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Beclazon eco application. Instructions for use of beclazone

"Beclazon Eco" is an inhalation drug intended for basic therapy bronchial asthma. This is a dosed aerosol for inhalation, released from an aluminum cylinder under pressure. There should be no leaks, external damage or corrosion of the bottle. When spraying an aerosol onto a glass surface, the contents of the container leave a stain light color. The medicine is packaged in cardboard boxes 1 bottle containing 200 doses.

Release forms of this drug

  • Aerosol for inhalation with a dosage of 50 mcg.
  • Aerosol for inhalation, which is activated by inhalation with dosages of 50 mcg, 100 mcg and 250 mcg ("Beclazon Eco Easy Breathing").

One dose of the drug contains the main active substance - beclomethasone dipropionate, as well as auxiliary elements: ethanol and hydrofluoroalkane.

Pharmacological action

"Beclazon Eco" is a representative of the pharmacological category of drugs called glucocorticosteroids. It has an unexpressed tropism for GCS receptors. It is converted into active metabolites under the influence of enzymes, in particular beclomethasone-17-monopropionate, which contributes to a pronounced local anti-inflammatory effect.

The main properties of the drug “Beclazone Eco Easy Breathing”:

  • reduction of manifestations of the inflammatory process due to inhibition of the formation of chemotaxis substance (impact on late allergic reactions);
  • inhibition of immediate allergic reactions (associated with suppression of the production of arachidonic acid metabolites and inhibition of the release of mediators that stimulate the inflammatory process from mast cells);
  • normalization of mucociliary transport;
  • reduction in the number of mast cells in the bronchial mucosa;
  • reduction of swelling of the epithelial layer, bronchial hyperreactivity, mucus production, accumulation of neutrophils, production of lymphokines and inflammatory exudate;
  • decreased macrophage migration activity;
  • reducing the intensity of the infiltration and granulation process;
  • increasing the number of active beta-adrenergic receptors;
  • stabilization of the patient’s response to bronchodilators, which makes it possible to significantly reduce the frequency of their use.

This drug, after administration by inhalation, has virtually no resorptive effect. The drug does not relieve bronchospasms. Achievement therapeutic effect occurs slowly, usually after a week of treatment.

Pharmacokinetics

More than 1/4 of the inhaled dosage active substance medicine settles in the respiratory organs, the remaining amount, as a rule, settles in the pharynx, oral cavity, and is subsequently swallowed.

In the lungs, the active element is actively metabolized to the main metabolite, B-17-MP, before absorption begins. The total absorption of this metabolite occurs in the tissues of the lungs (37% of the pulmonary fraction), in the digestive tract (25% of the dosage received upon ingestion). The complete bioavailability of the main substance and its metabolite is approximately 2 and 62% of the inhalation dosage, respectively.

According to the instructions for Beklazon Eco, beclomethasone is absorbed quickly, the time to reach the highest concentration in the blood occurs after 19 minutes. Absorption of the metabolite is slow, the time to reach maximum concentrations is 1 hour. Observed linear dependence between increasing dosages received and systemic exposure of the main element.

The distribution of beclomethasone and its metabolite in tissues is 20 and 424 l. A relatively strong association with plasma proteins is observed - approximately 88%. Beclomethasone and B-17-MP have a fairly high plasma clearance (150 and 120 l/h). The half-life of these substances from the body is 0.5 and 2.7 hours, respectively.

Beclazon Eco also has analogues; they will be described below.

The drug can be prescribed at the stage of basic therapy of bronchial asthma.

Contraindications for the use of the medication

There are certain restrictions when using Beclazon Eco Easy Breathing" Their list includes absolute and relative contraindications.

The absolute ones are:

  • child's age up to 4 years;
  • cases of individual intolerance to the main element of the drug or its metabolite;

Relative contraindications are:

In these cases, the drug is used only under the supervision of the attending physician.

Rules for use and dosage regimen of the drug

The drug "Beclazon Eco" in the form of aerosols is intended for inhalation use. To administer it, you must use a special inhalation device. After each inhalation, the throat and mouth should be thoroughly rinsed with water. This medication is recommended for regular use, even in the absence of symptoms of the disease.

The dosage is determined by a specialist individually based on the clinical effect. After switching to higher dosages of the inhaled main substance of the drug, most patients who receive systemic corticosteroids reduce their dose or completely cancel it.

As the instructions for Beclazon Eco indicate, the initial dosage of the medicine should depend on the degree of bronchial asthma:

  1. Mild course: peak expiratory flow or forced expiratory volume is more than 80% of optimal values ​​with a variation in PEF levels of up to 20%.
  2. Moderate course: the above indicators range from 60 to 80% of the optimal values, the spread of PSV indicators per day is 20-30%.
  3. Severe course: PEF and FEV - less than 60% of optimal values, the spread of PEF indicators per day is more than 30%.

The instructions for Beclazon Eco 250 mcg say that the daily dosage of the drug should be divided into several administrations (from two to four inhalations).

  • for mild cases: 0.2-0.6 mg;
  • for moderate cases - 0.6-1 mg;
  • for severe cases - 1-2 mg.

Standard daily allowance maximum dosage is usually 1 mg.

In extremely severe cases, the dose may be increased to 1.5-2 mg per day through several inhalations.

The instructions for use for Beclazon Eco 250 mcg confirm this.

Therapy of bronchial asthma is based on a stepwise method. It is recommended to start it in accordance with the stage that takes into account the severity of the disease. Inhaled glucocorticosteroids are prescribed, as a rule, from the second stage pathological process. The drug "Beclazon Eco" 250 mcg is not intended for use in pediatrics.

The drug can be used in high daily dosages in combination with inhaled beta 2-adrenergic agonists with long-term effects in a standard dose.

If you miss an inhalation, take the next dose pharmacological agent should be taken in accordance with the therapeutic regimen at the appropriate time. Administration can be done using spacers (special dispensers), which help improve the distribution of the drug in the lungs and reduce the likelihood of side effects. Before using the inhalation device for the first time, you must check its functionality. The same applies to cases if it has not been used for a certain period of time. To do this, press the valve of the can and release a dose of the medicine into the air.

Before using Beclazon Eco 100 mcg or 250 mcg, you must remove the protective cap from the inhalation device and make sure that the outlet tube is clean. The inhalation device should be held vertically, between the thumb and forefinger. The thumb must be placed on the bottom of the device, and the index finger on the top of the aluminum can.

The container with the medicine must be shaken vigorously from top to bottom. After this, the patient should exhale deeply through his mouth, tightly clamp the outlet tube of the inhalation device with his lips, and take a slow and deep breath. If you inhale the medicine index finger it is necessary to sharply press the dosing valve of the can. In this case, one dose of the Beclazon Eco medication is released, which should be slowly inhaled. After this, you need to take the inhalation device out of your mouth and hold your breath for 10 seconds. This time may vary depending on how comfortable the patient is with this, then exhale (slowly).

