Beclometasone-Aeronative aerosol 250mcg/dose 200doses

Beclometasone-Aeronative instruction for use

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Pharmacological properties

Pharmacodynamics

Beclometasone dipropionate is a prodrug and has a weak tropism for GCS receptors. Under the action of esterases, it turns into an active metabolite - Beclometasone-17-monopropionate (B-17-MP), which has a pronounced local anti-inflammatory effect. Reduces inflammation by reducing the formation of the chemotaxis substance (influence 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 Beclometasone, the number of mast cells in the bronchial mucosa decreases, the epithelial edema diminishes, the mucus secretion by the bronchial glands, the bronchial hyperreactivity, the neutrophil vascular congestion, the inflammatory exudate and the production of lymphokines, the macrophage migration is inhibited, the intensity of the 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 dipropionate.

Pharmacokinetics

Suction
More than 25% of the dose of the inhaled drug settles in the airways, the remaining amount settles in the mouth, pharynx and is swallowed. In the lungs, before absorption of beclomethasone, dipropionate 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 when the dose is ingested). The absolute bioavailability of unchanged beclomethasone dipropionate and B-17-MP is approximately 2% and 62% of the inhaled dose, respectively. Beclomethasone dipropionate is rapidly absorbed, the time to reach the maximum plasma concentration (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 the drug.
Distribution
Distribution in tissues is 20 liters for beclomethasone dipropionate and 424 liters for B-17-MP. The connection with plasma proteins is relatively high - 87%.
Metabolism and excretion
Beclomethasone dipropionate 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 for use

    Basic therapy of various forms of bronchial asthma in adults and children older than 4 years.
    Supportive therapy for chronic obstructive pulmonary disease (COPD) in patients with forced expiratory volume (FEV1)

Contraindications

    Age up to 4 years.
    Hypersensitivity to any component of the drug.
Caution should be applied Beclomethasone Aeronative with glaucoma, systemic infections (bacterial, viral, fungal, parasitic), osteoporosis, pulmonary tuberculosis, liver cirrhosis, hypothyroidism, pregnancy, lactation.

Application in pregnancy and during breastfeeding

During pregnancy and during breastfeeding, beclomethasone Aeronative can be prescribed only if the intended benefit to the mother exceeds any possible risk to the fetus or child.

Dosing and Administration

The drug "Beclomethasone Aeronative" is intended only for inhalation.

Bronchial asthma

Adults and children aged 12 years and over:
Beclomethasone Aeronative is used regularly (even in the absence of symptoms of the disease), the dose of beclomethasone dipropionate is selected taking into account the severity of bronchial asthma and the clinical effect in each specific case.
The daily dose is divided into several doses.
Recommended initial doses of the drug:
A bronchial asthma of a lung current - 200 - 600 mkg / sut
A bronchial asthma of a moderate course - 600 - 1000 mkg / day
bronchial asthma severe course - 1000 - 2000 mcg / day Children aged 4 to 12 years:
Up to 400 mcg per day in several doses.
Depending on the individual response of the patient, the dose of the drug can be increased until the appearance of a clinical effect or reduced to the minimum effective dose.
When switching to a high dose of inhaled beclomethasone dipropionate, many patients receiving systemic glucocorticosteroids will be able to reduce their dose or cancel them altogether. Chronic obstructive pulmonary disease The maximum recommended dose of beclomethasone Aeronative with COPD is 2000 μg per day.
If you miss an inhalation accidentally, the next dose should be taken at the appropriate time in accordance with the treatment regimen.
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. Patients with hepatic impairment
In patients with impaired liver function, a dose reduction is not required. Patients with impaired renal function
In patients with impaired renal function, a dose reduction is not required. Instruction for inhalation of beclomethasone Aeronative is intended only for inhalation. Before using the inhaler for the first time or if the inhaler has not been used for a week or longer, check its operation. To do this, remove the protective cap from the mouthpiece of the inhaler, shake the inhaler well and press the balloon, releasing one jet of the drug into the air.

Carrying out inhalations

Step 1. Remove the protective cap from the inhaler mouthpiece.
Step 2. Vigorously shake the inhaler.
Step 3. Make a slow, full exhalation.
Step 4. Hold the balloon, tightly grasp the mouthpiece.
The balloon should be pointed upside down.
Step 5. Exercise as deep as possible, simultaneously quickly press the bottom of the cylinder until one inhalation dose is released.
Step 6. Hold your breath for a few seconds, then take the mouthpiece out of your mouth and exhale slowly.
Step 7. Put the protective cap on the mouthpiece of the inhaler.
Repeat steps 3-6 to obtain a second inhalation dose, if necessary.
After inhalation, it is recommended to rinse the mouth and throat with water.
Do not swallow water.
Cleaning the inhaler Regularly (once a week), you should clean the mouthpiece of the inhaler.
Remove the metal can from the plastic case and rinse the case and cap with warm water. Do not use hot water. Thoroughly dry, but do not use heating devices for this. Place the can in the case and put on the cap. Do not immerse the metal can into the water.

Side effect

Frequency determination: very often (> 1/10), often (from 1/100 to 1/10), infrequently (from 1/1000 to 1/100), rarely (from 1/10000 to 1/000), very rarely (
From the side of metabolism: rarely - hypercortisy; very rarely - symptoms of systemic glucocorticosteroid effects (including adrenal hypofunction, Cushing's syndrome).
From the immune system: rarely - hypersensitivity reactions, rashes, hives, angioedema, itching.
On the part of the musculoskeletal system: a decrease in bone mineral density.
From the respiratory system: often - cough; rarely - paradoxical bronchospasm, irritation of the pharynx, dysphonia, disappearing after discontinuing therapy or reducing the dose of the drug.
Other: often - Candidiasis of the mucous membrane of the mouth and larynx.
The systemic effect of inhaled glucocorticosteroids can be observed when taking the drug in high doses for a long time.

