Salamol eco easy breathing instructions for use, contraindications, side effects, reviews. Beclazone Eco Easi Breath
Beclazon Eco Easy Breathing
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DOSAGE FORMS
aerosol for inhalation dosed 250mcg/dose 200dz
MANUFACTURERS
Norton Waterford
speaking under the so-called Ivax Pharmaceuticals Ireland
packaged by Ivex Pharmaceuticals s.r.o. (Ireland)
GROUP
Drugs with glucocorticosteroid activity
COMPOUND
Active ingredient: Beclomethasone.
INTERNATIONAL NON-PROPENTED NAME
Beclomethasone
SYNONYMS
Aldecin, Beklazon Eco, Beklat, Beklojet 250, Beklokort, Beklomet, Beclomethasone Orion Pharma, Beklospir, Bekloforte, Bekotid, Klenil, Klenil UDV, Nasobek, Rinoklenil
PHARMACOLOGICAL ACTION
Anti-inflammatory, anti-allergic, decongestant, anti-asthmatic. It has pronounced glucocorticoid and weak mineralocorticoid activity. When administered endobronchially, it inhibits the migration and activation of cells involved in the allergic inflammatory process, compacts the basement membrane of the epithelium, reduces the secretion of mucus by goblet cells, reduces the number of mast cells in the bronchial mucosa, relaxes the smooth muscles of the bronchi, and restores its sensitivity to adrenergic agonists. Systemic absorption is possible with any form of administration (endobronchial, intranasal, oral inhalation). The therapeutic effect develops within 4-5 days from the start of treatment and reaches its maximum within several weeks. Excreted in feces and urine.
INDICATIONS FOR USE
Bronchial asthma, chronic obstructive pulmonary diseases, vasomotor rhinitis, recurrent nasal polyposis, allergic rhinitis (seasonal and permanent), juvenile rheumatoid arthritis, inflammatory bowel diseases, dysphonia in systemic lupus erythematosus, persistent inflammation of the middle ear in children, bronchopulmonary dysplasia of newborns.
CONTRAINDICATIONS
Hypersensitivity, first trimester of pregnancy, breastfeeding. Restrictions on use. Systemic infections, tuberculosis, herpetic eye lesions, II and III trimester of pregnancy.
SIDE EFFECTS
Hoarseness, sore throat, bronchospastic reactions, sneezing attacks, rhinorrhea, feeling of dryness and irritation in the nose, nosebleeds, atrophic rhinitis, ulceration of the nasal mucosa, perforation of the nasal septum, headaches, dizziness, cataracts, increased intraocular pressure, leukocytosis (including neutrophilic), lymphopenia, eosinopenia, manifestations of hypercortisolism, incl. Cushing's syndrome (when using high doses), oropharyngeal candidiasis and aspergillosis, nasal candidiasis, eosinophilic pneumonia, urticaria, angioedema.
INTERACTION
Increases the effect of beta-agonists, which enhance the anti-inflammatory properties of beclomethasone (increase its penetration into the distal bronchi).
OVERDOSE
Symptoms: hypothalamic-pituitary-adrenal insufficiency. A temporary transfer to systemic glucocorticoids and ACTH are indicated.
SPECIAL INSTRUCTIONS
Cannot be used to relieve an acute asthmatic attack. If an acute asthma attack develops in response to the use of beclomethasone, it should be discontinued immediately. If there are signs of hypothalamic-pituitary-adrenal insufficiency, inhalations should be continued, but be sure to monitor the level of basal cortisol in the blood plasma. The same monitoring is needed when using high doses of beclomethasone. The transfer of patients with bronchial asthma from systemic glucocorticoids to inhaled forms of beclomethasone dipropionate must be carried out gradually: immediate withdrawal or too rapid dose reduction is unacceptable.
STORAGE CONDITIONS
List B. At a temperature not exceeding 30 °C (do not freeze).
Beta-adrenergic agonist with a predominant effect on 2-adrenergic receptors.