After the procedure, it is necessary to rinse the mouth with water, being careful not to swallow the medicine that came into contact with the oral mucosa during inhalation. In cases where it is necessary to administer a repeated dosage of the medication, this should be done as described above, step by step, a minute after the first procedure.

The inhalation device must be cleaned at least once every few days. To do this, you need to remove the medicine canister from it, and then thoroughly rinse the protective cap and the inhalation device itself in warm water. hot water however, it is not recommended to use it.

To remove any remaining water, shake the cap and the device. They must be dried without the use of various heating devices. The aluminum can cannot be allowed to come into direct contact with water.

Side effects from using the drug

This medication can cause numerous side effects, which include:

  1. Endocrine system(with prolonged use in high dosages) - inhibition of the HPA axis (hypothalamic-pituitary-adrenal system).
  2. Respiratory organs- irritation of the pharyngeal mucosa, paradoxical bronchospasm, hoarseness, eosinophilic pneumonia.
  3. Musculoskeletal system - decreased density bone tissue.
  4. Visual organs - cataracts, glaucoma.
  5. Allergic phenomena - angioedema, skin rashes, erythema, itchy skin, urticaria.
  6. Infectious diseases(with long-term use in high doses) - candidiasis of the oral cavity, pharynx and respiratory tract.
  7. Common manifestations are nausea, cephalalgia, hematoma formation and thinning of the skin.

Symptoms of drug overdose

Acute overdose medical device"Beclazon Eco" may occur after inhalation of a single dose of more than 1 g. Symptoms of suppression of the activity of the adrenal cortex emergency treatment, as a rule, is not required, since such a violation goes away on its own after a few days.

In case of systematic overdose (long-term therapy at a dosage of more than 1.5 g), a persistent decrease in the activity of the adrenal cortex may develop. In such a case, control of their backup functions is indicated.

Treatment data pharmacological drug in case of overdose, it is allowed to continue in doses sufficient to achieve therapeutic effectiveness.

Special instructions for the use of the drug

In cases where the effectiveness of a standard dose of a medication decreases or the duration of its effect decreases, you should consult a specialist. Changing the dosage regimen on your own is strictly contraindicated. When carrying out therapy using high doses, candidiasis of the pharynx and oral cavity may occur, especially for patients with a history of similar phenomena. The rapid elimination of a fungal infection is usually facilitated by the administration of antifungal drugs. medical supplies. In such a case, there is no need to change the beclomethasone dosage regimen.

If Beclazon Eco is prescribed against the background of oral corticosteroids, then you can start reducing the dosage of the latter after 1-2 weeks.

Most often, patients who are undergoing prednisone therapy (no more than 15 mg) can completely switch to using beclomethasone only in the form of inhalations. In the first months after the transition, systematic monitoring of the HPA axis is required.

Against the background of decreased adrenal function after switching to the drug "Beclazon Eco", you should always have a supply of GCS with you, as well as a card with information that in emergency situations they need systemic GCS. With progressive worsening of bronchial asthma, increasing doses of GCS is recommended. To eliminate bronchospasm attacks, beta 2-adronomimetics, in particular salbutamol, should be used. At severe stages disease or insufficient effectiveness of this medication, it is necessary to increase its dose, and also decide on the use of GCS orally. In addition, it is possible to use antibacterial drugs, for example, for an infectious inflammatory process.

If so-called paradoxical bronchospasm occurs, this drug should be discontinued. Treatment should not be interrupted abruptly. It is also necessary to avoid getting the medication into the eyes.

Drug interactions

In accordance with the instructions, “Beclazon Eco” 250 mcg, when used with beta 2-adrenergic agonists, enhances their effect, with methandienone, estrogens, theophylline, corticosteroids - the effectiveness of the drug increases. When used with drugs such as phenytoin, phenobarbital, rifampicin and other inducers of microsomal liver enzymes, the effectiveness of the drug is reduced.

Analogues of "Beclazone Eco" 250 mcg

Analogues of the drug for inhalation are:

  • "Rinoklenil";
  • "Boson";
  • "Beclomethasone";
  • "Klenil";
  • "Nasobek";
  • "Beklospira".

The cost of Beklazon Eco aerosol for 1 can is approximately 180-500 rubles, depending on the dosage of the medicinal substance.

GCS for inhalation

Active ingredient

Release form, composition and packaging

Excipients: hydrofluoroalkane (HFA-134a) - 75.86 mg, ethanol - 2.09 mg.

Aerosol for inhalation, dosed, activated by inhalation, in the form of a solution which, when sprayed onto glass, forms a colorless spot.

Excipients: hydrofluoroalkane (HFA-134a) - 74.79 mg, ethanol - 3.11 mg.

200 doses - aluminum cylinders (1) - aerosol inhalers activated by inhalation (Light Breathing) (1) - cardboard packs.

Aerosol for inhalation, dosed, activated by inhalation, in the form of a solution which, when sprayed onto glass, forms a colorless spot.

Excipients: hydrofluoroalkane (HFA-134a) - 71.75 mg, ethanol - 6 mg.

200 doses - aluminum cylinders (1) - aerosol inhalers activated by inhalation (Light Breathing) (1) - cardboard packs.

Pharmacological action

GCS for inhalation use. Beclomethasone dipropionate is a prodrug and has weak affinity for GCS receptors. Under the influence of esterases, it is converted into an active metabolite - beclomethasone-17-monopropionate (B-17-MP), which has a pronounced local anti-inflammatory effect. Reduces inflammation by reducing the formation of a chemotaxis substance (impact on “late” allergy reactions), inhibits the development of an immediate allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells) and improves mucociliary transport. Under the influence of beclomethasone, the number of mast cells in the bronchial mucosa decreases, epithelial edema, mucus secretion by bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils, inflammatory exudate and the production of lymphokines are reduced, the migration of macrophages is inhibited, and the intensity of infiltration and granulation processes is reduced.

Increases the number of active β-adrenergic receptors, restores the patient’s response to bronchodilators, and allows to reduce the frequency of their use. Has virtually no resorptive effect after inhalation administration.

It does not relieve bronchospasm; the therapeutic effect develops gradually, usually after 5-7 days of course use of beclomethasone dipropionate.

Pharmacokinetics

Suction

After inhalation, up to 56% of the drug dose settles in the lower respiratory tract; the remaining amount settles in the mouth, pharynx and is swallowed. In the lungs, before absorption of beclomethasone, dipropionate is intensively metabolized to the active metabolite B-17-MP. Systemic absorption of B-17-MP occurs in the lungs (36% of the pulmonary fraction), in the gastrointestinal tract (26% of the dose received here when swallowed). The absolute bioavailability of unchanged beclomethasone dipropionate and B-17-MP is approximately 2% and 62% of the inhalation dose, respectively. Beclomethasone dipropionate is rapidly absorbed, Cmax is reached after 0.3 hours. B-17-MP is absorbed more slowly, Cmax is reached after 1 hour. There is an approximately linear relationship between increasing doses and systemic exposure of the drug.

Distribution

Vd is 20 L for beclomethasone dipropionate and 424 L for B-17-MP. Blood protein binding is relatively high - 87%.

