BEKLAZON ECO Easy Breathe

Active material: Beklometazon
When ATH: R03BA01
CCF: GCS for inhalation
ICD-10 codes (testimony): J45
When CSF: 04.03
Manufacturer: NORTON WATERFORD (Ireland)

Pharmaceutical form, composition and packaging

Aerosol for inhalation dose, breath activated, as a solution, which when sprayed on the glass forms a colorless slick.

Excipients: ethanol, gidroftoralkan (HFA-134a).

200 doses – aluminum cylinders (1) – aerosol inhalers, breath activated, (1) – packs cardboard.

Pharmacological action

Beclomethasone dipropionate is a prodrug and has a weak affinity for corticosteroids receptors. Under the action of the esterases it is converted into the active metabolite – beclomethasone-17-monopropionat (B-17-MP), which has a pronounced local anti-inflammatory effect. It reduces inflammation by reducing the formation Substance chemotaxis (influence on “later” allergy reactions), inhibits the development of immediate allergic reaction (caused by inhibition of production of metabolites of arachidonic acid and decrease the release of mast cell mediators of inflammation) and improves mucociliary transport. Under the effect of beclomethasone reduced number of mast cells in bronchial mucosa, decreases swelling of the epithelium, mucus secretion of bronchial glands, bronchial hyperreactivity, accumulation of neutrophils boundary, inflammatory exudation and production of lymphokines, inhibits the migration of macrophages, decreases the intensity of infiltration and granulation.

It increases the number of active β-adrenoceptor, restores the patient's response to bronchodilators, It reduces the frequency of their use. Almost no resorptive action after inhalation.

Not relieves bronchospasm, therapeutic effect develops gradually, usually via 5-7 days a course of beclomethasone dipropionate.

Pharmacokinetics

Absorption

After inhalation to 56% the dose deposited in the lower respiratory tract; the remaining amount is deposited in the mouth, throat and swallowed. The absorption of light in front of beclomethasone dipropionate is extensively metabolized to the active metabolite B-17-MP. Systemic absorption of B-17 MP occurs in the lungs (36% pulmonary faction), in the digestive tract (26% received here from the ingestion dose). The absolute bioavailability of unchanged BDP and B-17-MP is respectively about 2% and 62% by inhalation dose. Beclomethasone dipropionate is rapidly absorbed, C_max achieved through 0.3 no. B-17-MP is absorbed slowly, C_max achieved through 1 no. An estimated linear relationship between increasing dose and systemic drug exposure.

Distribution

V_d is 20 l for beclomethasone dipropionate and 424 l for B-17-MP. Binding to plasma proteins is relatively high – 87%.

Deduction

BDP and B-17-MP have high plasma clearance (150 l / h 120 l / hr, respectively). T_1/2 is 0.5 and h 2.7 h, respectively.

Testimony

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

Dosage regimen

Beklazon Eco Easy Breath is only intended for administration by inhalation.

Beklazon Eco Easy Breath is used regularly (even in the absence of symptoms), dose of beclomethasone dipropionate is selected considering the clinical effect in each case.

In less severe asthma forced expiratory volume (OFV₁) or peak expiratory flow rate (PSV) account for more than 80% on the proper values ​​to spread PEF less 20%.

When to moderate FEV₁ or PSV is 60-80% by proper values, daily disorder of indicators PSV 20-30%.

In severe FEV₁ or PSV up 60% by proper values, PEF diurnal variation more 30%.

When you go to a high dose of inhaled beclomethasone dipropionate, many patients, receiving systemic corticosteroids, You can reduce their dose or stop them altogether.

The initial dose Beklazona Eco Easy Breath determine the severity of asthma. The daily dose is divided into several stages.

Depending on the individual patient's response the dose can be increased before the appearance of clinical effect or reduce to the minimum effective dose.

Adults and children aged 12 and older Recommended initial dose of the drug in asthma lung flow up 200-600 mg / day; at asthma moderate flow – 600-1000 mg / day; at severe bronchial asthma – 1000-2000 mg / day.

Children aged 4 to 12 years dose up to 400 ug / day in divided doses.

There is no need to adjust the dose Beklazona ECO Easy Breathe in the elderly, in patients with renal or hepatic insufficiency.

At accidental omission inhalation next dose should be taken in due time in accordance with the treatment.

Beklazon Eco Easy Breath with the content 1 dose 250 micrograms of beclomethasone is not intended for pediatric use.

Before the appointment of inhaled drugs should instruct the patient on the rules of their application, ensuring the fullest penetration of the active substance in the desired parts of the lungs.

Instructions for use of the inhaler without the optimizer

Holding the inhaler upright, Open the cover. Take a deep breath. Desktop ranges mouthpiece gubami. Check, that your hand does not block the vents on the top of the inhaler, and, that you keep the inhaler in a vertical position. Take a slow breath in through the mouthpiece maximum. Hold your breath for 10 seconds or so, how you want it. Then remove the inhaler from the mouth and breathe out slowly. After application, continue to keep the inhaler in a vertical position. Close the lid. If you need to make more than one inhalation, Close the lid, wait, at least, One minute, and then repeat the process of inhalation.

Instructions for use of the inhaler Optimizer

Holding the inhaler upright, open the cover and push as the optimizer on the mouthpiece of the inhaler. Take a deep breath. Desktop ranges mouthpiece Optimizer gubami. Check, that your hand does not block the vents on the top of the inhaler, and, that you keep the inhaler in a vertical position. Take a slow breath in through the mouthpiece maximum Optimizer. Hold your breath for 10 seconds or so, how you want it. Then remove the inhaler from the mouth and breathe out slowly. After application, continue to keep the inhaler in a vertical position. Remove Optimizer. Close the lid. If you need to make more than one inhalation, Close the lid, wait, at least, One minute, and then repeat the process of inhalation.

