Beclomethasone, aerosol 100 mcg/dose 200 doses

Beclomethasone dipropionate is a prodrug and has weak tropicity to GCS receptors‑. ‑

It is converted under the action of esterases to the active metabolite – beclomethasone17-monopropionate ‑(B-17-MP), which has a pronounced local anti-inflammatory effect.

It reduces inflammation due to decrease in formation of chemotaxis substance (effect on “late” allergic reactions), inhibits development of “immediate” allergic reaction (conditioned by inhibition of production of arachidonic acid ‑metabolites and decrease in release of inflammatory mediators from mast cells) and improves mucociliary transport.

Beclomethasone decreases the number of mast cells in the bronchial mucosa, decreases edema of epithelium, mucus secretion by bronchial glands, bronchial hyperresponsiveness, edge accumulation of neutrophils, inflammatory exudate and lymphokine production, decreases the migration of macrophages and the intensity of infiltration and granulation.

It increases the number of active beta-adrenoreceptors, restores the patient’s response to bronchodilators and allows to reduce the frequency of their use. It has practically no resorptive action after inhalation administration.

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

Indications

Active ingredient

Composition

1 dose of the drug contains:

The active ingredient:

Beclomethasone dipropionate – 0.1 mg

(in terms of 100% substance)

Excipients:

Ethanol 96% 4.2 mg,

Norflurane (tetrafluoroethane) 84.0 mg.

How to take, the dosage

Beclomethasone is for inhaled use only.

Beclomethasone is used regularly (even in the absence of symptoms), and the dose of beclomethasone dipropionate is adjusted for the clinical effect in each case.

In mild bronchial asthma, the inspiratory forced expiratory volume (PEF) 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 PEF or PSV is 60-80% of the proper values, the daily variation of PSV is 20-30%.

In a severe course the ROS 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 receiving systemic glucocorticosteroids will be able to reduce their dose, to stop them altogether.

The starting dose of Beclomethasone 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 may be increased until clinical effect occurs or decreased to the lowest effective dose.

Children aged 4 to 12 years

The starting dose is 50 mcg 2 times daily. If necessary, the initial dose can be increased to 100 mcg 2 times a day. The maximum single dose is 200 mcg.

The maximum daily dose is 400 mcg. The daily dose is divided into 2 to 4 doses.

Adults and children 12 years of age and older:

The recommended starting dose of the drug:

– mild bronchial asthma, 200-600 mcg/day;

– moderate to severe bronchial asthma, 600-1000 mcg/day;

– severe bronchial asthma, 1000-2000 mcg/day.

The treatment of bronchial asthma is based on a step-by-step approach – therapy is started according to the step corresponding to the severity of the disease.

Inhaled GCSs are prescribed in the second step of therapy.

Stage 2. Baseline therapy.

Beclomethasone dipropionate 100-400 mcg 2 times a day.

Stage 3. Baseline therapy.

The use of high-dose inhaled GCS or standard dose, but in combination with long-acting inhaled β2-adrenomimetics.

Beclomethasone dipropionate in high dose – 800-1600 mcg/day, in some cases megadoses up to 2000 mcg/day.

Stage 4. Severe asthma.

Beclomethasone dipropionate in high dose – 800-1600 mcg/day, in some cases megadoses up to 2000 mcg/day.

Stage 5: Severe asthma.

Beclomethasone dipropionate in high dose (see steps 3 and 4).

Particular patient groups

There is no need to adjust the dose of Beclomethasone in the elderly or in patients with renal or hepatic impairment.

Missing a dose of the drug

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

Interaction

Beclomethasone restores the patient’s response to beta-adrenomimetics, allowing the frequency of their use to be reduced.

When coadministered with microsomal oxidation inducers (including phenobarbital, phenytoin, rifampicin, etc.), the effectiveness of beclomethasone may decrease.

Concomitant use with methandienone, estrogens, beta2-adrenomimetics, theophylline, and systemic GCS increases the effectiveness of beclomethasone.

Concomitant use of beclomethasone increases the effect of beta-adrenomimetics.

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.

The development of oral candidiasis is most likely in patients with high levels of precipitating antibodies against Candida fungus in the blood, indicating a previous fungal infection. Rinse the mouth and throat with water after inhalation. Topical antifungal medications may be used to treat candidiasis while continuing therapy with Beclomethasone.

If patients are taking oral GCS, Beclomethasone should be given with 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.

The regular use of inhaled GCS allows discontinuation of oral GCS in most cases (patients who do not require more than 15 mg of prednisolone may be fully switched to inhaled therapy).

In this case, for the first few months after transition, the patient’s pituitary-adrenal system should be closely monitored until the patient has recovered sufficiently to allow an adequate response to stressful situations (e.g., trauma, surgery, or infection).

If patients switch 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 who are 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 (the GCS dose can be reduced again once the stressful situation is resolved).

The sudden and progressive worsening of asthma symptoms is a potentially dangerous condition, not infrequently life-threatening, and requires an increase in the dose of GCS. An indirect indicator of ineffective therapy is more frequent use of short-acting β2-adrenergic stimulants than before.

Beclomethasone dipropionate for inhalation is not intended for seizure control but for regular daily use. Short-acting β2adrenergic stimulants (e.g., salbutamol) are used to stop attacks.

In severe exacerbations of bronchial asthma or if the current therapy is not effective, the dose of inhaled beclomethasone dipropionate should be increased and if necessary a systemic GCS and antibiotic should be prescribed if infection develops.

If paradoxical bronchospasm develops, Beclomethasone should be discontinued immediately, the patient’s condition should be evaluated, an examination should be performed, and if necessary, therapy with other medications should be prescribed. With long-term use of any inhaled GCS, especially in high doses, systemic effects may occur (see “Side effects”), but the probability of their development is significantly lower than with oral GCS.

Hence, 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 the 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 taking oral GCS to beclomethasone treatment.

We recommend regular monitoring of growth in children who receive inhaled GCS for prolonged periods of time.

Injection can be done with special dispensers (spacers) to improve distribution of the medication in the lungs and decrease the risk of side effects.

Harsh withdrawal of Beclomethasone Aerosol is not recommended.

The eyes should be protected from contact with the drug. Washing after inhalation may prevent damage to the skin of the eyelids and nose.

A Beclomethasone bottle must not be punctured, disassembled, or thrown into a fire, even if it is empty. Like most other aerosol-packed inhalers, Beclomethasone may be less effective at low temperatures.

If the cylinder gets cold, it is recommended that you remove the inhaler nozzle and warm it up with your hands for a few minutes.

Information on the possible effect of the drug on the ability to drive vehicles, machinery

No data.

Contraindications

Hypersensitivity to any component of the drug.

Pulmonary tuberculosis.

Children under 4 years of age. Beclomethasone containing 250 micrograms in 1 dose is not intended for pediatric use (i.e., in children under 18 years of age).

With caution

Perhaps use in glaucoma, systemic infections (bacterial, viral, fungal, parasitic), osteoporosis, liver cirrhosis, hypothyroidism, pregnancy, lactation.

Side effects

Unwanted reactions are listed according to anatomophysiological classification and frequency of occurrence. The frequency of occurrence is defined as follows: very common ≥1/10, common ≥1/100 and <1/10, infrequent ≥1/1000 and <1/100, rare ≥1/10000 and <1/1000 and very rare <1/10000.

Infections: very common: oral and pharyngeal candidiasis. Using a spacer and rinsing the mouth and throat with water after inhalation reduces the chance of these side effects.

Immune system disorders: infrequent – skin hypersensitivity reactions, including rash, urticaria, itching, redness and swelling of the eyes, face, lips, and mucous membranes of the mouth and throat; very rare – angioedema, anaphylactic reactions.

Endocrine system disorders: systemic effects are possible: very rare – inhibition of adrenal cortex function, stunted growth in children and adolescents, cataracts, glaucoma.

Respiratory system disorders: frequently dysphonia (hoarseness of voice) or pharyngeal mucosa irritation, very rarely – paradoxical bronchospasm, which must be immediately treated with inhaled β2-adrenergic stimulator of short action. In case of paradoxical bronchospasm, the use of the drug in inhalation should be stopped immediately, the patient’s condition should be evaluated, the necessary examination should be performed, and the necessary treatment should be prescribed.

Skin and subcutaneous fat: often – bruising, thinning of the skin.

Overdose

Pregnancy use

Similarities