Product: SALAMOL ECO EASY BREATHING
Active substance of the drug:
salbutamol
ATX coding: R03AC02
CFG: Bronchodilator - beta2-adrenergic agonist
Registration number: P No. 014097/01
Registration date: 04/17/07
Owner reg. credential: NORTON WATERFORD (Ireland)
Release form Salamol eco easy breathing, drug packaging and composition.
Aerosol for inhalation is dosed, activated by inhalation, in the form of a white suspension, which, when sprayed onto glass, forms a white spot.
1 dose
salbutamol sulfate
124 mcg,
which corresponds to the content of salbutamol
100 mcg
Excipients: ethanol, hydrofluoroalkane (HFA-134a).
200 doses - aluminum cylinders (1) - aerosol inhalers activated by inhalation, (1) - cardboard packs.
The description of the drug is based on the officially approved instructions for use.
Pharmacological action Salamol eco easy breathing
Beta-adrenergic agonist with a predominant effect on 2-adrenergic receptors. In therapeutic doses, the drug acts on 2-adrenergic receptors of the smooth muscles of the bronchi, providing a pronounced bronchodilator effect, prevents and relieves bronchospasm, and increases the vital capacity of the lungs. Prevents the release of histamine, a slow-reacting substance from mast cells and neutrophil chemotaxis factors. It has a slight positive chrono- and inotropic effect on the myocardium, dilates the coronary arteries, and has virtually no effect on blood pressure.
It has a tocolytic effect: it reduces the tone and contractile activity of the myometrium. The effect of the drug begins 5 minutes after inhalation administration and continues for 4-6 hours. It has a number of metabolic effects: it reduces the content of potassium ions in plasma, affects glycogenolysis and insulin secretion, has a hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect , increases the risk of developing acidosis.
Pharmacokinetics of the drug.
After inhalation administration, up to 21% of the dose enters the respiratory tract. The rest remains in the device or settles in the oropharynx and is then swallowed.
The binding of salbutamol to plasma proteins is 10%. Cmax in blood plasma - 30 ng/ml. T1/2 - 3.7-5 hours.
Part of the dose that enters the respiratory tract is absorbed by lung tissue, does not undergo biotransformation and enters the bloodstream. When it enters the systemic circulation, salbutamol is partially metabolized in the liver and excreted primarily by the kidneys unchanged or in the form of phenolic sulfate.
Part of the dose that enters the gastrointestinal tract is absorbed and undergoes a “first pass” effect through the liver, turning into phenolic sulfate. It is excreted primarily by the kidneys unchanged and in the form of a conjugate. Most of the dose of salbutamol administered by inhalation is eliminated within 72 hours.
Indications for use:
Prevention and relief of bronchospasm:
For bronchial asthma;
For chronic obstructive pulmonary disease (COPD);
For chronic bronchitis;
With emphysema.
Dosage and method of administration of the drug.
For adults and children over 12 years of age, Salamol Eco Easy Breathing is prescribed 100-200 mcg (1-2 inhalation doses) to relieve bronchospasm attacks. To control the course of mild asthma, it is recommended to prescribe 1-2 doses 1-4 times a day; for moderate severity of the disease - in the same dosage in combination with other anti-asthmatic drugs. To prevent physical exertion asthma attacks, the drug is used 20-30 minutes before exercise at a dose of 100-200 mcg (1-2 inhalation doses).
For children from 2 to 12 years old with the development of an attack of bronchial asthma, as well as to prevent attacks of bronchial asthma associated with exposure to an allergen or caused by physical activity, the recommended dose is 100-200 mcg (1 or 2 inhalations).
The daily dose of Salamol Eco Easy Breathing should not exceed 800 mcg (8 inhalations).
Instructions for using the inhaler
Shake the inhaler several times before use. Then, holding the inhaler upright, open the lid. Exhale deeply, then wrap your lips tightly around the mouthpiece. Make sure that your hand does not block the ventilation openings on the top of the inhaler and that the inhaler is in an upright position. You should take a slow, maximum breath through the mouthpiece and hold your breath for 10 seconds or as long as is comfortable. Then you need to remove the inhaler from your mouth and exhale slowly. After use, continue to hold the inhaler in an upright position and close the lid. If you need to do more than one inhalation, close the lid and, after waiting at least one minute, repeat the inhalation process.
