Beklazone Eco - instructions for use, dose, side effects, contraindications

Each dose of the drug contains active substance: beclomethasone dipropionate 50.0 μg / 100.0 μg / 250.0 μg; Excipients: hydrofluoroalkane (HFA-134a) 75.86 mg / 74,79 mg / 71.75 mg; ethanol 2.09 mg / 3.11 mg / 6.00 mg.

Description:

Aerosol for inhalation in an aluminum canister under pressure. There must be no external damage, corrosion or leakage.

The contents of the canister leave a white spot on the glass when sprayed onto the glass.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

R.01.A.D.01 Beclomethasone

Pharmacodynamics:

Beclomethasone is a glucocorticosteroid (GCS) and has a weak tropism for GCS receptors. Under the action of enzymes 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 the chemotaxis substance (effect on the "late" allergy reaction), 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 action of beclomethasone, the number of mast cells in the mucous membrane of the bronchi decreases, the epithelial edema decreases,secretion of mucus by bronchial glands, hyperreactivity of bronchial tubes, neutrophils marginal accumulation, inflammatory exudate and production of lymphokines, migration of macrophages is inhibited, intensity of infiltration and granulation processes decreases. Increases the number of active beta-adrenergic receptors, restores the patient's response to bronchodilators, and 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.

Pharmacokinetics:

More than 25% of the dose of inhaled beclomethasone deposits in the respiratory tract; The remaining amount settles in the mouth, pharynx and is swallowed. In the lungs before absorption beclomethasone 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 has been ingested here when the dose is ingested). The absolute bioavailability of unchanged beclomethasone and B-17-MP is approximately 2% and 62% of the inhalation dose. Beclomethasone the time to reach the maximum concentration in the blood plasma (Tmax) is 0.3 hours. The B-17-MP is absorbed more slowly, Tmax is 1 hour. There is an approximately linear relationship between the increase in the inhaled dose and the system exposure of beclomethasone.

Distribution in tissues is 20 liters for beclomethasone and 424 liters for B-17-MP. The connection with plasma proteins is relatively high - 87%.

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

Indications:Basic therapy of various forms of bronchial asthma in adults and children.

Contraindications:

Hypersensitivity to beclomethasone and other components of the drug; children under 4 years.

Carefully:

With glaucoma, systemic infections (bacterial, viral, fungal, parasitic), osteoporosis, pulmonary tuberculosis, liver cirrhosis, hypothyroidism, pregnancy, during breastfeeding.

Pregnancy and lactation:

With extreme caution, the drug Beklazone Eco should be used during pregnancy and during breastfeeding only if the expected benefit for the mother exceeds the possible risk to the fetus and the baby.

Dosing and Administration:

The preparation Beklazon Eco is intended for inhalation with an inhalation device (see "Instructions for the patient on the use of an inhalation device"). After each inhalation, it is necessary to thoroughly rinse the mouth and throat with water.

Apply regularly (even in the absence of symptoms of the disease). The dose is selected taking into account individual clinical efficacy, increasing to the appearance of a clinical effect or reducing to the minimum effective dose. When switching to a high dose of inhaled beclomethasone, many patients receiving system GCS, can reduce their dose or cancel them altogether.

Initial dose is determined by the severity of bronchial asthma. When easy current bronchial asthma, the forced expiratory volume (FEV) or peak expiratory flow (PSV) is more than 80% of the required values with a PSV score of less than 20%. When middle-aged current of bronchial asthma FEV or PSV is 60-80% of the due values, the daily spread of PSV indicators is 20-30%. In severe bronchial asthma, FEV or PSV account for less than 60% of the values, The daily spread of PSV indicators is more than 30%.The daily dose is divided into several doses (2-4 inhalations per day).

Adults and children aged 12 years and over

Recommended initial daily doses:

- bronchial asthma of the lung course - 200-600 mcg / day (for 2 inhalations per day);

- bronchial asthma of moderate course - 600-1000 mcg / day (for 2-4 inhalations per day);

- bronchial asthma of severe course - 1000-2000 mkg / day (for 2-4 inhalations per day).

The standard maximum daily dose is 1000 mcg. In some very serious cases, the daily dose can be increased to 1500-2000 μg (for 2-4 inhalations per day).

Treatment of bronchial asthma is based on step approach - therapy is started according to the stage corresponding to the severity of the disease. Inhaled glucocorticosteroids are prescribed at the second stage of therapy.

Step 2. Basic therapy. 100-400 mcg twice a day.

Step 3. Basic therapy. Inhaled glucocorticosteroids are used in a high daily dose or in a standard daily dose, but in combination with long-acting inhaled beta2-adrenomimetics. The recommended daily dose is 800-1600 μg, in some cases the daily dose can be increased to 2000 μg.

