The drug beclazone eco easy breathing. Use during pregnancy and lactation. Side effect of Salamol eco easy breathing
Beclazone Eco Easy Breath
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Beclazone Eco Easy Breathing in the medicine guide
DOSAGE FORMS
aerosol for inhalation dosed 250mcg/dose 200dz
MANUFACTURERS
Norton Waterford
acting under the so-called. Ivax Pharmaceuticals Ireland
packed by Ivex Pharmaceuticals s.r.o. (Ireland)
GROUP
Agents with glucocorticosteroid activity
COMPOUND
The active substance is Beclomethasone.
INTERNATIONAL NON-PROPRIETARY NAME
beclomethasone
SYNONYMS
Aldecin, Beclazone Eco, Beklat, Beclodjet 250, Beclocort, Beclomet, Beclomethasone Orion Pharma, Beclospir, Becloforte, Bekotid, Klenil, Klenil UDV, Nasobek, Rinoklenil
PHARMACHOLOGIC EFFECT
Anti-inflammatory, anti-allergic, anti-edema, anti-asthma. It has a pronounced glucocorticoid and weak mineralocorticoid activity. With endobronchial administration, it inhibits the migration and activation of cells involved in the allergic inflammatory process, thickens 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 adrenomimetics. Systemic absorption is possible with any form of administration (endobronchial, intranasal, inhalation through the mouth). The therapeutic effect develops after 4-5 days from the start of treatment and reaches a maximum within a few weeks. Excreted in faeces and urine.
INDICATIONS FOR USE
Bronchial asthma, chronic obstructive pulmonary disease, vasomotor rhinitis, recurrent nasal polyposis, allergic rhinitis (seasonal and permanent), juvenile rheumatoid arthritis, inflammatory bowel disease, dysphonia in systemic lupus erythematosus, persistent otitis media in children, bronchopulmonary dysplasia of newborns.
CONTRAINDICATIONS
Hypersensitivity, I trimester of pregnancy, breastfeeding. Application restrictions. Systemic infections, tuberculosis, herpetic eye disease, II and III trimester of pregnancy.
SIDE EFFECT
Hoarseness, sore throat, bronchospastic reactions, sneezing attacks, rhinorrhea, feeling of dryness and irritation in the nose, epistaxis, 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, the appointment of ACTH is shown.
SPECIAL INSTRUCTIONS
It should not be used to relieve an acute asthmatic attack. In the event of an acute asthma attack in response to the use of beclomethasone, it should be immediately discontinued. With signs of hypothalamic-pituitary-adrenal insufficiency, inhalations should be continued, but it is imperative to control the level of basal cortisol in the blood plasma. The same control is needed when using high doses of beclomethasone. The transfer of patients with bronchial asthma from systemic glucocorticoids to inhaled forms of beclomethasone dipropionate should be carried out gradually: simultaneous cancellation or too rapid dose reduction is unacceptable.
STORAGE CONDITIONS
List B. At a temperature not higher than 30 ° C (do not freeze).
Beklazon Eco: instructions for use and reviews
Latin name: Beclazone Eco
ATX Code: R03BA01
Active substance: beclomethasone (beclometasone)
Manufacturer: Norton Waterford trading as IVAX Pharmaceuticals Ireland (Ireland)
Description and photo update: 22.11.2018
Beclazone Eco is an inhalation drug intended for basic therapy of bronchial asthma.
Release form and composition
The dosage form of Beclazone Eco release is a dosed aerosol for inhalation: placed under pressure in an aluminum can; external damage, leakage or corrosion must be absent; when sprayed onto glass, the contents of the can leave a white spot (in a carton box 1 bottle of 200 doses).
Composition of 1 dose:
- active substance: beclomethasone dipropionate - 0.05 mg, 0.1 mg or 0.25 mg;
- auxiliary components (0.05 / 0.1 / 0.25 mg): ethanol - 2.09 / 3.11 / 6 mg; hydrofluoroalkane (HFA-134a) - 75.86 / 74.79 / 71.75 mg.
Pharmacological properties
Pharmacodynamics
Beclomethasone is one of the corticosteroids (glucocorticosteroids). It has a weak tropism for GCS receptors.
Under the influence of enzymes, it is converted into an active metabolite - B-17-MP (beclomethasone-17-monopropionate), which has a pronounced local anti-inflammatory effect.
The main properties of Beclazone Eco:
- reduction of inflammation by reducing the formation of chemotaxis substance (influence on late allergy reactions);
- inhibition of the development of an immediate allergic reaction (associated with inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells);
- improvement of mucociliary transport;
- decrease in the number of mast cells in the bronchial mucosa;
- reduction of epithelial edema, mucus secretion by bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils, inflammatory exudate and production of lymphokines;
- inhibition of macrophage migration;
- decrease in the intensity of granulation and infiltration processes;
- an increase in the number of active beta-adrenergic receptors;
- restoration of the patient's response to bronchodilators, which reduces the frequency of their use.
