Beclazone ECO Easi breathe (Aerosol) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Norton (Waterford) Limited T/A IVAX Pharmaceuticals Ireland T/A Teva Pharmaceuticals Ireland (Ireland)

Contact Information

TEVA (Israel)

ATC Code

R03BA01 (Beclometasone)

Active Substance

Beclometasone (Rec.INN registered by WHO)

Dosage Forms

	Beclazone ECO Easi breathe	Metered dose inhalation aerosol, breath-activated, 50 mcg/1 dose: canister 200 doses
		Metered dose inhalation aerosol, breath-activated, 100 mcg/1 dose: canister 200 doses
		Metered dose inhalation aerosol, breath-activated, 250 mcg/1 dose: canister 200 doses

Dosage Form, Packaging, and Composition

Metered dose inhalation aerosol, breath-activated, in the form of a solution, which when sprayed onto glass forms a colorless spot.

Excipients : hydrofluoroalkane (HFA-134a) – 75.86 mg, ethanol – 2.09 mg.

200 doses – aluminum canisters (1) – breath-activated aerosol inhalers (Easy Breath) (1) – cardboard packs.

Metered dose inhalation aerosol, breath-activated, in the form of a solution, which when sprayed onto glass forms a colorless spot.

Excipients : hydrofluoroalkane (HFA-134a) – 74.79 mg, ethanol – 3.11 mg.

200 doses – aluminum canisters (1) – breath-activated aerosol inhalers (Easy Breath) (1) – cardboard packs.

Metered dose inhalation aerosol, breath-activated, in the form of a solution, which when sprayed onto glass forms a colorless spot.

Excipients : hydrofluoroalkane (HFA-134a) – 71.75 mg, ethanol – 6 mg.

200 doses – aluminum canisters (1) – breath-activated aerosol inhalers (Easy Breath) (1) – cardboard packs.

Clinical-Pharmacological Group

Inhaled corticosteroids

Pharmacotherapeutic Group

Topical glucocorticosteroid

Pharmacological Action

Inhaled glucocorticosteroid. Beclometasone dipropionate is a prodrug and has low affinity for glucocorticosteroid receptors. Under the action of esterases, it is converted into an active metabolite – beclometasone-17-monopropionate (B-17-MP), which exerts a pronounced local anti-inflammatory effect. It reduces inflammation by decreasing the formation of chemotaxis substance (effect on “late” allergic reactions), inhibits the development of an immediate-type allergic reaction (due to inhibition of the production of arachidonic acid metabolites and reduction of 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, epithelial edema, mucus secretion by bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils, inflammatory exudate and lymphokine production are reduced, macrophage migration is inhibited, and the intensity of infiltration and granulation processes is reduced.

It increases the number of active β-adrenergic receptors, restores the patient’s response to bronchodilators, and allows reducing the frequency of their use. It has practically 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 beclometasone dipropionate.

Pharmacokinetics

Absorption

After inhalation, up to 56% of the drug dose is deposited in the lower respiratory tract; the remaining amount is deposited in the mouth, pharynx and is swallowed. In the lungs, before absorption, beclometasone dipropionate is intensively 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 entered here upon swallowing). The absolute bioavailability of unchanged beclometasone dipropionate and B-17-MP is about 2% and 62% of the inhalation dose, respectively. Beclometasone dipropionate is rapidly absorbed, C_max is reached in 0.3 h. B-17-MP is absorbed more slowly, C_max is reached in 1 h. An approximately linear relationship is noted between the increase in dose and the systemic exposure of the drug.

Distribution

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

Elimination

Beclometasone dipropionate and B-17-MP have high plasma clearance (150 L/h and 120 L/h, respectively). T_1/2 is 0.5 h and 2.7 h, respectively.

Indications

• Basic therapy of various forms of bronchial asthma in adults and children over 4 years of age.

ICD codes

Dosage Regimen

Beclazone ECO Easy Breath is intended for inhalation administration only.

Beclazone ECO Easy Breath is used regularly (even in the absence of disease symptoms), the dose of beclometasone dipropionate is selected taking into account the clinical effect in each specific case.

