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Instruction for use: Beclometasone + Formoterol (Beclomethasonum+ Formoterolum)

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Pharmacological group

Glucocorticosteroids in combinations

Nosological classification (ICD-10)

J44 Other chronic obstructive pulmonary disease

Allergic bronchitis, Bronchitis asthma, Asthmatic bronchitis, wheeze bronchitis, Bronchitis is an obstructive, bronchi disease, Shortness of sputum in acute and chronic respiratory diseases, Cough in inflammatory diseases of the lung and bronchus, Reversible airflow obstruction, Reversible obstructive airway disease, Obstructive bronchitis disease, Obstructive lung disease, Obstructive bronchitis, Spastic bronchitis, Chronic lung disease, Chronic nonspecific lung diseases, Chronic obstructive pulmonary disease, Chronic obstructive bronchitis, Chronic obstructive airway disease, Chronic obstructive pulmonary disease, Restrictive lung pathology

J45 Asthma

Asthma physical effort, status asthmaticus, Bronchial asthma, Asthma lung flow, Bronchial asthma with obstruction of sputum discharge, Bronchial asthma heavy currents, Bronchial asthma physical effort, hypersecretory asthma, Hormone-dependent form of bronchial asthma, Relief of asthma attacks in bronchial asthma, Non-allergic asthma, nocturnal asthma, Exacerbation of asthma, Asthma attacks, Endogenous forms of asthma, Night asthma, Cough with bronchial asthma

Pharmacology

The pharmacological action is bronchodilating, glucocorticoid, beta2-adrenomimetic.

Pharmacodynamics

The combination contains beclomethasone dipropionate and formoterol. These two active substances with different mechanisms of action show additive effects in reducing the frequency of exacerbations of bronchial asthma.

Used in inhalation at recommended doses of beclomethasone dipropionate has an anti-inflammatory effect characteristic of the GCS at the level of the airways and lungs, reduces the severity of symptoms of bronchial asthma and the frequency of its exacerbations, but it has fewer side effects than GCS (systemic glucocorticosteroids).

Formoterol is a selective β2-adrenergic receptor agonist, which causes relaxation of the smooth muscles of the bronchi in patients with reversible airway obstruction. Bronchodilator effect after inhalation of a single dose of formoterol occurs quickly (within 1-3 min) and lasts for 12 hours.

Bronchial asthma

Clinical efficacy of combination beclomethasone + formoterol when used as a regular therapy. Addition of formoterol to beclomethasone dipropionate reduces the severity of symptoms of bronchial asthma, improves the function of external respiration (FVD) and reduces the frequency of exacerbations of bronchial asthma.

In the course of the clinical study, it was shown that the effect on HPF of the combination beclomethasone + formoterol corresponds to that in the combined use of mono preparations beclomethasone dipropionate and formoterol and exceeds the effect on HPF of one beclomethasone dipropionate.

Clinical efficacy of combination beclomethasone + formoterol when used as a regular and facilitating therapy (Maintenance and Relief Therapy (MART). In a clinical study in adults with uncontrolled moderate to severe bronchial asthma, a comparison of the efficacy of beclomethasone + formoterol as regular therapy (1 inhalation twice daily) and the need for asthma symptoms (a total of up to 8 inhalations / Day) and the effectiveness of the combination beclomethasone + formoterol as a regular therapy (1 inhalation 2 times a day) plus the use of salbutamol as needed. It was shown that the combination of beclomethasone + formoterol in its use for regular therapy and asthma symptoms reliably increased the time to the development of the first severe exacerbation of bronchial asthma (defined as the weighting of the course of bronchial asthma leading to hospitalization or treatment in the intensive care unit or to the need for oral administration GCS for more than 3 days), compared with the use of this combination as a regular therapy plus the use of salbutamol on demand.

The incidence of severe exacerbation of bronchial asthma for 1 patient-year was significantly and statistically significantly lower in the group of patients receiving beclomethasone + formoterol combination as a regular therapy and for relieving asthma symptoms compared to the group of patients who took this combination as a regular therapy and Salbutamol with symptoms of asthma (0.1476 vs 0.2229, respectively). Patients in the combination group beclomethasone + formoterol as regular therapy and to relieve asthma symptoms achieved a more significant clinical improvement in the control of asthma symptoms. In both groups, there was an equal decrease in the average number of inhalations per day for the removal of asthma symptoms and the percentage of patients taking drugs to relieve asthma symptoms.

In another clinical study conducted in patients with bronchial asthma, with the use of provocation of bronchospasm with methacholine, it was shown that a single dose of a combination of beclomethasone + formoterol 100/6 μg provided a rapid bronchodilator effect and a rapid decrease in dyspnea, similar to that when using salbutamol at a dose of 200 μg.

COPD (chronic obstructive pulmonary disease)

In patients with severe COPD (mean FEV1 values, accounting for 42-43% of the calculated norm), the combination beclomethasone + formoterol at a dose of 100/6 μg 2 times a day caused an improvement in the FEV1 index, determined in the morning before the next inhalation dose, comparable to the improvement of that When using a fixed combination of budesonide + formoterol (400/12 μg 2 times a day), and more effective than monotherapy with formoterol (12 μg 2 times a day). In the combination of beclomethasone + formoterol, the average number of exacerbations per year, defined as a persistent increase in symptoms requiring oral glucocorticosteroids and / or antibiotics, appealing to the emergency room or hospitalization of the patient, was similar to that of a fixed combination of budesonide + formoterol. With regard to the frequency of exacerbations of COPD (chronic obstructive pulmonary disease), the combination beclomethasone + formoterol had no advantages compared to monotherapy with formoterol.

Pharmacokinetics

Systemic exposure of active substances (beclomethasone dipropionate and formoterol) in a fixed combination was compared with that of beclomethasone dipropionate and formoterol alone.

In healthy volunteers who received a single combination of beclomethasone + formoterol (4 doses of 100/6 μg) or beclomethasone dipropionate once with propellant chlorofluorocarbon (4 doses of 250 μg) and formoterol with propellant hydrofluoroalkane (4 doses of 6 μg), AUC (The area under the concentration-time curve) of the main active metabolite beclomethasone dipropionate-beclomethasone-17-monopropionate (B-17-MP) -and its Cmax, when using the fixed combination, were respectively 35 and 19% lower than with beclomethasone dipropionate from Propellant of CFC and non-extramelodisperse dispersion of aerosol particle sizes, and the absorption rate was vice versa higher (0.5 vs 2 h).

After using a fixed combination or beclomethasone dipropionate and formoterol separately (from two separate metered-dose inhalers), Cmax formoterol in plasma was similar and its systemic exposure was slightly higher when using a fixed combination than with beclomethasone dipropionate and formoterol in the free combination.

No data have been obtained confirming the presence of pharmacokinetic or pharmacodynamic (systemic) interactions between beclomethasone dipropionate and formoterol.

In healthy volunteers, the use of the spacer Aerochamber Plus 8 in comparison with the standard actuator increased the intake of the active metabolite B-17-MP and formoterol into the lungs by 41 and 45%, respectively. The total system exposure of formoterol did not change, the total system exposure of the B-17-MP decreased by 10%, and the total system exposure of unchanged beclomethasone dipropionate increased.

Pharmacokinetics

Absorption, distribution and metabolism. Beclomethasone dipropionate is a prodrug with a weak affinity for glucocorticoid receptors, which under the action of esterases present in most tissues, turns into its active metabolite B-17-MP, which has a more pronounced anti-inflammatory effect than a pro-drug.

After inhalation of beclomethasone dipropionate is rapidly absorbed from the lungs, its absorption is preceded by an intensive conversion of beclomethasone dipropionate into the active metabolite B-17-MP. Systemic bioavailability of B-17-MP consists of its absorption from the lungs (36%) and gastrointestinal tract (from the swallowed part of the inhalation dose). The bioavailability of the swallowed portion of the dose of beclomethasone dipropionate is negligible, but the pre-systemic conversion of beclomethasone dipropionate in B-17-MP results in 41% of the swallowed dose being absorbed as the active metabolite of B-17-MP. With an increase in the inhalation dose, an almost linear increase in the systemic exposure of B-17-MP is observed. Absolute bioavailability after inhalation for unchanged beclomethasone dipropionate and B-17-MP is approximately 2 and 62% of the nominal dose, respectively. After intravenous injection of beclomethasone, dipropionate and its active metabolite B-17-MP are characterized by high plasma clearance (150 and 120 l / h, respectively), a small Vd (volume of distribution) in the state of reaching Css (equilibrium concentration) in the blood Beclomethasone dipropionate (20 L) and a large Vd of its active metabolite B-17-MP (42 L). The main product of metabolism of beclomethasone dipropionate is its active metabolite B-17-MP. Less active metabolites of beclomethasone dipropionate are beclomethasone-21-monopropionate (B-21-MP) and beclomethasone, but their role in the systemic action of beclomethasone dipropionate is very low. The connection with plasma proteins is moderately high.

Excretion. The bulk of beclomethasone dipropionate is excreted through the intestine with feces in the form of polar metabolites. Renal excretion of beclomethasone dipropionate and its metabolites is insignificant. T1 / 2 beclomethasone dipropionate and B-17-MP are 0.5 and 2.7 hours, respectively.

Special patient groups. The pharmacokinetics of beclomethasone dipropionate in patients with renal or hepatic insufficiency has not been studied. However, when hepatic failure is not expected to change the pharmacokinetics and safety profile of beclomethasone dipropionate, tk. It undergoes very rapid metabolism under the action of esterases, present in the liquid contents of the small intestine, blood serum, lungs and liver, with the formation of more polar products - B-21-MP, B-17-MP and beclomethasone.

It is not expected to increase the system exposure of beclomethasone dipropionate and its metabolites in patients with renal failure, They are practically not excreted by the kidneys.

Pharmacokinetics

Absorption and distribution. After inhalation, formoterol is absorbed from both the lungs and the gastrointestinal tract. From the digestive tract absorbed is the swallowed part of the inhalation dose, which can be 60 to 90% of the inhalation dose depending on the type of inhalation device and inhalation technique, with at least 65% of the swallowed dose being absorbed from the gastrointestinal tract. After ingestion of Cmax unchanged formoterol is achieved within 0.5-1 hour. The relationship of formoterol with plasma proteins is 61-64% with 34% binding to albumin. There was no saturation of the connection between formoterol and blood plasma proteins in the range of plasma concentrations achieved with the use of therapeutic doses. T1 / 2 after oral administration is 2-3 hours. Absorption of formoterol in the dosage range of formoterol fumarate from 12 to 96 μg is linear.

Metabolism. Formoterol is extensively metabolized mainly in the liver, the main way of its metabolism is conjugation with glucuronic acid with the formation of an inactive metabolite. The second important pathway of metabolism is O-demethylation followed by conjugation. In the O-demethylation of formoterol, cytochrome P450 isoenzymes CYP2D6 (cytochrome P450 isoenzyme), CYP2C19 (cytochrome P450 isoenzyme) and CYP2C9 (cytochrome P450 isoenzyme) are involved. Formoterol at therapeutically significant concentrations does not inhibit cytochrome P450 isoenzymes.

Excretion. After a single inhalation of formoterol in doses of 12 to 96 μg, a linear increase in the total renal excretion of formoterol from the powder inhaler is observed. On average, 8 and 25% of the dose is excreted by the kidneys in the form of unchanged formoterol and the sum of all its metabolites, respectively. After a single dose inhalation, 120 μg of T1 / 2 from the plasma is 10 hours. The right-handed and levorotatory enantiomers of unchanged formoterol released by the kidneys are approximately 40 and 60%, respectively.

The relative proportion of the two enantiomers remained constant throughout the range of doses studied, and after the use of repeated doses, the relative accumulation of one enantiomer was not observed compared to the other. After taking formoterol (40-80 μg) in healthy volunteers, 6-10% of the dose was detected in the urine as unchanged formoterol and up to 8% in the form of glucuronides.

A total of 67% of the dose of formoterol when ingested is excreted by the kidneys (mainly in the form of metabolites), and the rest - through the intestine with feces. The renal clearance of formoterol is 150 ml / min.

Special patient groups. The pharmacokinetics of formoterol in patients with hepatic or renal insufficiency have not been studied.

Application of Beclomethasone + Formoterol

Basic therapy of bronchial asthma, which involves the use of a long-acting inhaled glucocorticosteroid (glucocorticosteroids) + β2-adrenomimetic combination in patients whose symptoms are not adequately controlled by the use of inhaled glucocorticosteroids and fast-acting β2-adrenomimetics, or already receiving effective maintenance doses of inhaled glucocorticosteroids and long-acting β2-adrenomimetics actions.

Chronic obstructive pulmonary disease - treatment of bronchial obstruction in patients with severe COPD (FEV1 <50% of the calculated normal value), which, despite conventional bronchodilator therapy, retains significant symptoms of the disease.

Contraindications

Hypersensitivity to active ingredients combination; Age to 18 years.

Restrictions for use

Tuberculosis of the lungs, fungal, viral or bacterial infections of the respiratory system; Thyrotoxicosis; Pheochromocytoma; diabetes; Uncorrectable hypokalemia (because treatment with β2-adrenomimetics in itself can cause potentially dangerous hypokalemia, especially when taking drugs that can cause hypokalemia, such as xanthine derivatives, corticosteroids and diuretics, and because patients with Severe bronchial asthma, hypoxia can potentiate the effects associated with hypokalemia) (See "Precautions"); Idiopathic hypertrophic subaortic stenosis; Hypertrophic obstructive cardiomyopathy; Heart rhythm disturbances, especially with AV-blockade of the third degree and tachyarrhythmias; Severe arterial hypertension; Presence of an aneurysm of any localization; Presence of other severe cardiovascular diseases (acute myocardial infarction, chronic ischemic heart disease, chronic heart failure, occlusive vascular lesions, especially atherosclerotic); Congenital or developed with the use of LS prolongation of the interval QTc (> 0.44 s) (reception of formoterol may cause lengthening of the interval QTc); pregnancy; lactation.

pregnancy and lactation

There are no clinical data on the use of combination beclomethasone + formoterol during pregnancy. Studies carried out on animals with simultaneous application of beclomethasone dipropionate and formoterol showed the presence of reproductive toxicity only at their high system exposure. In connection with the tocolytic action of β2-adrenomimetics, special care should be taken during labor. Formoterol should not be recommended for use during pregnancy, and especially at the end of pregnancy or during labor. If possible, another, more safe pregnancy treatment should be used.

During pregnancy, the combination beclomethasone + formoterol should only be used when the benefits of using it exceed the potential risk to the fetus. It is recommended to apply a minimum dose, which provides effective control of symptoms of bronchial asthma or COPD.

There is insufficient clinical data on the use of the combination beclomethasone + formoterol during breastfeeding in humans.

Although there are no experimental data on animals, it can be assumed that beclomethasone dipropionate, like other GCS, is secreted into breast milk. It is not known whether formoterol is excreted in breast milk in humans, but in animals it was excreted in breast milk.

The combination of beclomethasone + formoterol can be used in nursing women only when the expected therapeutic effect for the mother exceeds the potential risk for the child.

Side effects

The combination contains beclomethasone dipropionate and formoterol fumarate, so it can be expected that it can cause side effects that are characteristic of these components. There is no evidence that their simultaneous use causes additional side effects.

The undesirable effects associated with beclomethasone dipropionate and formoterol, used as a fixed combination or separate drugs, are presented below and grouped according to the system-organ classes. The frequency of their occurrence was determined as follows: very often (≥1 / 10); Often (≥1 / 100, <1/10); Infrequently (≥1 / 1000, <1/100); Rarely (≥1 / 10000, <1/1000); Very rarely (<1/10000); The frequency is unknown (according to available data, it is not possible to determine the frequency of occurrence of an undesirable effect).

Infectious and parasitic diseases: often - pharyngitis; Infrequently - flu, fungal infections of the mouth, candidiasis of the pharynx and esophagus, vaginal candidiasis, gastroenteritis, sinusitis.

From the side of blood and lymphatic system: infrequently - granulocytopenia; Very rarely - thrombocytopenia.

From the immune system: infrequently - allergic dermatitis; Very rarely - hypersensitivity reactions, including erythema, swelling of the lips, face, eyes and pharynx.

From the endocrine system: very rarely - oppression of the adrenal glands.

From the side of metabolism and nutrition: infrequently - hypokalemia, hyperglycemia.

Disorders of the psyche: infrequently - dysphoria; Very rarely - deviations in behavior, sleep disorders, hallucinations.

From the nervous system: often - headache; Infrequently - a tremor, a giddiness.

From the side of the organ of vision: very rarely - glaucoma, cataract.

From the side of the hearing organ and labyrinthine disturbances: infrequently - tubo-otitis.

From the heart: infrequent - a feeling of heartbeat, prolongation of the QTc interval, changes in the ECG (electrocardiogram, electrocardiography), tachycardia, tachyarrhythmia; Rarely - ventricular extrasystoles, angina pectoris; Very rarely - atrial fibrillation.

