Beclomethasone-aeronativ spray ing. scrapper. 100mcg / dose 200doz cylinders

Description

Composition
Active substance:
1 dose contains 100 mg of beclomethasone dipropionate.
Excipients:
Ethyl alcohol, absolute mark A, triethylcitrate, R propellant 134a (1,1,1,2-tetrafluoroethane).
Description:
A colorless, transparent solution, which is under pressure in the cylinder with an aluminum spray nozzle dispensing action; preparation at the outlet of the container is sprayed in the form of an aerosol jet.
Product form:
Aerosol for inhalation dose of 100 ug / dose.
200 doses in the canister with an aluminum spray nozzle of the metering action.
Each cylinder together with instructions for use placed in a pile of cardboard boxed.
Contraindications
Age up to 4 years.
Hypersensitivity to any component of the drug.
Precautions should be used Beclomethasone-aeronativ glaucoma, systemic infections (bacterial, viral, fungal, parasitic), osteoporosis, tuberculosis, lung, liver cirrhosis, hypothyroidism, pregnancy, lactation.
Indications
Basic therapy of various forms of bronchial asthma in adults and children older than 4 years.
Supportive therapy for chronic obstructive pulmonary disease (COPD) patients with a value of forced expiratory volume (FEV1)
Interaction with other drugs
There are no confirmed data on the interaction of beclomethasone dipropionate with other drugs.
Overdose
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 level of cortisol in the plasma.
In chronic overdose may experience persistent suppression of adrenocortical function. 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.
To avoid overdose, patients should not use beclomethasone-aeronativ at doses higher than recommended. Of great importance is the regular evaluation of therapy and dose reduction Beclomethasone-aeronativ to the minimum level which ensures effective control of the disease symptoms.
pharmachologic effect
Pharmacological group:
Glucocorticosteroid (GCS) for topical 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:
Suction. More than 25% of the dose of inhaled drug deposited in the respiratory tract, the remaining amount is deposited in the mouth, pharynx and swallowed. The light absorption before beclomethasone dipropionate extensively metabolized to the active metabolite 17-B-IP. Systemic absorption of B-17-MP occurs in the lungs (pulmonary fraction 36%) in the GI tract (26% of the dose received here when swallowed). The absolute bioavailability of unchanged beclomethasone dipropionate and B-17-MP are respectively about 2% and 62% of the inhaled dose. Beclomethasone dipropionate is rapidly absorbed, time to maximum plasma concentration (T max) is 0.3 hours. The B-17 MP-absorbed slower Tmax of 1 hour. It is noted approximately linear relationship between increasing doses of inhaled and systemic exposure of the drug
Distribution. tissue distribution of 20 l for beclomethasone dipropionate and 424 L-17 to B-IP. Relation to plasma proteins is relatively high – 87%.
Metabolism and excretion. Beclomethasone dipropionate-17 and B-MP have high plasma clearance (150 l / h 120 l / h, respectively). The half-life was 0.5 hours and 2.7 hours, respectively.
Pregnancy and breast-feeding
During pregnancy and breastfeeding period Beclomethasone-aeronativ can be given only if the expected benefit to the mother outweighs any possible risk to the fetus or child.
Conditions of supply of pharmacies
On prescription.
side effects
Determination of the frequency: very often (> 1/10), often (1/100 to 1/10) infrequently (from 1/1000 to 1/100), rare (from 1/000 to 1/10000), very seldom (
On the part of metabolism: rarely – hypercortisolism; very rare – systemic glucocorticosteroid effects, symptoms (including hypofunction of the adrenal glands, Cushing’s syndrome).
Immune system: rarely – hypersensitivity reactions, rash, urticaria, angioedema, pruritus.
On the part of the musculoskeletal system: decrease in bone mineral density.
The respiratory system: often – cough; rarely – paradoxical bronchospasm, throat irritation, hoarseness, which disappears after discontinuation of therapy or dose reduction.
Other: often – candidiasis of mouth and throat mucosa.
Systemic effects of inhaled corticosteroids may be observed while taking the drug at high doses for a prolonged time.
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. For the prevention of candidiasis of the oral cavity upon inhalation should rinse the mouth and throat with water. For the treatment of candidiasis can be used antifungals local action while continuing therapy Beclomethasone-aeronativ.
If patients take corticosteroids inside, Beclomethasone-aeronativ appointed 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, to cancel oral corticosteroids (patients needing admission no more than 15 mg of prednisolone can be fully transferred to the inhalation therapy), while in the first months after the transition should carefully monitor the patient until it gipofizarnonadpochechnikovaya not the system recovers sufficiently to provide an adequate response to stressful situations (e.g., 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, often life-threatening patients, and requires higher doses of corticosteroids. An indirect measure of treatment failure is more frequent than in the past, the use of beta2-agonists of short action.
Beclomethasone-aeronativ is not for relief of attacks, and for regular daily use. For cupping used beta2-adrenostimulyatorov short-acting (eg, salbutamol). In severe exacerbations of asthma or lack of efficacy of the therapy should increase the dose of the drug “Beclomethasone-aeronativ” and, if necessary, appoint a systemic corticosteroids and / or antibiotics when infections develop.
With the development of paradoxical bronchospasm should immediately discontinue use Beclomethasone-aeronativ 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 for the treatment of drug inside “Beclomethasone-aeronativ”.
Not recommended abrupt withdrawal of the drug “Beclomethasone-aeronativ”.
Be particularly careful in the treatment of inhaled corticosteroids in patients with active or inactive forms of pulmonary tuberculosis. 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-aeronativ 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-aeronativ may be less effective at low temperatures. Upon cooling spray is recommended to get it out of the plastic and warm hands for a few minutes
Features of the medicinal product with its abolition. Because of the danger of exacerbation should avoid sudden withdrawal of the drug “Beclomethasone-aeronativ”. The dose should be reduced gradually under medical supervision.
Effects on ability to drive vehicles and management mechanisms.
Beclomethasone-aeronativ does not affect the ability to drive vehicles and management mechanisms.
Storage conditions
In the dark place at a temperature not higher than 25 C, away from the heater.
Do not freeze.
Keep out of the reach of children.
Dosing and Administration
Drug “Beclomethasone-aeronativ” is only intended for administration by inhalation.
Bronchial asthma.
Adults and children aged 12 years and older:
Beclomethasone-aeronativ regularly applied (even in the absence of symptoms), the dose of beclomethasone dipropionate is selected considering the severity of asthma and the clinical effect in each case.
The daily dose is divided into several stages.
The recommended initial dose: asthma lung flow – 200 – 600 mcg / day; asthma moderate flow – 600 – 1000 mg / day; severe bronchial asthma – 1000 – 2000 mg / day.
Children aged 4 to 12 years:
Up to 400 micrograms per day in divided doses.
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. In the transition to a high dose of inhaled beclomethasone dipropionate, many patients receiving systemic steroids, will be able to reduce their dose or stop them altogether.
Chronic obstructive pulmonary disease.
The maximum recommended dose Beclomethasone-aeronativ in COPD is 2000 mg per day. In case of accidental inhalation skipping the next dose should be taken in due time in accordance with the scheme of treatment.
Administration can be carried out using special dispensers (spacers), improving the distribution of the drug in the lungs and reduce the risk of side effects
Patients with impaired liver function.
Patients c impaired hepatic function dose reduction is required.
Patients with impaired renal function.
Patients c impaired renal function dose reduction is required.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist