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Berotek - instructions for use, reviews, analogs and forms of release (inhalation solution, inhaled aerosol H) for the treatment and prevention of asthma attacks in adults, children and pregnancy. Composition

Berotek - instructions for use, reviews, analogs and forms of release (inhalation solution, inhaled aerosol H) for the treatment and prevention of asthma attacks in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Berotek. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Berotek in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Berotech analogs in the presence of existing structural analogues. Use for the treatment and prevention of asthma attacks,bronchoobstructive syndrome in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

 

Berotek - bronchodilator, selective beta2-adrenomimetic. It is an effective bronchodilator for the prevention and relief of bronchospasm attacks in bronchial asthma and other conditions accompanied by reversible airway obstruction, such as chronic obstructive bronchitis with or without emphysema.

 

Fenoterol is a selective stimulator of beta2-adrenoreceptors. When the drug is used in higher doses, beta1-adrenergic receptors are stimulated (for example, when prescribed for tocolytic therapy).

 

Binding of beta2-adrenergic receptors activates adenylate cyclase through the stimulatory Gs protein, followed by an increase in the formation of cyclic adenosine monophosphate (cAMP), which activates protein kinase A. Protein kinase A deprives myosin of the ability to bind to actin, which inhibits smooth muscle contraction and promotes bronchodilator action and bronchospasm elimination.

 

In addition, fenoterol inhibits the release of mast cells from inflammatory mediators of inflammation, thereby exerting a protective effect on the influence of such bronchoconstrictors as histamine, methacholine, cold air and allergens.

 

The intake of fenoterol in doses of 600 μg increases the activity of the ciliated epithelium of the bronchi and speeds up the mucociliary transport.

 

Due to the stimulating effect on beta-adrenergic receptors, fenoterol can exert an effect on the myocardium (especially in doses exceeding the therapeutic ones), causing an increase and increase in heart rate.

 

Fenoterol prevents and quickly reduces bronchospasm of various genesis. The start of action after inhalation - after 5 minutes, a maximum - after 30-90 minutes, duration - 3-5 hours.

 

Composition

 

Fenoterol hydrobromide + auxiliary substances.

 

Pharmacokinetics

 

Depending on the method of inhalation and the inhalation system used, about 10-30% of Beroteka reaches the lower respiratory tract, and the remainder is deposited in the upper respiratory tract and swallowed. This part of the active substance undergoes biotransformation due to the effect of "first passage" through the liver.The swallowed amount of the drug has no effect on the concentration of the active substance in the blood plasma, achieved after inhalation. Fenoterol hydrobromide in unchanged form penetrates the placental barrier and is excreted in breast milk. Metabolised in the liver. Fenoterol in humans undergoes intensive metabolism by conjugation to glucuronides and sulfates. If swallowed, fenoterol is metabolized, mainly, by sulphation. This metabolic inactivation of the starting material begins already in the wall of the intestine. Biotransformation, including excretion with bile, is exposed to the bulk of the dose (approximately 85%). The excretion of fenoterol with urine (0.27 L / min) corresponds to approximately 15% of the average total clearance of the systemically available dose. The volume of renal clearance testifies to the tubular secretion of fenoterol in addition to glomerular filtration. After inhalation unchanged, 2% of the dose is excreted through the kidneys within 24 hours. It is excreted in urine and bile in the form of inactive sulfate conjugates.

 

Indications

  • attacks of bronchial asthma or other conditions with reversible airway obstruction (incl.chronic bronchitis, chronic obstructive pulmonary disease (COPD));
  • prevention of asthma attacks due to physical stress;
  • as a bronchodilator before inhalation of other drugs (antibiotics, mucolytics, glucocorticosteroids (GCS));
  • bronchodilator tests in the study of external respiration function.

 

Forms of release

 

Solution for inhalation.

 

Aerosol for inhalation dosed (Berotek H).

 

Instructions for use and dosage

 

Solution

 

The drug is administered by inhalation (possibly with the aid of an inhaler). It should be taken into account that 20 drops = 1 ml, 1 drop contains 50 μg of fenoterol hydrobromide. Doses should be selected according to the individual needs of the patient; In addition, during treatment the patient should be under the supervision of a doctor.

