Universal reference book for medicines
Product name: BECLAZONE ECO EASY BREATHE (BECLAZONE ECO EASI BREATHE)

Active substance: beclometasone

Type: GCS for inhalation

Manufacturer: NORTON WATERFORD (Ireland), acting under the trade name IVAX Pharmaceutical Ireland (Ireland)
Composition, form of production and packaging
The aerosol for inhalations is dosed, activated by inhalation,
in the form of a solution, which when sprayed onto the glass forms a colorless spot.

1 dose

beclomethasone dipropionate 50 Ојg

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

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

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

1 dose

beclomethasone dipropionate 100 Ојg

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

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

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

1 dose

beclomethasone dipropionate 250 Ојg

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

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

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

GCS for inhalation use.
Beclomethasone dipropionate is a prodrug and has a weak tropism for GCS receptors. Under the action of esterases, it turns into an active metabolite - beclomethasone-17-monopropionate (B-17-MP), which has a pronounced local anti-inflammatory effect. Reduces inflammation by decreasing the formation of the chemotaxis substance (effect on the "late" allergy reaction), inhibits the development of an allergic reaction of an immediate type (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 action of beclomethasone, the number of mast cells in the bronchial mucosa decreases, the epithelial edema diminishes, the mucus secretion by the bronchial glands, the bronchial hyperreactivity, the neutrophil accumulation, the inflammatory exudate and the production of lymphokines, the macrophage migration is inhibited, the intensity of the infiltration and granulation processes decreases.
Increases the number of active? -adrenoceptors, restores the patient's response to bronchodilators, reduces the frequency of their use.
Virtually does not have a resorptive effect after inhalation.
Do not stop bronchospasm, the therapeutic effect develops gradually, usually after 5-7 days of course use beclomethasone dipropionate.

PHARMACOKINETICS

Suction

After inhalation, up to 56% of the dose of the 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, dipropionate is extensively 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 that was ingested when the dose was ingested). 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, C max is reached after 0.3 hours. B-17-MP is absorbed more slowly, C max is reached after 1 hour. There is an approximately linear relationship between the dose increase and the system exposure of the drug.
Distribution

V d is 20 liters for beclomethasone dipropionate and 424 liters for B-17-MP.
Binding to plasma proteins is relatively high - 87%.
Excretion

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

- Basic therapy of various forms of bronchial asthma in adults and children older than 4 years.

DOSING MODE

Beklazone Eco Light Breath is only for inhalation.

Beklazone Eko 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.

With an easy course of bronchial asthma, the forced expiratory volume (FEV 1 ) or peak expiratory flow (PSV) is more than 80% of the required values ​​with a PSV score of less than 20%.

In the medium-heavy current FEV 1 or PSV is 60-80% of the required values, the daily spread of PSV indicators is 20-30%.

In severe FEV 1 or PSV, 60% of the required values, the daily spread of PSV indicators is more than 30%.

When switching to a high dose of inhaled beclomethasone dipropionate, many patients receiving systemic GCS can reduce their dose or cancel them altogether.

Initial dose of Beklazone Eco Light Breath is determined by the severity of bronchial asthma.
The daily dose is divided into several doses.
Depending on the individual response of the patient, the dose of the drug can be increased to the appearance of a clinical effect or reduced to the minimum effective dose.

For adults and children 12 years of age and older, the recommended initial doses of the drug for bronchial asthma of the lung current are 200-600 Ојg / day;
at abronchial asthma of an average course - 600-1000 mkg / sut; at a bronchial asthma of a heavy current - 1000-2000 mkg / sut.
Children aged 4 to 12 years, the dose of the drug is up to 400 mcg / day in several receptions.

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

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

Beklazone Eco Light Breath with a dose of 250 Ојg of beclomethasone is not intended for pediatric use.

Instructions for use of the inhaler

While holding the inhaler in the vertical position, open the lid.
Make a deep exhalation. Tightly grasp the mouthpiece with your lips. Make sure that the hand does not block the ventilation holes on the top of the inhaler, and the inhaler is in an upright position. Make a slow maximum breath through the mouthpiece. Hold your breath for 10 seconds or as much as possible. Then the inhaler should be removed from the oral cavity and exhaled slowly. After use, keep the inhaler in an upright position.Close the cover. If more than one inhalation is necessary, close the lid, wait at least 1 min, and then repeat the inhalation process.
Cleaning the inhaler

Remove the upper part of the inhaler.
Remove the metal can. Rinse the bottom of the inhaler in warm water and dry. Insert the can into place. Close the cover and screw the upper part of the inhaler to its housing. Do not wash the top of the inhaler. If the inhaler does not work properly, unscrew its upper part and manually press the can.
SIDE EFFECT

Local reactions: candidiasis of the oral cavity and throat is possible (the likelihood of candidiasis increases with beclomethasone dipropionate in doses exceeding 400 Ојg / day), dysphonia (hoarseness), or irritation of the pharyngeal mucosa.

On the part of the respiratory system: a paradoxical bronchospasm is possible, which must be immediately stopped with a short-acting inhaled beta 2 -adrenostimulator.

