Beklazon-Eko Easy Breath

General characteristics. Structure:

Each inhaler contains 200 doses of drug.
Active agent: One inhalation dose contains beclomethasone of a dipropiostalemate 50, 100, 250 mkg.
Excipients: ethanol, гидрофторалкан (HFA-134a).

Description:
Aerosol for inhalations in an aluminum barrel under pressure with the final valve and the sprayer. There have to be no external damages, corrosion or leakages. Contents of a barrel represent solution which when spraying on glass leaves a colourless spot. The barrel is placed also an inhaler, two-piece and a safety cover.

Pharmacological properties:

Beclomethasone Dipropionas is pro-medicine and possesses a weak tropnost to GKS-receptors. Under the influence of esterases it turns into an active metabolite - beclomethasone - 17 monopropionate (B-17-MP) which renders the expressed local antiinflammatory effect. Reduces an inflammation due to decrease in formation of substance of a chemotaxis (influence on "late" reactions of an allergy), slows down development of "immediate" allergic reaction (it is caused - braking of products of metabolites of arachidonic acid and decrease in release from mast cells of mediators of an inflammation) and improves mukotsiliarny transport. Under the influence of beclomethasone the quantity of mast cells in a mucous membrane of bronchial tubes decreases, epithelium hypostasis, slime secretion by bronchial glands decreases, hyperreactivity of bronchial tubes, regional accumulation of neutrophils, inflammatory exudate and products of lymphokines, is braked migration of macrophages, intensity of processes of infiltration and granulation decreases. Increases quantity of active beta adrenoceptors, recovers reaction of the patient to bronchodilators, allows to reduce the frequency of their use. Practically has no resorptive effect after inhalation introduction.

Does not stop бронхосиазм, the therapeutic effect develops gradually, usually in 5-7 days of course use of beclomethasone of Dipropionas.

Pharmacokinetics
Absorption. To 56% of a dose of the inhalated drug settles in the lower respiratory tracts; the remained quantity settles in a mouth, a throat and is swallowed. In lungs before beclomethasone absorption the dipropiostalemate is intensively metabolized to an active metabolite of B-17-MP. System absorption of B-17-MP happens in lungs (36% of pulmonary fraction) and in digestive tract (26% from arrived here at a dose proglatyvaniye). Absolute bioavailability of invariable beclomethasone of Dipropionas and B-17-MP makes respectively about 2% and 62% of an inhalation dose. Beclomethasone дипронионат it is quickly soaked up, time of achievement of the maximum concentration in a blood plasma (Tmax) makes 0.3 p. B-17-MP is soaked up more slowly. Tmax makes I h. Approximately linear dependence between increase in the inhalated dose and system exposure of drug is noted.

Distribution.
Distribution in fabrics makes 20 l for a beklometazoi of Dipropionas and 424 l for B-17-MP. Communication with proteins of a blood plasma of rather high 87%.

Elimination.
Beklometazoia the dipropiostalemate and B-17-MP have high plasma clearance (150 l/h and 120 l/h respectively). The elimination half-life makes 0,5 h and 2,7 hours respectively.

Indications to use:

Basic therapy of various forms of bronchial asthma at adults and children is more senior than 4 years.

Route of administration and doses:

Beklazon Eko Easy Breath is intended ONLY for inhalation introduction. Beklazon Eko Easy Breath is applied regularly (even in the absence of disease symptoms), the dose of beclomethasone of Dipropionas is selected taking into account clinical effect in each case.

At the easy course of bronchial asthma the volume of the forced exhalation (OFV1) or the peak expiratory rate (PER) make more than 80% of due sizes with dispersion of indicators of PSV less than 20%.

At a medium-weight current of OFV1 or PSV makes 60-80% of due sizes, daily dispersion of indicators of PSV of 20-30%.

At a heavy current of OFV1 or PSV make 60% of due sizes, daily dispersion of indicators of PSV more than 30%.

Upon transition to a high dose of inhalation beclomethasone of Dipropionas many patients receiving system GKS will be able to reduce their dose or to cancel them absolutely.

Initial dose of Beklazon Eko Easy Breath will be defined by severity of bronchial asthma. The daily rod is divided into several receptions.

Depending on the individual answer of the patient, the dose of drug can be increased before emergence of clinical effect or to reduce to a minimal effective dose.

Adults and children at the age of 12 it is put and is more senior:

The recommended initial doses of drug:

Bronchial asthma of an easy current - 200 - 600 mkg/days;
Bronchial asthma so-so heavy current of 600 1000 mkg/days;
Bronchial asthma of a heavy current - 1000 2000 mkg/days.
Children aged from 4 up to 12 years
To 400 mkg a day in stages.

