Beclazone Eco instruction
You can buy Beclazone Eco here
Beclazone Eco is an inhalation preparation intended for basic therapy of bronchial asthma.
Release form and composition
The dosage form for the release of Beclazone Eco is a metered-dose aerosol for inhalation: placed under pressure in an aluminum can; external damage, leaks or corrosion should be absent; when sprayed onto glass, the contents of the can leave a white spot (in a cardboard bundle 1 bottle of 200 doses).
Composition of 1 dose:
active substance: beclomethasone dipropionate - 0.05 mg, 0.1 mg or 0.25 mg;
auxiliary components (0.05 / 0.1 / 0.25 mg): ethanol - 2.09 / 3.11 / 6 mg; hydrofluoroalkane (HFA-134a) - 75.86 / 74.79 / 71.75 mg.
Pharmacodynamics
Beclomethasone is among the corticosteroids (glucocorticosteroids). It has a weak tropism for corticosteroids receptors.
Under the influence of enzymes, it is converted into an active metabolite - B-17-MP (beclomethasone-17-monopropionate), which has a pronounced local anti-inflammatory effect.
The main properties of Beclazone Eco:
reduction in inflammation by reducing the formation of chemotaxis substance (effect on late allergy reactions);
inhibition of the development of an immediate allergic reaction (associated with inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells);
improvement of mucociliary transport;
decrease in the number of mast cells in the mucous membrane of the bronchi;
reduction of edema of the epithelium, mucus secretion by the bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils, inflammatory exudate and production of lymphokines;
inhibition of macrophage migration;
decrease in the intensity of granulation and infiltration processes;
increase in the number of active beta-adrenergic receptors;
restoration of the patient's response to bronchodilators, which reduces the frequency of their use.
Beclomethasone after inhalation administration has practically no resorptive effect.
Beclazone Eco does not stop bronchospasm. The development of the therapeutic effect occurs gradually, as a rule, after 5-7 days of course use.
Pharmacokinetics
More than 1/4 of the dose of inhaled beclomethasone settles in the airways, the remaining amount settles in the mouth, pharynx and is swallowed. In the lungs, beclomethasone is intensively metabolized prior to absorption to the active metabolite B-17-MP.
Systemic absorption of the metabolite B-17-MP occurs in the lungs (36% of the pulmonary fraction), in the gastrointestinal tract (26% of the dose received when swallowed).
The absolute bioavailability of unchanged beclomethasone and B-17-MP is approximately 2 and 62% of the inhaled dose, respectively. Beclomethasone is rapidly absorbed, Tmax (time to reach maximum plasma concentration) - 18 minutes. The absorption of the B-17-MP is slow, its Tmax is 60 minutes.
A linear relationship is noted between the increase in the dose received and the systemic exposure of the substance.
The distribution in the tissues of beclomethasone and B-17-MP is 20 and 424 liters, respectively. A relatively high association with plasma proteins is noted - 87%.
Beclomethasone and B-17-MP have a high plasma clearance (150 and 120 l / h, respectively). The half-life is 0.5 and 2.7 hours, respectively.
Indications for use
According to the instructions, Beclazone Eco is prescribed for basic therapy of various forms of bronchial asthma.
Contraindications
Absolute:
age up to 4 years;
individual intolerance to the components of the drug.
Relative (Beclazone Eco is prescribed under medical supervision):
cirrhosis of the liver;
glaucoma;
systemic infections (bacterial, viral, fungal, parasitic);
hypothyroidism;
pulmonary tuberculosis;
osteoporosis;
pregnancy and lactation.
Instructions for use Beclazone Eco: method and dosage
Beclazone Eco Aerosol is intended for inhalation administration. For its use, an inhalation device is used. After each inhalation, the mouth and throat should be thoroughly rinsed with water.
The drug should be used regularly, even in cases where there are no symptoms of the disease. The dose is selected by the doctor individually based on clinical effectiveness. After switching to a high dose of inhaled beclomethasone, most patients receiving systemic corticosteroids reduce their dose or cancel it completely.
