Expiration date: 11/2026

Composition and form of release:

Solution for inhalation 0.1% .1 ml contains:

phenoterol hydrobromide 1 mg

excipients: benzalkonium chloride disodium edetate sodium dihydrate 1 n. acid hydrochloric distilled water

in dark glass dropper bottles of 20 ml (1 ml = 20 drops) in a pack of cardboard 1 dropper bottle.

Aerosol inhalation dosed. 1 dose contains:

phenoterol hydrobromide 100 mcg

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

excipients: citric acid anhydride distilled water ethanol

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

Description of the dosage form:

Solution for inhalation: clear colorless or almost colorless liquid, free of particles. The smell is almost imperceptible.

Pharmacological action:

Selectively stimulates beta2-adrenergic receptors. 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). Immediately after administration, phenoterol blocks the release of inflammatory mediators and bronchial obstruction from mast cells. In addition, when using phenoterol in higher doses, there was an increase in 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.

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

Pharmacokinetics:

Depending on the method of inhalation and the inhalation system used, about 10-30% of the active substance 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 phenoterol enters the gastrointestinal tract. After inhalation of 1 dose of the drug, the degree of absorption is 17% of the administered dose. The absorption is two-phase — 30% of hydrobromide phenoterol is rapidly absorbed from T1 / 2 11 min, and 70% is slowly absorbed from T1 / 2 120 min.

After oral administration, about 60% of hydrobromide phenoterol 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 with bile in the form of inactive sulfate conjugates.

When parenteral administration of phenoterol hydrobromide is excreted according to the three-phase model with T1/2-0, 42 min, 14, 3 min and 3, 2 h. Biotransformation of phenoterol hydrobromide in humans occurs exclusively by conjugation with sulfates mainly in the intestinal wall.

Fenoterol hydrobromide can penetrate in unaltered form through the placental barrier and appear in breast milk.

Description pharmacological action:

Fenoterol warns and quickly eliminates bronhospazm different Genesis. The onset of action after inhalation-in 5 minutes, maximum-30-90 minutes, duration-3-6 hours.

Indications:

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

Use during pregnancy and lactation:

Contraindicated in the first trimester of pregnancy, the drug may be prescribed in the second-third trimester of pregnancy and during breastfeeding only if the expected effect of therapy exceeds the potential risk to the fetus or child.

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.

Drug interaction:

Beta-adrenergic and anticholinergic agents, xanthine derivatives (theophylline) can enhance the bronchodilator effect. 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 Berotec N.

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

Against the background of the use of Berotec N, 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, for relief of an attack of bronchial asthma-0, 5 ml (0, 5 mg-10 drops), in severe cases — 1-1, 25 ml (1-1, 25 mg — 20-25 drops), in exceptionally severe cases (under the supervision of a doctor) — 2 ml (2 mg — 40 drops).

Prevention of physical effort asthma and symptomatic treatment of bronchial asthma and chronic obstructive pulmonary disease-0, 5 ml (0, 5 mg-10 drops) up to 4 times a day.

Children 6-12 years old (body weight 22-36 kg) for relief of an attack of bronchial asthma — 0, 25-0, 5 ml (0, 25-0, 5 mg — 5-10 drops), in severe cases — 1 ml (1 mg — 20 drops), in exceptionally severe cases (under the supervision of a doctor) — 1, 5 ml (1, 5 mg — 30 drops).

Prevention of physical effort asthma and symptomatic treatment of bronchial asthma and other conditions with reversible narrowing of the respiratory tract — 0, 5 ml (0, 5 mg-10 drops) up to 4 times a day. Children under 6 years of age (body weight less than 22 kg) (only under the supervision of a doctor) — about 50 mcg/kg per reception (0, 25-1 mg-5-20 drops) up to 3 times a day.

The recommended dose immediately before use is diluted with saline to a volume of 3-4 ml. The dose depends on the method of inhalation and the quality of spray. If necessary, repeated inhalations are performed at intervals of at least 4 hours.

Aerosol. Acute attack of bronchial asthma — 1 dose, if necessary, after 5 minutes of inhalation can be repeated. The next appointment of the drug is possible no earlier than 3 hours. If there is no effect and additional inhalations are required, you should immediately seek medical attention at the nearest hospital.

Prevention of asthma of physical effort and symptomatic treatment of bronchial asthma and other conditions accompanied by reversible narrowing of the respiratory tract-1-2 doses per 1 reception, but no more than 8 doses 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 container 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 the Berotec N dosed aerosol and is used for precise dosing of the drug. The adapter should not be used with other metered-dose aerosols. You can also not use metered-dose Tetrafluoroethane - containing aerosol Berotec N 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.

Precautionary measures:

With caution, prescribe for diabetes, recently suffered myocardial infarction, severe diseases of the cardiovascular system, hyperthyroidism, pheochromocytoma.

When using beta2-agonists, serious hypokalemia may develop.

In acute, rapidly increasing dyspnea (shortness of breath), consult a doctor immediately.

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 with inhaled corticosteroids.

Particular caution should be exercised in severe bronchial asthma, since this effect can be enhanced by the concomitant use of xanthine derivatives, glucocorticoids and diuretics. In addition, hypoxia can increase the effect of hypokalemia on the heart rhythm. In such situations, it is recommended to regularly monitor the level of potassium in the blood serum.

Special instruction:

At the first application of a new form of metered-dose aerosol Berotec N, 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.

Other sympathomimetic bronchodilators should be prescribed simultaneously with Berotec N only under medical supervision.