Cleaning the inhaler
The top part of the inhaler must be unscrewed and the metal canister removed. Then rinse the lower part of the inhaler in warm water and dry. Then insert the can into place. Close the lid and screw the upper part of the inhaler to its body. The top of the inhaler is not washed.
Side effects of Salamol eco easy breathing:
From the side of the central nervous system: tremor of the hands (a typical side effect for all beta2-agonists), headache, dizziness, increased excitability, anxiety, sleep disturbance, insomnia. The drug may cause agitation and increased motor activity in children.
From the cardiovascular system: expansion of peripheral blood vessels (facial skin hyperemia), slight compensatory increase in heart rate, increased blood pressure. Arrhythmias may occur (including atrial fibrillation, supraventricular tachycardia and extrasystole).
Allergic reactions: in isolated cases - angioedema, urticaria, erythema, nasal congestion, bronchospasm, arterial hypotension, collapse.
From the digestive system: nausea, vomiting, dyspepsia.
From the respiratory system: paradoxical bronchospasm, irritation of the mucous membrane of the mouth and pharynx (pharyngitis), cough.
Metabolism: possible hypokalemia (can pose a serious danger to the patient), reversible hyperglycemia.
Other: muscle cramps.
Contraindications to the drug:
Heart rhythm disturbances (paroxysmal tachycardia, polytopic ventricular extrasystole), tachyarrhythmias;
Myocarditis;
Heart defects, aortic stenosis;
Coronary heart disease;
Thyrotoxicosis;
Decompensated diabetes mellitus;
Glaucoma;
Epilepsy;
Pyloroduodenal narrowing;
Liver failure;
Kidney failure;
Pregnancy;
Simultaneous use of non-selective beta-blockers;
Children under 2 years of age;
Hypersensitivity to any component of the drug.
The drug is prescribed with caution for chronic heart failure, hyperthyroidism, arterial hypertension, and pheochromocytoma.
Use during pregnancy and lactation.
The drug is contraindicated for use during pregnancy. During lactation (breastfeeding) it is prescribed only in cases where the expected benefit to the mother outweighs any potential risk to the child.
Special instructions for use of Salamol eco easy breathing.
In patients with severe or unstable asthma, the use of bronchodilators should not be the main or only method of therapy. The patient must be warned about the need to consult a doctor if the use of the drug Salamol Eco Light Breathing in a standard dose becomes less effective or less durable (the effect of the drug should last at least 3 hours).
Frequent use of salbutamol can lead to increased bronchospasm and various complications (including sudden death), and therefore it is necessary to take breaks of several hours between successive inhalations.
An increased need for the use of short-acting inhaled beta-agonists to control the symptoms of bronchial asthma indicates an exacerbation of the disease. In such cases, the patient's treatment plan should be reviewed and the issue of prescribing or increasing the dose of inhaled or systemic corticosteroids should be decided.
Therapy with beta2-agonists can lead to hypokalemia. Particular caution is recommended when treating severe attacks of bronchial asthma, since in these cases hypokalemia may increase as a result of the simultaneous use of xanthine derivatives, corticosteroids, diuretics, as well as due to hypoxia. In such situations, it is necessary to monitor the level of potassium in the blood serum.
The can of Salamol Eco Easy Breathing cannot be pierced, disassembled or thrown into fire, even if it is empty.
Like most other inhalation products in aerosol packages, Salamol Eco Easy Breathing may be less effective at low temperatures. When the canister cools down, it is recommended to remove it from the plastic case and warm it with your hands for a few minutes
Drug overdose:
Symptoms: nausea, vomiting, increased excitability, hallucinations, tachycardia, ventricular flutter, peripheral vasodilation, decreased blood pressure, hypoxemia, acidosis, hypokalemia, hyperglycemia, muscle tremors, headache.
Treatment: drug withdrawal, cardioselective beta-blockers; If necessary, carry out symptomatic therapy. If overdose is suspected, serum potassium levels should be monitored.
