Beclazone ECO inhalation aerosol 250 μg/dose, spray can of 200 doses — Made in Ireland — Free Delivery

Pharmacological properties

Pharmacodynamics. Beclomethasone dipropionate is a precursor of the active substance with a weak affinity for cc-receptors. it is hydrolyzed by esterases to form the active metabolite of beclomethasone-17-monopropionate, which has a high local anti-inflammatory activity.

Pharmacokinetics. When inhaled, systemic absorption of unchanged beclomethasone dipropionate occurs through the lungs with insignificant oral absorption of the dose that has entered the gastrointestinal tract. Before absorption, beclomethasone dipropionate is intensively converted to its active metabolite, beclomethasone-17-monopropionate. Systemic absorption of beclomethasone-17-monopropionate consists of absorption in the lungs and in the gastrointestinal tract. The absolute bioavailability with inhalation is approximately 60% of the administered dose for beclomethasone-17-monopropionate.

Beclomethasone dipropionate is very quickly eliminated from the systemic circulation by metabolism with the participation of esterases. The main metabolic product is the active beclomethasone-17-monopropionate.

The volume of distribution of beclomethasone dipropionate in the plateau phase is moderate (20 L), but in beclomethasone-17-monopropionate it is higher (424 L). Plasma protein binding is moderately high (87%).

Beclomethasone dipropionate and beclomethasone-17-monopropionate have high plasma clearance (150 and 120 l / h), T1 / 2 are 0.5 and 2.7 hours. Approximately 60% of the dose is excreted in the feces, 12% - in the urine as free and conjugated polar metabolites. Renal clearance of beclomethasone dipropionate and its metabolites is negligible.

Indications

Beclazone -Eco, 100 mcg: prophylactic treatment for mild, moderate and severe chronic BA.

Beclazone -Eco, 250 mcg: treatment of severe asthma in adults, as well as treatment of patients requiring the use of systemic steroids for adequate control of asthma symptoms.

Application

The drug is prescribed for oral inhalation only. the therapeutic effect is observed after treatment for several days and reaches a maximum after 2-3 weeks. when transferring a patient from other inhaled drugs to beclazon-eco, it is necessary to leave the same dose of beclomethasone dipropionate, which is subsequently determined individually.

Beclazone -Eco, 100 mcg. For optimal results, Beclazone -Eco should be used regularly. The initial dose should be appropriate for the severity of the disease.

The minimum dose should be established at which effective BA control is ensured.

Adults and children over the age of 12 years: the initial dose is from 100 to 500 mcg / day (the maximum daily dose is 1000 mcg), depending on the severity of the BA patient.

The maintenance dose is usually 200–400 mcg, evenly distributed throughout the day. If necessary, you can use higher doses, up to 1000 mcg during the day.

Children aged 7–12 years: the initial dose is 100 mcg 2 times a day (the maximum daily dose is 200 mcg), depending on the severity of the BA patient.

If asthma symptoms remain satisfactory, then the dose can be gradually reduced to the minimum effective dose that ensures effective asthma control.

Beclazone -Eco, 250 mcg. Patients should be aware that Beclazone -Eco should be used to prevent the disease and therefore should be used regularly, even in the absence of asthma attacks.

The dose of the drug is adjusted depending on the individual reaction.

If the improvement in the condition after the use of short-acting bronchodilators becomes less effective or more inhalations are required than usual, treatment should be reconsidered.

The initial dose should be appropriate for the severity of the disease. For patients requiring a high dose of inhaled corticosteroids, the initial dose should be 1000 mcg / day. The dose of the drug can then be adjusted until control of AD symptoms is achieved or reduced to the minimum effective, depending on the patient's individual response.

Adults and children over the age of 12 years (including elderly patients): 1000 mcg / day; the dose can be increased to 2000 mcg / day. After stabilization of the patient's condition, the dose can be reduced. The daily dose can be prescribed for 2; 3 or 4 receptions.

For optimal results, Beclazone -Eco must be used regularly, even in the absence of symptoms.

Instructions for using inhalers

Check the operation of the inhaler before using it.

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 index finger on the bottom and your thumb on the top of the can. Shake the can vigorously up and down.

3. Make an exhalation as full as possible (without tension). Clamp the outlet tube of the can tightly with your lips. Take a slow deep breath. At the moment of the beginning of inhalation, press the bottom of the can with the index finger, releasing the dose of the medicine. Continue to inhale slowly and deeply.

4. Remove the inhaler tube from your mouth and hold your breath for 10 seconds or as long as you can do without tension. Exhale slowly.

5. If you need to take more than one dose of medication, wait about 1 minute and then repeat the action from step 2. Put the cap back on the inhaler.

Take your time while performing step 3. At the time the dose is released, it is important to inhale as slowly as possible.

Inhaler care

1. Remove the aluminum cartridge from the plastic case. Avoid contact of the can with water.

2. Remove the protective cap.

3. Rinse the plastic case with the oral applicator with hot water and dry well (do not use direct heat).

4. After drying, put the cartridge back in the plastic case, close the mouth applicator with a protective cap.

The mouth applicator should be washed once a week.

