Pharmacological properties

Pharmacodynamics. beclomethasone Dipropionas — the predecessor of active agent with weak affinity to gks-receptors.

At inhalation application the system absorption of not changed beclomethasone of Dipropionas happens in lungs to insignificant oral absorption of the dose which got into a GIT. Before absorption there is an intensive transformation of beclomethasone of Dipropionas in its active metabolite beclomethasone-17-monopropionate. System absorption of beclomethasone-17-monopropionate consists of absorption in lungs and in a GIT. The absolute bioavailability at inhalation application is about 60% of the entered dose for beclomethasone-17-monopropionate.

Dipropionas is very quickly brought by

Beclomethasone out of system blood circulation by metabolism with participation of esterases. The main product of metabolism — active beclomethasone-17-monopropionate.

Dipropionas beclomethasone distribution Volume in a plateau phase moderated (20 l), however at beclomethasone-17-monopropionate it is more (424 l). Linking with proteins of blood plasma moderately high (87%).

Beclomethasone Dipropionas and beclomethasone-17-monopropionate have high plasma clearance (150 and 120 l/h), T _½ make 0.5 and 2.7 h. About 60% of a dose of medicine are removed with a stake, 12% — with urine in the form of the free and conjugated polar metabolites. Renal clearance of beclomethasone of Dipropionas and its metabolites insignificant.

Indication

Treatment oh heavy degree at adults and also treatment of the patients needing use of system steroids for adequate control of symptoms oh.

Use

by

Drug beklofort an evokhaler is appointed only for oral inhalations.

Patients have to know

what Beklofort Evokhaler should be applied to prevention of a disease and therefore it should be accepted regularly, even in the period of lack of attacks OH.

Dose is korrigirut depending on individual reaction.

If improvement of a state after use of bronchodilators of short action becomes less effective or there is a need of increase in number of inhalations, than usually, it is necessary to reconsider treatment.

to Patients, it is heavy to them to synchronize breath using an inhaler, recommends to use in addition a spacer — the device for simplification of inhalation of inhalation medicines.

Initial dose of medicine has to correspond to severity of a disease. For the patients needing a high dose of inhalation GKS, the initial dose has to make 1000 mkg/days. Further the dose of medicine can be otkorrigirovat before achievement of control of symptoms OH or to reduce to minimum effective, depending on individual reaction of the patient.

Adults and children are aged more senior than 12 years (including elderly people): 1000 mkg/days; the dose can be raised to 2000 mkg/days. After stabilization of a condition of the patient the dose should be lowered. The daily dose can be divided into 2, 3 or 4 receptions.

For obtaining optimum result Beklofort Evokhaler needs to be accepted regularly, even in the absence of symptoms.

to Patients, it is heavy to them to synchronize breath using an inhaler, recommends to use in addition a spacer.

As well as at use of other inhalation medicines, the therapeutic effect can decrease when cooling a cylinder. The cylinder cannot be broken, pierced or burned even if it is empty.

Before the first use of an inhaler or after a break in use lasting 3 days and more remove a mouthpiece cap, having slightly pressured him on each side, well stir up an inhaler and make two squirts in air to be convinced of its serviceability.

Rule of use of an inhaler

1. Remove a mouthpiece cap, having slightly pressured him on each side.

2. Make sure that in and outside of an inhaler, including a mouthpiece, there are no foreign objects.

3. Well stir up an inhaler for removal of a foreign subject from an inhaler and uniform hashing of its contents.

4. Take in a hand an inhaler vertically, having arranged it between big and other fingers, at the same time the thumb has to be on the inhaler body below a mouthpiece. Other fingers hold a bottle from below.

5. Make the deepest exhalation, then take a mouthpiece in a mouth between teeth and clasp it with lips, without biting.

6. Taking a breath through a mouth, press an inhaler top to execute spraying of medicine, at the same time continue to inhale slowly and deeply (thus 1 dose of aerosol is released).

7. Hold the breath, take an inhaler from a mouth and remove a finger from an inhaler top. Continue to hold the breath most long as far as it is possible.

8. In case of need further dispersion wait for about 30 with, holding an inhaler vertically. After that perform the operations described in Paragraphs 3-7.

9. Put on a cap a mouthpiece, carefully pressing it before emergence of characteristic click.

it is IMPORTANT

!

Perform the operations described in Paragraphs 5, 6 and 7, slowly. Just before pressing it is necessary to inhale as it is possible more slowly. The first several times it is necessary to be trained in front of the mirror. If the top of an inhaler or near corners of a mouth has "cloudlet", it is necessary to start the procedure over again from Paragraph 2.

If the doctor gave to

other operation manuals of an inhaler, carry out them and also address for council at emergence of any difficulties.

Cleaning

in general does not have

need for cleaning of an inhaler, but at emergence that it is necessary to be guided by the following recommendations.

1. Take a metal cylinder from a plastic case of an inhaler and remove a mouthpiece cap.

2. Wash a plastic case and a cap of a mouthpiece with warm water.

3. Dry up them outside and inside.

4. Place a metal cylinder and a cap of a mouthpiece into place.

DO NOT PUT the METAL CYLINDER IN WATER.

Contraindication

Hypersensitivity to any of medicine components.

Side effects

Side reactions are classified by

by bodies and systems depending on emergence frequency: very often (≥1/10), it is frequent (from ≥1/100 to 1/10), infrequently (from ≥1/1000 to 1/100), is rare (from ≥1/10 000 to 1/1000) and is very rare (1/10,000), including single messages. data on the side reactions arising very often often and infrequently, mainly are based on clinical trials. data on the side reactions arising seldom and very seldom, mainly receive spontaneously.

Infection and invasion: very often — candidiasis of a mouth and throat.

Immune system. It was reported about reactions of hypersensitivity, such as: infrequently — skin rash, a small tortoiseshell, an itch, an erythema; very seldom — a Quincke's disease, respiratory symptoms (short wind and/or a bronchospasm with strengthening of goose breathing, cough) and anaphylactoid/anaphylactic reactions.

Endocrine system. Perhaps systemic action which includes (see. Special INSTRUCTIONS): very seldom — Cushing's syndrome, cushingoid signs, oppression of function of adrenal glands, a growth inhibition at children and teenagers, decrease in a mineralization of bones, a cataract and glaucoma.

Mental disorders: very seldom — concern, a sleep disorder, a depression, aggression, change of behavior, including hyperactivity and excitement (generally at children).

Respiratory system: often — hoarseness, irritation in a throat; very seldom — a paradoxical bronchospasm (see. Special INSTRUCTIONS).

Special instructions

Treatment at oh should be carried out by

according to the step-by-step program, the condition of the patient needs to be controlled regularly as clinically, and by definition of indicators of function of external respiration.

Increase in frequency of use of inhalation agonists β - adrenoceptors of short action signals ₂ about gradual loss of control OH. In these conditions it is necessary to reconsider therapy. The sudden and progressing deterioration in control OH is potentially life-threatening therefore it is necessary to raise GKS dose. At the patients belonging to risk group it is required to carry out a pikfloumetriya.

Beklofort Evokhaler is intended to

not for knocking over of bad attacks OH, and for long-term preventive treatment. At bad asthmatic attacks it is necessary to apply fast and short-range inhalation bronchodilators to simplification of a state.

needs to use

correctly an inhaler to provide hit of medicine in bronchial tubes.

Insufficient response to treatment or heavy aggravation OH are demanded by increases in a dose of the medicine Beklofort Evokhaler and if necessary — use of system steroids and/or antibiotics in the presence of an infection.

At application of inhalation GKS, especially in high doses and for a long time, systemic action can arise, but it is much less, than at intake of oral steroids. Systemic action can be shown by Cushing's syndrome, cushingoid signs, oppression of function of adrenal glands, a growth inhibition at children and teenagers, reduction of a mineralization of a bone tissue, a cataract and glaucoma. Therefore it is important that the dose of inhalation GKS was reduced to minimum possible which would support effective control of symptoms OH (see. Side EFFECTS).

recommends to control

regularly growth of the children performing long-term treatment by inhalation GKS.

individual hypersensitivity to inhalation GKS Exists.

Due to a possibility of oppression of function of adrenal glands the translation of patients from oral GKS on Beklofort Evokhaler requires special attention and constant control of function of adrenal glands.