Interaction of Salamol eco easy breathing with other drugs.
Theophylline and other xanthines, when used simultaneously with salbutamol, increase the likelihood of developing tachyarrhythmias; and agents for inhalational anesthesia, levodopa - severe ventricular arrhythmias.
MAO inhibitors and tricyclic antidepressants enhance the effect of salbutamol and can lead to a sharp decrease in blood pressure.
With simultaneous use, salbutamol enhances the effect of drugs with a stimulating effect on the central nervous system, side effects of thyroid hormones, cardiac glycosides.
When used simultaneously, salbutamol reduces the effectiveness of antihypertensive drugs and nitrates.
When used simultaneously with xanthine derivatives, corticosteroids, and diuretics, hypokalemia may increase.
Simultaneous administration with anticholinergic drugs (including inhaled ones) may increase intraocular pressure.
Terms of sale in pharmacies.
The drug is available with a prescription.
Storage conditions for the drug Salamol eco: easy breathing.
The drug should be stored out of direct sunlight and out of reach of children at a temperature not exceeding 30°C. Shelf life: 3 years.
GCS for inhalation
Active ingredient
Release form, composition and packaging
Excipients: hydrofluoroalkane (HFA-134a) - 75.86 mg, ethanol - 2.09 mg.
Aerosol for inhalation, dosed, activated by inhalation, 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 cylinders (1) - aerosol inhalers activated by inhalation (Light Breathing) (1) - cardboard packs.
Aerosol for inhalation, dosed, activated by inhalation, 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 cylinders (1) - aerosol inhalers activated by inhalation (Light Breathing) (1) - cardboard packs.
Pharmacological action
GCS for inhalation use. Beclomethasone dipropionate is a prodrug and has weak affinity for GCS receptors. Under the influence of esterases, it is converted into an active metabolite - beclomethasone-17-monopropionate (B-17-MP), which has a pronounced local anti-inflammatory effect. Reduces inflammation by reducing the formation of a chemotaxis substance (impact on “late” allergy reactions), inhibits the development of an immediate allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells) and improves mucociliary transport. Under the influence of beclomethasone, 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 the production of lymphokines are reduced, the migration of macrophages is inhibited, and the intensity of infiltration and granulation processes is reduced.
Increases the number of active β-adrenergic receptors, restores the patient’s response to bronchodilators, and allows to reduce the frequency of their use. It has virtually 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
Suction
After inhalation, up to 56% of the drug dose settles in the lower respiratory tract; the remaining amount settles in the mouth, pharynx and is swallowed. In the lungs, before absorption of beclomethasone, 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 received here when swallowed). The absolute bioavailability of unchanged beclomethasone dipropionate and B-17-MP is approximately 2% and 62% of the inhalation dose, respectively. Beclomethasone dipropionate is rapidly absorbed, Cmax is reached after 0.3 hours. B-17-MP is absorbed more slowly, Cmax is reached after 1 hour. There is an approximately linear relationship between increasing doses and systemic exposure of the drug.
Distribution
Vd is 20 L for beclomethasone dipropionate and 424 L for B-17-MP. Blood protein binding is relatively high - 87%.
Removal
Beclomethasone 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
Contraindications
- children under 4 years of age;
- hypersensitivity to the components of the drug.
Dosage
Beclazon Eco Easy Breathing is intended for inhalation administration only.
Beclazone Eco Easy Breathing 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 mild cases of bronchial asthma, forced expiratory volume (FEV 1) or peak expiratory flow (PEF) is more than 80% of the expected values, with a spread in PEF values of less than 20%.
In moderate cases, FEV 1 or PEF is 60-80% of the required values, the daily spread of PEF indicators is 20-30%.
In severe cases, FEV 1 or PEF is 60% of the expected values, the daily spread of PEF indicators is more than 30%.
When switching to a high dose of inhaled beclomethasone dipropionate in many patients receiving systemic corticosteroids, their dose can be reduced or discontinued altogether.
The initial dose of Light Breathing 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 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; at moderate bronchial asthma- 600-1000 mcg/day; at severe bronchial asthma- 1000-2000 mcg/day.
Children aged 4 to 12 years the dose of the drug is up to 400 mcg/day in several doses.
There is no need to adjust the dose of Beclazone Eco Easy Breathing in the elderly or in patients with renal or hepatic insufficiency.
At accidentally missing an inhalation the next dose must be taken at the appropriate time in accordance with the treatment regimen.
Beclazone Eco Easy Breathing containing 250 mcg of beclomethasone in 1 dose is not intended for use in pediatrics.
Instructions for using the inhaler
Hold the inhaler in an upright position and open the cap. Take a deep breath. Cover the mouthpiece tightly with your lips. Make sure that your hand does not block the ventilation openings on the top of the inhaler and that the inhaler is in an upright position. Take a slow, maximum breath through the mouthpiece. Hold your breath for 10 seconds or as long as possible. Then you should remove the inhaler from your mouth and exhale slowly. After use, keep the inhaler upright. Close the lid. If more than one inhalation is necessary, close the lid, wait at least 1 minute, and then repeat the inhalation process.
Cleaning the inhaler
Unscrew the top of the inhaler. Pull out the metal can. Rinse the bottom of the inhaler in warm water and dry. Insert the can into place. Close the lid and screw the upper part of the inhaler to its 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 on the canister.
Side effects
Local reactions: possible candidiasis of the mouth and throat (the likelihood of developing candidiasis increases when using beclomethasone dipropionate in doses exceeding 400 mcg/day), dysphonia (hoarseness of voice) or irritation of the pharyngeal mucosa.
From the respiratory system: Paradoxical bronchospasm is possible, which must be immediately relieved with an inhaled short-acting beta 2-adrenergic agonist.
Allergic reactions: possible rash, hives, itching, redness and swelling of the eyes, face, lips and mucous membranes of the mouth and throat.
Effects due to systemic action: include headache, nausea, bruising or thinning of the skin, unpleasant taste, decreased adrenal function, osteoporosis, growth retardation in children and adolescents, cataracts, glaucoma.
Overdose
Acute overdose can lead to a temporary decrease in the function of the adrenal cortex, which does not require emergency treatment, because adrenal function is restored within a few days, as evidenced by plasma cortisol levels.
At chronic overdose Persistent suppression of adrenal function may occur.
In such cases, 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.
Drug interactions
There is no confirmed data on the interaction of beclomethasone dipropionate with other drugs.
Special instructions
Before prescribing inhaled corticosteroids, it is necessary to instruct the patient on the rules for their use, ensuring the most complete delivery of the medicine to the desired areas of the lungs. The development of oral candidiasis is most likely in patients with high levels of precipitating antibodies in the blood against the Candida fungus, which indicates a previous fungal infection. After inhalation, you should rinse your mouth and throat with water. To treat candidiasis, topical antifungal drugs can be used while continuing therapy with Beclazone Eco Easy Breathing.
If patients take GCS orally, then Beclazon Eco Easy Breathing is prescribed while taking the previous dose of GCS, and the patients should be in a relatively stable condition. After about 1-2 weeks, the daily dose of oral corticosteroids begins to be gradually reduced. The dose reduction scheme depends on the duration of previous therapy and the size of the initial dose of GCS. Regular use of inhaled GCS allows in most cases to cancel oral GCS (patients needing to take no more than 15 mg can be completely transferred to inhaled therapy), while in the first months after the transition the patient’s condition should be carefully monitored while his pituitary-adrenal system will not recover sufficiently to provide an adequate response to stressful situations (such as injury, surgery, or infection).
When transferring patients from taking systemic corticosteroids to inhalation therapy, allergic reactions (for example, allergic rhinitis, eczema), which were previously suppressed by systemic drugs, may occur.
Patients with reduced function of the adrenal cortex who are transferred to inhalation treatment should have a supply of GCS and always carry a warning card with them, which should indicate that in stressful situations they need additional systemic administration of GCS (after eliminating the stressful situation, the dose of GCS can be repeated reduce). A 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 GCS. An indirect indicator of the ineffectiveness of therapy is the more frequent use of short-acting beta 2-agonists than before.
