Beclazon Eco Easy Breath, aerosol 250 mcg/dose 200 doses

Pharmacotherapeutic group: glucocorticosteroid (GCS) for topical use

ATX code: R03BA01

Pharmacological properties

Pharmacodynamics<

Beclomethasone dipropionate is a prodrug and has weak tropicity to GCS receptors. Under the action of esterases it is converted into the active metabolite – beclomethasone-17-monopropionate (B-17-MP), which has a pronounced local anti-inflammatory effect. It reduces inflammation by reducing the formation of chemotaxis substance (effect on “late” allergy reactions), inhibits the development of an “immediate” allergic reaction (due to inhibition of production of arachidonic acid metabolites and reducing the release of inflammatory mediators from mast cells) and improves mucociliary transport. Beclomethasone reduces the number of mast cells in the bronchial mucosa, decreases epithelial edema, mucus secretion by bronchial glands, bronchial hyperresponsiveness, marginal accumulation of neutrophils, inflammatory exudate and lymphokine production, inhibits macrophage migration, reduces the intensity of infiltration and granulation. It increases the number of active beta-adrenoreceptors, restores the patient’s response to bronchodilators, allows reducing the frequency of their use. It practically has no resorptive effect after inhalation administration.

It does not relieve bronchospasm; the therapeutic effect develops gradually, usually after 5-7 days of course use of beclomethasone dipropionate.

Pharmacokinetics

Absorption. Up to 56% of the inhaled dose is deposited in the lower respiratory tract; the remaining amount is deposited in the mouth, pharynx, and swallowed. In the lungs, beclomethasone dipropionate is extensively metabolized to the active metabolite B-17-MP prior to absorption. Systemic absorption of B-17-MP occurs in the lungs (36% of the pulmonary fraction) and in the gastrointestinal tract (26% of the ingested dose). 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; time to reach maximum plasma concentration (Tmax) is 0.3 h. B-17-MP is absorbed more slowly, Tmax is 1 h. There is an approximately linear relationship between the increase in inhaled dose and systemic exposure to the drug.

Distribution. Tissue distribution is 20 L for beclomethasone dipropionate and 424 L for B-17-MP. The binding to plasma proteins is relatively high at 87%.

Elimination. Beclomethasone dipropionate and B-17-MP have high plasma clearance (150 l/h and 120 l/h, respectively). The elimination half-life is 0.5 h and 2.7 h, respectively.

Indications

Bronchial asthma, Chronic obstructive pulmonary diseaseBasic therapy for various forms of bronchial asthma in adults and children over 4 years.

Active ingredient

Beclomethasone

Composition

1 dose of the drug contains the active ingredient beclomethasone dipropionate 50.00 µg/100.00 µg/250.00 µg; excipients: hydrofluralcane (HFA-134a) 75.86 mg/74.79 mg/71.75 mg, ethanol 2.09 mg/3.11 mg/6.00 mg

How to take, the dosage

Beclazon Eco Lung Breath is intended for inhalation administration only.

Beclazon Eco Lung Breath is used regularly (even in the absence of symptoms), the dose of beclomethasone dipropionate is selected according to the clinical effect in each case.

In mild bronchial asthma, the forced expiratory volume (EVP₁) or peak expiratory flow (PEF) is greater than 80% of appropriate values with a PEF variation of less than 20%.

In a moderate course, the PEF₁ or PSV is 60-80% of the proper values, the daily variation of PSV is 20-30%.

In a severe course, the BEF₁ or PSV is 60% of the proper values, the daily variation of PSV is more than 30%.

When switching to high-dose inhaled beclomethasone dipropionate, many patients who receive systemic GCS will be able to reduce their dose or stop it altogether.

The starting dose of Beclazon Eco Lung Breath is determined by the severity of bronchial asthma. The daily dose is divided into several doses.

Depending on the patient’s individual response, the dose of the drug may be increased until clinical effect occurs or decreased to the lowest effective dose.

Adults and children 12 years of age and older

The recommended starting doses of the drug:

• Mild bronchial asthma – 200 to 600 mcg/day;
• Moderate bronchial asthma – 600 to 1000 mcg/day;
• Severe bronchial asthma – 1000 to 2000 mcg/day.

Children aged 4 to 12 years

Up to 400 mcg per day in several doses.

Special patient groups

There is no need to adjust the dose of Beclazon Eco Lung Breath in the elderly or in patients with renal or hepatic impairment.

Missing one dose of the drug

If you accidentally miss an inhalation, the next dose should be taken at the proper time according to the treatment regimen.

Beclazon Eco Lung Breath, containing 250 micrograms in 1 dose, is not intended for pediatric use.

Interaction

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

Special Instructions

Before inhaled medications are administered, the patient should be instructed on how to administer them to ensure that the medication reaches the correct areas of the lungs as completely as possible. Oral candidiasis is most likely to occur in patients with high levels of pre-precipitated antibodies against Candida fungus, indicating a previous fungal infection. Rinse the mouth and throat with water after inhalation. For the treatment of candidiasis, topical antifungal drugs can be used while continuing therapy with Beclazon Eco Easy Breath.

If patients are taking oral GCS, then Beclazon Eco Easy Breath is prescribed against the previous dose of GCS, and patients should be in a relatively stable condition. After about 1-2 weeks, the daily dose of oral GCS is gradually reduced. The scheme of dose reduction depends on the duration of previous therapy and the initial dose of GCS. Regular use of inhaled GCS allows in most cases to discontinue oral GCS (patients requiring no more than 15 mg prednisolone can be fully switched to inhaled therapy), however, in the first months after transfer the patient’s condition should be carefully monitored until the pituitary-adrenal system has sufficiently recovered to ensure an adequate response to stressful situations (e.g., trauma, surgery or infection).

