Beklazon ECO aerosol 250mkg / dose, 200 dose

Basic therapy of various forms of bronchial asthma in adults and children over 4 years old.

Beklazon Eco Light Breath is intended for inhalation administration ONLY. Beklazon Eco Light 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 case.

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

With a moderate course of FEV1 or PSV is 60-80% of the proper values, the daily range of PSV values ??is 20-30%.

In severe cases of FEV1 or PSV are 60% of the proper values, the daily range of PSV values ??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 cancel them altogether.

The initial dose of Beklazon Eco Light Breath will be determined by the severity of bronchial asthma. The daily vine is divided into several receptions.

Depending on the individual patient's 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 and over:

Recommended starting doses of the drug:

• 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 groups of patients It is
not necessary to adjust the dose of Beklazon Eco Light Breathing in elderly people, in patients with renal or hepatic insufficiency.

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

Beklazon Eco Light Breath, containing 250 mcg in 1 dose, is not intended for pediatric use.

The introduction can be carried out using a special optimizer that improves the distribution of the drug in the lungs and reduces the risk of side effects.

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

Hypersensitivity to any component of the drug. Children under 4 years of age.

Use with caution in glaucoma, systemic infections (bacterial, viral, fungal, parasitic), osteoporosis. pulmonary tuberculosis, liver cirrhosis, hypothyroidism, pregnancy, lactation.

Trade name of the drug:

BECLAZON ECO EASY BREATH.

International non-proprietary name:

Beclomethasone.

Dosage form:

metered dose inhalation aerosol activated by inhalation.

Composition:

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

Description:
Aerosol for inhalation in a pressurized aluminum cartridge with a release valve and a spray. There must be no external damage, corrosion or leaks. The contents of the can is a solution that, when sprayed on glass, leaves a colorless spot. A can is placed and a two-piece inhaler with a safety cap.

Pharmacotherapeutic group:

Glucocorticosteroid (GCS) for topical use. ATX code: R03BA01.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics
Beclomethasone dipropionate is a prodrug and has a weak affinity for GCS receptors. Under the influence 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 reducing the formation of chemotaxis substance (effect on 'late' allergy reactions), inhibits the development of an 'immediate' allergic reaction (due to inhibition of the production of metabolites of arachidonic acid 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 the bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils decrease,inflammatory exudate and production of lymphokines, the migration of macrophages is inhibited, the intensity of the processes of infiltration and granulation decreases. Increases the number of active beta-adrenergic receptors, restores the patient's response to bronchodilators, and reduces the frequency of their use. Virtually no resorptive effect after inhalation.

Does not relieve bronchosyasm, the therapeutic effect develops gradually, usually after 5-7 days of the course application of beclomethasone dipropionate.

Pharmacokinetics
Absorption. Up to 56% of the dose of the inhaled drug is deposited in the lower respiratory tract; the remaining amount settles in the mouth, throat and is swallowed. In the lungs, before the absorption of beclomethasone, dipropiopath 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) and in the gastrointestinal tract (26% of the ingested dose). The absolute bioavailability of unchanged beclomethasone dipropionate and B-17-MP is about 2% and 62% of the inhalation dose, respectively. Beclomethasone dipronionate is rapidly absorbed, the time to reach the maximum plasma concentration (Tmax) is 0.3 hours. B-17-MP is absorbed more slowly. Tmax is I hour. There is an approximately linear relationship between the increase in the inhaled dose and the systemic exposure of the drug.

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

Elimination.
Beclometazoia dipropiopath 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 of various forms of bronchial asthma in adults and children over 4 years old.

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

Use with caution in glaucoma, systemic infections (bacterial, viral, fungal, parasitic), osteoporosis. pulmonary tuberculosis, liver cirrhosis, hypothyroidism, pregnancy, lactation.

APPLICATION DURING PREGNANCY AND LACTATION
With extreme caution Beklazon Eco Light Breath should be used during pregnancy and lactation and only if the potential benefit to the mother outweighs the possible risk to the fetus and child.

DOSAGE AND METHOD OF APPLICATION Beklazon Eco Light Breath is intended ONLY for inhalation administration. Beklazon Eco Light 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 case.

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

With a moderate course of FEV1 or PSV is 60-80% of the proper values, the daily range of PSV values ??is 20-30%.

In severe cases of FEV1 or PSV are 60% of the proper values, the daily range of PSV values ??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 cancel them altogether.

The initial dose of Beklazon Eco Light Breath will be determined by the severity of bronchial asthma. The daily vine is divided into several receptions.

Depending on the individual patient's 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 and over:

Recommended starting doses of the drug:

• 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 groups of patients It is
not necessary to adjust the dose of Beklazon Eco Light Breathing in elderly people, in patients with renal or hepatic insufficiency.

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

Beklazon Eco Light Breath, containing 250 mcg in 1 dose, is not intended for pediatric use.

The introduction can be carried out using a special optimizer that improves the distribution of the drug in the lungs and reduces the risk of side effects.

SIDE EFFECTS
In some patients, candidiasis of the mouth and throat may develop (the likelihood of developing candidiasis increases with the use of bsklometazopa dipropionate in doses exceeding 400 mcg per day).

Some patients may have dysphonia (hoarseness) or throat irritation.

Inhaled drugs can cause paradoxical bronchospasm, which must be stopped immediately with an inhaled short-acting b-2 adrenostimulant.