Beclazon Eco Easy Breathing is not intended for relieving attacks, but for regular daily use. To relieve attacks, short-acting beta 2-agonists are used (for example,). In case of severe exacerbation of bronchial asthma or insufficient effectiveness of the therapy, the dose of Beclazone Eco Easy Breathing should be increased and, if necessary, a systemic corticosteroid and/or an antibiotic should be prescribed if the infection develops.
If paradoxical bronchospasm develops, you should immediately stop using Beclazone Eco Easy Breathing, assess the patient's condition, conduct an examination and, if necessary, prescribe therapy with other drugs.
With long-term use of any inhaled corticosteroids, especially in high doses, systemic effects may be observed, but the likelihood of their development is much lower than when taking corticosteroids orally. Therefore, it is especially important that when a therapeutic effect is achieved, the dose of inhaled corticosteroids 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 function in most patients. Due to the possible development of adrenal insufficiency, special care should be taken and regular monitoring of adrenal function indicators when transferring patients taking GCS orally to treatment with Beclazone Eco Easy Breathing.
Particular care should be taken when treating patients with active or inactive forms of pulmonary tuberculosis with inhaled corticosteroids.
It is necessary to protect the eyes from contact with the drug. By washing after inhalation you can prevent damage to the skin of the eyelids and nose.
The can of Beclazone Eco Light Breathing cannot be pierced, disassembled or thrown into fire, even if it is empty. Like most other inhalation products in aerosol packages, Beclazon Eco Easy Breathing may be less effective at low temperatures. When the canister cools down, it is recommended to remove it from the plastic case and warm it with your hands for a few minutes.
Use in pediatrics
For liver dysfunction
There is no need to adjust the dose of Beclazone Eco Easy Breathing in patients with liver failure.
WITH caution used for liver cirrhosis.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
Storage conditions and periods
The drug should be stored out of the reach of children, protected from direct sunlight at a temperature not exceeding 25°C; do not freeze. Shelf life – 3 years.
The aerosol is produced in aluminum cans equipped with a special dispenser valve and an inhalation device with a protective cap. The cylinders are designed for 200 doses and are packaged in cardboard boxes.
IN Beclazon Eco Easy breathing the cans are located in a special aerosol inhaler, which is activated by active inhalation. The cardboard pack contains an optimizer and an inhaler with a balloon.
Pharmacological action
Inhalation form glucocorticosteroid has anti-allergic and anti-inflammatory effects. The active component prevents the release of mediators responsible for the inflammatory process; inhibits the synthesis process, reduces the amount of produced arachidonic acid , enhances the production of lipomodulin.
Slowing down granulation and infiltration is achieved through inhibition, reducing the production of lymphokines and inflammatory exudate. During treatment, it is possible to restore the patient's sensitivity to bronchodilators , which allows you to use them much less often.
The medication does not have a mineralocorticoid effect. The active component relaxes the smooth muscle tissue of the bronchi, improving the performance of external respiration and reducing the hyperreactivity of the bronchial tree. Beclomethasone reduces the swelling of epithelial cells, reduces the production of mucus by the bronchial glands, and reduces the number of mast cells in the mucous membranes of the bronchi. Therapeutic doses of Beclazon Eco do not cause systemic reactions characteristic of most glucocorticosteroids.
Intranasal inhalation allows you to get rid of swelling and hyperemia of the mucous membranes of the nasal cavity. The therapeutic effect is registered on the 5th day of the course of treatment.
Pharmacodynamics and pharmacokinetics
Part of the single dose, which settles in the respiratory system after inhalation, is absorbed by the lung tissue, where the active substance is quickly hydrolyzed to the monoprorionate form. The latter is hydrolyzed to beclomethasone.
A small part of the dose is ingested and swallowed, but is inactivated in the hepatic system after the first passage. In the liver, the drug is metabolized to polar compounds. The active component is capable of binding to plasma proteins by 87%.
Indications for use
Contraindications
Intranasal and inhalation use is contraindicated in:
- respiratory system;
- severe attacks of bronchial asthma;
- (I trimester);
- to the components.