Process of transition on Beklofort Evokhaler and the termination of system therapy have to be

gradual and patients should have at themselves a special card with a warning of need of additional administration of system steroid during the stressful period, for example at a heavy asthmatic attack, a serious intercurrent illness, surgical interventions, injuries.

to

It is similar, replacement of system steroid therapy by inhalation can sometimes unmask the allergic diseases, such as allergic rhinitis or eczemas which are earlier controlled by system intake of steroids. These allergic manifestations it is necessary to treat antihistamines and/or topical medicines including GKS.

Beklofort Evokhaler Drug treatment not to stop

suddenly!

by

As well as at treatment by other inhalation GKS, needs extra care when prescribing the medicine Beklofort Evokhaler to the patient with an active and latent pulmonary tuberculosis. Treatment of GKS can mask symptoms of a pulmonary tuberculosis and other bacterial, viral and fungal respiratory infections. Reactivation of a pulmonary tuberculosis is possible. In case of prescribing of medicine to patients with the accompanying respiratory infections they have to be treated properly. With restrictions to use medicament for treatment of patients with anomalies of lungs, such as bronchietasia and pneumoconiosis, because of a possibility of a fungal infection. After use of medicine it is required to rinse an oral cavity water.

should not appoint medicine sick in the presence of a herpes simplex and the asthmatic status.

As well as at treatment by other inhalation medicines, development of a paradoxical bronchospasm with the fast-progressing asthma after inhalation is possible

. In that case it is necessary to apply immediately high-speed inhalation bronchodilators, at once to stop inhalation of the medicine Beklofort Evokhaler, to perform examination of the patient and if necessary to appoint alternative therapy.

Patients needs to warn that medicine contains a small amount of ethanol and glycerin. In therapeutic doses the amount of ethanol and glycerin very little also does not represent risk for patients.

Use during pregnancy and feeding by a breast. Safety of use of the medicine Beklofort Evokhaler during pregnancy is not finalized. At the solution of a question of use of medicine during pregnancy it is required to estimate a ratio of the expected advantage for mother and potential risk for a fruit. Inhalation of beclomethasone can be followed by a pre-natal growth inhibition of a fruit.

Drug gets into breast milk, but in very insignificant quantity. Prescribing of medicine during feeding by a breast has to be weighed taking into account that the therapeutic advantage of use of medicine has to be above possible risk for a fruit.

Children. It is not recommended to apply at children aged 12 years are younger.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Beklofort Evokhaler does not affect ability to steer vehicles and to work with other mechanisms.

Interaction

Beklofort the evokhaler contains very insignificant amount of ethanol therefore theoretically at patients with hypersensitivity the interaction at a concomitant use with Disulfiramum or metronidazole is possible.

Overdose

At use of medicine beklofort an evokhaler in the doses exceeding recommended perhaps temporary oppression of function of bark of adrenal glands. this state does not demand emergency aid as function of bark of adrenal glands will be restored in several days that is confirmed by cortisol level in blood plasma. however at use of medicine in the doses exceeding recommended for a long time perhaps some oppression of function of adrenal glands. in such cases it is necessary to check a reserve of function of adrenal glands. medicament treatment beklofort an evokhaler should be continued in the doses approved for control oh.

is not present

Specific treatment at overdose of beclomethasone of Dipropionas. In case of overdose it is necessary to carry out maintenance therapy with the corresponding control if necessary. Further treatment — according to a clinical state or local recommendations at their existence.

Storage conditions

At a temperature not above 30 °C.

Directly after use to close a mouthpiece a cap, carefully pressing it before emergence of characteristic click. To avoid influence of direct sunshine. Not to freeze.

you can Report

about the undesirable phenomenon in LLC GlaksoSmitKlyayn Pharmasyyutikals Ukraina by ph.: (044) 585-51-85 or e-mail: oax70065@gsk.com. You can complain of quality of medicine by ph.: (044) 585-51-85, +38 (050) 381-43-49 or e-mail: ua.complaints@gsk.com

apply For additional information in LLC GlaksoSmitKlyayn Pharmasyyutikals Ukraina: 02152, Kiev, Pavel Tychina Avenue, 1B.

Ph.: (044) 585-51-85, fax: (044) 585-51-92.

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UA/RESP/0053/18.11.20