The initial dose of Beclazone Eco depends on the severity of bronchial asthma:
mild course: FEV (forced expiratory volume) or PSV (peak expiratory flow rate) is more than 80% of the proper values with a range of PSV indicators up to 20%;
moderate course: FEV or PSV is from 60 to 80% of the proper values, the daily dispersion of PSV indicators is in the range of 20-30%;
severe course: FEV or PSV - less than 60% of the proper values, daily variation in PSV indicators - more than 30%.
The daily dose is divided into several doses (from 2 to 4 inhalations per day).
Adults and children over 12 years old
Recommended starting daily dose of Beclazone Eco:
mild course: 0.2-0.6 mg (for 2 inhalations);
moderate course: 0.6–1 mg (for 2–4 inhalations);
severe course: 1-2 mg (for 2-4 inhalations).
The standard maximum daily dose is 1 mg. In a very severe course, it can be increased to 1.5–2 mg (for 2–4 inhalations).
The treatment of bronchial asthma is based on a stepwise approach. Therapy should be started according to the stage, which corresponds to the severity of the disease. Inhaled GCS are prescribed from the second stage.
Recommended dosage:
II stage: basic therapy; 0.1-0.4 mg 2 times a day;
III stage: basic therapy; Beclazone Eco can be used in a high daily dose or in combination with long-acting inhaled beta2-adrenergic agonists in a standard daily dose; the recommended daily dose is 0.8–1.6 mg, in some cases it can reach 2 mg;
IV – V stage: severe bronchial asthma; the recommended daily dose is 0.8–1.6 mg, in some cases it can reach 2 mg.
Children aged 4–12 years
The recommended initial daily dose is 0.1-0.2 mg (for 2 inhalations). The standard maximum daily dose is 0.2 mg. In very severe cases, it can be increased to 0.4 mg (for 2–4 inhalations).
Beclazone Eco aerosol with a single dose of 0.25 mg beclomethasone is not intended for use in this group of patients.
Additional Information
If you accidentally skip inhalation, the next dose should be taken in accordance with the treatment regimen at the appropriate time. The introduction can be carried out using special dispensers (spacers), which improve the distribution of the drug in the lungs and reduce the likelihood of adverse reactions.
Before using the inhalation device for the first time or in cases where it has not been used for some time, check that it is in good working order. To do this, press the cartridge valve and release a dose of medication into the air.
Before using Beclazone Eco, you need to remove the protective cap from the inhalation device and make sure that the outlet tube is clean.
The inhalation device should be held vertically between the index finger and thumb, while the thumb should be placed on the bottom of the inhalation device, and the index finger should be placed on top of the aluminum balloon.
The aluminum can must be shaken vigorously in the vertical direction.
A deep exhalation should be made through the mouth, after which the lips should pinch the outlet tube of the inhalation device tightly and take a deep and slow breath. At the moment of inhalation, you need to press the metering valve of the balloon with your index finger, and a dose of Beclazone Eco is released. Continue to slowly inhale.
It is necessary to remove the inhalation device from the mouth and hold your breath for 10 seconds or for a time that does not cause discomfort, then slowly exhale.
After the procedure, you need to rinse your mouth with water, trying not to swallow the drug that got on the mucous membrane of the oral cavity during inhalation.
If it is necessary to introduce a second dose, wait 1 minute and repeat all steps.
Clean your inhalation device at least once a week. To do this, remove the aluminum can from it. Then it is necessary to rinse the inhalation device and the protective cap with warm water. Hot water must not be used. To remove residual water, shake the inhalation device and cap. They should be dried without using heating devices. Do not allow the aluminum cylinder to come into contact with water.