Side effects
Respiratory tract:
- paradoxical bronchospasm ;
- cough;
- hoarseness;
- eosinophilic ;
- irritation in the throat.
With intranasal use, oral candidiasis may develop or perforation of the nasal septum . Possible:
- swelling of the lips, larynx, face;
- erythema;
Less frequently registered system responses:
- growth retardation (in pediatrics);
- dysfunction ;
If other negative reactions are registered, consultation with a doctor and discontinuation of the drug Beclazone is required.
Instructions for use (Method and dosage)
The average dose for inhalation is 400 mcg/day. The number of inhalations per day is 2-4. The daily dose of beclomethasone can be increased to 1 g. Children are prescribed 50-100 mcg.
Instructions for use Beclazon Eco nasal: 1-4 times a day, 100 mcg.
Overdose
In case of acute overdose, dysfunction of the adrenal cortex is noted. After a few days, normal functioning of the adrenal glands is restored on its own, as evidenced by the level.
Chronic overdose inhibits the functioning of the adrenal system, which requires monitoring of the reserve functions of the adrenal glands.
Interaction
Other glucocorticosteroids in combination with Beclazone additionally inhibit the adrenal system. Previous therapy with beta-agonists in the form of inhalations may increase the effectiveness of the drug.
Terms of sale
Prescription medication.
Storage conditions
Do not freeze. Store cylinders away from sunlight. The preferred temperature is up to 30 degrees.
Best before date
Special instructions
The medication is not intended for the relief (relief of symptoms) of acute attacks. The attending physician should conduct explanatory conversations that reveal to patients the important aspects of the preventive use of inhalers. The optimal therapeutic effect is achieved only with regular and correct use of the medication.
In patients who used bronchodilators and did not achieve the desired results, improvement is recorded after just 1 week of using Beclazone.
When switching from oral forms of glucocorticosteroids to inhaled ones, you should be careful, because Long-term therapy disrupts the functioning of the adrenal system, and recovery is quite slow. Some patients experience general malaise upon withdrawal, although respiratory function indicators increase significantly. It is important to explain to patients that this is temporary discomfort and to monitor the regularity of inhalations.
Analogues
Level 4 ATX code matches:
- Beclospira;
- Beklat;
- Klenil.
Beclazon Eco Easy breathing- an inhalation drug for the treatment of obstructive airway diseases.
Beclamethasone dipropionate is a prodrug and has weak affinity for GCS receptors. Under the influence of esterases, it is converted into an active metabolite - beclomethasone-17-monopropionate (B-17-MP), which has a pronounced local anti-inflammatory effect. Reduces inflammation by reducing the formation of a chemotaxis substance (impact on “late” allergic reactions), inhibits the development of an “immediate” allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells) and improves mucociliary transport. Under the influence of beclomethasone, 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 the production of lymphokines are reduced, the migration of macrophages is inhibited, and the intensity of infiltration and granulation processes is reduced. Increases the number of active beta-adrenergic receptors, restores the patient's response to bronchodilators, and allows to reduce the frequency of their use. It has virtually 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
More than 25% of the dose of the inhaled drug is deposited in the respiratory tract; the remaining amount settles in the mouth, pharynx and is swallowed. In the lungs, before absorption of beclomethasone, 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 received here when swallowed). The absolute bioavailability of unchanged beclomethasone dipropionate and B-17-MP is about 2% and 62%, respectively. from the inhalation dose. Beclamethasone dipropionate is rapidly absorbed, the time to reach maximum plasma concentration (Tmax) is 0.3 hours. B-17-MP is absorbed more slowly, Tmax is 1 hour. There is an approximately linear relationship between increasing the inhaled dose and systemic exposure of the drug.Distribution in tissues is 20 l for beclazone dipropionate and 424 l for B-17-MP. The connection with blood plasma proteins is relatively high - 87%.
Beclamethasone dipropionate and B-17-MP have high plasma clearance (150 l/h and 120 l/h, respectively). The half-life is 0.5 hours and 2.7 hours, respectively.
