Beclomethasone spray ing. scrapper. 250mkg / dose 200doz cylinders supplied with spray

Description

Composition
Active substance:
beclomethasone dipropionate – 0.25 mg (in terms of 100% substance)
Excipients:
ethanol 96% 10.5 mg, norfluran (tetrafluoroethane) 74.4 mg.
Description:
The drug is a colorless or almost colorless solution under pressure into an aluminum canister with a metering valve provided with a nozzle-sprayer with a protective cap; preparation at the outlet of the container is sprayed in the form of an aerosol jet.
Product form:
Aerosol for inhalation dose of 250 ug / dose.
At doses of 200 to aluminum cylinders with a protective coating, and sealed with a metering valve provided with a nozzle-sprayer with a protective cap. Each cylinder with nasadkoy- spray and protective cap, as well as instructions for use placed into the package.
Contraindications
Hypersensitivity to any component of the drug.
Pulmonary tuberculosis.
Children under 4 years of age. Beclomethasone containing 250 ug 1 dose not intended for use in pediatric patients (i.e., children under 18 years).
Carefully:
Use glaucoma, systemic infections (bacterial, viral, fungal, parasitic), osteoporosis, liver cirrhosis, hypothyroidism, pregnancy, lactation.
Indications
Basic therapy of various forms of asthma in adults and children older than 4 years.
Interaction with other drugs
Beclomethasone restores the patient’s reaction to the beta-agonists by reducing the frequency of their use.
When combined with inductors microsomal oxidation (including phenobarbital, phenytoin, rifampin, etc.) May reduce the effectiveness of beclomethasone.
In an application with methandienone, estrogens, beta2- agonists, theophylline, and systemic corticosteroids beclomethasone efficiency is improved.
With simultaneous application of beclomethasone enhances the effect of beta-adrenoceptor agonists.
Overdose
symptoms:
Acute overdose of the drug may lead to a temporary decrease in the function of the adrenal cortex, which requires emergency treatment, as a function of the adrenal cortex is restored within a few days, as evidenced by the concentration of plasma cortisol. In chronic overdose may experience persistent suppression of adrenocortical function.
Treatment:
In such cases, it is recommended to monitor the backup function of the adrenal cortex. In overdose beclomethasone dipropionate treatment may be continued at a dose sufficient to maintain therapeutic effect.
pharmachologic effect
Pharmacological group:
Glucocorticosteroids for local use
Pharmacodynamics:
Beclomethasone dipropionate is a prodrug and has weak affinity for corticosteroids receptors. Under the action of the esterases it is converted into the active metabolite – beclomethasone-17-monopropionat (B-17-IP), which has a pronounced local anti-inflammatory effect. Reduces inflammation by reducing the formation of chemotactic substance (influence on the “late” reactions allergies), inhibits the development of “immediate” allergic reaction (caused by inhibition of the production of arachidonic acid metabolites, and decrease the release of mast cell mediators of inflammation) and improves mucociliary transport. Under the effect of beclomethasone reduced number of mast cells in bronchial mucosa, epithelial edema decreases, secretion of bronchial mucus glands, bronchial hyperreactivity, accumulation of neutrophils boundary, inflammatory exudate and production of lymphokines, inhibited migration of macrophages, the intensity decreases infiltration and granulation processes. It increases the amount of active beta-adrenergic receptors, restores the patient response to bronchodilators, reduces the frequency of their use. Almost no resorptive action after inhalation.
Not relieves bronchospasm, the therapeutic effect develops gradually, usually within 5-7 days of a course of beclomethasone dipropionate.
Pharmacokinetics:
In lung tissue beclomethasone dipropionate is rapidly hydrolyzed to bek¬lometazona monopropionata, which in turn is hydrolyzed to beklo¬metazona. Part of the dose that is swallowed accidentally, substantially inactivated at stepe¬ni “first pass” through the liver. The process of converting liver prois¬hodit beclomethasone dipropionate, beclomethasone in mono¬propionat and then – into polar metabolites. Plasma protein binding ak¬tivnogo substance present in the systemic circulation, is 87%. Os¬novnaya of the drug (35-76%) is excreted within 96 hours, the digestive tract, preimuschest¬venno as polar metabolites, 10-15% – kidneys.
Pregnancy and breast-feeding
Beclomethasone be used during pregnancy and lactation and only if the potential benefit to the mother outweighs the potential risk to the fetus and child.
Conditions of supply of pharmacies
Prescription
side effects
Adverse reactions are listed according to the classification and anatomo¬fiziologicheskoy occurrence. Incidence is defined as follows: very often (> 1/10, often (> 1/100 and
special instructions
Before the appointment of inhaled drugs should instruct the patient on the rules of their application, providing the most complete getting medication in the right parts of the lungs. The development of oral candidiasis is most likely in patients with high levels of precipitating antibodies in blood against the fungus Candida, which indicates a previously transferred fungal infection. After inhalation should rinse the mouth and throat with water. For the treatment of candidiasis can be used antifungals local action while continuing therapy beclomethasone.
If patients taking corticosteroids by mouth, it is assigned beclomethasone in patients receiving the same dose of corticosteroids, the patients should be in a relatively stable state. After about 1-2 weeks the daily dose of oral corticosteroids are gradually reduced. Scheme dose reduction depends on the length of previous therapy, and the magnitude of the initial dose of corticosteroids. Regular use of inhaled corticosteroids in most cases, allows to cancel oral corticosteroids (patients in need of receiving no more than 15 mg of prednisolone may be completely transferred to the inhalation therapy). In the first months after the transition, you should carefully monitor the patient until it gipofizarno¬nadpochechnikovaya system does not recover sufficiently to provide an adequate response to stressful situations (eg trauma, surgery, or infection).
When transferring patients receiving systemic corticosteroids to inhalation therapy may manifest allergic reactions (e.g., allergic rhinitis, eczema), which previously suppressed systemic drugs.
Patients with impaired function of the adrenal cortex, translated into the inhalation therapy should have a supply of corticosteroids and always carry a warning card, which must indicate that they are in stressful situations require additional systemic administration of corticosteroids (after the elimination of stress dose of corticosteroids may be again lower). Sudden and progressive deterioration of asthma symptoms is a potentially dangerous condition, not infrequently threatening life of the patient, and requires higher doses of corticosteroids. An indirect measure of treatment failure is more frequent than before the use of short-acting agonists 0-2-.
Beclomethasone dipropionate for inhalation is not for relief of attacks, and for regular daily use. Cupping is used (3-2 adrenostimulyatorov short-acting (eg, salbutamol). In severe exacerbations of asthma or lack of efficacy of the therapy should increase the dose of inhaled beclomethasone dipropionate and, if necessary, appoint a systemic corticosteroids and antibiotics when infections develop.
With the development of paradoxical bronchospasm should immediately discontinue use Beclomethasone, to assess the patient’s condition, to conduct a survey and optionally assign therapy with other drugs. Prolonged use of any of inhaled corticosteroids, particularly at high doses, systemic effects may occur (see., “Side effects”), but the likelihood of their development is much lower than when corticosteroids inside. It is therefore particularly important that the therapeutic effect, the dose of inhaled corticosteroids has been reduced to the minimum effective dose, for controlling diseases. The dose of 1500 mg / day in most patients the drug does not cause significant suppression of adrenal function. In connection with a possible adrenal insufficiency should be particularly careful and regular monitoring of indicators of adrenocortical function when transferring patients taking corticosteroids by mouth, for the treatment of beclomethasone.
It is recommended to regularly monitor the dynamics of the growth of children receiving inhaled corticosteroids for a long time.
Administration may be by means of special metering devices (spacers), improving the distribution of the drug in the lungs and reduce the risk of side effects.
Not recommended abrupt withdrawal of the drug beclomethasone aerosol.
It is necessary to protect the eyes from contact with the drug. Washing after inhalation can prevent skin damage eyelids and nose.
Can of beclomethasone can not puncture, disassemble or dispose of in a fire, even if it is empty. Like most other means for inhalation in aerosol containers, Beclomethasone may be less effective at low temperatures. Upon cooling cylinder it is advisable to remove it from the nozzle inhaler and warm hands for a few minutes.
Effect on the ability to drive mechanisms and
No data.
Storage conditions
Store at a temperature not higher than 25 ° C.
Keep away from the heating system and direct sunlight.
Keep out of the reach of children!
Protect against drops and bumps.
Dosing and Administration
Beclomethasone is only for inhalation use.