Removal

Beclomethasone dipropionate and B-17-MP have high plasma clearance (150 l/h and 120 l/h, respectively). T 1/2 is 0.5 h and 2.7 h, respectively.

Indications

Contraindications

- children under 4 years of age;

- hypersensitivity to the components of the drug.

Dosage

Beclazon Eco Easy Breathing is intended for inhalation administration only.

Beclazone Eco Easy Breathing is used regularly (even in the absence of symptoms of the disease), the dose of beclomethasone dipropionate is selected taking into account the clinical effect in each specific case.

In mild cases of bronchial asthma, forced expiratory volume (FEV 1) or peak expiratory flow (PEF) is more than 80% of the expected values, with a spread in PEF values ​​of less than 20%.

In moderate cases, FEV 1 or PEF is 60-80% of the required values, the daily spread of PEF indicators is 20-30%.

In severe cases, FEV 1 or PEF is 60% of the expected values, the daily spread of PEF indicators is more than 30%.

When switching to a high dose of inhaled beclomethasone dipropionate in many patients receiving systemic corticosteroids, their dose can be reduced or discontinued altogether.

The initial dose of Easy Breathing is determined by the severity of bronchial asthma. The daily dose is divided into several doses.

Depending on the patient’s individual response, the dose of the drug can be increased until a clinical effect appears or reduced to a minimum effective dose.

Adults and children aged 12 years and older recommended initial doses of the drug for mild bronchial asthma are 200-600 mcg/day; at moderate bronchial asthma- 600-1000 mcg/day; at severe bronchial asthma- 1000-2000 mcg/day.

Children aged 4 to 12 years the dose of the drug is up to 400 mcg/day in several doses.

There is no need to adjust the dose of Beclazone Eco Easy Breathing in the elderly or in patients with renal or hepatic insufficiency.

At accidentally missing an inhalation the next dose must be taken at the appropriate time in accordance with the treatment regimen.

Beclazone Eco Easy Breathing containing 250 mcg of beclomethasone in 1 dose is not intended for use in pediatrics.

Instructions for using the inhaler

Holding the inhaler in vertical position, open the lid. Take a deep breath. Cover the mouthpiece tightly with your lips. Make sure that your hand does not block the ventilation openings on the top of the inhaler and that the inhaler is in an upright position. Take a slow, maximum breath through the mouthpiece. Hold your breath for 10 seconds or as long as possible. Then you should remove the inhaler from your mouth and exhale slowly. After use, keep the inhaler upright. Close the lid. If more than one inhalation is necessary, close the lid, wait at least 1 minute, and then repeat the inhalation process.

Cleaning the inhaler

Unscrew top part inhaler. Pull out the metal can. Rinse bottom part inhaler in warm water and dry. Insert the can into place. Close the lid and screw the upper part of the inhaler to its body. Do not wash the top of the inhaler. If the inhaler does not work properly, unscrew the top of the inhaler and manually press on the canister.

Side effects

Local reactions: possible candidiasis of the mouth and throat (the likelihood of developing candidiasis increases when using beclomethasone dipropionate in doses exceeding 400 mcg/day), dysphonia (hoarseness of voice) or irritation of the pharyngeal mucosa.

From the respiratory system: paradoxical bronchospasm is possible, which must be immediately relieved with an inhaled beta 2-adrenergic agonist short acting.

Allergic reactions: possible rash, hives, itching, redness and swelling of the eyes, face, lips and mucous membranes of the mouth and throat.

Effects due to systemic action: include headache, nausea, bruising or thinning of the skin, unpleasant taste sensations, decreased function of the adrenal cortex, osteoporosis, growth retardation in children and adolescents, cataracts, glaucoma.

Overdose

Acute overdose can lead to a temporary decrease in the function of the adrenal cortex, which does not require emergency treatment, because adrenal function is restored within a few days, as evidenced by plasma cortisol levels.

At chronic overdose Persistent suppression of adrenal function may occur.

In such cases, it is recommended to monitor the reserve function of the adrenal cortex. In case of overdose, treatment with beclomethasone dipropionate can be continued in doses sufficient to maintain the therapeutic effect.

Drug interactions

There is no confirmed data on the interaction of beclomethasone dipropionate with other medicines.

Special instructions

Before prescribing inhaled corticosteroids, it is necessary to instruct the patient on the rules for their use, ensuring the most complete delivery of the medicine to the desired areas of the lungs. The development of oral candidiasis is most likely in patients with high level precipitating antibodies in the blood against the Candida fungus, which indicates a previous history of fungal infection. After inhalation, you should rinse your mouth and throat with water. Can be used to treat candidiasis antifungal drugs local action while continuing therapy with Beclazone Eco Easy Breathing.

If patients take GCS orally, then Beclazon Eco Easy Breathing is prescribed while taking the previous dose of GCS, and the patients should be in a relatively stable condition. In about 1-2 weeks daily dose oral corticosteroids begin to be gradually reduced. The dose reduction scheme depends on the duration of previous therapy and the size of the initial dose of GCS. Regular use of inhaled GCS allows, in most cases, to cancel oral GCS (patients who need to take no more than 15 mg can be completely switched to inhalation therapy), while in the first months after the transition the patient’s condition should be carefully monitored until his pituitary-adrenal system has recovered sufficiently to ensure an adequate response to stressful situations (for example, injury, surgery or infection).

When transferring patients from taking systemic corticosteroids to inhaled therapy, allergic reactions may occur (for example, allergic rhinitis, eczema), which were previously suppressed by systemic drugs.

Patients with reduced adrenal cortex function who are transferred to inhalation treatment should have a supply of GCS and always carry a warning card with them, which should indicate that in stressful situations they need additional systemic administration of GCS (after eliminating stressful situation The dose of GCS can be reduced again). A sudden and progressive worsening of asthma symptoms is potentially dangerous condition, often life-threatening patients, and requires increasing the dose of GCS. An indirect indicator of the ineffectiveness of therapy is the more frequent use of short-acting beta 2-agonists than before.

Beclazon Eco Easy Breathing is not intended for relieving attacks, but for regular daily use. To relieve attacks, short-acting beta 2-agonists are used (for example,). In case of severe exacerbation of bronchial asthma or insufficient effectiveness of the therapy, the dose of Beclazone Eco Easy Breathing should be increased and, if necessary, a systemic corticosteroid and/or an antibiotic should be prescribed if the infection develops.

If paradoxical bronchospasm develops, you should immediately stop using Beclazone Eco Easy Breathing, assess the patient's condition, conduct an examination and, if necessary, prescribe therapy with other drugs.

With long-term use of any inhaled corticosteroids, especially in high doses, systemic effects may be observed, but the likelihood of their development is much lower than when taking corticosteroids orally. Therefore, it is especially important that when a therapeutic effect is achieved, the dose of inhaled corticosteroids is reduced to the minimum effective dose that controls the course of the disease. At a dose of 1500 mcg/day, the drug does not cause significant suppression of adrenal function in most patients. Due to possible development adrenal insufficiency, special care should be taken and regular monitoring of adrenal cortex function indicators when transferring patients taking GCS orally to treatment with Beclazone Eco Easy Breathing.