Beclomethasone after inhalation administration has practically no resorptive effect.
Beclazone Eco does not stop bronchospasm. The development of the therapeutic effect occurs gradually, as a rule, after 5-7 days of course use.
Pharmacokinetics
More than 1/4 dose of inhaled beclomethasone settles in the respiratory tract, the rest settles in the mouth, pharynx and is swallowed. In the lungs, beclomethasone is extensively metabolized to the active metabolite B-17-MP before absorption.
Systemic absorption of the metabolite B-17-MP occurs in the lungs (36% of the lung fraction), in the gastrointestinal tract (26% of the dose received by ingestion).
The absolute bioavailability of unchanged beclomethasone and B-17-MP is approximately 2 and 62% of the inhalation dose, respectively. Beclomethasone is rapidly absorbed, T max (time to reach maximum plasma concentration) - 18 minutes. The absorption of B-17-MP is slow, its T max is 60 minutes.
There is a linear relationship between the increase in the received dose and the systemic exposure of the substance.
The distribution in the tissues of beclomethasone and B-17-MP is 20 and 424 liters, respectively. There is a relatively high connection with blood plasma proteins - 87%.
Beclomethasone and B-17-MP have high plasma clearance (150 and 120 l/h, respectively). The half-life is 0.5 and 2.7 hours, respectively.
Indications for use
According to the instructions, Beclazon Eco is prescribed for the basic therapy of various forms of bronchial asthma.
Contraindications
Absolute:
- age up to 4 years;
- individual intolerance to the components of the drug.
Relative (Beklazon Eco is prescribed under medical supervision):
Aerosol Beklazon Eco is intended for inhalation administration. For its application, an inhalation device is used. After the end of each inhalation, the mouth and throat should be thoroughly rinsed with water.
The drug should be used regularly, even in cases where there are no symptoms of the disease. The dose is selected by the doctor individually based on clinical efficacy. After switching to a high dose of inhaled beclomethasone, most patients receiving systemic corticosteroids reduce their dose or cancel completely.
The initial dose of Beclazone Eco depends on the severity of bronchial asthma:
- mild course: FEV (forced expiratory volume) or PSV (peak expiratory flow rate) is more than 80% of the expected values with a spread in PSV values of up to 20%;
- moderate course: FEV or PSV is from 60 to 80% of the proper values, the daily variation of PSV values is in the range of 20-30%;
- severe course: FEV or PSV - less than 60% of the expected values, the daily variation of PSV indicators - more than 30%.
The daily dose is divided into several doses (from 2 to 4 inhalations per day).
Adults and children over 12 years old
- mild course: 0.2–0.6 mg (for 2 inhalations);
- moderate course: 0.6–1 mg (for 2–4 inhalations);
- severe course: 1-2 mg (for 2-4 inhalations).
The standard maximum daily dose is 1 mg. In very severe cases, it can be increased to 1.5–2 mg (for 2–4 inhalations).
Treatment of bronchial asthma is based on a stepwise approach. Therapy should be started according to the stage, which corresponds to the severity of the disease. Inhaled corticosteroids are prescribed from the second stage.
- Stage II: basic therapy; 0.1–0.4 mg 2 times a day;
- Stage III: basic therapy; Beclazone Eco can be used in a high daily dose or in combination with long-acting inhaled beta 2-agonists in a standard daily dose; the recommended daily dose is 0.8-1.6 mg, in some cases it can reach 2 mg;
- IV-V stage: severe bronchial asthma; the recommended daily dose is 0.8-1.6 mg, in some cases it can reach 2 mg.
Children aged 4-12
Aerosol Beclazone Eco containing 0.25 mg of beclomethasone in one dose is not intended for use in this group of patients.
Additional Information
In case of accidental skipping of inhalation, the next dose should be taken in accordance with the treatment regimen at the scheduled time. The introduction can be carried out using special dispensers (spacers), which improve the distribution of the drug in the lungs and reduce the likelihood of adverse reactions.
Before using the inhalation device for the first time, or if it has not been used for some time, it should be checked for proper operation. To do this, press the valve of the can and release the dose of the medicine into the air.
Before using Beclazone Eco, you need to remove the protective cap from the inhalation device and make sure that the outlet tube is clean.
The inhalation device must be held vertically between the index finger and thumb, with the thumb placed on the bottom of the inhalation device and the index finger on the top of the aluminum canister.
The aluminum can must be vigorously shaken in a vertical direction.