 

Adults (including patients older than 75 years) and adolescents over 12 years of age

 

Attacks of bronchial asthma and other conditions, accompanied by reversible airway obstruction

 

Assign inhalation 0.5 ml (10 drops = 500 μg fenoterol hydrobromide), which in most cases is sufficient for immediate arrest of the attack; if necessaryreappointment of the drug inhaled by 0.5 ml (10 drops = 500 μg fenoterol hydrobromide) up to 4 times a day, but it is possible to reduce the individual dose depending on the effectiveness of the nebulizer. In severe cases, if a dose of 1 ml (20 drops) is ineffective, higher doses of 1 to 1.25 ml (20-25 drops = 1-1.25 mg of fenoterol hydrobromide) may be required; in extremely severe cases, if the dose to 2 ml (40 drops) is ineffective, 2 ml (40 drops = 2 mg fenoterol hydrobromide) are inhaled under the supervision of the doctor.

 

Preventing attacks of bronchial asthma due to physical stress

 

Assign an inhalation of 0.5 ml (10 drops = 500 μg fenoterol hydrobromide) to physical activity.

 

Children from 6 to 12 years (with a body weight of about 22-36 kg)

 

Attacks of bronchial asthma and other conditions with reversible airway obstruction

 

Assign inhalation 0.25-0.5 ml (5-10 drops = 250-500 μg fenoterol hydrobromide), which in most cases is sufficient for immediate relief of the symptom; if necessary, reappointment of the drug inhaled by 0.5 ml (10 drops = 500 μg fenoterol hydrobromide) up to 4 times a day, but it is possible to reduce the individual dose, depending on the effectiveness of the nebulizer.In severe cases, if the dose to 1 ml (20 drops) is ineffective, higher doses of 1 ml (20 drops = 1 mg fenoterol hydrobromide) may be required. In extremely severe cases, if the dose to 1.5 ml (30 drops) is ineffective, 1.5 ml (30 drops = 1.5 mg fenoterol hydrobromide) is inhaled under the supervision of the doctor.

 

Preventing attacks of bronchial asthma due to physical stress

 

Assign an inhalation of 0.5 ml (10 drops = 500 μg fenoterol hydrobromide) to physical activity.

 

Children under 6 years of age (with a body weight of less than 22 kg)

 

Due to the limited information on this age group, treatment is performed only under the supervision of a doctor, prescribing the drug in the following dose: inhalation of about 50 μg / kg per reception (= 0.05 ml or 1 drop) / kg body weight, but not more than 0.5 ml (10 drops) per dose up to 3 times a day.

 

Treatment is usually started with the lowest recommended dose.

 

Terms of use

 

The recommended dose should be diluted with 0.9% sodium chloride solution to a final volume of 3-4 ml, sprayed and inhaled until the full consumption of the dilution obtained.

 

Solution for inhalation can not be diluted with distilled water.

 

Dilution of the solution should be carried out every time before use; the remnants of the diluted solution are poured.

 

A solution for inhalation is recommended for use with an inhalation nebulizer device. In the presence of oxygen breathing apparatus, the solution is best inhaled at a flow rate of 6-8 l / min.

 

The solution for inhalation can be inhaled simultaneously with compatible with it cholino- and mucolytic agents (for example, ipratropium bromide, Ambroxol in the form of solutions for inhalation).

 

Aerosol

 

Adults and teenagers over 12 years of age

 

Attacks of bronchial asthma and other conditions, accompanied by reversible airway obstruction

 

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

 

If the effect is absent after 2 inhalations, and additional inhalations are required, the doctor should be consulted without delay.

 

Prevention of asthma physical effort

 

1-2 inhalation doses to exercise, up to 8 inhalations per day.

 

Children from 6 to 12 years old

 

Attacks of bronchial asthma and other conditions, accompanied by reversible airway obstruction

 

In most cases, 1 inhalation dose is sufficient to stop bronchospasm; if no breathing has occurred 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 help.

 

Prevention of asthma physical effort

 

1-2 inhalation doses to exercise, up to 8 inhalations per day.