Particular care should be taken when treating patients with active or inactive forms of pulmonary tuberculosis with inhaled corticosteroids.

It is necessary to protect the eyes from contact with the drug. By washing after inhalation you can prevent damage to the skin of the eyelids and nose.

The can of Beclazone Eco Light Breathing cannot be pierced, disassembled or thrown into fire, even if it is empty. Like most other inhalation products in aerosol packages, Beclazon Eco Easy Breathing may be less effective at low temperatures. When the canister cools down, it is recommended to remove it from the plastic case and warm it with your hands for a few minutes.

Use in pediatrics

For liver dysfunction

There is no need to adjust the dose of Beclazone Eco Easy Breathing in patients with liver failure.

WITH caution used for liver cirrhosis.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children, protected from direct contact sun rays place at a temperature not exceeding 25°C; do not freeze. Shelf life – 3 years.

Catad_pgroup Antiasthmatic drugs

Beclazon Eco Easy Breathing - instructions for use

Beclazone Eco Easy Breathe

Registration number:

P N 014096/01-280407

Trade name drug: BEKLAZON ECO EASY BREATHING.

International nonproprietary name:

Beclomethasone.

Dosage form:

aerosol for inhalation, dosed, activated by inhalation.

Compound:

Each inhaler contains 200 doses of the drug.
Active substance: One inhalation dose contains beclomethasone dipropiopathate 50, 100, 250 mcg.
Excipients: ethanol, hydrofluoroalkane (HFA-134a).

Description:
Aerosol for inhalation in an aluminum pressure canister with a release valve and a spray nozzle. There must be no external damage, corrosion or leaks. The contents of the can is a solution that, when sprayed onto glass, leaves a colorless stain. The canister is placed and the inhaler, consisting of two parts and safety covers.

Pharmacotherapeutic group:

Glucocorticosteroid (GCS) for local application. ATX code: R03BA01.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics
Beclomethasone dipropionate is a prodrug and has weak affinity for GCS receptors. Under the influence of esterases, it is converted into an active metabolite - beclomethasone-17-monopropionate (B-17-MP), which has a pronounced local anti-inflammatory effect. Reduces inflammation by reducing the formation of a chemotaxis substance (impact on “late” allergic reactions), inhibits the development of an “immediate” allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells) and improves mucociliary transport. Under the influence of beclomethasone, the number of mast cells in the bronchial mucosa decreases, epithelial edema, mucus secretion by bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils, inflammatory exudate and the production of lymphokines are reduced, the migration of macrophages is inhibited, and the intensity of infiltration and granulation processes is reduced. Increases the number of active beta-adrenergic receptors, restores the patient's response to bronchodilators, and allows to reduce the frequency of their use. It has virtually no resorptive effect after inhalation administration.

It does not relieve bronchosiasm; the therapeutic effect develops gradually, usually after 5-7 days of course use of beclomethasone dipropionate.

Pharmacokinetics
Absorption. Up to 56% of the dose of the inhaled drug settles in the lower respiratory tract; the remaining amount settles in the mouth, pharynx and is swallowed. In the lungs, before absorption of beclomethasone, dipropiopathate is intensively metabolized to the active metabolite B-17-MP. Systemic absorption of B-17-MP occurs in the lungs (36% of the pulmonary fraction) and in gastrointestinal tract(26% of the dose received here when swallowed). The absolute bioavailability of unchanged beclomethasone dipropionate and B-17-MP is approximately 2% and 62% of the inhalation dose, respectively. Beclomethasone dipronionate is rapidly absorbed, the time to reach maximum plasma concentration (Tmax) is 0.3 hours. B-17-MP is absorbed more slowly. Tmax is 1 hour. There is an approximately linear relationship between increasing the inhaled dose and systemic exposure of the drug.

Distribution.
Distribution in tissues is 20 l for beclometazoan dipropionate and 424 l for B-17-MP. The binding to plasma proteins is relatively high - 87%.

Elimination.
Beclometazoa dipropiopathate and B-17-MP have high plasma clearance (150 l/h and 120 l/h, respectively). The half-life is 0.5 hours and 2.7 hours, respectively.

INDICATIONS FOR USE
Basic therapy for various forms of bronchial asthma in adults and children over 4 years of age.

CONTRAINDICATIONS
Hypersensitivity to any component of the drug. Childhood up to 4 years.

USE IN PREGNANCY AND LACTATION
Beclazon Eco Easy Breathing should be used with extreme caution during pregnancy and lactation and only if the potential benefit to the mother exceeds possible risk for the fetus and child.

METHOD OF APPLICATION AND DOSES
Beclazon Eco Easy Breathing is intended ONLY for inhalation administration. Beclazone Eco Easy Breathing is used regularly (even in the absence of symptoms of the disease), the dose of beclomethasone dipropionate is selected taking into account the clinical effect in each specific case.

In mild cases of bronchial asthma, the forced expiratory volume (FEV1) or peak expiratory flow (PEF) is more than 80% of the expected values, with a spread of PEF values ​​of less than 20%.

In moderate cases, FEV1 or PEF is 60-80% of the required values, the daily spread of PEF indicators is 20-30%.

In severe cases, FEV1 or PEF is 60% of the required values, the daily spread of PEF indicators is more than 30%.

When switching to a high dose of inhaled beclomethasone dipropionate, many patients receiving systemic corticosteroids will be able to reduce their dose or stop them altogether.

The initial dose of Beclazone Eco Easy Breathing is determined by the severity of bronchial asthma. The daily vine is divided into several stages.

Depending on the patient's individual response, the dose of the drug can be increased until a clinical effect appears or reduced to the minimum effective dose.

Adults and children age 12 and older:

  • Mild bronchial asthma - 200 - 600 mcg/day;
  • Moderately severe bronchial asthma 600-1000 mcg/day;
  • Severe bronchial asthma - 1000-2000 mcg/day.

Children aged 4 to 12 years
Up to 400 mcg per day in several doses.

Special patient groups
There is no need to adjust the dose of Beclazone Eco Easy Breathing in individuals elderly, in patients with renal or hepatic insufficiency.

Skipping one dose of the drug
If you accidentally miss an inhalation, the next dose must be taken at the scheduled time in accordance with the treatment regimen.

Beclazon Eco Easy Breathing, containing 250 mcg per dose, is not intended for use in pediatrics.

Administration can be carried out using a special optimizer, which improves the distribution of the drug in the lungs and reduces the risk of side effects.

SIDE EFFECTS
Some patients may develop candidiasis of the mouth and throat (the likelihood of developing candidiasis increases when using bsclometazope dipropionate in doses exceeding 400 mcg per day).

Some patients may experience dysphonia (hoarseness) or irritation of the pharyngeal mucosa.

Inhaled drugs can cause paradoxical bronchospasm, which must be immediately relieved with an inhaled short-acting beta-2 agonist.

