Berotek n aerosol 100mkg/dose vial 10 ml 200 doses

Active ingredient

1 ml (20 drops) contains fenoterol hydrobromide 1 mg;
Excipients: benzalkonium chloride; disodium edetate dihydrate; sodium chloride; 1 n. hydrochloric acid; distilled water;
20 ml in dropper bottles of dark glass; in a carton pack 1 bottle

1 dose contains fenoterol hydrobromide 100 mcg;
propellant: 1,1,1,2 - tetrafluoroethane (HFA 134a);
Excipients: citric anhydride; distilled water; ethanol;
10 ml (200 doses) in aerosol cans with a mouthpiece, in a box 1 cylinder.

Mechanism of action

Bronchodilator drug, beta₂-adrenomimetic.
Fenoterol hydrobromide selectively stimulates b₂-adrenoreceptors.
Fenoterol relaxes the smooth muscles of the bronchi and blood vessels and counteracts the development of bronchospastic reactions caused by the effect of histamine, methacholine, cold air and allergens (immediate type hypersensitivity reactions). Fenoterol blocks the release of inflammatory mediators and bronchial obstruction from mast cells. In addition, when used in higher doses, increased mucociliary clearance was noted.
The effect of fenoterol on heart activity, due to beta-adrenomimetic activity, incl. increase in the frequency and strength of heart contractions associated with the action of fenoterol on the vessels, stimulation b₂-adrenoreceptors of the heart, and when used in doses exceeding therapeutic - with stimulation b₁-adrenoreceptors. Tremor is the most common undesirable effect with beta-agonists.
The drug reduces the contractile activity and tone of the myometrium.

Suction
Depending on the method of inhalation and the inhalation system used, about 10-30% of the active substance released after inhalation from the aerosol preparation reaches the lower respiratory tract, and the rest is deposited in the upper respiratory tract and is swallowed. As a result, a certain amount of inhaled fenoterol enters the gastrointestinal tract. After inhalation of a single dose of the drug Berotek, the degree of absorption is 17% of the dose. Suction is biphasic - 30% of fenoterol hydrobromide is absorbed with a semi-absorption period of 11 minutes; 70% is absorbed slowly with a semi-absorption period of 120 minutes.
There is no correlation between plasma concentrations of fenoterol, achieved after inhalation, and the time-effect pharmacodynamic curve. The prolonged bronchodilator effect of the drug after inhalation, comparable to the corresponding effect achieved after intravenous administration,not supported by high concentrations of the active substance in the systemic circulation. After oral administration, about 60% of the ingested dose is absorbed. Time to reach C_max - 2 hours
Distribution
Binding to plasma proteins - 40-55%. Fenoterol hydrobromide penetrates the placental barrier and is excreted in breast milk.
Metabolism
It biotransformed in the liver and COMT is not destroyed.
Removal
Excreted by the kidneys and with bile in the form of inactive sulfate conjugates. After 24 hours, 60% of the intravenous dose and 35% of the oral dose is excreted in the urine. This part of the active substance is subject to the effect of the first passage through the liver, resulting in a bioavailability of approximately 1.5%. In this regard, the swallowed amount of the drug has almost no effect on the concentration of the active substance in the blood plasma, achieved after inhalation.
Fenoterol hydrobromide is derived according to a three-phase model with half-life Ta_1/2 0.42 min, Tb_1/2 14.3 min, Tg_1/2 3.2 hours

Indications and usage

- prevention and relief of bronchospasm in bronchial asthma, chronic obstructive bronchitis, pulmonary emphysema;
- prevention of asthma physical effort.

Contraindications

- tachyarrhythmia;
- heart defects, aortic stenosis;
- hypertrophic obstructive cardiomyopathy;
- decompensated diabetes;
- thyrotoxicosis;
- glaucoma;
- I trimester of pregnancy;
- Hypersensitivity to fenoterol and other components of the drug.
Berotek should not be taken with threatened abortion.

Dosage and administration

Inhalation. Solution for inhalation. Adults and children over 12 years old for relief 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 extremely severe cases (under the supervision of a physician) - 2 ml (2 mg - 40 drops).
Preventing physical 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 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 extremely severe cases (under the supervision of a physician) - 1, 5 ml (1.5 mg - 30 drops).
Preventing physical asthma and symptomatic treatment of bronchial asthma and other conditions with reversible narrowing of the airways - 0.5 ml (0.5 mg - 10 drops) up to 4 times a day.
Children under 6 years old (body weight less than 22 kg) (only under the supervision of a physician) - about 50 mg / kg per dose (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 the spray. If necessary, repeated inhalations are held at intervals of not less than 4 hours.