Allergic reactions: rashes, hives, itching, redness and swelling of the eyes, face, lips and mucous membranes of the mouth and pharynx are possible.

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

CONTRAINDICATIONS

- Children's age up to 4 years;

- Hypersensitivity to the components of the drug.

They are used with caution in glaucoma, systemic infections (bacterial, viral, fungal) and parasitic invasions, osteoporosis, pulmonary tuberculosis, liver cirrhosis, hypothyroidism, during pregnancy, during lactation.

PREGNANCY AND LACTATION

With extreme caution Beklason Eco Light Breath should be used during pregnancy and lactation and only if the potential benefit to the mother exceeds the possible risk to the fetus and the baby.

APPLICATION FOR FUNCTIONS OF THE LIVER

There is no need to adjust the dose of Beklazone Eco Light Breathing in patients with renal insufficiency.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

There is no need to adjust the dose of Beklazone Eco Light Breathing in patients with hepatic insufficiency.

Use with caution in cirrhosis.

APPLICATION FOR CHILDREN

Contraindication: children under 4 years.
Children aged 4 to 12 years, the dose of the drug is up to 400 mcg / day in several receptions.
SPECIAL INSTRUCTIONS

Before prescribing inhalation GCS, it is necessary to instruct the patient about the rules of their application, which ensure the most complete entry of the drug into the necessary areas of the lungs.
The development of oral candidiasis is most likely in patients with a high level of precipitating antibodies in the blood against the Candida fungus, indicating a previously transferred fungal infection. After inhalation, rinse the mouth and throat with water. For the treatment of candidiasis, antifungal agents of local action can be used while continuing therapy with Beklazone Eco Light Breathing.
If patients take GCS inside, then Beclason Eco Light Breathing is prescribed against the background of taking the previous dose of GCS, while patients should be in a relatively stable state.
After about 1-2 weeks, the daily dose of oral glucocorticosteroids is gradually reduced. The dose reduction scheme depends on the duration of the previous therapy and on the initial dose of GCS. Regular use of inhaled glucocorticosteroids allows in most cases to cancel oral GCS (patients who need to take no more than 15 mg of prednisolone can be fully switched to inhalation therapy), and 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 (for example, trauma, surgery or infection).
When transferring patients from receiving systemic GCS to inhalation therapy, allergic reactions (for example, allergic rhinitis, eczema), which were previously suppressed by systemic drugs, may appear.

Patients with a reduced function of the adrenal cortex, transferred to inhalation treatment, should have a stock of GCS and always carry a warning card, which should indicate that they need additional systemic appointment of SCS in stressful situations (after a stressful situation, the dose of GCS can be again reduce).
Sudden and progressive worsening of asthma symptoms is a potentially dangerous condition, often life-threatening patients, and requires an increase in the dose of GCS. An indirect indicator of the ineffectiveness of therapy is the more frequent, than before, use of beta 2 -adrenostimulators of short-acting.
Beklazone Eco Light Breath is not designed to stop seizures, but for regular daily use.
For relief of attacks, beta 2 -adrenostimulators of short action (for example, salbutamol) are used. In case of severe exacerbation of bronchial asthma or inadequate effectiveness of the therapy, increase the dose of Beclason Eco Light Breathing and, if necessary, prescribe a systemic SCS and / or antibiotic for the development of infection.
With the development of paradoxical bronchospasm should immediately stop using Beklazone Eco Light Breathing, assess the patient's condition, conduct a survey and, if necessary, prescribe therapy with other medications.

With long-term use of any inhaled glucocorticosteroids, especially in high doses, systemic effects may be noted, but the likelihood of their development is much lower than when ingesting GCS inside.
Therefore, it is especially important that when a therapeutic effect is achieved, the dose of inhaled glucocorticosteroids is reduced to the lowest effective dose controlling the course of the disease. At a dose of 1500 mcg / day, the drug in most patients does not cause significant suppression of the adrenal glands. In connection with the possible development of adrenal insufficiency, special care should be taken and regular monitoring of the function of the adrenal cortex in the transfer of patients taking SCS inwards for treatment with Beklazone Eco Light Breathing.
It is not recommended to abruptly cancel the drug Beklazone Eco Light Breath.

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

It is necessary to protect eyes from getting the drug.
By washing after inhalation, it is possible to prevent damage to the skin of the eyelids and nose.
Balloon with Beclazone Eco Light Breathing can not be pierced, disassembled or thrown into the fire, even if it is empty.
Like most other inhalation agents in aerosol packs, Beclason Eco Light Breathing can be less effective at low temperatures. When cooling the can, it is recommended to remove it from the plastic case and warm it with your hands for several minutes.
Use in Pediatrics

It is recommended to regularly monitor the dynamics of growth in children receiving inhaled glucocorticosteroids for a long time.

OVERDOSE

Acute overdose can lead to a temporary decrease in the function of the adrenal cortex, which does not require emergency therapy, because
the function of the adrenal cortex is restored within a few days, which is confirmed by the level of cortisol in the plasma.
In chronic overdosage , persistent suppression of adrenal cortex function can be noted.

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

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, protected from direct sunlight at a temper
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