 

Children from 4 to 6 years

 

Due to limited experience in children younger than 6 years of age, the drug should be used only as directed by a doctor and under the supervision of adults.

 

Attacks of bronchial asthma and other conditions, accompanied by reversible airway obstruction

 

To stop bronchospasm, 1 inhalation dose is sufficient. If there is no effect, you should seek medical help without delay.

 

Prevention of asthma physical effort

 

1 inhalation dose to exercise, up to 4 inhalations per day.

 

Terms of use

 

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

 

For the first time, use the dosed aerosol twiceto the bottom of the can.

 

Each time using a metered aerosol, the following rules must be observed:

  1. Remove the protective cap.
  2. Make a slow, deep exhalation.
  3. Holding the balloon, tightly grasp the tip of the lips. In this case, the arrow and the bottom of the can should be directed upwards.
  4. While drawing the deepest breath, simultaneously quickly press the bottom of the can before releasing 1 inhalation dose. Hold the breath for a few seconds, then take the mouthpiece out of the mouth and exhale slowly. If repeated inhalation is required, repeat the same procedure (points 2-4).
  5. Put the protective cap on.
  6. If the aerosol can is not used for more than 3 days, it is necessary to press the bottom of the canister once before use.

 

The cylinder is designed for 200 inhalations. Then the cylinder should be replaced. Despite the fact that some contents may remain in the container, the amount of drug released by inhalation decreases.

 

The balloon is opaque, so the amount of the drug in the bottle can be determined as follows: remove the protective cap, the balloon is immersed in a container filled with water.The amount of the preparation is determined depending on the position of the cylinder in the water.

 

The inhaler should be washed 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 spraying.

 

For cleaning, first remove the dustproof cap and remove the container from the inhaler. Rinse the inhaler with warm water to remove accumulated medication and / or visible dust.

 

After cleaning, shake the inhaler and allow it to air dry without the use of heating devices. When the mouthpiece has dried, return the container and dust cap to their place.

 

The plastic mouthpiece is specially designed for the dispensed Berotek H aerosol and serves for accurate dosing of the drug. The mouthpiece should not be used with other metered aerosols. It is also not possible to use the Berotec H metered aerosol with other adapters.

 

Side effect

  • excitation;
  • nervousness;
  • tremor;
  • headache;
  • dizziness;
  • myocardial ischemia;
  • arrhythmia;
  • tachycardia;
  • palpitation;
  • increase or decrease in systolic blood pressure;
  • cough;
  • irritation of larynx and pharynx;
  • paradoxical bronchospasm;
  • nausea, vomiting;
  • hyperhidrosis;
  • skin reactions (rash, itching, urticaria);
  • muscle spasm;
  • myalgia;
  • muscle weakness;
  • hypersensitivity.

 

Contraindications

  • tachyarrhythmia;
  • hypertrophic obstructive cardiomyopathy;
  • children age up to 4 years (for Berotek H aerosol);
  • hypersensitivity to fenoterol and other components of the drug.

 

Because information about the use of the drug in a solution for inhalation in children under 6 years of age is limited, treatment is carried out with caution, only under the supervision of a doctor.

 

Application in pregnancy and lactation

 

The results of preclinical studies, combined with the experience of clinical use of Berotek, suggest that it does not cause any undesirable effects in pregnancy. However, caution should be exercised in pregnancy, especially in the first trimester, if the potential benefit to the mother exceeds the potential risk to the fetus.

 

Consider the possibility of the inhibitory effect of fenoterol on contractile activity of the uterus.

 

Preclinical studies have shown that fenoterol penetrates into breast milk.The safety of the drug during lactation is not known. During lactation, the drug can be used if the potential benefit to the mother exceeds the potential risk for the child.

 

Use in children

 

The drug form in the form of aerosol preparation Berotek N is contraindicated in children under 4 years of age.

 

Because information on the use of the drug in children aged 4-6 years is limited, treatment is carried out with caution, only under the supervision of a doctor (age dosages for children are indicated in the instructions for use above).

 

special instructions

 

In patients with diabetes mellitus during treatment, regular monitoring of glucose in the plasma should be carried out.

 

At the first use of the Berotec H metered aerosol, patients can note 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, containing freon to Berotek H, which does not contain freon. Patients should be aware that Berotek H, containing freon and Berotek H preparation, does not contain freon completely interchangeable, and the change in taste has no effect on the efficacy and safety of the drug.

 

Other sympathomimetic bronchodilators can be used together with the drug Berotek only under the supervision of a doctor.

 

In acute, rapidly increasing dyspnea, the patient should immediately consult a doctor.

 

Coping asthma attacks may be preferable to regular use of the drug (symptomatic treatment). Patients should be monitored to detect the need for additional or more intensive treatment of inflammatory (e.g., inhaled corticosteroids) to control airway inflammation and prevent prolonged exacerbations of asthma.

 

In the event the bronchial obstruction is considered unacceptable, and may even be hazardous increase multiplicity receiving beta2-adrenergic agonists in doses exceeding the recommended or increasing the recommended duration of application. In such a situation, a treatment plan and, especially, the adequacy of anti-inflammatory therapy should be reviewed.

 

In the treatment of beta2-adrenergic agonists, development of severe hypokalemia is possible. Particular care should be exercised in severe bronchial asthma, t.this effect can be enhanced by the concomitant use of xanthine derivatives, GCS and diuretics. With hypoxia, it is possible to increase the effect of hypokalemia on the heart rhythm. In such situations, regular monitoring of serum potassium concentration is recommended. In rare cases, myocardial ischemia associated with beta2-adrenoreceptor agonists was observed.

 

Hypokalemia in patients receiving Digoxin increases the sensitivity of the myocardium to cardiac glycosides and can cause arrhythmia.

 

The drug contains a preservative of benzalkonium chloride and a disodium edetate stabilizer. It has been shown that these components in some patients can cause bronchospasm.

 

Impact on the ability to drive vehicles and manage mechanisms

 

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

 

Drug Interactions

 

With the simultaneous use of beta-adrenomimetics, anticholinergics, xanthine derivatives (eg, theophylline), cromoglycic acid, GCS, diuretics, the effect and side effects of fenoterol may be increased.

 

Perhaps a significant weakening of the bronchodilator effect of fenoterol with simultaneous use of beta-blockers.

 

Care should be taken to prescribe Berotek to patients receiving MAO inhibitors and tricyclic antidepressants, these drugs can enhance the effect of fenoterol.

 

Means for inhalation anesthesia (halothane, trichlorethylene, enflurane) enhance the effect of fenoterol on the cardiovascular system. Halothane promotes the development of arrhythmia.

 

Simultaneous appointment with other bronchodilators with a similar mechanism of action leads to an additive effect and the development of an overdose.

 

Analogues of drug Berotek

 

Structural analogs for the active substance:

  • Berotek H;
  • Partusisten;
  • Fenoterol;
  • Fenoterol hydrobromide.

 

Analogues for the pharmacological group (beta-adrenomimetic drugs):

  • Aloprole;
  • Astalin;
  • Asthmopent;
  • Atimos;
  • Berodual;
  • Berodualal H;
  • Biasten;
  • Brikanil;
  • Ventolin;
  • Ventolin Nebula;
  • Volmaks;
  • Ginipral;
  • Ditek;
  • Dobutamine;
  • Dobutrex;
  • Zhenheil;
  • Intal plus;
  • Infintispier Respimat;
  • Ipladol;
  • Iprimol Steri Neb;
  • Cough;
  • Clenbuterol;
  • Combination;
  • Kombipack;
  • Oxys Turbuhaler;
  • Onbres Brizhaler;
  • Partusisten;
  • Salamol;
  • Salmeterol xinafoate;
  • Salmo;
  • Salben;
  • Salvobent;
  • Salbutabs;
  • Salbutamol;
  • Salgim;
  • Salmecort;
  • Salmeter;
  • Saltos;
  • Serevent;
  • Seretid;
  • Seredid Multidisk;
  • Symbicort Turbuhaler;
  • Tevakomb;
  • Fenoterol;
  • Foradyl;
  • Formoterol;
  • Cibutocaps Cibutocaps.

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