Indications for use
Beclazon Eco Easy breathing used for bronchial asthma of various forms in adults and children over 4 years of age.Directions for use
Beclazon Eco Easy Breathing intended for inhalation administration only.Beclazone Eco Easy Breathing 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 mild cases of bronchial asthma, the forced expiratory volume (FEV) or peak expiratory flow (PEF) is more than 80% of the expected values, with a spread of PEF values of less than 20%.
In moderate cases, FEV or PEF is 60-80% of the required values, the daily spread of PEF indicators is 20-30%.
In severe cases, FEV or PEF is 60% of the expected values, the daily spread of PEF indicators is more than 30%.
When switching to a high dose of inhaled beclamethasone dipropionate, many patients receiving systemic corticosteroids will be able to reduce their dose or stop them altogether.
The initial dose of Beclazone Eco Easy Breathing 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 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:
- 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 is based on a stepwise approach - therapy begins according to the step corresponding to the severity of the disease.
Inhaled corticosteroids are prescribed at the second stage of therapy.
Stage 2. Basic therapy.
Beclamethasone dipropionate 100-400 mcg 2 times a day.
Stage 3. Basic therapy.
Inhaled corticosteroids are used in a high dose or in a standard dose, but in combination with inhaled long-acting β-2-adrenergic receptor antagonists.
Beclomethasone dipropionate in a high dose - 800-1600 mcg/day, in some cases megadoses up to 2000 mcg/day.
Stage 4. Severe asthma.
Beclomethasone dipropionate in a high dose of 800-1600 mcg/day, in some cases megadoses up to 2000 mcg/day.
Stage 5. Severe asthma.
Beclamethasone dipropionate in high dose (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 Beclazone Eco Easy Breathing in the elderly or in patients with renal or liver failure.
Skipping one dose of the drug
If you accidentally miss an inhalation, the next dose must be taken at the scheduled time in accordance with the treatment regimen.
The course of treatment is individual.
Side effects
Some patients may develop candidiasis of the mouth and throat (the likelihood of developing candidiasis increases when using beclamethasone dipropionate in doses exceeding 400 mcg per day).Some patients may experience dysphonia (hoarseness) or irritation of the pharyngeal mucosa. Using a spacer reduces the likelihood of developing these side effects.
Inhaled drugs can cause paradoxical bronchospasm, which must be relieved immediately with an inhaled short-acting agonist. There have been reports of hypersensitivity reactions, including rash, urticaria, itching, redness and swelling of the eyes, face, lips and mucous membranes of the mouth and pharynx. Possible systemic effects include headache, nausea, bruising or thinning of the skin, unpleasant taste, decreased adrenal function, osteoporosis, growth retardation in children and adolescents, cataracts, glaucoma.
Contraindications
Contraindications to the use of aerosol Beclazon Eco Easy breathing are: hypersensitivity to any component of the drug; children up to 4 years old.Pregnancy
There is not enough data on the use of the drug Beclazon Eco Easy breathing in pregnant and breastfeeding women, therefore it should be used with caution and only when the expected benefit outweighs the potential risk.Interaction with other drugs
There is no confirmed data on the interaction of beclomethasone dipropionate with other drugs.Overdose
Acute drug overdose Beclazon Eco Easy breathing may lead to a temporary decrease in adrenal function, which does not require emergency treatment, since adrenal function is restored within a few days, as confirmed by plasma cortisol levels.In case of chronic overdose, persistent suppression of the function of the adrenal cortex may be observed. In such cases, 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.
Storage conditions
Store at a temperature not exceeding 25°C.Do not freeze.
Keep out of the reach of children!
Release form
Beclazon Eco Easy breathing - aerosol for inhalation dosed, breath-activated, 100 mcg/dose and 250 mcg/dose.200 doses of the drug are placed in an aluminum can filled with aerosol under pressure.
1 canister along with a breath-activated inhaler in a pack.
Compound
1 dose Beclazon Eco Easy breathing contains the active substance: beclomethasone dipropionate anhydrous 100 mcg, 250 mcg.Excipients: norflurane (hydrofluoroalkane NFE 134a), anhydrous ethanol 99.5%.