There are isolated reports of the development of reactions hypersensitivity, including rash, hives, itching, redness and swelling of the eyes, face, lips and mucous membranes of the mouth and throat. Possible systemic effects characteristic of GCS. include headache, nausea, bruising or thinning of the skin, unpleasant taste, decreased adrenal function, osteoporosis, growth retardation in children and adolescents, cataracts, glaucoma.

OVERDOSE
An acute overdose of the drug can lead to a temporary decrease in the function of the adrenal cortex, which does not require emergency treatment, since the function of the adrenal cortex is restored within several days, as confirmed by the level of cortisol in plasma. In case of chronic overdose, persistent suppression of the function of the adrenal cortex may be observed. In such cases, it is recommended to monitor the reserve function of the adrenal cortex. In case of overdose, treatment with beclomethasone dipropionate can be continued in doses sufficient to maintain the therapeutic effect.

INTERACTION WITH OTHER MEDICINES
There is no confirmed data on the interaction of beclomethasone dipropionate with other drugs.

SPECIAL INSTRUCTIONS
Before prescribing inhaled drugs, it is necessary to instruct the patient on the rules for their use, ensuring the most complete delivery of the drug to the desired areas of the lungs. The development of oral candidiasis is most likely in patients with high levels of precipitating antibodies in the blood against the Candida fungus, which indicates a previous fungal infection. After inhalation, you should rinse your mouth and throat with water. To treat candidiasis, topical antifungal drugs can be used while continuing therapy with Beclazone Eco Easy Breathing. If the Nazis take GCS orally, then Beclazon Eco Easy Breathing is prescribed while taking the previous dose of GCS, and the patients must be in a relatively stable condition. After about 1-2 weeks, the daily dose of oral corticosteroids begins to be gradually reduced. The dose reduction scheme depends on the duration of previous therapy and the size of the initial dose of GCS. Regular use of inhaled GCS allows in most cases to cancel oral GCS (patients who need to take no more than 15 mg of prednisolope can be completely transferred to inhaled therapy), while in the first months after the transition the patient’s condition should be carefully monitored until his pituitary-adrenal the system will not recover sufficiently to provide an adequate response to stressful situations (such as injury, surgery, or infection).

When transferring patients from taking systemic corticosteroids to inhalation therapy, allergic reactions may occur (for example, allergic rhinitis, eczema), which were previously suppressed by systemic drugs.

Patients with reduced function of the adrenal cortex who are transferred to inhalation treatment should have a supply of GCS and always carry a warning card with them, which should indicate that in stressful situations they need additional systemic administration of GCS (after eliminating the stressful situation, the dose of GCS can be repeated reduce). A sudden and progressive worsening of asthma symptoms is a potentially dangerous condition, often life-threatening for patients, and requires an increase in the dose of GCS. An indirect indicator of the ineffectiveness of therapy is the more frequent use of short-acting b-2-agonists than before.

Beclazon Eco Easy Breathing is not intended for relieving attacks, but for regular daily use. To relieve attacks, short-acting β-2 adrenergic stimulants (for example, salbutamol) are used. In case of severe exacerbation of bronchial asthma or insufficient effectiveness of the therapy, the dose of Beclazone Eco Easy Breathing should be increased and, if necessary, prescribe systemic corticosteroids and/or an antibiotic if infection develops.

If paradoxical bronchospasm develops, you should immediately stop using Beclazone Eco Easy Breathing, assess the patient's condition, conduct an examination and, if necessary, prescribe therapy with other drugs. With long-term use of any inhaled corticosteroids, especially in high doses, systemic effects may be observed (see “Side effects”), but the likelihood of their development is much lower than when taking corticosteroids orally. Therefore, it is especially important that when a therapeutic effect is achieved, the dose of inhaled corticosteroids is reduced to the minimum effective dose that controls the course of the disease. At a dose of 1500 mcg/day, the drug does not cause significant suppression of adrenal function in most patients. Due to possible adrenal insufficiency, special caution and regular monitoring of adrenal cortex function indicators should be observed when transferring patients taking oral corticosteroids to treatment with Beclazone Eco Easy Breathing.

Abrupt withdrawal of Beclazone Eco Easy Breathing is not recommended. Particular care should be taken when treating patients with active or inactive forms of pulmonary tuberculosis with inhaled corticosteroids. It is necessary to protect the eyes from contact with the drug. By washing after inhalation you can prevent damage to the skin of the eyelids and nose.

The can of Beclazone Eco Light Breathing cannot be pierced, disassembled or thrown into fire, even if it is empty. Like most other inhalation products in aerosol packages, Beclazon Eco Easy Breathing may be less effective at low temperatures. When the canister cools down, it is recommended to remove it from the plastic case and warm it with your hands for a few minutes.

PATIENT INSTRUCTIONS FOR OPERATING THE INHALER

Instructions for use) inhaler without optimizer
Hold the inhaler upright and open the cap. Take a deep breath. Cover the mouthpiece tightly with your lips. Make sure your hand is not blocking the vents on the top of the inhaler and that you are holding the inhaler upright. Take a slow, maximum breath through the mouthpiece. Hold your breath for 10 seconds or as long as is comfortable for you. Then remove the inhaler from your mouth and exhale slowly. After use, continue to hold the inhaler upright. Close the lid. If you need to take more than one inhalation, close the lid, wait at least one minute, and then repeat the inhalation process.

Instructions for using an inhaler with an optimizer
Holding the inhaler upright, open the cap and fit the Optimizer tightly onto the mouthpiece of the inhaler. Take a deep breath. Place your lips tightly around the mouthpiece of the optimizer. Make sure your hand is not blocking the vents on the top of the inhaler and that you are holding the inhaler upright. Take a slow, maximum breath through the optimizer mouthpiece. Hold your breath for 10 seconds or as long as is comfortable for you. Then remove the inhaler from your mouth and exhale slowly. After use, continue to hold the inhaler upright. Remove the optimizer. Close the lid.

If you need to take more than one inhalation, after 1-2 minutes, open the lid again and fit the optimizer tightly onto the mouthpiece of the inhaler, and then repeat the inhalation process.

Cleaning the inhaler
Unscrew the top of the inhaler. Pull out the metal can. Rinse the bottom of the inhaler in warm water and dry. Insert the can into place. Close the lid and screw the top of the inhaler to its body. Do not wash the top of the inhaler. If the inhaler is not working properly, unscrew the top of the inhaler and press down on the canister by hand.

RELEASE FORM
Aerosol for inhalation dosed, activated by inhalation 50 mcg/dose, 100 mcg/dose, 250 mkg/dose.

200 doses each active substance in an aluminum can filled with aerosol under pressure. The aluminum canister is contained in a breath-activated aerosol inhaler (Light Breathing).

An aerosol inhaler with a can is placed in a cardboard box along with an optimizer and instructions for use.

BEST BEFORE DATE
3 years.
Do not use after expiration date.

STORAGE CONDITIONS
At a temperature not exceeding 30°C, protecting from direct sunlight. Do not freeze. Keep out of the reach of children.