You should take a deep exhalation through the mouth, then tightly clamp the outlet tube of the inhalation device with your lips and take a deep and slow breath. At the moment of inhalation, with the index finger, you need to press the metering valve of the balloon, while a dose of Beclazone Eco is released. You should continue to inhale slowly.
It is necessary to remove the inhalation device from the mouth and hold the breath for 10 seconds or for a time that does not cause discomfort, then exhale slowly.
After the end of the procedure, you need to rinse your mouth with water, trying not to swallow the drug that got on the mucous membrane of the oral cavity during inhalation.
If a second dose is required, wait 1 minute and repeat all steps.
The inhalation device should be cleaned at least once a week. To do this, remove the aluminum cylinder from it. Then it is necessary to rinse the inhalation device and the protective cap with warm water. Hot water cannot be used. To remove residual water, shake the inhalation device and the cap. Dry them without the use of heating devices. It is impossible to allow contact of an aluminum cylinder with water.
Side effects
Possible adverse reactions (> 10% - very often; > 1% and< 10% – часто; >0.1% and< 1% – нечасто; >0.01% and< 0,1% – редко; < 0,01%, включая отдельные сообщения – очень редко):
- endocrine system (with prolonged use of doses of more than 1500 mg per day): very rarely - inhibition of the HPA system (hypothalamic-pituitary-adrenal system);
- respiratory system: often - hoarseness of voice, irritation of the mucous membrane of the pharynx; rarely - paradoxical bronchospasm; very rarely - eosinophilic pneumonia;
- musculoskeletal system: very rarely - a decrease in bone mineral density;
- organ of vision: very rarely - glaucoma, cataract;
- allergic reactions: rarely - angioedema, erythema, pruritus, skin rash, urticaria;
- infectious diseases (with prolonged use in doses of 0.4 mg per day): often - candidiasis of the oral cavity, pharynx and upper respiratory tract;
- systemic reactions: nausea, headache, thinning of the skin or bruising.
Overdose
An acute overdose of Beclazone Eco can develop with inhalation of a single dose of more than 1000 mg. Symptoms of suppression of the function of the adrenal cortex do not require emergency therapy, since the violation disappears within a few days.
In case of chronic overdose (long-term therapy at a dose of more than 1500 mg), persistent suppression of the function of the adrenal cortex may develop. At the same time, monitoring of the reserve function of the adrenal cortex is shown.
Treatment with beclomethasone in case of overdose can be continued at doses that are sufficient to maintain the therapeutic effect.
special instructions
If the effectiveness of the usual dose decreases, or the duration of Beclazone Eco decreases, you should consult your doctor. You cannot change the dosing regimen yourself.
When carrying out therapy with high doses (from 0.4 mg per day), candidiasis of the oral cavity and pharynx may develop, especially in patients who have previously had a fungal infection. The rapid elimination of a fungal infection is usually facilitated by the use of antifungal drugs. The dose of beclomethasone should not be changed in this case.
If Beclazon Eco is prescribed against the background of taking GCS orally, then you can start reducing the dose of the latter after 7-14 days. In most cases, patients who take no more than 15 mg of prednisolone can completely switch to the use of inhaled beclomethasone alone. During the first months after the transition to inhalation therapy with beclomethasone, careful monitoring of the state of HPA is required.
Against the background of reduced adrenal function after a complete transition to Beclazone Eco, patients should always have a supply of corticosteroids with them, and also carry a card with information that they need systemic corticosteroids in stressful situations.
With a sudden and progressive worsening of the course of bronchial asthma, an increase in the dose of corticosteroids is required. An indirect indicator of treatment failure is the more frequent use of short-acting beta2-agonists.
To stop attacks of bronchospasm, beta 2 -adronomimetics, including salbutamol, should be used. In case of a severe course of the disease or insufficient effectiveness of Beclazon Eco, its dose should be increased, and the use of GCS orally should be considered. It is also possible to use antibacterial drugs, in particular for infectious inflammation.
In case of paradoxical bronchospasm, Beclazone Eco is canceled. After the examination, the doctor decides on the appointment of another drug.
It is impossible to abruptly interrupt therapy.
With prolonged use of Beclazone Eco in children, the dynamics of their growth should be monitored.
When using the drug in patients with active / inactive pulmonary tuberculosis, caution should be exercised.
Avoid getting Beclazone Eco in the eyes.
Use during pregnancy and lactation
Beclazone Eco during pregnancy / lactation should be used under medical supervision.
Application in childhood
Beclazone Eco is not prescribed for patients under 4 years of age.
drug interaction
Beclazone Eco restores the response to beta-agonists, which reduces the frequency of their use.
