Symptoms: tachycardia, palpitations, arterial hyper-or hypotension, increased pulse pressure, anginal pain, arrhythmias, flushes of blood to the face, tremor.
Treatment: the appointment of sedatives, tranquilizers, in severe cases — intensive care. 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.
Hypersensitivity, hypertrophic obstructive cardiomyopathy, tachyarrhythmias,
heart disease, aortic stenosis, decompensated diabetes mellitus, thyrotoxicosis, glaucoma, threatened abortion, pregnancy (I trimester).
Beta-adrenergic and anticholinergic agents, xanthine derivatives (theophylline) can enhance the bronchodilator effect. Concomitant administration of other beta-adrenomimetics, anticholinergic agents or xanthine derivatives (for example, theophylline) entering the systemic bloodstream may lead to increased side effects.
It is possible to significantly weaken the bronchodilator effect with the simultaneous appointment of beta-blockers.
Concomitant use with MAO inhibitors and tricyclic antidepressants increases the effect of Berotec N.
Inhalation of halogenated hydrocarbon anesthetics (halothane, trichloroethylene, enflurane) can enhance the effect of Berotec H on the cardiovascular system.
Against the background of the use of Berotek H, hypokalemia may develop, which may increase with the simultaneous administration 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 may 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.
From the central nervous system: minor tremor, nervousness, rarely-headache, dizziness, violation of accommodation, in isolated cases-a change in the psyche.
From the cardiovascular system: tachycardia, palpitations (especially in patients with aggravating factors), rarely (when used in high doses) — decreased dBP, increased sBP, arrhythmia.
From the respiratory system: in rare cases-cough, local irritation, very rarely — paradoxical bronchospasm.
From the gastrointestinal tract: nausea, vomiting.
Allergic reactions: rarely-rash, angioedema of the tongue, lips and face, urticaria.
Other: hypokalemia, increased sweating, weakness, myalgia, convulsions, urinary retention.
At the first application of the new form of the metered-dose aerosol Berotek 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.
Other sympathomimetic bronchodilators should be prescribed simultaneously with Berotec H only under medical supervision.
Fenoterol prevents and quickly relieves bronchospasm of various origins. The onset of action after inhalation-after 5 minutes, maximum-30-90 minutes, duration-3-6 hours.
Depending on the inhalation method 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 biphasic - 30% of phenoterol hydrobromide is rapidly absorbed with T1/2 11 min, and 70% is absorbed slowly with T1/2 120 min.
After oral administration, about 60% of phenoterol hydrobromide is absorbed. Time to reach Cmax blood plasma-2 hours. Binding to plasma proteins — 40-55%. It is metabolized in the liver. It is excreted by the kidneys and with bile in the form of inactive sulfate conjugates.
With parenteral administration of fenoterol, 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.
Phenoterol hydrobromide can penetrate unchanged through the placental barrier and enter breast milk.
At a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life of the drug Berotek® Nsolution for inhalation of 1 mg / ml — 5 years.
aerosol for inhalation dosed 100 mcg / dose — 3 years.
Do not use after the expiration date indicated on the package.
| Solution for inhalation 0.1% | 1 ml |
| fenoterol hydrobromide | 1 mg |
| excipients: benzalkonium chloride, disodium edetate dihydrate, sodium chloride, 1 n. hydrochloric acid, distilled water |
in dark glass dropper bottles of 20 ml (1 ml = 20 drops), in a cardboard pack of 1 dropper bottle.
| Aerosol, inhaled, metered | 1 dose |
| fenoterol 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 of 1 cylinder.
It is contraindicated in the first trimester of pregnancy, the drug can 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.
Inhaled.
Solution for inhalation. Adults and children over 12 years of age, for the 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 extremely 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 the 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 extremely severe cases (under the supervision of a doctor) - 1.5 ml (1.5 mg-30 drops).
Prevention of asthma of physical effort 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 dose (0.25-1 mg-5-20 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. The dose depends on the method of inhalation and the quality of the spray. If necessary, repeated inhalations are carried out at intervals of at least 4 hours.
Aerosol. Acute attack of bronchial asthma — 1 dose, if necessary, after 5 minutes, the inhalation can be repeated. The next appointment of the drug is possible no earlier than 3 hours. If there is no effect and additional inhalation is 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 dose, but no more than 8 doses per day.
To get the maximum effect, it is necessary to use the dosed aerosol correctly.
Before using the metered aerosol for the first time, shake the balloon and press the bottom of the balloon twice.
Each time you use a metered-dose aerosol, you must observe the following rules::
1. Remove the protective cap.
2. Take a slow, deep breath.
3. While holding the balloon, wrap your lips around the tip. The cylinder should be directed upside down.
4. While inhaling as deeply as possible, simultaneously quickly press on the bottom of the balloon until one inhaled dose is released. Hold your breath for a few seconds, then remove the tip from your mouth and exhale slowly. Repeat the steps to obtain a second inhaled 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 cylinder should be replaced. Although a certain amount of the contents may remain in the balloon, the amount of the drug 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: after 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 if necessary, it can be washed in warm water. After using soap or detergent, rinse the tip thoroughly with clean water.
Warning: The plastic mouth adapter is designed specifically for the metered aerosol Berotek H and is used for precise dosing of the drug. The adapter should not be used with other metered-dose aerosols. Do not use the metered-dose tetrafluoroethane-containing aerosol Berotek H with any other adapters other than the adapter supplied with the cylinder.
The contents of the cylinder are under pressure. The cylinder must not be opened and subjected to heat above 50 °C.
R03AC04 Phenoterol