If patients are switched from systemic GCS to inhaled therapy, allergic reactions (e.g., allergic rhinitis, eczema) that were previously suppressed by systemic medications may occur.
Patients with decreased adrenal cortex function transferred to inhaled treatment should have a supply of GCS and always carry a warning card stating that they need additional systemic GCS administration in stressful situations (once the stressful situation is resolved, the GCS dose can be reduced again). Sudden and progressive worsening of asthma symptoms is a potentially dangerous condition, often life-threatening, and requires increasing the dose of GCS. Indirect indicator of ineffectiveness of therapy is more frequent use of short-acting b-2-adrenergic stimulants than before.
Beclazon Eco Easy Breath is not intended for relief of attacks, but for regular daily use. Short-acting b-2-adreno stimulants (e.g. salbutamol) are used to stop attacks. In severe exacerbation of bronchial asthma or ineffectiveness of current therapy, the dose of Beclazon Eco Lung Breath should be increased and if necessary, a systemic GCS and/or antibiotic should be prescribed if infection develops.
If paradoxical bronchospasm occurs, Beclazon Eco Lung Breath should be stopped immediately, the patient’s condition should be evaluated, an examination should be performed and if necessary, therapy with other medicines should be appointed. During long-term use of any inhaled GCS, especially in high doses, systemic effects may be noted (see “Side effects”), however, the probability of their development is much lower than when GCS are taken orally. Therefore, it is especially important that the dose of inhaled GCS be reduced to the lowest effective dose to control the course of the disease when therapeutic effect is achieved. At a dose of 1500 mcg/day, the drug does not cause significant suppression of adrenal function in most patients. Due to possible adrenal insufficiency, special caution should be exercised and adrenal function parameters should be regularly monitored when transferring patients receiving oral GCS to Beclazon Eco Lung Breath.
It is recommended to monitor regularly the growth dynamics of children receiving inhaled GCS for a long time.
Abrupt withdrawal of Beclazon Eco Lung Breath is not recommended.
Special caution should be exercised during inhaled GCS treatment of patients with active or inactive forms of pulmonary tuberculosis.
The eyes should be protected against contact with the drug. Washing after inhalation may prevent damage to the skin of the eyelids and nose.
The bottle with Beclazon Eco Lung Breath must not be pierced, disassembled or thrown into the fire, even if it is empty. Like most other aerosol-packed inhalation products, Beclazon Eco Lung Breath may be less effective at low temperatures. When the canister cools, it is recommended that you take it out of the plastic case and warm it up with your hands for a few minutes.
Instructions for the patient to use the inhaler
Hold the inhaler upright, open the lid. Take a deep exhalation. Wrap your lips tightly around the mouthpiece. Make sure that your hand is not blocking the ventilation holes on top of the inhaler and that you are holding the inhaler upright. Take a slow maximum breath through the mouthpiece. Hold your breath for 10 seconds or as long as you are comfortable. Then remove the inhaler from your mouth and exhale slowly. Continue to hold the inhaler upright after application. Close the lid. If you need more than one inhalation, close the lid, wait at least one minute and then repeat the inhalation.

Clean the inhaler
Unscrew the top part of the inhaler.
Pull out the metal bottle.
Rinse the bottom part in warm water and dry. Reinsert the balloon. Close the lid and screw the top of the inhaler to the body of the inhaler. Do not wash the top of the inhaler. If the inhaler is not working properly, unscrew the top of the inhaler and manually press on the cylinder.

Synopsis

Aerosol for inhalation in a pressurized aluminum can with a discharge valve and atomizer. Must be free of external damage, corrosion and leaks. The contents of the cylinder is a solution which leaves a colorless stain when sprayed on glass. The cylinder is placed in an inhaler consisting of two parts and a safety cap.

Contraindications

High sensitivity to any component of the drug. Children under 4 years of age.

With caution use in glaucoma, systemic infections (bacterial, viral, fungal, parasitic), osteoporosis, pulmonary tuberculosis, liver cirrhosis, hypothyroidism, pregnancy, lactation.

Side effects

Some patients may develop candidiasis of the mouth and throat (the likelihood of candidiasis increases with the use of beclomethasone dipropionate in doses greater than 400 mcg per day).

In some patients there may be dysphonia (hoarseness of voice) or pharyngeal irritation.

The inhaled drugs may cause paradoxical bronchospasm, which must be immediately managed with a short-acting inhaled b-2-adrenergic stimulator.

There have been isolated reports of hypersensitivity reactions, including rash, urticaria, itching, redness and swelling of the eyes, face, lips and oral mucosa, and pharynx.

Possible systemic effects common with GKS include headache, nausea, bruising or thinning of the skin, unpleasant taste, decreased adrenal function, osteoporosis, growth retardation in children and adolescents, cataracts, and glaucoma.

Overdose

Acute overdose of the drug may lead to a temporary decrease in adrenal cortex function, which does not require emergency therapy, since the adrenal cortex function recovers within a few days, as evidenced by the plasma cortisol level. In chronic overdose, persistent suppression of adrenal cortex function may be noted. In such cases, it is recommended to monitor the reserve function of the adrenal cortex. In case of overdose, treatment with beclomethasone dipropionate may be continued in doses sufficient to maintain the therapeutic effect.

Pregnancy use

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

Similarities

Beclomethasone Eco, Beclomethasone, Beclomethasone-Aeronative