Description
Latin name
BECLAZONE ECO
Release form
Dosage inhalation aerosol.
Packaging
In an aluminum can with an inhalation device 200 doses. In a plastic case 1 cylinder.
Pharmacological action of
GCS for inhalation use. It has anti-inflammatory and anti-allergic effects.
Inhibits the release of inflammatory mediators, increases the production of lipomodulin – an inhibitor of phospholipase A, reduces the release of arachidonic acid, inhibits the synthesis of prostaglandins. Prevents 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 -adrenoreceptors, neutralizes their desensitization, restores the patient’s reaction to bronchodilators, allowing to reduce the frequency of their use.
Under the action of beclomethasone, the number of mast cells in the bronchial mucosa decreases, edema of the epithelium and mucus secretion by the bronchial glands decrease. It causes relaxation of the smooth muscles of the bronchi, reduces their hyperreactivity and improves external respiration function.
Does not have mineralocorticoid activity.
In therapeutic doses, does not cause side effects, characteristic of systemic corticosteroids.
With intranasal use, it eliminates edema, hyperemia of the nasal mucosa.
The therapeutic effect usually develops after 5-7 days of course use of beclomethasone.
When applied topically and locally, it has anti-allergic and anti-inflammatory effects.
Indications
For inhalation use: treatment of bronchial asthma (including with insufficient effectiveness of bronchodilators and / or cromolyn sodium, as well as severe hormone-dependent bronchial asthma in adults and children).
For intranasal use: prevention and treatment of perennial and seasonal allergic rhinitis, including rhinitis with hay fever, vasomotor rhinitis.
For external and local 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 only possible if the intended benefit to the mother outweighs the potential risk to the fetus. Newborns whose mothers received beclomethasone during pregnancy should be carefully monitored for adrenal insufficiency.
If necessary, use during lactation should decide on the termination of breastfeeding.
Composition
1 dose of aerosol contains:
Active ingredients – beclomethasone dipropionate 100 mcg.
Excipients – ethanol, hydrofluoroalkane (HFA-134a).
Dosage and Administration
Beclazone Eco is for inhalation only.
Beklazone Eco is used regularly (even in the absence of disease symptoms), the dose of beclomethasone dipropionate is selected taking into account the clinical effect in each case:
For mild cases of bronchial asthma, forced expiratory volume (FEV) or peak expiratory flow rate (PSV) is more than 80% of due values with a spread of PSV indicators of less than 20%.
In the moderate course of FEV or PSV, it is 60-80% of the proper values, the daily spread of PSV indicators is 20-30%.
In severe course of FEV or PSV, they account for 60% of the proper values, 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 Beclazone Eco 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 a clinical effect appears or reduced to a minimum of 1 effective dose.
Adults and children 12 years of age and older:
Recommended starting doses of the drug Mild bronchial asthma – 200-600 mcg / day.
Bronchial asthma of moderate severity – 600-1000 mcg / day.
Severe bronchial asthma – 1000-2000 mcg / day.
Treatment of bronchial asthma
Treatment of bronchial asthma is based on a stepwise approach – therapy is started according to the stage corresponding to the severity of the disease.
Inhaled corticosteroids are prescribed in the second stage of therapy.
Stage 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 long-acting beta-2 adrenoreceptor antagonists. Beclomethasone dipropionate in a high dose is 800-1600 mcg / day, in some cases mega doses up to 2000 mcg / day.
Step 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
Beclomethasone dipropionate in high dose (see step 3.4).
Children aged 4 to 12 years to 400 mcg per day in several doses.
Special patient groups
There is no need to adjust the dose of Beclazone Eco in the elderly, in patients with renal or liver failure.
Skipping one dose of
If you accidentally skip inhalation, take the next dose at the right time in accordance with the treatment regimen.
Inhaler Instructions Without Optimizer Shake the inhaler several times.
Then, holding the inhaler in an upright position, open the cover, take a deep breath.
Grasp the mouthpiece tightly with your lips.
Make sure that your hand does not block the ventilation openings and that you are holding the inhaler upright.
Take a slow maximum breath through the mouthpiece.
Hold your breath for 10 seconds or as much as you feel comfortable.
Then remove the inhaler from the oral cavity and exhale slowly.
After use, keep the inhaler upright and close the cap.
If you need to do more than one inhalation, close the lid, wait at least one minute, and then repeat the process.
Inhaler Instructions for Use with the Optimizer Shake the inhaler vigorously.
Then, holding the inhaler in an upright position, open the lid, push the optimizer firmly onto the mouthpiece of the inhaler.
Take a deep breath.
Grasp the mouthpiece of the optimizer tightly with your lips.
Make sure that your hand does not block the ventilation openings, 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 much as you feel comfortable.
Then remove the inhaler from the oral cavity and exhale slowly.
After use, keep the inhaler upright. Close the cover.
If you need to do more than one inhalation, close the lid, wait at least one minute, and then repeat the process.
Inhaler Cleaning Unscrew the top of the inhaler.
Remove the metal can (do not lower the can into water).
Rinse the inhaler body in warm water and dry.
Insert the can into place.
Close the cap and screw the top of the inhaler to its body.
Do not wash the top of the inhaler.
If the inhaler does not work correctly, unscrew the top of it and manually press the can.
Side effects of the
From the respiratory system: hoarseness, sensation of irritation in the throat, sneezing rarely – coughing 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, urticaria, pruritus, erythema and edema of the eyes, face, lips and larynx.
Effects due to systemic effects: decreased adrenal cortex function, osteoporosis, cataracts, glaucoma, growth retardation in children.
Drug Interaction
Concurrent use of beclomethasone with other ACS for systemic or intranasal administration may increase the suppression of adrenal cortex function. Prior inhalation of beta-adrenostimulators may increase the clinical efficacy of beclomethasone.
overdose Acute
overdose Symptoms: Temporal decrease in adrenal cortex function.
Treatment: No emergency therapy is required as the function of the adrenal cortex is restored within a few days, which is confirmed by plasma cortisol levels.
Chronic overdose
Symptoms: There may be persistent suppression of adrenal cortex function.
Treatment: It is recommended to monitor the adrenal cortex reserve function.
With overdose, beclomethasone dipropionate treatment may be continued at doses sufficient to maintain the therapeutic effect.
Storage conditions
Store in a dark place at a temperature not exceeding 30 ° C (do not freeze or heat).
Keep out of the reach of children.
Expiration
2 years.
Active ingredient
Beclomethasone
pharmacy terms and conditions
prescription
dosage form
dosage form
aerosol for inhalation
Teva Pharmaceutical Enterprises Co., Ltd., Israel