CONDITIONS OF VACATION FROM PHARMACIES
According to the recipe.

MANUFACTURER
Norton Waterford, Ireland IDEA International Park. Cork Road, Waterford, Ireland

Moscow representative office;
107031, Moscow, Dmitrovsky lane, building 9

Latin name: Beclazone Eco Easy Breath
ATX code: R03B A01
Active ingredient: Beclometasone
Manufacturer: Norton (Ireland), Teva
Pharmaceutical Industries (Israel)
Dispensing from the pharmacy: by prescription
Storage conditions: t up to 30 °C
Best before date: 3 years

Indications for use

Beclazon Eco Easy Breathing is hormonal drug. Designed for preventive therapy bronchial asthma chronic form, flowing with varying degrees severity, and other obstructive respiratory diseases.

Composition and release form

International generic name inhaled drugs: Beclomethasone.

The medicine is produced in the form of a dosed aerosol for inhalation. Activated by inhalation. It is produced with different concentrations of the active component beclamethasone:

  • Aerosol with 50 mcg per dose

Auxiliary components: hydrofluoroalkane – 75.8 mg, 2.09 mg alcohol

  • Aerosol with 100 mcg per dose

Auxiliary components: 74.79 mg of hydrofluoroalkane, 3.1 mg of ethanol.

  • Aerosol with 250 mcg per dose

Auxiliary components: 71.7 mg hydrofluoroalkane, 6 mg alcohol.

The medicine is presented in the form of a clear liquid that smells of alcohol. Each type of drug is designed for 200 doses. The product is contained in a pressure container (can) made of aluminum, placed in an inhalation device, which consists of two parts and a lid. Packaged together with accompanying manual in cardboard boxes.

Medicinal properties

The therapeutic effect of Beclazone is achieved due to the properties inherent in the main component of the inhalation solution. Beclomethasone in the form of dipropionate belongs to the group of prodrugs: it acquires medicinal properties after penetration into the body, transforming into an active metabolite under the influence of esterase enzymes. The new compound has anti-inflammatory properties in areas of deposition.

Thanks to the effect of the substance, the content of mast cells in bronchial tissues is reduced, swelling of the epithelium is relieved, the amount of mucus formed in the bronchi is reduced, and the intensity of inflammatory processes is reduced. At the same time, the number of beta receptors responsible for dilation of the bronchi increases, and sensitivity to drugs is restored.

Inhaled drugs do not have the ability to relieve bronchospasms. The effect of application develops gradually with systematic application– usually within a week.

After inhalation use, the substance is distributed in the respiratory tract: more than half of the dose (about 57%) settles in the lower sections, a certain amount remains in the oral cavity and pharynx, and some is swallowed. After penetration into the body, beclamethasone is absorbed at high speed. The highest concentrations are formed 20 minutes after the procedure.

The medicine is excreted from the body mainly with feces, a small part - with urine.

Directions for use

Average cost: ing. (0.05 mg/dose) – 228 rubles, (0.1 mg/dose) – 643 rubles, (0.25 mg/dose) – 1084 rubles.

Beclazon Eco Easy Breathing should be used only by inhalation. It should be used regularly throughout the course, even if the patient feels normal and is not bothered by any manifestations of the disease.

The dosage and duration of the course are determined individually for each patient, based on his indications. Daily norm Beclazone is distributed over several procedures.

For children from 4 to 12 years old – 400 mcg

For adults and children over 12 years of age, depending on the course of asthma:

  • Lung: 200 to 600 mcg
  • Average: 600 to 1000 mcg
  • Severe: from 1000 mcg to 2000.

The dosage of Beclazone Eco Easy Breathing for elderly patients, patients with insufficient functioning of the liver or kidneys is prescribed on a general basis. No correction required.

During pregnancy and pregnancy

The drug should not be used by pregnant women during the first stage of pregnancy. Prescribing Beclazone is possible in the following months, but only after a thorough examination, and also if the benefit to the mother outweighs the risk of threats to the fetus. If a woman was treated with inhalations in the last weeks of pregnancy, then the condition of the adrenal glands of the newborn child needs to be checked.

Breastfeeding women should avoid using the beclomethasone inhaler, as it is unknown whether the substance passes into milk and how dangerous it is for infants.

Contraindications and precautions

Inhaler Beclazon Eco Easy Breathing is prohibited for use when:

  • Individual hypersensitivity to drug ingredients
  • Severe bronchial asthma, attacks
  • Tuberculosis
  • Candidiasis and fungal infection upper respiratory tract
  • First trimester of pregnancy
  • Up to 4 years of age.

The drug can be prescribed with precautions when:

  • Glaucoma
  • Systemic infections of any origin
  • Osteoporosis
  • Pulmonary tuberculosis
  • Liver cirrhosis
  • Reduced levels of thyroid hormones in the body
  • Carrying a child and breastfeeding.

When prescribing Beclazone, the doctor must proceed from the patient’s condition and the proportionality of benefit and harm and take control of the course of therapy.

Special instructions

When prescribing the medication Beclazon Eco Easy Breathing, the patient must be familiar with the operating features of the inhaler so that during the procedure the drug is guaranteed to penetrate certain areas of the lungs.

Patients with a high concentration of precipitins in the blood are most susceptible to the occurrence of candidiasis in the oral cavity, which is evidence of a previous infectious disease.

If the patient takes oral corticosteroids, then Beclazon-Eco is recommended to be used in the appropriate dose. Provided that the patient's condition is stable. After approximately 1-2 weeks, the dosage of GCS in tablets is gradually reduced. The reduction scheme is determined by the doctor depending on the duration of the previous course and the size of the initial dose of the drugs. Systematic therapy of GCS in the form of inhalations allows you to abandon oral medications. After discontinuation of GCS, the patient’s condition should be monitored for at least 3 months, that is, until full recovery pituitary-adrenal system.

Switching from oral to inhaled GCS can provoke severe allergic symptoms, which were previously blocked by GCS tablets. Therefore, at the first stages of adaptation, it is advisable for patients to always have spare GCS tablets with them and a note warning them that in a stressful situation they need to take this drug.

Unexpected and intensified manifestations of asthma can pose a threat to life, and therefore high dosages of corticosteroids are needed to relieve them. The ineffectiveness of previous treatment can be judged by the increasing number of cases of use of β-2-adrenergic stimulants.

The drug Beclazon Eco LD is not intended for emergency relief of asthma attacks; its therapeutic effect develops with daily systematic use.

If asthma is severe, this is a reason to increase the dosage inhalation medicine, prescribing oral corticosteroids or antibiotics (if there is an infection).

If bronchospasm develops, it is necessary to immediately discontinue the use of Beclazone, conduct an examination of the patient and make changes to the treatment regimen.

Long-term therapy with any inhaled corticosteroids can lead to systemic disorders. Although this form of medication is less likely to cause complications than oral medications, after stabilizing the patient's condition, it is necessary to reduce the dosage to the minimum at which the course of the disease can be controlled.

If Beclazone is used for a long time by children, they may experience growth retardation. To prevent this, it is necessary to constantly monitor the nature of development.