Possible interactions:
- beta-agonists: their effect is enhanced;
- methandienone, estrogens, beta 2-agonists, theophylline, systemic corticosteroids: the effectiveness of beclomethasone increases;
- phenobarbital, phenytoin, rifampicin and other inducers of microsomal liver enzymes: the effectiveness of beclomethasone is reduced.
Analogues
The analogues of Beclazon Eco are: Beclazon Eco Easy Breathing, Rinoclenil, Beclomethasone, Bozon, Nasobek, Klenil, Beclospir.
Terms and conditions of storage
Store in a place protected from direct sunlight at temperatures up to 25 °C. Keep away from children. Do not freeze.
Shelf life - 3 years.
The aerosol is produced in aluminum cans, equipped with a special dosing valve and an inhalation device with a protective cap. The cylinders are designed for 200 doses and are packed in cardboard boxes.
AT Beclason Eco Easy Breath the cans are in a special aerosol inhaler, which is activated with an active breath. In a pack of cardboard there is an optimizer and an inhaler with a balloon.
pharmachologic effect
inhalation form glucocorticosteroid has anti-allergic and anti-inflammatory effects. The active ingredient 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.
Deceleration of granulation and infiltration is achieved by inhibition, a decrease in the production of lymphokines and inflammatory exudate. During treatment, it is possible to restore the patient's sensitivity to bronchodilators which allows them to be used much less often.
The drug does not have a mineralocorticoid effect. The active ingredient relaxes the smooth muscle tissue of the bronchi, improving the performance of external respiration and reducing the hyperreactivity of the bronchial tree. Beclomethasone reduces 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 recorded on the 5th day of the course of treatment.
Pharmacodynamics and pharmacokinetics
Part of a single dose that settles in the respiratory system after inhalation is absorbed by the lung tissue, where the active substance is hydrolyzed rather quickly 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. The active ingredient is able to bind 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 ;
- throat irritation.
With intranasal use, candidiasis of the oral cavity may develop or perforation of the nasal septum . Possible:
- swelling of the lips, larynx, face;
- erythema;
Registered less frequently system responses:
- growth retardation (in pediatrics);
- dysfunction ;
When registering other negative reactions, a doctor's consultation and the abolition of Beclazone are 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 nasally: 1-4 times a day, 100 mcg.
Overdose
In acute overdose, dysfunction of the adrenal cortex is noted. After a few days, the normal functioning of the adrenal glands is restored on its own, as evidenced by the level.
Chronic overdose depresses the adrenal system, which requires monitoring of the reserve functions of the adrenal glands.
Interaction
Other glucocorticosteroids in combination with Beclazone additionally inhibit the work of the adrenal system. Prior 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 drug is not intended for the relief (removal of symptoms) of acute attacks. The attending physician should conduct explanatory conversations that reveal to patients important aspects of the preventive use of inhalers. The optimal therapeutic effect is achieved only with regular and proper use of the medication.
In patients who used bronchodilators and did not achieve the desired results, improvement is recorded after 1 week of Beclazone use.
When switching from oral forms of glucocorticosteroids to inhaled ones, one should be careful, because. long-term therapy disrupts the adrenal system, and recovery is quite slow. In some patients, upon cancellation, there is a general malaise, although the indicators of the function of external respiration increase significantly. It is important to explain to patients that this is a temporary discomfort, and to monitor the regularity of inhalation.
Analogues
Coincidence in the ATX code of the 4th level:
- Beclospir;
- Beklat;
- Klenil.
Beclazone Eco
200 doses in an aluminum can with a metering valve, equipped with an inhalation device with a protective cap; in a cardboard pack 1 bottle.
Beclazone Eco Easy Breath
200 doses in an aluminum can contained in a breath-actuated aerosol inhaler (Easy Breathing); in a cardboard box 1 aerosol inhaler with a cartridge and an optimizer.
Description of the dosage form
Beclazone Eco
Aerosol for inhalation in a pressurized aluminum can. There must be no external damage, corrosion or leakage. The contents of the can leave a white spot when sprayed onto glass.
Beclazone Eco Easy Breath
Aerosol for inhalation in a pressurized aluminum can with a release valve and atomizer. There must be no external damage, corrosion or leakage. The contents of the can are a solution that leaves a colorless stain when sprayed onto glass. The cartridge is placed in an inhaler, consisting of two parts and a safety cap.
pharmachologic effect
pharmachologic effect- local anti-inflammatory, glucocorticoid.Pharmacodynamics
Beclomethasone dipropionate is a prodrug and has a weak tropism for GCS receptors. Under the action of esterases, it turns into an active metabolite - B-17-MP, which has a pronounced local anti-inflammatory effect. It reduces inflammation by reducing the formation of chemotaxis substance (influence 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 action 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 production of lymphokines decrease; migration of macrophages is inhibited; the intensity of infiltration and granulation processes decreases. Increases the number of active beta-adrenergic receptors, restores the patient's response to bronchodilators, and reduces the frequency of their use. Virtually no resorptive effect after inhalation.