Step 4. Severe bronchial asthma. The recommended daily dose is 800-1600 μg, in some cases the daily dose can be increased to 2000 μg. Step 5. Severe bronchial asthma.The recommended daily dose is 800-1600 μg, in some cases the daily dose can be increased to 2000 μg.

Children between the ages of 4 and 12 pet

Recommended primary daily dose of 100-200 mcg (behind 2 inhalation per day). Standard the maximum daily dose of 200 mcg. In some very serious cases, the daily dose may be increased to 400 mcg (for 2-4 inhalations per day).

The preparation of Beclozone Eco, containing 250 μg of beclomethasone in 1 dose, is not intended for use in this group of patients.

Special patient groups

There is no need to adjust the dose in individuals elderly age, the patients with renal or hepatic insufficiency.

Skipping a single dose of the drug

When accidental skip inhalation following dose is necessary take in due time in accordance with the scheme of treatment. The introduction can be carried out using special dispensers (spacers) that improve the distribution of the drug in the lungs and reduce the risk of side effects.

Instructions for the patient to use the inhalation device

Before using the inhalation device for the first time, or if you have not used it for a while, it is necessary to check its health by pressing the valve of the can and releasing the dose of the medicine into the air.

1.Remove the protective cap from the inhalation device and make sure that the outlet tube of the inhalation device is clean. Hold the inhalation device between the index and thumb in an upright position, with the thumb on the bottom of the inhalation device and the index finger on the top of the aluminum can.

2. Intensely Shake the aluminum cylinder up and down.

3. Take a deep breath through your mouth. Clamp the mouth of the inhalation device tightly with your lips.

4. Take a slow and deep breath. At the moment of inspiration, press the index finger on the balloon metering valve, releasing the dose of Beclason Eco, continue to inhale slowly.

5. Remove the inhalation device from the mouth and hold your breath for 10 seconds or at a time that will not cause you any discomfort. Slowly exhale.

6. After inhalation, rinse your mouth with water, trying not to swallow the aerosol that was ingested during inhalation on the oral mucosa.

7. If more than one dose is required, wait 1 minute and repeat all steps from step 2 to step 6.

8. Close inhalation device protective cap. In steps 3 and 4, do not rush.

At the time of vine release, it is important to inhale as slowly as possible. Before use, practice in front of the mirror. If you notice "steam" coming from the top of the can or from the corners of the mouth, then start again from step 2.

Cleaning the inhaler

The inhalation device should be cleaned at least once a week. Remove the aluminum can from the inhalation device. Gently rinse the inhalation device and protective cap with warm water. Do not use hot water! Shake the inhalation device and the protective cap to remove the remaining water, and dry them without using heating devices. Do not allow the aluminum container to come into contact with water!

Side effects:The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely (including isolated cases) - less than 0.01%.

Infectious diseases: often - candidiasis of the oral cavity and upper respiratory tract and pharynx (with prolonged use in high doses of more than 400 mcg per day).

Allergic reactions: rarely - skin rash, itchy skin, urticaria, erythema, angioedema, including edema of the paraorbital region, oral and pharyngeal mucosa, lips and face.

From the endocrine system: very rarely - oppression of the hypothalamic-pituitary-adrenal system (GGNS) (with prolonged use of high doses of more than 1.5 g / day), including growth retardation in children.

From the side of the organ of vision: very rarely - cataract, glaucoma.

From the respiratory system, chest and mediastinum: often - hoarseness of voice, irritation of the mucous membrane of the pharynx (application of the spacer reduces the likelihood of these side effects); rarely - paradoxical bronchospasm (stop with short-acting inhaled beta2-adrenomimetics); very rarely zoeinophilic pneumonia.

From the side of the musculoskeletal and connective tissue: very rarely a decrease in bone mineral density.

Effects due to systemic action: headache, nausea; the formation of bruising or thinning of the skin.

Overdose:

Acute overdose of the drug may occur with inhalation of a high single dose of more than 1 g. The manifestation, in this case, of symptoms of oppression of adrenal cortex function does not require emergency therapy, since the function is restored for several days, which is confirmed by the level of cortisol in the plasma.

In chronic overdose (long-term treatment with a dose of more than 1.5 g), a persistent suppression of the function of the adrenal cortex 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 can be continued at doses sufficient to maintain a therapeutic effect.