The effectiveness of Beclazone decreases when cooled. Therefore, before the procedure, it is advisable to hold the inhaler in your hands or place it in the room for natural warming.

  • Safety instructions for using the inhaler

The medicine in the can is contained under compressed gas pressure, so the container must not be heated, pierced or broken. The empty container must be disposed of according to the conditions for this pharmaceutical form. To avoid accidents, do not give the aerosol to children.

Side effects and cross-interactions

Although the drug Beclazon Eco Easy Breathing is usually well tolerated if the recommendations are followed, it, like any medication, can cause a negative response from the body. Undesirable symptoms appear as:

  • Immune system: Quincke's edema, dyspnea, bronchospasm, anaphylactic reactions
  • Endocrine system: hypercortisolism syndrome, manifestations of Cushingoid, adrenal suppression, growth retardation in children and adolescents
  • Visual organs: cataracts, in some patients glaucoma is not excluded
  • Respiratory organs: irritation of the throat mucosa, hoarseness, bronchospasm
  • Skin: rash, itching, urticaria, erythema
  • Locomotor system: decreased bone density (with systemic exposure)
  • Mental: disorder emotional state, depression, nervousness, sleep disturbance, children most often experience hyperactivity and nervous agitation.

Taking Beclazone aerosol with other drugs

There is no data yet indicating the development of negative reactions after combining beclomethasone with other medications.

During therapy, it should be taken into account that joint use an inhaler with other corticosteroids (for oral or nasal administration) may increase the effect on the adrenal cortex.

If the patient has previously used intranasal drugs of the beta-agonist group, then an increase in the effect of beclomethasone cannot be ruled out.

Overdose

Despite the low toxicity of dosed inhalation aerosol, too frequent or excessive injection can lead to an overdose. At acute form there is a decrease in the functioning of the adrenal cortex. However, no special therapy is required, since negative symptom goes away on its own within a few days. The most dangerous thing that can happen after overdoses of Beclazone Easy Breathing is the suppression of the hypothalamic-pituitary-adrenal system. But even in this case there is no need for special events. It is also not worth interrupting therapy; it should be continued at the prescribed dosage. Restoring normal functioning of the system takes an average of 1-2 days. You can verify this by reading plasma cortisol levels.

In the case of long-term use of overdoses of drugs, a chronic form of overdose and increased suppression of the adrenal glands may occur. In such conditions, it is recommended to constantly monitor the functioning of the organ. Treatment with Beclazon-Eco instructions for use allows you to continue, but only with strict adherence to the recommended doses.

Analogues

Only a doctor can choose a remedy identical to Beclazone.

TEVA (Israel, Czech Republic)

Average cost: fl. (200 doses) – 196-219 rubles.

The drug is in the form of a spray for intranasal use. Intended for seasonal or permanent use for allergic and vasomotor rhinitis.

The main component of the drug is beclamethasone in the form of dipropionate. Its content in one dose is 50 mcg. The spray neutralizes inflammatory processes, eliminates allergy symptoms, suppresses local immunity to ensure therapeutic action PM.

Pros:

  • Makes breathing easier
  • Relieves inflammation.

Flaws:

  • Not intended for small children.

Instructions for medical use

medicine

BEKLAZON ECO

Trade name

Beclazon Eco

International nonproprietary name

Beclomethasone

Dosage form

Aerosol for inhalation dosed,

100 mcg/dose, 250 mcg/dose - 200 doses

Compound

One dose contains

active substance: - beclomethasone dipropionate anhydrous 100 mcg, 250 mcg

excipients: norflurane (hydrofluoroalkane NFE 134a), anhydrous ethanol

Description

Aerosol for inhalation in an aluminum can under pressure.

There must be no external damage, cracks, corrosion or leaks. Contents of the can: suspension white. When spraying the drug onto glass, a white spot remains.

Pharmacotherapeutic group

Other inhaled drugs for the treatment of obstructive airway diseases. Glucocorticosteroids.

ATX code R03BA01

Pharmacological properties

F armakokineti ka

More than 25% of the dose of the inhaled drug is deposited in the respiratory tract; the remaining amount settles in the mouth, pharynx and is swallowed. In the lungs, before absorption of beclomethasone, dipropionate is intensively metabolized to the active metabolite B-17-MP. Systemic absorption of B-17-MP occurs in the lungs (36% of the pulmonary fraction) in the gastrointestinal tract (26% of the dose received here when swallowed). The absolute bioavailability of unchanged beclomethasone dipropionate and B-17-MP is about 2% and 62%, respectively. from the inhalation dose. Beclamethasone dipropionate is rapidly absorbed, the time to reach maximum plasma concentration (Tmax) is 0.3 hours. B-17-MP is absorbed more slowly, Tmax is 1 hour. There is an approximately linear relationship between increasing the inhaled dose and systemic exposure of the drug.

Distribution in tissues is 20 l for beclazone dipropionate and 424 l for B-17-MP. The connection with blood plasma proteins is relatively high - 87%.

Beclamethasone dipropionate and B-17-MP have high plasma clearance (150 l/h and 120 l/h, respectively). The half-life is 0.5 hours and 2.7 hours, respectively.

F armakodynes ka

Beclamethasone dipropionate is a prodrug and has weak affinity for GCS receptors. Under the influence of esterases, it is converted into an active metabolite - beclomethasone-17-monopropionate (B-17-MP), which has a pronounced local anti-inflammatory effect. Reduces inflammation by reducing the formation of a chemotaxis substance (impact on “late” allergic reactions), inhibits the development of an “immediate” allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells) and improves mucociliary transport. Under the influence of beclomethasone, the number of mast cells in the bronchial mucosa decreases, epithelial edema, mucus secretion by bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils, inflammatory exudate and the production of lymphokines are reduced, the migration of macrophages is inhibited, and the intensity of infiltration and granulation processes is reduced. Increases the number of active beta-adrenergic receptors, restores the patient's response to bronchodilators, and allows to reduce the frequency of their use. It has virtually no resorptive effect after inhalation administration.

It does not relieve bronchospasm; the therapeutic effect develops gradually, usually after 5-7 days of course use of beclomethasone dipropionate.

Pprovision for use

Bronchial asthma of various forms in adults and children over 4 years of age

WITHDirections for use and dosage

Beclazon Eco is intended for inhalation administration only.

Beclazone Eco is used regularly (even in the absence of symptoms of the disease), the dose of beclomethasone dipropionate is selected taking into account the clinical effect in each specific case.

In mild cases of bronchial asthma, the forced expiratory volume (FEV) or peak expiratory flow (PEF) is more than 80% of the expected values, with a spread of PEF values ​​of less than 20%.

In moderate cases, FEV or PEF is 60-80% of the required values, the daily spread of PEF indicators is 20-30%.

In severe cases, FEV or PEF is 60% of the expected values, the daily spread of PEF indicators is more than 30%.

When switching to a high dose of inhaled beclamethasone dipropionate, many patients receiving systemic corticosteroids will be able to reduce their dose or stop them altogether.