Side effects
Possible adverse reactions (> 10% - very often;> 1% and <10% - often;> 0.1% and <1% - infrequently;> 0.01% and <0.1% - rarely; <0, 01%, including individual messages - very rarely):
endocrine system (with prolonged use of doses of more than 1500 mg per day): very rarely - inhibition of HHF (hypothalamic-pituitary-adrenal system);
respiratory system: often - hoarseness, irritation of the pharyngeal mucosa; rarely - paradoxical bronchospasm; very rarely - eosinophilic pneumonia;
musculoskeletal system: very rarely - lower bone mineral density;
organ of vision: very rarely - glaucoma, cataract;
allergic reactions: rarely - angioedema, erythema, pruritus, skin rash, urticaria;
infectious diseases (with prolonged use in doses of 0.4 mg per day): often - candidiasis of the oral cavity, pharynx and upper respiratory tract;
systemic reactions: nausea, headache, thinning of the skin, or bruising.
Overdose
An acute overdose of Beclazone Eco can develop with a single dose inhalation of more than 1000 mg. Symptoms of inhibition of the function of the adrenal cortex do not require emergency therapy, since the violation disappears within a few days.
In case of chronic overdose (long-term therapy at a dose of more than 1500 mg), persistent suppression of adrenal cortex function may develop. At the same time, monitoring of the reserve function of the adrenal cortex is shown.
Treatment with beclomethasone in case of an overdose can be continued in doses that are sufficient to maintain a therapeutic effect.
special instructions
If the effectiveness of the usual dose is reduced, or the duration of the action of Beclazone Eco is reduced, you should consult your doctor. You cannot change the dosage regimen yourself.
When conducting therapy using high doses (from 0.4 mg per day), candidiasis of the oral cavity and pharynx may develop, in particular this applies to patients who have previously suffered a fungal infection. The rapid elimination of fungal infections is usually facilitated by the use of antifungal drugs. In this case, the dose of beclomethasone should not be changed.
If Beclazone Eco is prescribed against the background of taking GCS inside, then you can start lowering the dose of the latter after 7-14 days. In most cases, patients who take no more than 15 mg of prednisolone can fully switch to the use of inhaled beclomethasone only. During the first months after the transition to beclomethasone inhalation therapy, careful monitoring of the state of the central nervous system is required.
Against the background of decreased adrenal function, after a full transition to Beclazone Eco, patients should always have a reserve of GCS with them, as well as carry a card with information that in stressful situations they need systemic GCS.
With a sudden and progressive deterioration in the course of bronchial asthma, an increase in the dose of corticosteroids is required. An indirect indicator of treatment failure is the more frequent use of short-acting beta2-adrenergic agonists.
To stop attacks of bronchospasm, beta2-hadronomimetics, including salbutamol, should be used. In severe cases of the disease or insufficient effectiveness of Beclazone Eco, it is necessary to increase its dose, and also consider the use of GCS inside. It is also possible to use antibacterial drugs, in particular for infectious inflammation.
In the case of paradoxical bronchospasm, Beclazone Eco is canceled. After the examination, the doctor decides on the appointment of another drug.
It is impossible to abruptly interrupt therapy.
With prolonged use of Beclazone Eco in children, their growth dynamics should be controlled.
When using the drug in patients with an active / inactive form of pulmonary tuberculosis, care must be taken.
Avoid contact with Beclazone Eco in the eyes.
Pregnancy and lactation
Beclazone Eco during pregnancy / lactation should be used under medical supervision.
Use in childhood
Beclazone Eco is not prescribed for patients under 4 years of age.
Drug interaction
Beclazone Eco restores the reaction to beta-adrenergic agonists, which reduces the frequency of their use.
Possible interactions:
beta-adrenergic agonists: their effect is enhanced;
methandienone, estrogens, beta2-adrenergic agonists, theophylline, systemic corticosteroids: the effectiveness of beclomethasone increases;
phenobarbital, phenytoin, rifampicin and other inducers of microsomal liver enzymes: the effectiveness of beclomethasone decreases.
Terms and conditions of storage
Store in a place protected from direct sunlight at temperatures up to 25 ° C. Keep out of the reach of children. Do not freeze.
Shelf life is 3 years.
Reviews
According to reviews, Beclazone Eco is effective with constant use. It is noted that the drug has an acceptable cost. Of the shortcomings indicate the development of side effects, including stomatitis.
Terms of sell
You don't need a prescription to buy Beclazone Eco.