Overdose

Acute overdose of the drug may lead to a temporary decrease in the function of the adrenal cortex, which does not require emergency therapy, since the function of the adrenal cortex is restored within a few days, which is confirmed by the level of cortisol in the plasma. In chronic overdosage, persistent suppression of adrenal cortex function 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 dipropionate can be continued at doses sufficient to maintain a therapeutic effect. To avoid an overdose, patients should not use beclomethasone Aeronative at doses exceeding the recommended levels. Of great importance is the regular evaluation of the effectiveness of therapy and reduction of the dose of Beclomethasone Aeronative to a minimum level, which provides effective control of the symptoms of the disease. Interaction with other drugs There is no confirmed data on the interaction of beclomethasone dipropionate with other drugs.

special instructions

Before prescribing inhalants, the patient should be instructed on the rules for their use, ensuring the most complete entry of the drug into the right areas of the lungs. To prevent oral cavity candidiasis after inhalation, rinse the mouth and throat with water. For treatment of candidiasis, antifungal agents of local action can be used while continuing therapy with Beclomethasone-Aeronative.
If patients take GCS inside, then beclomethasone Aeronative are prescribed against the background of taking the previous dose of SCS, while patients should be in a relatively stable state. After about 1 to 2 weeks, the daily dose of oral glucocorticosteroids is gradually reduced. The dose reduction scheme depends on the duration of the previous therapy and on the initial dose of GCS. Regular use of inhaled glucocorticosteroids allows in most cases to cancel oral GCS (patients who need to take no more than 15 mg of prednisolone can be fully switched to inhalation therapy), and in the first months after the transition, the patient's condition should be carefully monitored until his pituitary-adrenal the system will not recover sufficiently to provide an adequate response to stressful situations (for example, trauma, surgery or infection).
When transferring patients from receiving systemic GCS to inhalation therapy, allergic reactions (for example, allergic rhinitis, eczema), which were previously suppressed by systemic drugs, may appear.
Patients with a reduced function of the adrenal cortex, transferred to inhalation treatment, should have a stock of GCS and always carry a warning card, which should indicate that they need additional systemic appointment of SCS in stressful situations (after a stressful situation, the dose of GCS can be again reduce). Sudden and progressive worsening of asthma symptoms is a potentially dangerous condition, often life-threatening patients, and requires an increase in the dose of GCS. An indirect indicator of treatment failure is the use of short-acting b2-adrenostimulators more frequently than before.
Beclomethasone Aeronative is not intended for arresting seizures, but for regular daily use. For relief of attacks b2-adrenostimulators of short action (for example, salbutamol) are used. In case of severe exacerbation of bronchial asthma or insufficient effectiveness of the therapy, increase the dose of Beclomethasone Aeronative and, if necessary, prescribe a systemic SCS and / or an antibiotic for the development of infection.
With the development of paradoxical bronchospasm should immediately stop using Beclomethasone Aeronative, assess the patient's condition, conduct a survey and, if necessary, prescribe therapy with other medications. With long-term use of any inhaled glucocorticosteroids, especially at high doses, systemic effects can be noted (see "Side Effects"), but the likelihood of their development is significantly lower than when ingesting GCS inside. Therefore, it is especially important that, when the therapeutic effect is achieved, the dose of inhaled glucocorticosteroids is reduced to the lowest effective dose controlling the course of the disease. At a dose of 1500 mcg / day, the drug in most patients does not cause significant suppression of the adrenal glands. In connection with a possible adrenal insufficiency, one should be extra careful and regularly monitor the indices of the function of the adrenal cortex when transferring patients taking SCS inside for treatment with Beclomethasone Aeronative.
It is not recommended to abruptly cancel the drug Beclomethasone Aeronative.
Special care should be taken when treating inhaled GCS patients with active or inactive forms of pulmonary tuberculosis.
It is necessary to protect eyes from getting the drug. By washing after inhalation, it is possible to prevent damage to the skin of the eyelids and nose.
Balloon with Beclometasone-Aeronative can not be pierced, disassembled or thrown into the fire, even if it is empty. Like most other means for inhalation in aerosol packages, Beclometasone aeronautics may prove less effective at low temperatures. When cooling the can, it is recommended to remove it from the plastic case and warm it with your hands for several minutes. Features of the drug during its cancellation Because of the danger of developing an exacerbation, sudden abolition of Beclometasone Aeronative should be avoided. The dose of the drug should be reduced gradually under the supervision of a doctor. Influence on the ability to drive vehicles and manage mechanisms Beclometasone-Aeronative does not affect the ability to drive vehicles and control mechanisms.

Form of issue

Aerosol for inhalation dosed, 50 mcg / dose, 100 mcg / dose, 250 mcg / dose.
For 200 doses of the drug in an aluminum bottle with a spray dosing nozzle.
Each cylinder, together with the instruction for use, is placed in a pack of cardboard box.

Storage conditions

In the dark place at a temperature of no higher than 25 ° C, away from heating appliances. Do not freeze.
Keep out of the reach of children.
Shelf life - 2 years.
Do not use after the expiry date printed on the package.

Leave conditions

You can buy Beclometasone-Aeronative without a prescription.