Cleaning the inhaler

Remove the upper part of the inhaler. Pull the metal canister. Rinse the bottom of the inhaler in warm water and dry. Insert the cartridge into place. Close the lid and tighten the upper part of the inhaler to his body. Do not wash the upper part of the inhaler. If the inhaler is not working properly, Unscrew the top part and manually click on the balloon.

Side effect

Local reactions: possible oral candidiasis and throat (Candida increases the likelihood of developing the application of beclomethasone dipropionate doses, exceeding 400 mg / day), disfonija (hoarseness) or irritation of the throat.

The respiratory system: possible paradoxical bronchospasm, which is necessary to stop immediately using inhaled beta₂-agonists short-acting.

Allergic reactions: possible eruption, hives, itch, redness and swelling of the eyes, person, lips and mucous membranes of the mouth and throat.

Effects, due to systemic action: They include headache, nausea, bruising or thinning of the skin, bad taste, loss of function of the adrenal cortex, osteoporosis, growth retardation in children and adolescents, cataracts, glaucoma.

Contraindications

- Children up to age 4 years;

- Hypersensitivity to the drug.

FROM caution used for glaucoma, systemic infections (bacterial, Viral, fungal) and parasitic infestations, osteoporosis, pulmonary tuberculosis, cirrhosis, gipotireoze, Pregnancy, lactation.

Pregnancy and lactation

With extreme caution Beklazon Eco Easy Breath should be used during pregnancy and lactation and only if, if the potential benefit to the mother outweighs the potential risk to the fetus and child.

Cautions

Before the appointment of inhaled corticosteroids is necessary to instruct the patient on the rules of their application, provides the most comprehensive drug hit in the right parts 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 fungus Candida, indicating that the previously transferred fungal infection. After inhalation should rinse the mouth and throat with water. For the treatment of candidiasis can be used topical antifungal drugs while continuing therapy Beklazonom Eco Easy Breath.

If patients taking corticosteroids inside, Beklazon the Eco Easy Breath appointed in patients receiving the same dose of GCS, Thus the patient should be in a relatively stable state. Approximately 1-2 week, the daily dose of oral corticosteroids begin to gradually reduce. Driving dose reduction depends on the duration of prior therapy, and the magnitude of the initial dose of corticosteroids. Regular use of inhaled corticosteroids in most cases, to cancel oral corticosteroids (Patients, need to receive no more than 15 mg prednisolone, It can be fully transferred to inhalation therapy), In the first months after the transition should carefully monitor the condition of the patient, until his pituitary-adrenal system does not recover sufficiently, to provide an adequate response to stressful situations (eg, injury, surgery or infection).

When transferring patients receiving systemic corticosteroids to inhalation therapy may manifest allergic reactions (eg, nasal allergy, eczema), which previously suppressed systemic drugs.

Patients with impaired function of the adrenal cortex, transferred to inhalation therapy, You should have a supply of Valium and always carry a warning card, which must be specified, that they are in stressful situations require additional systemic administration of corticosteroids (after the elimination of stress dose of corticosteroids can reduce again). Sudden and progressive deterioration of asthma symptoms is a potentially dangerous condition, often life-threatening patients, and require higher doses of corticosteroids. An indirect measure of treatment failure is more frequent, than before, use of beta₂-agonists short-acting.

Beklazon Eco Easy Breath is not for cupping, but for regular daily use. For cupping used beta₂-adrenostimulyatorov short-acting (eg, salbutamol). In severe asthma exacerbation or lack of effectiveness of the therapy should increase the dose Beklazona Eco Easy Breath and, if necessary, appoint a systemic corticosteroids and / or antibiotics in the development of infection.

With the development of paradoxical bronchospasm should immediately discontinue use of Beklazona Eco Easy Breath, assess the condition of the patient, to conduct a survey and, if necessary, appoint a therapy with other drugs.

Prolonged use of any inhaled GCS, especially in high doses, systemic effects may occur, However, the probability of their development is much lower, than when corticosteroids inside. It is therefore particularly important, to a therapeutic effect at the dose of inhaled corticosteroids has been reduced to the minimum effective dose, controlling the disease. At a dose of 1500 ug / day in most patients the drug does not cause significant suppression of adrenal function. In connection with the possible development of adrenal insufficiency should be treated very carefully and regularly monitor the performance of the functions of the adrenal cortex when transferring patients, taking into GCS, for treatment Beklazonom Eco Easy Breath.

Not recommended abrupt withdrawal of the drug Beklazon Eco Easy Breath.

Be particularly careful in the treatment of inhaled corticosteroids in patients with active or inactive pulmonary tuberculosis.

Protect the eyes from getting the drug. Washing after inhalation can be prevented defeat of the eyelid skin and nose.

Spray with Beklazonom Eco Easy Breath can not pierce, disassemble or dispose of in fire, even if it is empty. Like most other means of inhalation of aerosol dispensers, Beklazon Eco Easy Breath may be less effective at low temperatures. Upon cooling spray is recommended to get it out of the plastic case and warm hands for a few minutes.

Use in Pediatrics

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

Overdose

Acute overdose It can lead to a temporary decrease in the function of the adrenal cortex, that does not require emergency treatment, tk. adrenocortical function is restored within a few days, confirmed that cortisol level in plasma.

At Chronic overdose there may be a persistent suppression of adrenocortical function.

In such cases it is advisable to monitor the backup function of the adrenal cortex. In case of overdose treatment beclomethasone dipropionate may be continued at a dose, sufficient to maintain therapeutic effect.

Drug Interactions

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

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be protected from direct sunlight, inaccessible to children at temperature to 30 ° C; Do not freeze. Shelf life - 3 year.