In mild bronchial asthma, forced expiratory volume (FEV₁) or peak expiratory flow (PEF) is more than 80% of predicted values with a PEF variability of less than 20%.

In moderate asthma, FEV₁ or PEF is 60-80% of predicted values, daily PEF variability is 20-30%.

In severe asthma, FEV₁ or PEF is 60% of predicted values, daily PEF variability is more than 30%.

When switching to a high dose of inhaled beclometasone dipropionate, many patients receiving systemic glucocorticosteroids can have their dose reduced or discontinued completely.

The initial dose of Beclazone ECO Easy Breath is determined by the severity of bronchial asthma. The daily dose is divided into several doses.

Depending on the individual patient response, the drug dose can be increased until a clinical effect appears or reduced to the minimum effective dose.

Adults and children aged 12 years and older recommended initial doses of the drug for mild bronchial asthma are 200-600 mcg/day; for moderate bronchial asthma – 600-1000 mcg/day; for severe bronchial asthma – 1000-2000 mcg/day.

Children aged 4 to 12 years the drug dose is up to 400 mcg/day in several doses.

There is no need to adjust the dose of Beclazone ECO Easy Breath in elderly individuals, in patients with renal or hepatic impairment.

In case of accidental missed inhalation the next dose should be taken at the scheduled time according to the treatment regimen.

Beclazone ECO Easy Breath with a content of 250 mcg of beclometasone per 1 dose is not intended for use in pediatrics.

Instructions for using the inhaler

Holding the inhaler upright, open the cap. Take a deep exhalation. Firmly grasp the mouthpiece with your lips. Make sure your hand does not cover the ventilation holes on the top of the inhaler, and the inhaler is in an upright position. Take a slow, maximum inhalation through the mouthpiece. Hold your breath for 10 seconds or as long as possible. Then remove the inhaler from your mouth and exhale slowly. After use, keep the inhaler in an upright position. Close the cap. If more than one inhalation is needed, close the cap, wait at least 1 minute, and then repeat the inhalation process.

Cleaning the inhaler

Unscrew the top part of the inhaler. Remove the metal canister. Rinse the lower part of the inhaler in warm water and dry. Insert the canister back into place. Close the cap and screw the top part of the inhaler onto its body. Do not wash the top part of the inhaler. If the inhaler is not working properly, unscrew its top part and manually press the canister.

Adverse Reactions

Local reactions possible candidiasis of the mouth and throat (the likelihood of developing candidiasis increases when using beclometasone dipropionate in doses exceeding 400 mcg/day), dysphonia (hoarseness) or irritation of the pharyngeal mucosa.

From the respiratory system paradoxical bronchospasm is possible, which must be immediately relieved with an inhaled short-acting beta₂-adrenergic agonist.

Allergic reactions possible rash, urticaria, itching, redness and swelling of the eyes, face, lips and mucous membrane of the mouth and pharynx.

Effects due to systemic action include headache, nausea, bruising or thinning of the skin, unpleasant taste sensations, decreased function of the adrenal cortex, osteoporosis, growth retardation in children and adolescents, cataract, glaucoma.

Contraindications

• Children under 4 years of age;
• Hypersensitivity to the components of the drug.

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

Use in Pregnancy and Lactation

Beclazone ECO Easy Breath should be used with particular caution during pregnancy and lactation and only if the potential benefit to the mother outweighs the possible risk to the fetus and child.

Use in Hepatic Impairment

There is no need to adjust the dose of Beclazone ECO Easy Breath in patients with hepatic impairment.

Use with caution in liver cirrhosis.

Use in Renal Impairment

There is no need to adjust the dose of Beclazone ECO Easy Breath in patients with renal impairment.

Pediatric Use

Contraindication: children under 4 years of age. Children aged 4 to 12 years the drug dose is up to 400 mcg/day in several doses.

Special Precautions

Before prescribing inhaled glucocorticosteroids, the patient must be instructed on the rules of their use, ensuring the most complete delivery of the drug to the required areas 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 a previous fungal infection. After inhalation, the mouth and throat should be rinsed with water. For the treatment of candidiasis, topical antifungal drugs can be used while continuing therapy with Beclazone ECO Easy Breath.