Does not stop bronchospasm, the therapeutic effect develops gradually, usually after 5-7 days of course use of beclomethasone dipropionate.
Pharmacokinetics
Absorption
More than 25% of the dose of the inhaled drug Beclazon Eco is deposited in the respiratory tract and up to 56% of the dose of the inhaled drug Beclazon Eco Easy Breathing is deposited in the lower respiratory tract; the remaining amount settles in the mouth, pharynx and is swallowed. In the lungs, before the absorption of beclomethasone, dipropionate is extensively metabolized to the active metabolite, beclomethasone-17-monopropionate (B-17-MP). Systemic absorption of B-17-MP occurs in the lungs (36% of the lung fraction) and in the gastrointestinal tract (26% of the ingested dose). The absolute bioavailability of unchanged beclomethasone dipropionate and B-17-MP is about 2 and 62% of the inhalation dose, respectively. Beclomethasone dipropionate is rapidly absorbed, Tmax in plasma is 0.3 hours. B-17-MP is absorbed more slowly. T max is 1 hour. There is an approximately linear relationship between an increase in the inhaled dose and the systemic exposure of the drug.
Distribution
Distribution in tissues is 20 liters for beclomethasone dipropionate and 424 liters for B-17-MP. Communication with blood plasma proteins is relatively high - 87%.
Elimination
Beclomethasone dipropionate and B-17-MP have high plasma clearance (150 and 120 l/h, respectively). T 1/2 is 0.5 and 2.7 hours, respectively.
Indications for Beclazone Eco Easy Breathing
Basic therapy of various forms of bronchial asthma in adults and children over 4 years of age.
Contraindications
hypersensitivity to any component of the drug;
children's age up to 4 years.
Use during pregnancy and lactation
With extreme caution and only if the potential benefit to the mother outweighs the possible risk to the fetus and child.
Side effects
Some patients may develop candidiasis of the mouth and throat (the likelihood of developing candidiasis increases with the use of beclomethasone dipropionate in doses exceeding 400 mcg / day).
Some patients may experience dysphonia (hoarseness) or irritation of the pharyngeal mucosa. The use of a spacer reduces the likelihood of these side effects.
Inhaled drugs can cause paradoxical bronchospasm, which must be immediately stopped with a short-acting inhaled β 2 -agonist.
There are reports of the development of hypersensitivity reactions, including rash, hives, itching, redness and swelling of the eyes, face, lips and mucous membranes of the mouth and throat.
Possible systemic effects include headache, nausea, bruising or thinning of the skin, unpleasant taste sensations, decreased adrenal function, osteoporosis, growth retardation in children and adolescents, cataracts, glaucoma.
Interaction
There are no confirmed data on the interaction of beclomethasone dipropionate with other drugs.
Dosage and administration
Beclazone Eco and Beclazone Eco Easy Breathing are intended only for inhalation administration.
The drugs are 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 case.
With a mild course of bronchial asthma, the forced expiratory volume (FEV 1) or peak expiratory flow rate (PSV) is more than 80% of the proper values with a spread in PSV values of less than 20%.
With a moderate course of FEV 1 or PSV make up 60-80% of the proper values, the daily variation in PSV is 20-30%.
In severe cases, FEV 1 or PSV is 60% of the proper values, the daily variation in PSV is more than 30%.
When switching to a high dose of inhaled beclomethasone dipropionate, many patients receiving systemic corticosteroids will be able to reduce their dose or stop them altogether.
The initial dose of drugs 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 drugs can be increased until a clinical effect appears or reduced to the minimum effective dose.
Adults and children aged 12 and over
Mild bronchial asthma - 200-600 mcg / day;
Bronchial asthma of moderate course - 600-1000 mcg / day;
Bronchial asthma of severe course - 1000-2000 mcg / day.
The treatment of bronchial asthma is based on a stepwise approach - therapy is started according to the step 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.
Stage 3. Basic therapy
Inhaled corticosteroids are used in a high dose or in a standard dose, but in combination with long-acting inhaled β 2 -adrenergic agonists.
Step 4 severe bronchial asthma
Beclomethasone dipropionate in a high dose of 800-1600 mcg / day, in some cases, megadoses up to 2000 mcg / day.
Step 5 severe bronchial asthma
High dose beclomethasone dipropionate (see step 3, 4)
Children aged 4 to 12
Up to 400 mcg / day in several doses.
Special patient groups
There is no need to adjust the dose of drugs in the elderly, in patients with renal or hepatic insufficiency.
Missing one dose of medication
In case of accidental skipping of inhalation, the next dose should be taken at the appropriate time in accordance with the treatment regimen.
Preparations containing 250 mcg in 1 dose are not intended for use in pediatrics.
The introduction can be carried out using a special optimizer that improves the distribution of the drug in the lungs and reduces the risk of side effects.
Instruction for the patient
Beclazone Eco
Check the operation of the inhaler before using it for the first time, and also if you have not used it for a while.
1. Remove the cap from the inhaler. Make sure the outlet tube is free of dust and dirt.
2. Hold the can upright with your thumb on the bottom and your index finger on the top of the can. Shake the can vigorously up and down.
3. Exhale as deeply as possible (without tension). Close the outlet tube of the can tightly with your lips.
4. Take a slow deep breath. At the moment of inhalation, press the valve of the can with your index finger, releasing a dose of medicine. Continue to inhale slowly.
5. Remove the inhaler tube from your mouth and hold your breath for 10 seconds or as long as you can without exertion. Exhale slowly.
6. If more than one dose of medication is needed, wait about a minute and then repeat from step 2. Put the cap back on the inhaler.
When performing steps 3 and 4, take your time. It is important to inhale as slowly as possible when releasing a dose of medication. Practice in front of a mirror first. If you notice "steam" coming out of the top of the balloon or the corners of your mouth, then start again from step 2.
Cleaning the inhaler
The inhaler should be cleaned at least once a week. Remove the metal can from the plastic case and rinse the case and cap with warm water. Do not use hot water. Dry thoroughly, but do not use heating devices for this. Place the can back into the case and put on the cap. Do not dip a metal can in water.
Beclazone Eco Easy Breath
Instructions for using an inhaler without an optimizer
Holding the inhaler upright, open the lid. Take a deep breath. Close the mouthpiece tightly with your lips. Make sure your hand is not blocking the vents on the top of the inhaler and that you are holding the inhaler upright. 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 upright. Close the lid. If you need to take more than one inhalation, close the lid, wait at least one minute, and then repeat the inhalation process.
Instructions for using an inhaler with an optimizer
Holding the inhaler upright, open the lid and firmly fit the optimizer onto the mouthpiece of the inhaler. Take a deep breath. Close the mouthpiece of the optimizer tightly with your lips. Make sure your hand is not blocking the vents on the top of the inhaler and that you are holding the inhaler upright. 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, keep the inhaler upright. Remove the optimizer. Close the lid.
If you need to take more than one inhalation, after 1-2 minutes open the cap again and firmly place the optimizer on the inhaler mouthpiece, 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 top 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 it and manually press the can.
Overdose
An acute overdose of the drug can lead to a temporary decrease in the function of the adrenal cortex, which does not require emergency therapy, because. function of the adrenal cortex is restored within a few days, as evidenced by plasma cortisol levels. In chronic overdose, there may be a persistent suppression of the function of the adrenal cortex. In such cases, it is recommended to monitor the reserve function of the adrenal cortex. In case of overdose, treatment with beclomethasone dipropionate may be continued at doses sufficient to maintain the therapeutic effect.
special instructions
Before prescribing inhalation drugs, it is necessary to instruct the patient about the rules for their use, which ensure the most complete entry of the drug into the desired 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, rinse the mouth and throat with water. For the treatment of candidiasis, topical antifungals can be used while continuing therapy with beclomethasone dipropionate.
If patients take corticosteroids orally, then inhalations are prescribed while taking the previous dose of corticosteroids, while 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 magnitude of the initial dose of corticosteroids. Regular use of inhaled corticosteroids allows, in most cases, to cancel oral corticosteroids (patients who need to take no more than 15 mg of prednisolone can be completely transferred to inhaled therapy), while in the first months after the transition, the patient's condition should be carefully monitored until his pituitary-adrenal the system will not recover sufficiently to provide an adequate response to stressful situations (for example, trauma, surgery, or infection).
When transferring patients from taking systemic corticosteroids to inhaled therapy, allergic reactions (eg, allergic rhinitis, eczema), which were previously suppressed by systemic drugs, may occur.
Patients with reduced function of the adrenal cortex, transferred to inhalation treatment, should have a supply of corticosteroids and always carry a warning card with them, which should indicate that they need additional systemic administration of corticosteroids in stressful situations (after eliminating the stressful situation, the dose of corticosteroids can be taken again 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 corticosteroids. An indirect indicator of therapy failure is the more frequent use of short-acting β2-agonists than before.
Beclomethasone dipropionate for inhalation is not intended for relief of seizures, but for regular daily use. For the relief of seizures, short-acting β 2 -adrenergic stimulants (for example, salbutamol) are used. In case of severe exacerbation of bronchial asthma or insufficient effectiveness of the therapy, the dose of beclomethasone dipropionate should be increased and, if necessary, systemic corticosteroids and / or an antibiotic should be prescribed if the infection develops.
With the development of paradoxical bronchospasm, you should immediately stop the use of beclomethasone dipropionate, assess the patient's condition, conduct an examination and, if necessary, prescribe therapy with other drugs. With prolonged use of any inhaled corticosteroids, especially at high doses, systemic effects may be observed (see the section "Side Effects"), however, 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 should be reduced to the minimum effective dose that controls the course of the disease. At a dose of 1500 mcg / day, drugs in most patients do not cause significant suppression of adrenal function. In connection with possible adrenal insufficiency, special care should be taken and the indicators of the function of the adrenal cortex should be regularly monitored when transferring patients taking GCS orally to treatment with Beclazon Eco and Beclazon Eco easy breathing.
Special 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 getting drugs. Washing after inhalation can prevent damage to the skin of the eyelids and nose.
Do not puncture, take apart, or throw into fire even if they are empty. Like most other aerosol inhalers, Beclazone Eco and Beclazone Eco Easy Breathing may be less effective at low temperatures. When cooling the cylinder, it is recommended to remove it from the plastic case and warm it with your hands for several minutes.
Influence on the ability to drive a car / mechanisms
No data.
Terms of dispensing from pharmacies
On prescription.
Storage conditions of the drug Beclazon Eco Easy Breathing
In a place protected from direct sunlight, at a temperature not exceeding 25 ° C. Do not freeze.Keep out of the reach of children.
Expiry date of the drug Beclazon Eco Easy Breathing
3 years.Do not use after the expiry date stated on the packaging.
Synonyms of nosological groups
| Category ICD-10 | Synonyms of diseases according to ICD-10 |
|---|---|
| J45 Asthma | Asthma of physical effort |
| Asthmatic conditions | |
| Bronchial asthma | |
| Mild bronchial asthma | |
| Bronchial asthma with difficulty in sputum discharge | |
| Severe bronchial asthma | |
| Bronchial asthma physical effort | |
| hypersecretory asthma | |
| Hormone-dependent form of bronchial asthma | |
| Cough with bronchial asthma | |
| Relief of asthma attacks in bronchial asthma | |
| Non-allergic bronchial asthma | |
| Nocturnal asthma | |
| Nocturnal asthma attacks | |
| Exacerbation of bronchial asthma | |
| Asthma attack | |
| Endogenous forms of asthma |
GCS for inhalation
Active substance
Release form, composition and packaging
Excipients: hydrofluoroalkane (HFA-134a) - 75.86 mg, ethanol - 2.09 mg.
Aerosol for inhalation dosed, 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 cylinders (1) - breath-activated aerosol inhalers (Easy Breathing) (1) - cardboard packs.
Aerosol for inhalation dosed, 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 cylinders (1) - breath-activated aerosol inhalers (Easy Breathing) (1) - cardboard packs.
pharmachologic effect
GCS for inhalation use. Beclomethasone dipropionate is a prodrug and has a weak tropism for GCS receptors. Under the action of esterases, it turns 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 chemotaxis substance (influence 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 action of beclomethasone, the number of mast cells in the bronchial mucosa decreases, epithelial edema decreases, mucus secretion by bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils, inflammatory exudate and production of lymphokines, macrophage migration is inhibited, and the intensity of infiltration and granulation processes decreases.
Increases the number of active β-adrenergic receptors, restores the patient's response to bronchodilators, and reduces the frequency of their use. Virtually no resorptive effect after inhalation.
Does not stop 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 dose of the drug settles in the lower respiratory tract; the remaining amount settles in the mouth, pharynx and is swallowed. In the lungs, before the absorption of beclomethasone, dipropionate is extensively metabolized to the active metabolite B-17-MP. Systemic absorption of B-17-MP occurs in the lungs (36% of the lung 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% of the inhalation dose, respectively. Beclomethasone dipropionate is rapidly absorbed, C max is reached after 0.3 hours. B-17-MP is absorbed more slowly, C max is reached after 1 hour. There is an approximately linear relationship between increasing dose and systemic exposure of the drug.
Distribution
V d is 20 liters for beclomethasone dipropionate and 424 liters for B-17-MP. Binding to blood proteins is relatively high - 87%.
breeding
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's age up to 4 years;
- Hypersensitivity to the components of the drug.
Dosage
Beclazone Eco Easy Breathing is for inhalation use 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 case.
With a mild course of bronchial asthma, the forced expiratory volume (FEV 1) or peak expiratory flow rate (PSV) is more than 80% of the proper values with a spread in PSV values of less than 20%.
With a moderate course of FEV 1 or PSV is 60-80% of the proper values, the daily variation in PSV is 20-30%.
In severe cases, FEV 1 or PSV is 60% of the expected values, the daily variation in PSV 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 completely canceled.
The initial dose Easy Breathing 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 the minimum effective dose.
Adults and children aged 12 and over recommended initial doses of the drug for mild bronchial asthma make up 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 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, in patients with renal or hepatic insufficiency.
At accidental skipping of 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
Holding the inhaler upright, open the lid. Take a deep breath. Close the mouthpiece tightly with your lips. Make sure that the hand does not block the ventilation holes on the top of the inhaler, and 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 the mouth and exhale slowly. After use, keep the inhaler in an upright position. 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 bottle into place. Close the lid and screw the top of the inhaler to its body. Do not wash the top of the inhaler. If the inhaler does not work properly, unscrew its top and manually press the can.
Side effects
Local reactions: possible candidiasis of the mouth and throat (the likelihood of developing candidiasis increases with the use of beclomethasone 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 stopped with an inhaled beta 2 short-acting adrenostimulator.
Allergic reactions: rash, urticaria, itching, redness and swelling of the eyes, face, lips and mucous membranes of the mouth and pharynx are possible.
Effects due to systemic action: include headache, nausea, bruising or thinning of the skin, unpleasant taste sensations, 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 therapy, because. function of the adrenal cortex is restored within a few days, as evidenced by plasma cortisol levels.
At chronic overdose there may be persistent suppression of the function of the adrenal cortex.
In such cases, it is recommended to monitor the reserve function of the adrenal cortex. In case of overdose, treatment with beclomethasone dipropionate may be continued at doses sufficient to maintain the therapeutic effect.
drug interaction
There are 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 about the rules for their use, which ensure the most complete entry of the drug into the desired 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 Candida fungus, which indicates a previous fungal infection. After inhalation, rinse the mouth and throat with water. For the treatment of candidiasis, topical antifungal drugs can be used while continuing therapy with Beclazone Eco Easy Breathing.
If patients take corticosteroids orally, then Beclazon Eco Easy Breathing is prescribed while taking the previous dose of corticosteroids, while 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 on the initial dose of GCS. Regular use of inhaled corticosteroids allows in most cases to cancel oral corticosteroids (patients who need to take no more than 15 mg can be completely transferred to inhalation therapy), while in the first months after the transition, the patient's condition should be carefully monitored until his pituitary-adrenal system will not recover sufficiently to respond adequately to stressful situations (such as injury, surgery, or infection).
When transferring patients from taking systemic corticosteroids to inhaled therapy, allergic reactions (eg, allergic rhinitis, eczema), which were previously suppressed by systemic drugs, may occur.
Patients with reduced function of the adrenal cortex, transferred to inhalation treatment, should have a supply of corticosteroids and always carry a warning card with them, which should indicate that they need additional systemic administration of corticosteroids in stressful situations (after eliminating the stressful situation, the dose of corticosteroids can be taken again reduce). 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 corticosteroids. An indirect indicator of therapy failure is the more frequent use of short-acting beta2-adrenergic stimulants than before.
Beclazone Eco Light Breathing is not intended for stopping seizures, but for regular daily use. Short-acting beta 2-adrenergic stimulants (for example,) are used to stop seizures. 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, systemic corticosteroids and / or an antibiotic should be prescribed if the infection develops.
With the development of paradoxical bronchospasm, 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 prolonged use of any inhaled corticosteroids, especially at high doses, systemic effects may occur, 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 should be reduced to the minimum effective dose that controls the course of the disease. At a dose of 1500 mcg / day, the drug in most patients does not cause significant suppression of adrenal function. In connection with the possible development of adrenal insufficiency, special care should be taken and the indicators of the function of the adrenal cortex should be regularly monitored when transferring patients taking GCS orally to treatment with Beclazone Eco Easy Breathing.
Special 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 getting the drug. Washing after inhalation can prevent damage to the skin of the eyelids and nose.
A can of Beclazone Eco Easy Breath must not be pierced, disassembled or thrown into fire, even if it is empty. Like most other aerosol inhalers, Beclazone Eco Easy Breath may be less effective at low temperatures. When cooling the cartridge, it is recommended to remove it from the plastic case and warm it with your hands for several minutes.
Pediatric use
For impaired liver function
There is no need to adjust the dose of Beclazone Eco Easy Breathing in patients with hepatic insufficiency.
FROM caution used in cirrhosis of the liver.
Terms of dispensing from pharmacies
The drug is dispensed by prescription.
Terms and conditions of storage
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.