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

OVERDOSE
Acute overdose of the drug can lead to a temporary decrease in the function of the adrenal cortex, which does not require emergency therapy, since 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 overdose, there may be a persistent suppression of the function of the adrenal cortex. 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 DRUGS
There is no confirmed data on the interaction of beclomethasone dipropionate with other drugs.

SPECIAL INSTRUCTIONS
Before prescribing inhalation drugs, it is necessary to instruct the patient about the rules for their use, ensuring the most complete ingestion of the drug in 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 Candida, which indicates a previous fungal infection. After inhalation, rinse your mouth and throat with water. For the treatment of candidiasis, local antifungal drugs can be used while continuing therapy with Beklazon Eco Light Breath. If the Nazis take GCS inside, then Beklazon Eco Light Breath is prescribed while 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 corticosteroids is gradually reduced.The dose reduction scheme depends on the duration of previous therapy and on the value of the initial GCS dose. Regular use of inhaled GCS allows in most cases to cancel oral GCS (patients who need to take no more than 15 mg of prednisolop can be completely transferred to inhalation 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 trauma, surgery, or infection).those who need to take no more than 15 mg of prednisolop can be completely transferred to inhalation therapy), while in the first months after the transition, the patient's condition should be carefully monitored until his pituitary-adrenal system recovers sufficiently to ensure an adequate response to stressful situations (such as injury, surgery, or infection).those who need to take no more than 15 mg of prednisolop can be completely transferred to inhalation therapy), while in the first months after the transition, the patient's condition should be carefully monitored until his pituitary-adrenal system recovers sufficiently to ensure 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) may occur, which were previously suppressed by systemic drugs.

Patients with reduced function of the adrenal cortex, 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 GCS dose. An indirect indicator of therapy failure is the more frequent use of short-acting ?-2 -adrenostimulants than before.

Beklazon Eco Light Breathing is not intended for relief of attacks, but for regular daily use. To stop seizures, short-acting p-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 Beklazon Eco Light Respiration should be increased and, if necessary, systemic corticosteroids and / or an antibiotic should be prescribed if an infection develops.

With the development of paradoxical bronchospasm, you should immediately stop using Beklazon Eco Light Breath, assess the patient's condition, conduct an examination and, if necessary, prescribe therapy with other drugs. With prolonged use of any inhaled corticosteroids, especially in high doses, systemic effects may occur (see 'Side effects'), but the likelihood of their development is much lower than when taking corticosteroids inside. 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 in most patients does not cause significant suppression of adrenal function. Due to possible adrenal insufficiency, it is necessary to observe,special care and regularly monitor the indicators of adrenal cortex function when transferring patients taking GCS inside to treatment with Beklazon Eco Light Breathing.

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

Abrupt cancellation of Beklazon Eco Light Breathing is not recommended. Special care should be taken when treating inhaled corticosteroids in patients with active or inactive forms of pulmonary tuberculosis. It is necessary to protect the eyes from getting the drug. Washing after inhalation can prevent damage to the skin of the eyelids and nose.

Beklazon Eco Light Breath can not be pierced, disassembled or thrown into fire, even if it is empty. Like most other aerosol inhalation products, Beklazon Eco Light Breath may be less effective at low temperatures. When cooling the cartridge, it is recommended to take it out of the plastic case and warm it up with your hands for a few minutes.

PATIENT INSTRUCTIONS FOR USING THE INHALER

Instructions for use) of an inhaler without an optimizer
While holding the inhaler in an upright position, open the lid. Exhale deeply. Grasp the mouthpiece tightly with your lips. Make sure that your hand does not block the ventilation holes on the top of the inhaler and that you hold the inhaler in an upright position. Take a slow, maximum breath through the mouthpiece. Hold your breath for 10 seconds or as much as you feel comfortable with. Then remove the inhaler from your mouth and exhale slowly. Continue to keep the inhaler upright after use. Close the cover. If you need to do more than one inhalation, close the lid, wait at least one minute, and then repeat the inhalation process.

Instructions for use of the inhaler with the optimizer
Keeping the inhaler in an upright position, open the lid and firmly place the Optimizer on the mouthpiece of the inhaler. Exhale deeply. Grasp the optimizer mouthpiece tightly with your lips. Make sure that your hand does not block the ventilation holes on the top of the inhaler and that you hold the inhaler in an upright position. Take a slow, maximum breath through the optimizer mouthpiece. Hold your breath for 10 seconds or as much as you feel comfortable with. Then remove the inhaler from your mouth and exhale slowly. Continue to keep the inhaler upright after use. Remove the optimizer. Close the cover.

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

Cleaning the inhaler
Unscrew the upper part of the inhaler. Take out the metal can. Rinse the bottom of the inhaler in warm water and dry. Reinsert the can. Close the lid and screw the top 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 it and manually press on the can.

FORM OF RELEASE
Dosed inhalation aerosol activated by inhalation 50 ?g / dose, 100 ?g / dose, 250 m kg / dose.

200 doses of the active substance in an aluminum can filled with aerosol under pressure. The aluminum can is in an inhalation-activated aerosol inhaler (Light Breathing).

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

SHELF LIFE
3 years.
Do not use after the expiration date.

STORAGE CONDITIONS
At a temperature not exceeding 30 ? —, protected from direct sunlight. Do not freeze. Keep out of the reach of children.

TERMS OF RELEASE FROM PHARMACIES
By prescription.