Interaction:

Beclomethasone restores the patient's response to beta-adrenomimetics, thereby reducing the frequency of their use. With simultaneous use with phenobarbital, phenytoin, rifampicin and other inducers of microsomal liver enzymes, the effectiveness of beclomethasone decreases. With simultaneous use with methandienone, estrogens, beta2-adrenomimetics, theophylline,as well as systemic GCS, the efficacy of beclomethasone increases. With simultaneous application beclomethasone enhances the effect of beta-adrenomimetics.

Special instructions:

Before using Beclason Eco, you need to make sure that the patient correctly uses the inhalation device to ensure sufficient dosing of the drug.

Patients who use Beklazone Eco at home should be warned that if the usual dose becomes less effective or less prolonged, you can not increase the dose or frequency of the drug yourself, but you should immediately consult a doctor.

With long-term use of beclomethasone in high doses (more than 400 μg / day) candidiasis of the oral cavity and pharynx develops, especially in patients who have previously had a fungal infection, which is confirmed by the high content of precipitating antibodies against Candida fungi in the blood. As a rule, the use of antifungal drugs contributes to the rapid elimination of fungal infection. The dose of beclomethasone should not be changed in this case.

If treatment with inhaled beclomethasone begins on the background of ingestion of SCS, then a decrease in the dose of GCS can be started only 1-2 weeks after the start of simultaneous application. The scheme for reducing the dose of GCS for oral administration depends on the dose and duration of application of GCS. Regular use of inhaled beclomethasone in most cases can reduce the dose of GCS for oral administration. As a rule, patients taking no more than 15 mg of prednisolone, can completely switch to taking only inhaled beclomethasone. The first months after switching to inhalation therapy with beclomethasone, it is necessary to carefully monitor the state of the GGNS in order to prevent its inhibition.

Patients with reduced adrenal function, transferred completely to treatment with inhaled beclomethasone, should always carry a stock of GCS with them and carry a warning card with information that in stressful situations they need the use of systemic GCS. After the stressful situation is completed, the dose of GCS can be reduced or the GCS can be canceled.

An increase in the dose of GCS is required if there is a sudden and progressive deterioration in the course of bronchial asthma.An indirect indicator of the ineffectiveness of therapy is more frequent, the use of beta2-adrenomimetokov short-acting.

When transferring patients from oral glucocorticosteroids intake to inhaled GCS, including beclomethasone, various allergic reactions may occur, including allergic rhinitis and allergic dermatitis, which did not manifest themselves against the treatment of systemic SCS.

Beclomethasone for inhalations is intended for regular daily use, and not for relief of bronchospasm attacks. To stop the attacks of bronchospasm apply beta2-adronomimetics, including salbutamol. In severe bronchial asthma or inadequate effectiveness of inhaled beclomethasone, it is necessary to increase its dose, and also consider the use of GCS inside or, for example, the use of antibiotics in the case of infectious inflammation.

With the development of paradoxical bronchospasm follows beclomethasone cancel, conduct a patient examination and consider the possibility of using another drug.

You can not abruptly stop treatment with inhaled beclomethasone,

With long-term use of inhaled beclomethasone in a dose of more than 1.5 g / day, systemic reactions of various nature may develop, including symptoms of suppression of adrenal cortex function, decrease in growth rate in children, decrease in bone mineral density, cataract, glaucoma. Therefore, when the therapeutic effect is achieved, the dose of inhaled beclomethasone should be reduced to the minimum effective dose that controls the course of the disease. Patients with a high risk of developing adrenocortical insufficiency should be under the supervision of a doctor.

With prolonged use of beclomethasone in children, it is necessary to monitor the dynamics of their growth.

Care should be taken when using inhaled GCS in patients with active and inactive forms of pulmonary tuberculosis.

It is necessary to protect the eyes from getting the drug Beklazon Eco.

Aluminum can with the preparation Beklazon Eco can not be pierced, disassembled and heated, even if it is empty.

Effect on the ability to drive transp. cf. and fur:

Beclomethasone inhalations do not affect the driving of motor vehicles and occupations of potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Aerosol for inhalations dosed with 50 μg / dose, 100 μg / dose, 250 μg / dose.

Packaging:

For 200 doses in an aluminum canister with a metering valve, equipped with an inhalation device with a protective cap.

On 1 cylinder together with the instruction on application place in a cardboard pack.

Storage conditions:

Store at a temperature of no higher than 25 ° C, protecting from direct sunlight. Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N013291 / 01

Date of registration:28.12.2011

Expiration Date:Unlimited

The owner of the registration certificate:TEVA, LLC TEVA, LLC Russia

Manufacturer: & nbsp

IVAX Pharmaceutical Ireland, Ltd. Ireland

Information update date: & nbsp21.01.2017

Illustrated instructions

Instructions

Beklazon Eco (Beclazone Eco)