From the side of the vessels: infrequently - hyperemia, flushes of blood to the skin of the face.

From the respiratory system, chest and mediastinum: often - dysphonia; Infrequently - rhinitis, cough, productive cough, painful sensitivity of the pharynx, decreased effectiveness or inefficiency previously usually helped the patient with an attack of bronchospasm and drugs; Rarely - a paradoxical bronchospasm; Very rarely - shortness of breath, exacerbation of bronchial asthma.

From the digestive system: infrequently - diarrhea, dryness of the oral mucosa, dyspepsia, dysphagia, burning sensation in the lips, nausea, dysgeusia (distortion of taste).

From the skin and subcutaneous tissues: infrequently - itching, rash, hyperhidrosis; Rarely - hives, angioedema.

From the musculoskeletal system and connective tissue: infrequently - muscle spasms, myalgia; Very rarely - a slowdown in children and adolescents.

From the side of the kidneys and urinary tract: rarely - jade.

General disorders and disorders at the injection site: very rarely - peripheral edema; Frequency unknown - increased fatigue.

From laboratory and instrumental studies: infrequently - increase in the level of C-reactive protein, an increase in the number of platelets in the peripheral blood, an increase in the concentration of free fatty acids, insulin, ketone bodies, glycerol in the blood; Rarely - increased blood pressure, lower blood pressure; Very rarely - reduction of BMD.

As with any other inhaled therapy, paradoxical bronchospasm may develop (see "Precautions").

The following of the observed undesirable reactions are usually associated with formoterol: headache, tremor, palpitation, cough, muscle spasms and QTc interval prolongation.

The following undesirable reactions are usually associated with the use of beclomethasone dipropionate: fungal infections of the oral mucosa, candidiasis of the oral mucosa, dysphonia, painful sensitivity of the pharynx.

The possibility of developing dysphonia and candidiasis can be reduced by rinsing the mouth and throat with water or brushing teeth after using a combination of beclomethasone + formoterol. Candidiasis, which proceeds with clinical symptoms, can be treated with local antifungal therapy while continuing treatment with a combination of beclomethasone + formoterol.

When using inhaled GCS, including beclomethasone dipropionate, systemic effects of GCS may occur, especially when high doses of inhaled glucocorticosteroids are used for a long time. They can manifest themselves as oppression of adrenal function, decrease in BMD, slow growth in children and adolescents, development of cataracts and glaucoma (see "Precautions").

Hypersensitivity reactions may also develop, including rash, itching with hives, erythema, or swelling of the eyes, face, lips and throat (pharynx and larynx).

Interaction

Blockers of β-adrenergic receptors can weaken or completely neutralize the effect of formoterol. The combination of beclomethasone + formoterol should not be used concomitantly with β-blockers (including eye drops), except in cases of compulsion.

With the combined use of combination beclomethasone + formoterol and other β-adrenergic drugs, it is possible to increase the side effect of formoterol, therefore caution should be exercised when theophylline or other β-adrenergic drugs are used concomitantly with formoterol.

The combined use of combination beclomethasone + formoterol and quinidine, disopyramide, procainamide, phenothiazines, antihistamine drugs (terfenadine), MAO inhibitors (monoamine oxidase) and tricyclic antidepressants can prolong the QTc interval and increase the risk of ventricular arrhythmias.

In addition, levodopa, levothyroxine, oxytocin and ethanol can reduce the tolerance of the heart muscle to β2-adrenomimetics.

The combined use of MAO inhibitors, as well as drugs that have similar properties, such as furazolidone and procarbazine, can cause an increase in blood pressure (arterial pressure).

There is an increased risk of arrhythmia in patients with general anesthesia with halogenated hydrocarbons.

As a result of the use of β2-adrenomimetics, hypokalemia can occur, which can be intensified by concomitant treatment with xanthine derivatives, mineralocorticosteroids, GCS, and diuretics (see PRECAUTIONS). Hypokalemia may increase the predisposition to the development of arrhythmias in patients taking cardiac glycosides.

Overdose

Inhalation doses of combination beclomethasone + formoterol up to 12 cumulative (total dose of beclomethasone dipropionate 1200 μg, formoterol 72 μg) were studied in patients with bronchial asthma. Cumulative treatment did not cause undesirable effects on vital functions, neither serious nor severe adverse effects were observed.