Contraindications

Hypersensitivity to beclomethasone dipropionate or to any of the excipients.

Side effects

Infections and invasions: latent / opportunistic infections, oral and throat candidiasis.

Immune system disorders: allergic reactions, including angioedema of the eyes, throat, lips and face; respiratory symptoms (dyspnea and / or bronchospasm with increased wheezing, cough) and anaphylactoid / anaphylactic reactions.

Endocrine system disorders: Cushing's syndrome, cushingoid signs, suppression of adrenal function (systemic exposure), growth retardation in children and adolescents.

Disturbances from the organ of vision: cataract, blurred vision, central serous retinopathy, glaucoma (systemic exposure).

Respiratory system disorders: hoarseness, throat irritation, paradoxical bronchospasm.

Skin and subcutaneous tissue disorders: urticaria, rash, pruritus, erythema.

Musculoskeletal and connective tissue disorders: decreased bone mineral density (systemic exposure).

Mental disorders: sleep disturbances, anxiety, depression, aggression, behavior changes, including hyperactivity and agitation (mainly in children).

Special instructions

Treatment for BA should be carried out according to a step-by-step program, the patient's condition should be regularly monitored both clinically and by determining the parameters of the respiratory function.

An increase in the frequency of administration / doses of bronchodilators (in particular, rapid inhalations of β2-agonists) in order to eliminate BA symptoms indicates a deterioration in BA control. In these conditions, therapy needs to be reviewed. A sudden and progressive deterioration in asthma control is potentially life-threatening; therefore, the GCS dose should be increased. In patients at risk, peak flowmetry is required.

Beclazone -Eco is intended not for the relief of acute asthma attacks, but for long-term preventive treatment. To alleviate the condition in acute asthmatic attacks, fast- and short-acting inhaled bronchodilators should be used.

It is necessary to use the inhaler correctly in order to ensure that the drug enters the bronchi. Aerosol actuation should be synchronized with inhalation. Insufficient response to treatment or severe exacerbation of asthma requires an increase in the dose of Beclazone -Eco and, if necessary, the use of systemic steroids and / or antibiotics in the presence of an infection.

When using inhaled GCS, especially in high doses and for a long time, a systemic effect may occur, but much less than when taking oral steroids. Systemic action can be manifested by Cushing's syndrome, cushingoid symptoms, adrenal suppression, growth retardation in children and adolescents, decreased bone mineralization, cataracts and glaucoma. Therefore, it is important that the dose of inhaled corticosteroids is reduced to the minimum possible, which would support effective control of asthma symptoms. In such patients, the function of the adrenal cortex should be regularly monitored and the dose of the systemic steroid should be reduced with caution. Some patients experience discomfort (i.e., headache, nausea, joint or muscle discomfort) during the failure phase, despite maintaining or even improving respiratory function. They need to be encouraged to continue inhalation and withdrawal from the systemic steroid, except in cases where there are objective signs of adrenal insufficiency. It is recommended to regularly monitor the growth of children using long-term treatment with inhaled GCS.

There is an individual hypersensitivity to inhaled corticosteroids.

The transfer of patients from oral corticosteroids to Beclazone -Eco requires special attention and constant monitoring of adrenal function, mainly because the restoration of dysfunction of the adrenal cortex caused by prolonged systemic treatment with steroids is slow. The patient's condition should be moderately stable before the start of inhalation of Beclazone -Eco as an addition to the usual maintenance dose of a systemic steroid. After about 1 week, a gradual withdrawal of the systemic steroid begins, reducing the daily dose by 1 mg of prednisolone or its equivalent for other GCS, at least with weekly breaks.

A spirometric and clinical assessment should be used when reducing doses during oral administration of corticosteroids. Most patients can be successfully transferred to Beclazone -Eco while maintaining proper respiratory function, but special care is required in the first months after the transfer, until the hypothalamic-pituitary-adrenal function has recovered enough to allow the patient's body to cope with unforeseen events such as trauma , surgery or infection.

Due to the possibility of suppressing the function of the adrenal glands, the transfer of patients from oral corticosteroids to Beclazone -Eco requires special attention and constant monitoring of the function of the adrenal glands.

The process of switching to Beclazone -Eco and the termination of systemic therapy should be gradual and patients should have a special card with them warning about the need for additional administration of a systemic steroid during a stressful period, for example, in case of a severe asthmatic attack, severe intercurrent diseases, surgical interventions, injuries, they should also provide a supply of oral steroids for use in an unpredictable event, for example, when AD symptoms worsen as a result of an infection located in the chest area. It is necessary to increase the dose of Beclazone -Eco at this time, and after stopping the intake of a systemic steroid, reduce it to a maintenance level.

Similarly, replacing systemic steroid therapy with inhaled therapy can sometimes unmask allergic diseases, such as allergic rhinitis or eczema, previously controlled by systemic steroid use. These allergic manifestations should be treated with antihistamines and / or topical drugs, including corticosteroids.

Do not suddenly stop treatment with Beclazone -Eco!

Patients with high blood levels of Candida precipitins, which indicate a history of infection, are more likely to develop oral and throat candidiasis (candidal stomatitis). It may be beneficial for all patients to rinse their mouth with water after using the inhaler.