The initial dose of Beclazone Eco is determined by the severity of bronchial asthma. The daily dose is divided into several doses.

Depending on the patient's individual response, the dose of the drug can be increased until a clinical effect appears or reduced to the minimum effective dose.

Adults and children aged 12 years and older:

mild bronchial asthma - 200-600 mcg/day

· moderate bronchial asthma - 600-1000 mcg/day

· severe bronchial asthma - 1000-2000 mcg/day

Treatment of bronchial asthma is based on a stepwise approach - therapy begins according to the step corresponding to the severity of the disease.

Inhaled corticosteroids are prescribed at the second stage of therapy.

Stage 2.Basic therapy.

Beclamethasone dipropionate 100-400 mcg 2 times a day.

Stage 3.Basic therapy.

Inhaled corticosteroids are used in a high dose or in a standard dose, but in combination with inhaled long-acting beta-2 adrenergic receptor antagonists.

Beclomethasone dipropionate in a high dose - 800-1600 mcg/day, in some cases megadoses up to 2000 mcg/day.

Stage 4.Severe asthma.

Beclomethasone dipropionate in a high dose of 800-1600 mcg/day, in some cases megadoses up to 2000 mcg/day.

Stage 5.Severe asthma.

Beclamethasone dipropionate in high dose (see step 3.4)

Children aged 4 to 12 years

Up to 400 mcg per day in several doses.

Special patient groups

There is no need to adjust the dose of Beclazone Eco in elderly people or in patients with renal or liver failure.

Skipping one dose of the drug

If you accidentally miss an inhalation, the next dose must be taken at the scheduled time in accordance with the treatment regimen.

Course of treatment

Individual

Psideways actions

Some patients may develop candidiasis of the mouth and throat (the likelihood of developing candidiasis increases when using beclamethasone dipropionate in doses exceeding 400 mcg per day).

Some patients may experience dysphonia (hoarseness) or irritation of the pharyngeal mucosa. Using a spacer reduces the likelihood of developing these side effects.

Inhaled drugs can cause paradoxical bronchospasm, which must be treated immediately with an inhaled short-acting beta-2 agonist. Hypersensitivity reactions have been reported, including rash, urticaria, itching, redness and swelling of the eyes, face, lips and mucous membranes of the mouth and throat Possible systemic effects include headache, nausea, bruising or thinning of the skin, unpleasant taste, decreased adrenal function, osteoporosis, growth retardation in children and adolescents, cataracts, glaucoma.

Pcontraindications

Hypersensitivity to any component of the drug

Children under 4 years old

Drug interactions

Not installed.

Special instructions

Before prescribing inhaled drugs, it is necessary to instruct the patient on the rules for their use, ensuring the most complete delivery of the drug to the desired areas of the lungs. The development of oral candidiasis is most likely in patients with high levels of precipitating antibodies in the blood against the Candida fungus, which indicates a previous fungal infection. After inhalation, you should rinse your mouth and throat with water. To treat candidiasis, topical antifungal drugs can be used while continuing therapy with Beclazone Eco.

If patients take GCS orally, Beclazon Eco is prescribed while taking the previous dose of GCS, and the patients should be in a relatively stable condition. After about 1-2 weeks, the daily dose of oral corticosteroids begins to be gradually reduced. The dose reduction scheme depends on the duration of previous therapy and the size of the initial dose of GCS. Regular use of inhaled GCS allows in most cases to cancel oral GCS (patients who need to take no more than 15 mg of prednisolone can be completely transferred to inhaled therapy), while in the first months after the transition the patient’s condition should be carefully monitored until his pituitary-adrenal the system will not recover sufficiently to provide an adequate response to stressful situations (such as injury, surgery, or infection).

When transferring patients from taking systemic corticosteroids to inhalation therapy, allergic reactions (for example, allergic rhinitis, eczema), which were previously suppressed by systemic drugs, may occur.

Patients with reduced function of the adrenal cortex who are transferred to inhalation treatment should have a supply of GCS and always carry a warning card with them, which should indicate that in stressful situations they need additional systemic administration of GCS (after eliminating the stressful situation, the dose of GCS can be repeated reduce). A sudden and progressive worsening of asthma symptoms is a potentially dangerous condition, often life-threatening for patients, and requires an increase in the dose of GCS. An indirect indicator of the ineffectiveness of therapy is the more frequent use of short-acting b-2-agonists than before.

Beclazon Eco is not intended for relieving attacks, but for regular daily use. To relieve attacks, short-acting b-2-agonists (for example, salbutamol) are used. In case of severe exacerbation of bronchial asthma or insufficient effectiveness of therapy, the dose of inhaled beclomethasone dipropionate should be increased and, if necessary, a systemic corticosteroid and/or an antibiotic should be prescribed if infection develops.

If paradoxical bronchospasm develops, you should immediately stop using Beclazone Eco, assess the patient's condition, conduct an examination and, if necessary, prescribe therapy with other drugs. With long-term use of any inhaled corticosteroids, especially in high doses, systemic effects may be observed (see “Side effects”), but the likelihood of their development is much lower than when taking corticosteroids orally. Therefore, it is especially important that when a therapeutic effect is achieved, the dose of inhaled corticosteroids is reduced to the minimum effective dose that controls the course of the disease. At a dose of 1500 mcg/day, the drug does not cause significant suppression of adrenal function in most patients. Due to possible adrenal insufficiency, special care should be taken and regular monitoring of adrenal function indicators when transferring patients taking oral corticosteroids to treatment with Beclazone Eco.

Particular care should be taken when treating patients with active or inactive forms of pulmonary tuberculosis with inhaled corticosteroids.

It is necessary to protect the eyes from contact with the drug. By washing after inhalation you can prevent damage to the skin of the eyelids and nose.

The can of Beclazon Eco cannot be pierced, disassembled or thrown into fire, even if it is empty. Like most other inhalation products in aerosol packages, Beclazon Eco may be less effective at low temperatures. When the canister cools down, it is recommended to remove it from the plastic case and warm it with your hands for a few minutes.

Pregnancy and lactation,

There is insufficient data on the use of the drug in pregnant and breastfeeding women, so it should be used with caution and only when the expected benefit outweighs the potential risk.

Features of the effect of the drug on abilityatrule vehicle or potentially dangerous mechanisms

No data

Overdose

An acute overdose of the drug can lead to a temporary decrease in the function of the adrenal cortex, which does not require emergency treatment, since the function of the adrenal cortex is restored within several days, as confirmed by the level of cortisol in plasma. In case of chronic overdose, persistent suppression of the function of the adrenal cortex may be observed. In such cases, it is recommended to monitor the reserve function of the adrenal cortex. In case of overdose, treatment with beclomethasone dipropionate can be continued in doses sufficient to maintain the therapeutic effect.

Frelease form and packaging

200 doses of the drug in an aluminum can filled with aerosol under pressure. 1 can, along with an aerosol inhaler and instructions for medical use in the state and Russian languages, is placed in a cardboard pack.



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