Beclazonee Eco, inhalation aerosol 50 µg/dose 200 doses

Composition

1 dose of aerosol contains:

• Active ingredients
  • Beclomethasone dipropionate 50 mcg.

• Auxiliary substances

  Ethanol, hydrofluoroalkane (HFA-134a).

Pharmacological action

CORTICOSTEROIDS for inhalation use. It has an anti-inflammatory and anti-allergic effect.

It inhibits the release of inflammatory mediators, increases the production of lipomodulin, a phospholipase A inhibitor, reduces the release of arachidonic acid, and inhibits prostaglandin synthesis. Prevents the marginal accumulation of neutrophils, reducing the formation of inflammatory exudate and the production of lymphokines, inhibits the migration of macrophages, which leads to a slowdown in the processes of infiltration and granulation.

Increases the number of active beta-adrenergic receptors, neutralizes their desensitization, restores the patient’s response to bronchodilators, allowing to reduce the frequency of their use.

Under the influence of Beclomethasone, the number of mast cells in the bronchial mucosa decreases, epithelial edema and mucus secretion by the bronchial glands decreases. Causes relaxation of the smooth muscles of the bronchi, reduces their hyperreactivity and improves the function of external respiration.

It does not have mineralocorticoid activity.

In therapeutic doses, it does not cause side effects characteristic of systemic corticosteroids.

When applied intranasally, it eliminates edema, hyperemia of the nasal mucosa.

The therapeutic effect usually develops after 5-7 days of a course of Beclomethasone use.

When applied externally and topically, it has an anti-allergic and anti-inflammatory effect.

Indications

For inhalation use: treatment of bronchial asthma (including those with insufficient effectiveness of bronchodilators and / or sodium cromoglycate, as well as hormone-dependent bronchial asthma of severe course in adults and children).

For intranasal use: prevention and treatment of year-round and seasonal allergic rhinitis, including hay fever rhinitis, vasomotor rhinitis.

For external and topical use: in combination with antimicrobial agents-infectious and inflammatory diseases of the skin and ear.

Use during pregnancy and lactation

Contraindicated in the first trimester of pregnancy.

Use in the second and third trimesters of pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus. Newborns whose mothers received Beclomethasone during pregnancy should be carefully evaluated for adrenal insufficiency.

If it is necessary to use during lactation, the question of stopping breastfeeding should be decided.

Contraindications

Hypersensitivity to the components of the drug.

With caution:

-glaucoma;

– systemic infections (bacterial, viral, fungal, parasitic);

– osteoporosis;

– pulmonary tuberculosis;

– liver tyrrhosis;

– hypothyroidism;

– pregnancy;

– lactation.

Side effects

Respiratory system disorders:  hoarseness, irritation in the throat, sneezing; rarely-cough; in isolated cases-eosinophilic pneumonia, paradoxical bronchospasm, with intranasal use – perforation of the nasal septum. Candidiasis of the oral cavity and upper respiratory tract is possible, especially with prolonged use, passing with local antifungal therapy without stopping treatment.

Allergic reactions:  rash, hives, pruritus, erythema, and swelling of the eyes, face, lips, and larynx.

Effects due to systemic action:  reduced adrenal cortex function, osteoporosis, cataracts, glaucoma, growth retardation in children.

Interaction

Concomitant use of Beclomethasone with other corticosteroids for systemic or intranasal use may increase suppression of the adrenal cortex. Previous inhaled use of beta-adrenostimulants may increase the clinical efficacy of Beclomethasone.

How to take, course of use and dosage

Beclazoneee Ivf is intended for inhalation use only.

Beclazoneee Ivf is used regularly (even in the absence of symptoms of the disease), the dose of Beclomethasone dipropionate is selected taking into account the clinical effect in each specific case:

• In the mild course of bronchial asthma, forced expiratory volume (FEV) or peak expiratory velocity (PSV) is more than 80% of the required values with a spread of PSV indicators of less than 20%.
• With a moderate course of FEV or PSV is 60-80% of the proper values, the daily spread of PSV indicators is 20-30%.
• In severe cases, FEV or PSV make up 60% of the required values, and the daily spread of PSV indicators is more than 30%.

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.

The initial dose of Beclazoneee Ivf is determined by the severity of bronchial asthma.

The daily dose is divided into several doses. Depending on the individual response of the patient, the dose of the drug can be increased until the clinical effect appears or reduced to a minimum of 1 effective dose.

Adults and children aged 12 years and older:

• Recommended starting doses of the drug
  • Mild bronchial asthma – 200-600 mcg/day.
  • Moderate bronchial asthma-600-1000 mcg/day.
  • Severe bronchial asthma – 1000-2000 mcg/day.

• Treatment of bronchial asthma

  Treatment of bronchial asthma is based on a step – by-step approach-therapy begins according to the stage corresponding to the severity of the disease.

  Inhaled corticosteroids are prescribed at the second stage of therapy.

  • Step 2. Basic therapy

    Beclomethasone dipropionate 100-400 mcg 2 times a day.

  • Step 3. Basic therapy

    Use inhaled corticosteroids in a high dose or in a standard dose, but in combination with inhaled antagonists of long-acting beta-2 adrenergic receptors. Beclomethasone dipropionate in a high dose – 800-1600 mcg / day, in some cases mega doses up to 2000 mcg/day.

  • Stage 4. Severe asthma

    Beclomethasone dipropionate in a high dose of 800-1600 mcg / day, in some cases mega doses up to 2000 mcg/ day.

  • Step 5. Severe asthma

    High-dose Beclomethasone dipropionate (see step 3,4).

    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 Beclazoneee Ivf in the elderly, in patients with renal or hepatic insufficiency.

• Skipping a single dose of the drug

  If you accidentally miss an inhalation, the next dose should be taken at the appropriate time in accordance with the treatment regimen.

• Instructions for using the nebulizer without an optimizer
• Shake the inhaler several times.
• Then, holding the inhaler in an upright position, open the lid, take a deep exhalation.
• Cover the mouthpiece tightly with your lips.
• Make sure that your hand is not blocking the air vents, and that you are holding the inhaler in an upright position.
• Take a slow maximum breath through the mouthpiece.
• Hold your breath for 10 seconds or as long as you feel comfortable.
• Then remove the inhaler from your mouth and exhale slowly.
• After use, keep the inhaler in an upright position and close the lid.
• If you need to do more than one inhalation, close the lid, wait at least one minute, and then repeat the process.

• Instructions for using the nebulizer with optimizer
• Shake the inhaler vigorously.
• Then, while holding the inhaler in an upright position, open the lid and place the optimizer firmly on the mouthpiece of the inhaler.
• Take a deep breath out.
• Wrap your lips tightly around the optimizer mouthpiece.
• Make sure that your hand is not blocking the air vents, and that you are holding the inhaler in an upright position.
• Take a slow maximum breath through the mouthpiece of the optimizer.
• Hold your breath for 10 seconds or as long as you feel comfortable.
• Then remove the inhaler from your mouth and exhale slowly.
• After use, continue to hold the inhaler in an upright position. Close the lid.
• If you need to do more than one inhalation, close the lid, wait at least one minute, and then repeat the process.

• Cleaning the inhaler
• Unscrew the top of the inhaler.
• Remove the metal canister (do not put it in water).
• Rinse the body of the inhaler in warm water and dry it.
• Replace the canister.
• Close the lid and screw the top of the inhaler to the body.
• Do not wash the top of the inhaler.
• If the inhaler does not work properly, unscrew the top of the inhaler and manually press the canister.

Overdose

Acute overdose

• Symptoms: temporary decrease in the function of the adrenal cortex.
• Treatment: no emergency therapy is required, as the function of the adrenal cortex is restored within a few days, which is confirmed by the level of cortisol in plasma.

Chronic overdose

• Symptoms: persistent suppression of the adrenal cortex may occur.
• Treatment: it is recommended to monitor the reserve function of the adrenal cortex.

In case of overdose, treatment with Beclomethasone dipropionate can be continued in doses sufficient to maintain the therapeutic effect.

Special instructions

Beclomethasone is not intended for the relief of acute asthmatic attacks. It should also not be used for severe asthma attacks that require intensive care. The recommended route of use for the dosage form used should be strictly followed.

Beclomethasone should be used with extreme caution and under the close supervision of a doctor in patients with adrenal insufficiency.

Transfer of patients who are constantly taking corticosteroids inside, to inhaled forms can be made only in a stable condition.

If paradoxical bronchospasm is likely to develop, bronchodilators (for example, salbutamol) are inhaled 10-15 minutes before the introduction of Beclomethasone.

If candidiasis of the oral cavity and upper respiratory tract develops, local antifungal therapy is indicated without stopping treatment with Beclomethasone. Infectious and inflammatory diseases of the nasal cavity and paranasal sinuses with the appointment of appropriate therapy are not a contraindication for treatment with Beclomethasone.

Preparations for inhalation use containing 250 mcg of Beclomethasone in 1 dose are not intended for children under 12 years of age.

Form of production

Metered-dose aerosol for inhalation.

Storage conditions

Store in a dark place at a temperature not exceeding 30 °C (do not freeze or heat). Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Beclomethasone

Conditions of release from pharmacies

By prescription

Dosage form

aerosol for inhalation

Purpose

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

Chronic obstructive pulmonary disease, Bronchial asthma