Special groups of patients
There is no need to adjust Beklazon Eko's dose Easy Breath at persons elderly age, at patients with a renal or liver failure.

Admission of reception of one dose of drug
At the accidental admission of inhalation the following dose needs to be accepted according to the scheme of treatment in due time.

Beklazon Eko Easy Breath containing 250 mkg in 1 dose is not intended for use in pediatrics.

Introduction can be carried out with use of the special optimizer improving distribution of drug in lungs and reducing risk of development of side effects.

Features of use:

Before purpose of inhalation drugs it is necessary to instruct the patient about the rules of their use providing the fullest hit of medicine to the necessary sites of lungs. Development of candidiasis of an oral cavity is most probable at patients with the high level of precipitant antibodies in blood against Candida fungus that indicates earlier postponed fungal infection. After inhalation it is necessary to rinse an oral cavity and a throat water. For treatment of candidiasis it is possible to use antifungal drugs of local action at simultaneous continuation of therapy by Beklazon Eko Easy Breath. If Nazis accept GKS inside, Beklazon Eko Easy Breath is appointed against the background of reception of a former dose of GKS, at the same time patients have to be in rather stable state. Approximately in 1-2 weeks the daily dose of peroral GKS begins to be reduced gradually. The scheme of a dose decline depends on duration of the previous therapy and on the size of an initial dose of GKS. Regular use of inhalation GKS allows to cancel in most cases peroral GKS (the patients needing reception no more than 15 mg of a prednizolop can be completely transferred to inhalation therapy), at the same time in the first months after transition it is necessary to control carefully a condition of the patient until his pituitary and adrenal system is recovered sufficiently to provide proper response to stressful situations (for example, an injury, surgical intervention or an infection).

At transfer of patients from reception of system GKS of a pas inhalation therapy allergic reactions (for example, allergic rhinitis, eczema) which were suppressed with system drugs earlier can be shown.

The patients with reduced function of bark of adrenal glands transferred to inhalation treatment have to have a stock of GKS and always carry with themselves the warning card in which it has to be specified that they in stressful situations need additional system purpose of GKS (after elimination of a stressful situation the dose of GKS can be lowered again). The sudden and progressing deterioration in symptoms of asthma is potentially dangerous state, quite often life-threatening patients, and demands increase in a dose of GKS. An indirect indicator of inefficiency of therapy is more frequent, than before, use b-2-adrenostimulyatorov short actions.

Beklazon Eko Easy Breath is intended not for stopping of attacks, and for regular daily use. R-2-adrsnostimulyatory short actions are applied to stopping of attacks (for example, salbutamol). At a heavy exacerbation of bronchial asthma or insufficient efficiency of the carried-out therapy it is necessary to increase Beklazon Eko's dose Easy Breath and in case of need to appoint system GKS and/or an antibiotic at development of an infection.

At development of a paradoxical bronchospasm it is necessary to stop at once Beklazon Eko's use Easy Breath, to estimate the patient's condition, to conduct examination and if necessary to appoint therapy other medicines. At prolonged use of any inhalation GKS, especially in high doses, system effects can be noted (see. "Side effects"), however probability of their development are much lower, than at reception of GKS inside. Therefore it is especially important that at achievement of therapeutic effect the dose of inhalation GKS was lowered to the minimal effective dose controlling the course of a disease. In a dose of 1500 mkg/days drug does not cause essential suppression of functions of adrenal glands in most of patients. Due to the possible adrenal insufficiency it is necessary to observe, extra care and regularly to control indicators of function of bark of adrenal glands at transfer of the patients accepting GKS inside into treatment by Beklazon Eko Easy Breath.

It is recommended to watch dynamics of growth of the children receiving inhalation GKS for a long time regularly.

Sharp cancellation of Beklazon Eko Easy Breath is not recommended. It is necessary to observe extra care at treatment by inhalation GKS of patients е active or inactive forms of a pulmonary tuberculosis. It is necessary to protect eyes from drug hit. Washing after inhalation it is possible to prevent damage of skin a century and a nose.

The barrel with Beklazon Eko Easy Breath cannot be punctured, sorted or thrown into fire even if it is empty. As well as the majority of other means for inhalations in aerosol packages, Beklazon Eko Easy Breath can be less effective at low temperatures. When cooling a barrel it is recommended to get it from the plastic case and to warm hands within several minutes.

THE INSTRUCTION FOR THE PATIENT ON OPERATION OF THE INHALER

The instruction after use) an inhaler without optimizer
Keeping an inhaler in vertical position, open a cover. Make a deep exhalation. Densely clasp a mouthpiece with lips. Make sure that your hand does not block air vents of a pas of an upper part of an inhaler, and that you keep an inhaler in vertical position. Make a slow maximum breath through a mouthpiece. Hold the breath for 10 seconds or so as far as to you it is convenient. Then remove an inhaler from an oral cavity and slowly exhale. After use continue to keep an inhaler in vertical position. Close a cover. If you need to make more than one inhalation, close a cover, wait at least one minute, and then repeat inhalation process.

The instruction for use of an inhaler with the optimizer
Keeping an inhaler in vertical position, open a cover and densely get the Optimizer on an inhaler mouthpiece. Make a deep exhalation. Densely clasp the optimizer's mouthpiece with lips. Make sure that your hand does not block air vents on an upper part of an inhaler and that you keep an inhaler in vertical position. Make a slow maximum breath through the optimizer's mouthpiece. Hold the breath for 10 seconds or so as far as to you it is convenient. Then remove an inhaler from an oral cavity and slowly exhale. After use continue to keep an inhaler in vertical position. Remove the optimizer. Close a cover.

If you need to make more than one inhalation, in 1-2 minutes open a cover again and densely get the optimizer on an inhaler mouthpiece, and then repeat inhalation process.

Cleaning of an inhaler
Turn off an upper part of an inhaler. Pull out a metal barrel. Propoloskayte also dry up the lower part of an inhaler in warm water. Insert a barrel into place. Close a cover and fasten an upper part of an inhaler to its case. Do not wash an upper part of an inhaler. If the inhaler works incorrectly, turn off its upper part and manually press a barrel.

Side effects:

At some patients candidiasis of an oral cavity and throat can develop (the probability of development of candidiasis increases at use of a bsklometazop of Dipropionas in the doses exceeding 400 mkg a day).

At some patients the dysphonia (hoarseness of a voice) or irritation of a mucous membrane of a throat can be noted.

Inhalation drugs can cause a paradoxical bronchospasm which needs to be stopped immediately by means of inhalation b-2-adrenostimulyatora short actions.

There are separate messages on development of hypersensitivity reactions, including rash, urticaria, the itch, reddening and swelled an eye, persons, lips and a mucous membrane of a mouth and a throat. Possible system effects characteristic of GKS. include a headache, - nausea, formation of bruises or thinning of skin, unpleasant flavoring feelings, depression of function of bark of adrenal glands, osteoporosis, a growth inhibition at children and teenagers, a cataract, glaucoma.

Interaction with other medicines:

There are no confirmed data on Dipropionas beclomethasone interaction with other medicines.

Contraindications:

Hypersensitivity to any component of drug. Children's age up to 4 years.

With care to apply at glaucoma, system infections (bacterial, virus, fungal, parasitic), osteoporosis. a pulmonary tuberculosis, cirrhosis, a hypothyroidism, pregnancy, in the period of a lactation.

USE AT PREGNANCY AND THE LACTATION
With extra care Beklazon Eko Easy Breath should be applied at pregnancy and a lactation and only and that case if the potential advantage for mother surpasses possible risk for a fruit and the child.

Overdose:

The acute overdose of drug can lead to temporary depression of function of bark of adrenal glands that does not demand the emergency therapy as function of bark of adrenal glands is recovered within several days that is confirmed by cortisol level in plasma. At chronic overdose permanent suppression of function of bark of adrenal glands can be noted. In similar cases it is recommended to carry out monitoring of reserve function of bark of adrenal glands. At overdose treatment by beclomethasone can be continued by Dipropionas in the doses sufficient for maintenance of therapeutic effect.

Storage conditions:

Not to use after expiry date. At a temperature not above 30 °C, protecting from direct sunshine. Not to freeze. To store in the place, unavailable to children. A period of storage - 3 years.

Issue conditions:

According to the recipe

Packaging:

Aerosol for inhalations dosed activated by a breath of 50 mkg / a dose, 100 mkg / a dose, 250 m of kg/dose.

On 200 doses of active agent in an aluminum barrel, the aerosol filled under pressure. The aluminum barrel is in the aerosol inhaler activated by a breath (Easy Breath).

The aerosol inhaler with a barrel is placed in a cardboard pack together with the optimizer and the application instruction.