As with other inhaled drugs, paradoxical bronchospasm may develop with rapidly increasing shortness of breath after inhalation. In this case, fast-acting inhaled bronchodilators should be used immediately, the inhalation of Beclazone -Eco should be stopped immediately, the patient should be examined and, if necessary, an alternative therapy should be prescribed.

Patients should also be advised that Beclazone -Eco will have to be used regularly for optimal results, even if they do not have any symptoms. Patients receiving treatment with Beclazone -Eco at 100 μg / dose can be transferred directly to treatment with Beclazone -Eco at 250 μg / dose (in the same total daily dose, if necessary, increasing the dose to a maximum daily dose of 1000 μg) ... In most patients, there is no significant effect on the levels of free cortisone in blood plasma or urine until the dose of 1000 mcg / day is exceeded. In some patients who receive 2000 mcg / day of beclomethasone dipropionate, a decrease in the level of free cortisone in blood plasma or urine was noted, although the short-term adrenal reserve remains unchanged. In any patient, the risk of developing adrenal depression should be weighed against the therapeutic benefit and measures should be taken to provide support with systemic steroids in situations of prolonged stress.

As with the treatment of other inhaled corticosteroids, special care is required when prescribing Beclazone -Eco to patients with active and latent pulmonary tuberculosis. Treatment of corticosteroids can mask the symptoms of pulmonary tuberculosis and other bacterial, viral and fungal infections of the respiratory tract. Reactivation of pulmonary tuberculosis is possible. If the drug is prescribed to patients with concomitant respiratory tract infections, they should be treated appropriately. With restrictions on the use of the drug for the treatment of patients with lung abnormalities, such as bronchiectasis and pneumoconiosis due to the possibility of a fungal infection. After using the drug, rinse the mouth with water.

The drug should not be prescribed to patients with herpes simplex and status asthmaticus. Particular care should be taken to minimize the use of local corticosteroids in immunosuppressed patients.

The drug should be used with caution in patients with viral, bacterial and fungal infections of the eye or mouth, as well as the respiratory tract. In the case of a bacterial infection of the respiratory tract, an appropriate antibiotic may be necessary.

Patients should be warned that the drug contains a small amount of ethanol. At therapeutic doses, the amount of ethanol is extremely small and does not pose a risk to patients.

An aerosol can contains liquid under pressure of compressed gas, so it should not be exposed to temperatures above 50 ° C, punctured or broken, even when it is likely empty. Do not refrigerate or freeze.

Medicines that are no longer needed should be disposed of in accordance with the internal rules for the disposal of this type of product. These measures will help protect the environment.

Application during pregnancy or lactation. The safety of using Beclazone -Eco during pregnancy has not been completely established. Inhalation of beclomethasone may be accompanied by intrauterine growth retardation. When deciding on the use of beclomethasone during pregnancy, it is required to weigh the ratio of the expected benefits to the mother and the potential risk to the fetus.

Beclomethasone passes into breast milk, but in very small quantities. Prescription of the drug during lactation should be weighed taking into account the fact that the therapeutic benefit from the use of the drug should be greater than the possible risk to the fetus.

Children. Beclazone -Eco 100 mcg is not recommended for use in children under the age of 7 years due to insufficient data on its safety and effectiveness.

Beclazone -Eco 250 mcg is not recommended for children under 12 years of age.

The ability to influence the reaction rate when driving or working with other mechanisms. Does not affect.

Interactions

The simultaneous use of barbiturates, phenytoin or rifampicin can increase metabolism and reduce the effectiveness of oral corticosteroids. the response to anticoagulants can be reduced and in some cases increased due to the action of oral corticosteroids. the simultaneous use of oral corticosteroids or diuretics that do not retain potassium, such as thiazides or furosemide, can cause excessive loss of potassium. no interaction was reported with the use of the drug Beclazone -Eco.

Beclazone -Eco contains a very small amount of ethanol, therefore, theoretically, in patients with hypersensitivity, it is possible to interact while taking it with disulfiram or metronidazole.

Overdose

The acute toxicity of Beclazone -Ecois very low. the only harmful effect after inhalation of a large number of doses for a short time is the temporary suppression of the hypothalamic-pituitary-adrenal function. in this case, no special measures are required. treatment should be continued at the recommended dose. restoration of the hypothalamic-pituitary-adrenal function occurs within 1-2 days.

However, when using the drug in doses exceeding the recommended ones, for a long time, some suppression of adrenal function is possible in addition to suppression of the hypothalamic-pituitary-adrenal function. In such cases, it is necessary to check the reserve of adrenal function. The patient should be treated as a steroid dependent and transferred to an appropriate maintenance dose of a systemic steroid such as prednisone. As soon as the patient's condition stabilizes, he should be transferred to Beclazone -Ecousing the method described in the SPECIAL INSTRUCTIONS section.

There is no specific treatment for beclomethasone dipropionate overdose. In case of overdose, supportive therapy should be carried out with appropriate supervision if necessary. Further treatment is according to the clinical condition or according to local guidelines, if available.

Storage conditions

At a temperature not exceeding 25 ° c.