Beclomethasone regularly used (even in the absence of symptoms), the dose of beclomethasone dipropionate is selected considering the clinical effect in each case.
In less severe asthma forced inspiratory volume (FEV) or peak expiratory flow (PSV) constitute over 80% of predicted values ​​with scatter PEF less than 20%.
In moderate flow FEV or PEF is 60-80% of the normal value, the daily variation PEF 20-30%.
In severe FEV or PEF is 60% of the normal value, the daily variation PSV indices greater than 30%.
In the transition to a high dose of inhaled beclomethasone dipropionate, many patients receiving systemic steroids, will be able to reduce their dose, discard them altogether.
Initial dose Beclomethasone determined by the severity of bronchial asthma. The daily dose is divided into several stages.
Depending on the response of the individual patient, the dose can be increased before the appearance of clinical effect or reduce to the minimum effective dose.
Children aged 4 to 12 years
The initial dose is 50 mg 2 times a day. If necessary nachal¬naya dose may be increased to 100 mg 2 times a day. The maximum single dose of 200 micrograms.
The maximum daily dose – 400 micrograms. The daily dose is divided into 2-4 doses.
Adults and children aged 12 years and older:
The recommended initial dose:
asthma lung flow – 200-600 mg / day;
asthma moderate flow – 600-1000 mcg / day;
severe bronchial asthma – 1000-2000 mg / day.
Treatment of asthma is based on the stepwise approach – therapy is started according to step corresponding to severity of disease. Inhaled corticosteroids are assigned to the second stage treatment.
Step 2. Basic therapy.
Beclomethasone dipropionate 100-400 mg 2 times a day.
Step 3. Basic therapy.
Used inhaled corticosteroids or high dose in the standard dose, but in combination with inhaled p-2-agonists long-acting.
Beclomethasone dipropionate high dose – 800-1600 mg / day, in some cases, megadoses to 2000 micrograms / day.
Step 4. Severe asthma.
Beclomethasone dipropionate high dose – 800-1600 mg / day, in some cases, megadoses to 2000 micrograms / day.
Step 5. Severe asthma.
Beclomethasone dipropionate in the high dose (see. Step 3 and 4).
Special patient groups
There is no need to adjust the dose of beclomethasone in the elderly, in patients with renal or hepatic insufficiency.
Skipping receiving one dose
In case of accidental inhalation skipping the next dose should be taken in due time in accordance with the scheme of treatment.
Instructions for the patient on the use of the inhaler
Check the operation of the inhaler before the first use, and if you have not used it for some time, or if the container was cooled to a low temperature, and then it warmed you up to room temperature. To check remove the nozzle inhaler protective cap, invert cylinder bottomed up, putting the index finger on the bottom of a container and the thumb – on top of the inhaler nozzle shake cartridge up and down and make 2 is pressed between thumb and forefinger, sending output nozzle opening -ingalyatora aside. After the appearance of the aerosol jet after the second pressing proceed as described below, starting with the words “Check that the outlet tube is free from dust and dirt.”
With regular use of the drug must act in such a way:
Remove the inhaler nozzle cap. Make sure that the outlet tube is no dust and dirt.
Hold the bottle upright bottomed up, putting the index finger on the bottom of a container and the thumb – on top of the inhaler nozzle. Shake the cartridge up and down.
Make as much as possible a deep breath (without straining). Firmly hold lips outlet pipe inhaler nozzle.
Take a slow deep breath. At the moment of inspiration by pressing the thumb and forefinger release dose. Continue to slowly inhale.
Remove the tube from the mouth-inhaler nozzle and hold their breath for 10 seconds or so, as you can without tension. Exhale slowly.
If required more than one dose, wait about a minute, and then repeat from step 2. Put cap back on the nozzle inhaler.
In steps 3 and 4 are not in a hurry. At the time of release dose medication is important to breathe in as slowly as possible. At first, work out in the mirror. If you notice steam coming out of the corners of the mouth, then start again from step 2.
Cleaning the inhaler.
Nozzle inhaler should be cleaned at least once a week. Remove nasadku- inhaler and rinse the container and its cap with warm water. Do not use the hot water. Dry thoroughly, but do not use it for heating devices. Put cap back on the nozzle inhaler and its – the bulb. Do not soak in the water tank.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist