conditions associated with reversible airway obstruction

To stop bronchospasm,1 inhaled dose is sufficient. If there is no effect, you should immediately seek medical help.

Prevention of physical exertion asthma

1 inhaled dose before exercise, up to 4 inhalations/day.

Rules for using the drug

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

Before using the metered-dose spray for the first time, double-tap the bottom of the can.

Each time a metered-dose aerosol is used, the following rules must be observed.

The balloon is designed for 200 inhalations. The cylinder should then be replaced. Although some contents may remain in the balloon, the amount of drug released during inhalation is reduced.

The inhaler should be flushed at least once a week.

It is important to keep the mouthpiece of the inhaler clean so that the medicine does not accumulate and does not block the spray.

To clean, first remove the dust-proof cap and remove the container from the inhaler. Rinse the inhaler with warm water to remove any accumulated medication and / or visible dust.

After cleaning, you need to shake the inhaler and let it dry in the air without using heating devices. When the mouthpiece is dry, replace the container and dust cap.

The plastic mouthpiece is designed specifically for the Berotek ® metered dose aerosol H and is used for accurate dosage of the drug. The mouthpiece should not be used with other metered-dose aerosols. You can also not use metered-dose aerosol Berotek® N with other adapters.

Overdose

Symptoms: tachycardia, increased heart rate, tremor, decreased / increased blood pressure, increased pulse pressure, anginal pain, arrhythmias and facial flushing.

Treatment: sedatives and tranquilizers are prescribed; in severe cases, intensive symptomatic therapy is indicated. As specific antidotes, the use of beta-blockers is recommended (preferably selective beta% ^%1-blockers). However, it is necessary to take into account the possibility of increasing bronchial obstruction and carefully select the dose of these drugs for patients with bronchial asthma.

Special instructions

When using Berotek ® metered-dose aerosol for the first time However, patients may notice that the new aerosol has a slightly different taste compared to the previous aerosol containing freon.Patients should be warned about this when switching from Berotek ® H, which contains freon, to Berotek®H, which does not contain freon. Patients should be aware that Berotek ® H, which contains freon, and Berotek®H, which does not contain freon, are completely interchangeable, and the change in taste does not affect the effectiveness and safety of the drug.

Other sympathomimetic bronchodilators can be used together with Berotek®N only under the supervision of a doctor. In case of acute, rapidly increasing shortness of breath (difficulty breathing), you should immediately consult a doctor.

Long-term use:

• Relief of asthma attacks may be preferable to regular use of the drug (symptomatic treatment).
• Patients should be evaluated to determine whether additional or more intensive anti-inflammatory treatment (for example, corticosteroid inhalation) is needed to control airway inflammation and prevent long-term exacerbations of bronchial asthma.

In the case of increased bronchial obstruction, it is considered unacceptable and may even be risky to increase the frequency of taking beta_-2-adrenergic agonists contained in such drugs as Berotek® N metered-dose aerosol for inhalation, in excess of the recommended doses. In this situation, the treatment plan and, especially, the adequacy of anti-inflammatory therapy should be reviewed.

When treated with beta_-2-adrenergic agonists, severe hypokalemia may develop. Special care should be taken with severe bronchial asthma, as this effect may be enhanced by the concomitant use of xanthine derivatives, corticosteroids and diuretics. Hypoxia may increase the effect of hypokalemia on the heart rate. In such situations, regular monitoring of serum potassium concentrations is recommended.

In rare cases, myocardial ischemia associated with beta_-2-adrenergic agonists was observed.

Hypokalemia in patients receiving digoxin increases sensitivity to cardiac glycosides and may cause arrhythmia.

Influence on the ability to drive motor vehicles and manage mechanisms

The effect of the drug on the patient’s ability to perform work that requires increased attention and speed of psychomotor reactions has not been established.

Form of production

Metered-dose aerosol for inhalation.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Fenoterol

Conditions of release from pharmacies

By prescription

Dosage form

aerosol for inhalation

Purpose

For adults by doctor’s prescription, Children by doctor’s prescription, Children over 6 years of age

Indications

Chronic obstructive pulmonary disease, Bronchial asthma, Bronchospasm