Berotek

Description overdue on 09/21/2014

• Latin name: Berotec
• ATC code: R03AC04
• Active substance: Fenoterol (Fenoterol)
• Manufacturer: Boehringer Ingelheim Pharma KG, a division of Boehringer Ingelheim International GmbH, Germany (aerosol for inhalation dose). Boehringer Ingelheim Italy SpA, Italy (solution for inhalation).

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• Composition
• Product form
• Pharmacological action
• Pharmacodynamics and pharmacokinetics
• Indications
• Contraindications
• Side effects
• Berotek, instructions for use (method and dosage)
• Overdose
• Cooperation
• Terms of sale
• Storage conditions
• Shelf life
• Cautions
• Analogs
• Babies
• During pregnancy (and lactation)
• Reviews
• Price, where to buy

Composition

1 ml solution for inhalation   It comprises the following active ingredients:

• hydrobromide Fenoterola - 1 mg (liquid drug concentration - 0, 1%);
• benzalkonium chloride;
• dihydrate, disodium edetate;
• sodium chloride;
• hydrochloric acid molarity in 1N;
• distilled water.

1 dose inhalation Aerosol Berotek H contains biological material such as:

• hydrobromide F enoterola - 100 g;
• propellant - 1, 1, 1, 2 - tetrafluoroethane (HFA 134a);
• citric acid anhydride;
• ethanol;
• distilled water.

Product form

On the shelves of kiosks Berotek pharmaceutical preparation can be found in the following variations:

• The solution for inhalations - Clear and colorless liquid drug-free floating particles with a barely perceptible odor. Packaged preparation in dropper bottles of dark glass capacity of 20 ml (in terms of standard units of volume 1 ml = 20 drops). The carton is put one bottle.
• Inhalation metered aerosol in special stainless steel cylinders Conveniently mouthpiece (represented nonspecific inhaler dosing device) 10 ml (200 injections). The carton 1 comprises a cylinder with a drug.

Pharmacological action

Berotek - a drug on the basis of Fenoterola (international nonproprietary drug has the INN name or by the prevailing component in the composition), which in its pharmaceutical properties are classified as   selective stimulator beta-2 adrenoceptor Localized advantageously airway. Accordingly, the active component of the drug can acting relaxes smooth muscles of the bronchi   vessels and counteracting thus development bronchospastic reactions, for example, asthma .

Luminal narrowing bronchial occurs under methacholine . histamine , Cold air, and various exogenous allergens   (according to the mechanism of immediate hypersensitivity reaction). After entering the regional blood flow, Fenotreol suspend the release of the active inflammatory mediators from mast cells (basophils, released in tissue). This is the mechanism of therapeutic action of the drug in the development of bronchial obstruction.

Biochemical background effects Fenotela involves the interaction of the active ingredient with the stimulatory protein-GS, which activates cell adenylate cyclase . In response to this increased synthesis of second messenger such as cAMP . In turn messenger stimulates protein kinase A, which is the biological role of phosphorylation of cellular target proteins smooth muscle. In this way, inactivated light chain myosin (one of the main components of muscle fibers) open faster potassium channel That outwardly manifests as relaxation of smooth muscle layer of the respiratory tract and the vascular bed.

We should not forget that the beta-adrenergic receptors also are located in heart muscle Therefore the impact of the main active component berotek observed in the myocardium and the related bloodstream. Thus, significantly It increases strength and heart rate , Which greatly increases the blood flow in the microcirculation and the main blood supply to peripheral tissue levels.

High dosages   a pharmaceutical preparation which have a broader action which consists in:

• strengthening mucociliary transport;
• oppression of uterine activity;
• violation of fat (lipolysis) and glucose (glycogenolysis) exchanges;
• decrease in plasma potassium.

Pharmacodynamics and pharmacokinetics

The pharmaceutical formulation used Berotek topically As clinical trials of this drug have shown that its therapeutic effect is practically independent of the serum concentration of the active components. After inhalation   about 10-30% of the main active substance reaches the lower respiratory tract. The remainder of the spray is deposited in the upper parts of the respiratory ways, the mouth or swallowed entering the gastrointestinal tract. Bioavailability Fenoterol is about 18-19%.

Absorption surface easily occurs in two stages. During the first 11 minutes after administration of the drug is absorbed into the body of a single dose of 30%, then, over the next 2 hours and the remaining 70% slowly overcome physiological barriers, penetrating into the soft tissues. The maximum plasma concentration   preparation 45 3 pg / ml and observed after 15 minutes after inhalation.

Fenoterol inclined uniformly allocated in the body with a volume of 1, 9-2, 7 l / kg of body weight. This feature is most accurately described using pharmacokinetic models with three-phase half-lives on the 0, 42 minutes, 14 minutes and 3 3 2 hours. In the bloodstream   active ingredients bind to plasma protein in an amount of 40-55% of the original dose.

Metabolism   fenoterol hydrobromide extends in the wall of the intestine or liver, by conjugation (or sulfonatsii) to sulfates and glucuronides. After going through all the stages of the exchange and the provision of therapeutic effects of the active component is released through multiple paths. First of all biological substance output with bile into the lumen of the digestive tube with a velocity of about 1, 1-1, 8 ml / min. Approximately 15% general secondary clearance   fenoterol elimination is via the mechanisms of glomerular filtration (about 0 27 liter / min). Also, due to the connection of the active ingredient with the plasma proteins, the drug is shown with a tubular secretion.

Indications

• chronic obstructive lung disease ;
• bronchospasm   amid bronchial asthma;
• reversible airway constriction ;
• chronic obstructive bronchitis ;
• emphysema lung;
• and as a prophylactic agent in exercise-induced asthma .

Contraindications

• increased individual sensitivity to the constituent components of the pharmaceutical formulation;
• inherited or acquired intolerance Biologically active substances of the drug;
• aortic stenosis;
• hypertrophic obstructive cardiomyopathy ;
• thyrotoxicosis ;
• tachyarrhythmia ;
• heart disease ;
• uncompensated diabetes ;
• glaucoma ;
• 1 term pregnancy and breastfeeding ;
• the youngest age group of patients to 4 years .

Under constant supervision medical staff and hold regular Diagnostic assays   It is recommended for conservative treatment of a pharmaceutical preparation in the presence of the following pathologies:

• uncontrolled Arterial hypertension I;
• severe disease entities affecting the heart and vascular system;
• pheochromocytoma ;
• hyperthyroidism ;
• after suffering myocardial infarction ;
• compensated stage of development Diabetes .

Side effects

During the course of conservative therapy drug Berotek may experience the following adverse effects:

• by CNS   - Small, intention tremor . headache   and dizziness , Disturbance of accommodation, change in mental status (the latter side effect is noted only in a few cases).
• cardiovascular system   - Intensive tachycardia . palpitations, low blood pressure, increase systolic index BP, arrhythmia .
• by respiratory   or Respiratory system   - cough , Local irritation of the mucous membranes, paradoxical bronchospasm   (the latter is very rare, but we have to be).
• gastrointestinal tract   - Nausea, and should, as a rule, then vomiting.
• allergic reactions   - rash, urticaria, angioedema   tongue, lips and face.
• Other systems - weakness . hypokalemia with catastrophically large numbers (especially in patients with severe asthma who receive treatment as medicines based on corticosteroids, diuretics and xanthine) myalgia (muscle pain unexplained), increased sweating, urination delay active.

Berotek, instructions for use (method and dosage)

How to use solution for inhalation

The drug is intended for local the impact on the fabric of the airways. Immediately prior to the application of the recommended dose diluted with physiological saline   (strictly forbidden to use distilled water as a solvent) to a volume of 3-4 ml.

Inhalation recommended to be carried out with the help of special devices ENT - nebulizer . You can also use other oxygen-breathing equipment. The optimum air velocity enriched drug - 6.8 liters / min. According to the pharmaceutical dosages 20 drops = 1 ml, and one drop in turn comprises about 50 mg of fenoterol hydrobromide.

The dosage of the solution for inhalation

• children to 6 years   and weighing less than 22 kg - 0, 05 ml (1 drop) / kg body weight three times a day, but not more than 0, 5 ml (10 drops) a single amount of the drug;
• children from 6 to 12 years   and body weight in the range from 22 to 36 kg - 0, 25-0, 5 mL of a medicament for urgent relief of symptoms of urge bronchoconstriction 4 times a day, but the dosage may be increased in severe stages of asthma;
• teens over 12 years   and adults   (up to elderly patients over 75 years) - 0, 5 ml of the drug up to 4 times a day, but possibly as a decrease or increase of dose under certain medical conditions or individual doctor recommendations.

Instructions for use Berotek H

Before using metered spray bottle should be shaken and double-click on its bottom, so that following the injection was complete, and the components of the liquid drug is not lowered by the action of external forces, such as gravity. Then, to be adhered to the correct sequence of actions When the pharmaceutical preparation:

• remove the protective cap from the bottle;
• make a deep breath and slow;
• lips embrace the dispensing tip so that the axis of the cylinder was sent upside down;
  simultaneously with deep inhalation push the bottom steel container to release the required amount of the drug;
• hold your breath for a few seconds for a more complete penetration of pharmaceutical liquids;
• repeat step 3 for the second dose, if any, appointed by the attending physician;
• close the cap, turning the cylinder to its original position.

Aerosol is equipped with a special plastic Adapter for mouth   (mouthpiece for the exact dosage of the amount of inhaled berotek). This item is not universal, that is, should not be used with other cylinders.

The capacity of the drug is intended for 200 injections   or inhalation of uniform, but non-transparent bottle, because is difficult to determine what amount of the pharmaceutical preparation inside. To do this, remove the protective cap and immerse the container in a bowl of water. Under the influence of the physical laws of the drug a few pops up if it has a certain amount of free gas. Thus it determines the amount of liquid fenoterol and its supporting components.

Overdose

With an overdose of a pharmaceutical preparation is observed the following symptoms:

• tachycardia;
• anginal pain;
• palpitations;
• arrhythmia;
• angina;
• arterial hyper- or hypotension (depending on the predisposition of the patient);
• an increase in pulse pressure;
• Intensive hyperemia the skin of the face and upper body;
• intention tremor.

As pharmaceutical antidote   Berotek medicament for use, usually cardioselective beta-blockers Especially receptor blockers such as beta-1 (antagonistic action). One application of these drugs is fraught with increased bronchial obstruction, so be very careful to select the appropriate dose of antidote. Also used symptomatic therapy Involving the use of sedative drugs and tranquilizers. With appropriate medical indications resort to intensive care (monitoring vital signs).

Cooperation

Enhances the overall therapeutic effect   pharmaceutical preparation following medications:

• beta-adrenoceptor agonists;
• anticholinergics;
• tricyclic antidepressants;
• monoaminoskidazy enzyme inhibitors (MAO).

The combined use of these drugs stimulate the development of side effects :

• beta-agonists;
• anticholinergics;
• xanthine derivatives (including Theophylline ).

Others Interactions:

• beta-adrenergic receptors in the appointment in parallel with berotek can lead to a serious reduction in bronchodilation;
• halogenated gidrokarbonovye antiseptics (eg, Halothane , Trichlorethylene or Enflurane ) Enhance the effect of the active ingredients of the drug on the cardiovascular system.

Terms of sale

Prescription.

Storage conditions

Keep a pharmaceutical preparation to be out of reach of children at or above 30 degrees Celsius, away from direct sunlight and open flame (the latter condition is especially true for the inhalation aerosol in steel cylinders). It is strictly forbidden to freeze the liquid drug.

Shelf life

5 years

Cautions

The therapeutic effect of conservative rehabilitation of bronchial asthma and steroid-dependent chronic obstructive pulmonary disease will be much higher if treatment is anti-inflammatory supplement pharmaceuticals, for example, inhaled corticosteroids . However, in this case it is recommended therapy in appropriate hospitals. You also need to have regular diagnostic tests feasibility of such a regimen in each case, so as not to harm the patient.

If for any medical or personal preferences instead of the solution for inhalation Berotek was decided to use an aerosol Berotek H corresponding to treat disease, the patient should be warned that it tastes a little different. However, the difference organoleptic characteristics pharmaceuticals does not affect the therapeutic efficacy or safety of a list of side effects, and therefore drugs are completely interchangeable.

Analogs

Match code ATC 4th level:

• Ventolin
• Foradil

Analogs berotek make up a small number of pharmaceuticals - Partusisten . Fenoterol and Fenoterol hydrobromide . Also conservative treatment and prevention of diseases of the respiratory system Berotek may be replaced by other similar drug called Flomax . This metered aerosol inhalation at all sorts of respiratory pathologies.

On discussion forums often heard question: which is better - or Berotek Flomax   in a given clinical situation.

The answer lies in the composition of both drugs. The main active element is berotek fenoterol hydrobromide, whose action in the form of an aerosol or solution for inhalation efforts of various ancillary components. Berodual, in turn, among fenoterol also comprises Ipratropium bromide   - Biologically active anticholinergic agent   therapeutic properties which allow the best to eliminate the disease entities affecting the respiratory tract. However accordingly enhance the useful range of action is prolonged and a list of side effects.

Because confidently select any of the two pharmaceutical compositions in the conservative treatment of the respiratory system is difficult. It should listen to the instructions of a medical doctor and strictly follow all suggestions. For example, instruction in both drugs are quite clearly limits the permitted dosage, and therefore inhalation is carried out most carefully.

Babies

In pediatric patients the drug can only be used when the child is 4 years.

During pregnancy (and lactation)

The pharmaceutical preparation may be used for treatment of pregnant women Only in the second and third trimester .

During breastfeeding prescribing is justified only if the expected result of the therapeutic intervention is much greater than the potential risk to the baby, as Fenoterol, the main active component of aerosol, is able to penetrate into breast milk.

Reviews berotek

The pharmaceutical formulation has a good reputation in the discussion forums on the treatment of pathologies of the respiratory system. Much more positive feedback from patients using inhaled aerosol rather than a liquid solution. As a rule, the positive side is characterized by ease of use, time of manipulation, duration of the course and so on. We should not forget that bottle of medicine is small in size, respectively, it is possible to take to the countryside or to other destinations, in order not to skip a pharmaceutical.

Reviews berotek by qualified professionals also welcome the character. Of course, the list of side effects is great enough, but the drug allows to cope with a wide range of respiratory diseases. The drug can be used as a monotherapy in certain disease entities, act as a preventive or rehabilitation combined conservative course.

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