For relieving asthma attacks prescribe 1 dose, if necessary, after 5 minutes inhalation can be repeated.The next appointment of the drug may not earlier than 3 hours.
For prevention of bronchospasm in bronchial asthma and other conditions involving reversible narrowing of the airways 1-2 doses are prescribed per inhalation, if repeated inhalations are required, then no more than 8 doses / day.
For prevention of asthma physical effort 1-2 doses are prescribed per inhalation, up to 8 doses / day.
Terms of use of the drug
Before using the metered aerosol for the first time, shake the can and double click on the bottom of the can.
Each time you use a metered aerosol, you must observe the following rules.
1. Remove the protective cap.
2. Make a slow, deep breath.
3. While holding the bottle, clasp the tip with your lips. The cylinder must face upside down.
4. While producing the deepest possible breath, at the same time quickly press the bottom of the bottle until the release of 1 inhalation dose. Hold your breath for a few seconds, then remove the tip from the mouth and exhale slowly. Repeat steps to obtain 2 inhalation doses.
5. Put on a protective cap.
6.If the aerosol canister has not been used for more than 3 days, before using it, press the bottom of the canister once until the aerosol cloud appears.
The balloon is designed for 200 inhalations. Then the cylinder should be replaced. Although some contents may remain in the bottle, the amount of drug released during inhalation is reduced.
The tip should be kept clean; if necessary, it can be washed in warm water. After using soap or detergent, rinse the tip thoroughly with water.
The plastic adapter for the mouth is designed specifically for Berotec metered aerosol and is used for precise dosing of the drug. The adapter should not be used with other metered aerosols. You can not also use metered aerosol Berotek H with other adapters.

Adverse reactions

From the side of the central nervous system: often - a small tremor; possible (especially in patients with risk factors) dizziness, headache, nervousness; in some cases - changes in the psyche.
Since the cardiovascular system: possible (especially in patients with risk factors) tachycardia, feeling of heartbeat; rarely (when used in high doses) - a decrease in diastolic pressure, an increase in systolic pressure, arrhythmias.
Metabolism: possible increase in the concentration of glucose in the blood, severe hypokalemia.
From the side of the respiratory system: possible cough, local irritation; rarely, paradoxical bronchospasm.
From the digestive system: nausea, vomiting are possible.
Allergic reactions: rarely - skin rash, angioedema of the tongue, lips, face, urticaria.
Other: possible increased sweating, weakness, muscle pain, cramps.

In pregnancy, use is possible in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.
It is established that fenoterol is excreted in breast milk.
It is not recommended to prescribe the drug during lactation unless the expected benefits of therapy for the mother outweigh the potential risk to the infant.

Appointment of Berotec is possible only after a thorough assessment of the ratio of the perceived benefits of therapy and possible risk in case of inadequately controlled diabetes mellitus, recent myocardial infarction, severe organic heart or vascular diseases, hyperthyroidism, pheochromocytoma.
Regular use of Berotec in increasing doses to relieve bronchial obstruction can cause an uncontrolled deterioration in the course of the disease. In the case of increased bronchial obstruction, simply increasing the dose of Berotec more than recommended for a long time is not only unjustified, but also dangerous. To prevent a life-threatening deterioration in the course of the disease, consideration should be given to revising the patient's treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids.
Other sympathomimetic bronchodilators should be administered simultaneously with Berotek N only under medical supervision.
Control of laboratory parameters
During the period of application of Berotec it is recommended to control the level of potassium in the blood.
Use in pediatrics
Experience in the clinical use of the drug in children under 6 years of age is missing.

Symptoms: possible symptoms associated with excessive stimulation of beta-adrenergic receptors - tachycardia, palpitations, tremor, arterial hypertension, arterial hypotension, increased pulse pressure, angina pain, arrhythmias, flushing of the face.
Treatment: the appointment of sedatives, tranquilizers, in severe cases, intensive therapy is indicated.
As specific antidotes, the prescription of cardio-selective beta-blockers, preferably selective blockers, is recommended.₁-adrenoreceptors.

Beta adrenomimetics and anticholinergics, xanthine derivatives (including theophylline) can enhance the bronchodilator effect and side effects of Berotec.
With the simultaneous use of other beta-adrenergic agonists, anticholinergic agents or xanthine derivatives (including theophylline) entering the systemic circulation may increase side effects.
Perhaps a significant weakening of the bronchodilator action of Berotec, while the use of beta-blockers.
Against the background of the use of Berotec may develop hypokalemia, which may increase with the simultaneous appointment with xanthine derivatives,steroids and diuretics. This fact should be taken into account when treating patients with severe obstructive respiratory diseases.
Hypokalemia increases the risk of arrhythmias in patients receiving Digoxin . In addition, during hypoxia, the negative effect of hypokalemia on the heart rhythm is enhanced. In such cases, it is recommended to monitor the level of potassium in the serum.
Berotec should be used with caution in patients receiving MAO inhibitors and tricyclic antidepressants, since These drugs can enhance the action of beta adrenergic agonists.
Means for inhalation anesthesia containing halogenated hydrocarbons (including halothane, trichlorethylene, enflurane) can enhance the effect of Berotec on the cardiovascular system.

The drug should be stored at a temperature not exceeding 25 ° C, protected from direct sunlight, high and low temperatures.

3 years.
The cylinder is under pressure. The cylinder must not be opened and heated to a temperature above 50 ° C.
Pharmacy sales terms
The drug is available on prescription.