If patients are taking oral glucocorticosteroids, then Beclazone ECO Easy Breath is prescribed against the background of the previous dose of glucocorticosteroids, while patients should be in a relatively stable condition. After about 1-2 weeks, the daily dose of the oral glucocorticosteroid begins to be gradually reduced. The dose reduction scheme depends on the duration of prior therapy and the initial dose of the glucocorticosteroid. Regular use of inhaled glucocorticosteroids allows in most cases to discontinue oral glucocorticosteroids (patients requiring no more than 15 mg of prednisolone can be completely switched to inhalation therapy), while in the first months after the switch, the patient’s condition should be carefully monitored until their pituitary-adrenal system recovers sufficiently to provide an adequate response to stressful situations (e.g., trauma, surgery, or infection).

When transferring patients from systemic glucocorticosteroids to inhalation therapy, allergic reactions (e.g., allergic rhinitis, eczema) that were previously suppressed by systemic drugs may manifest.

Patients with reduced adrenal cortex function, transferred to inhalation treatment, should have a supply of glucocorticosteroids and always carry a warning card, which should indicate that they need additional systemic administration of glucocorticosteroids in stressful situations (after the stressful situation is eliminated, the dose of glucocorticosteroids can be reduced again). Sudden and progressive worsening of asthma symptoms is a potentially dangerous condition, often life-threatening for patients, and requires an increase in the dose of glucocorticosteroids. An indirect indicator of therapy ineffectiveness is more frequent use of short-acting beta₂-adrenergic agonists than before.

Beclazone ECO Easy Breath is intended not for relieving attacks, but for regular daily use. For relieving attacks, short-acting beta₂-adrenergic agonists (e.g., salbutamol) are used. In case of severe exacerbation of bronchial asthma or insufficient effectiveness of the therapy, the dose of Beclazone ECO Easy Breath should be increased and, if necessary, a systemic glucocorticosteroid and/or antibiotic should be prescribed in case of infection development.

If paradoxical bronchospasm develops, the use of Beclazone ECO Easy Breath should be stopped immediately, the patient’s condition should be assessed, an examination should be conducted and, if necessary, therapy with other medications should be prescribed.

With long-term use of any inhaled glucocorticosteroids, especially in high doses, systemic effects may be noted, but the likelihood of their development is significantly lower than with oral glucocorticosteroids. Therefore, it is especially important that after achieving a therapeutic effect, the dose of inhaled glucocorticosteroids is reduced to the minimum effective dose that controls the course of the disease. At a dose of 1500 mcg/day, the drug does not cause significant suppression of adrenal functions in most patients. Due to the possible development of adrenal insufficiency, particular caution should be exercised and indicators of adrenal cortex function should be regularly monitored when transferring patients taking oral glucocorticosteroids to treatment with Beclazone ECO Easy Breath.

Abrupt withdrawal of Beclazone ECO Easy Breath is not recommended.

Particular caution should be exercised when treating patients with active or inactive forms of pulmonary tuberculosis with inhaled glucocorticosteroids.

It is necessary to protect the eyes from getting the drug. Washing the face after inhalation can prevent damage to the skin of the eyelids and nose.

The Beclazone ECO Easy Breath canister must not be punctured, disassembled or thrown into fire, even if it is empty. Like most other inhalation agents in aerosol packaging, Beclazone ECO Easy Breath may be less effective at low temperatures. If the canister is cooled, it is recommended to remove it from the plastic case and warm it with hands for several minutes.

Use in pediatrics

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

Overdose

Acute overdose may lead to temporary reduction of adrenal cortex function, which does not require emergency therapy, because the adrenal cortex function recovers within a few days, as confirmed 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 beclometasone dipropionate can be continued at doses sufficient to maintain the therapeutic effect.

Drug Interactions

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

Storage Conditions

The drug should be stored out of the reach of children, protected from direct sunlight, at a temperature not exceeding 25°C (77°F); do not freeze.

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.