Symptoms: Excessively high doses of formoterol can lead to effects typical of β2-adrenomimetics - nausea, vomiting, headache, tremor, drowsiness, palpitations, tachycardia, ventricular arrhythmias, QTc interval prolongation, metabolic acidosis, hypokalemia, hyperglycemia.

Single inhalation of doses of beclomethasone dipropionate, significantly exceeding the recommended, may lead to a temporary inhibition of the function of the adrenal cortex. Usually this does not require taking any emergency measures, because in most cases (according to the determination of the concentration of cortisol in the blood plasma) the normal function of the adrenal glands is restored within a few days. Such patients should continue treatment in a dose sufficient to control the symptoms of bronchial asthma.

With chronic administration of excessive doses of beclomethasone dipropionate, its systemic effect may appear - a significant inhibition of the adrenal cortex up to adrenal crises. Acute adrenal crisis is manifested by hypoglycemia, accompanied by confusion and / or convulsions. Situations that can serve as triggers for an acute adrenal crisis include trauma, surgery, infection, or a rapid reduction in the dose of beclomethasone in the combination.

With a chronic overdose of beclomethasone dipropionate, there is a risk of suppressing the function of the adrenal cortex (see "Precautions").

Treatment: when symptoms of an overdose of formoterol are shown, it supports the basic functions of the body and symptomatic treatment. In severe cases - hospitalization. The use of cardioselective β-adrenergic blockers can be considered with extreme caution, The use of β-blockers can cause bronchospasm. It is necessary to monitor the potassium content in the blood plasma.

In chronic overdose of beclomethasone, it is recommended to monitor the reserve function of the adrenal cortex. Treatment should be continued at a dose sufficient to control the symptoms of asthma.

Routes of administration

Inhalation.

Precautions

If patients have such accompanying diseases as heart rhythm disturbances, especially AV-blockade of the third degree and tachyarrhythmia, idiopathic hypertrophic subaortal stenosis, hypertrophic obstructive cardiomyopathy; Severe cardiac disease - acute myocardial infarction, chronic ischemic heart disease, CHF, occlusive vascular lesions, especially atherosclerotic, aneurysm, hypertension, as well as prostatic hypertrophy, glaucoma, caution should be exercised when using the combination beclomethasone + formoterol, such patients may need to monitor them State.

Treatment of patients with known lengthening or suspected prolongation of the QTc interval (QTc> 0.44 s) both by congenital and drug-induced drug use should be carried out with caution. The use of formoterol may induce prolongation of the QTc interval.

Caution is also required when a combination of beclomethasone + formoterol is used in patients with thyrotoxicosis, diabetes, pheochromocytoma and uncorrected hypokalemia. In the treatment of β2-adrenomimetics, potentially severe hypokalemia can occur. Particular caution is recommended in patients with severe bronchial asthma, t. The undesirable effects associated with hypokalemia may be potentiated by hypoxia. Hypokalemia can also be potentiated with simultaneous treatment with other drugs that can cause hypokalemia, such as xanthine derivatives, mineralocorticosteroids, GCS, and diuretics (see "Interaction").

Special care should be taken in patients with unstable bronchial asthma who use fast-acting bronchodilators to relieve asthma symptoms. In such cases it is recommended to monitor the potassium content in the blood serum. Inhalations of high doses of formoterol can lead to an increase in the concentration of glucose in the blood. In patients with diabetes mellitus, the concentration of glucose in the blood should be monitored during the application of beclomethasone + formoterol combination.

If general anesthesia with halogenated hydrocarbons is planned, the patient should be warned that inhalations of beclomethasone + formoterol combination should not be performed for at least 12 hours prior to the onset of anesthesia (due to the risk of heart rhythm disturbances).

As with the use of other drugs containing inhaled glucocorticosteroids, the need to apply and dose combination beclomethasone + formoterol in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system should be reviewed.

Because of the risk of developing exacerbation of bronchial asthma or COPD, treatment with a combination of beclomethasone + formoterol can not be abruptly discontinued, the dose should be reduced gradually and under the supervision of a doctor.

If the patient considers treatment ineffective, he should consult a doctor. An increase in the need for bronchodilators to relieve asthma symptoms indicates a worsening of the course of the disease and requires a reassessment of the tactics of treating bronchial asthma. A sudden and progressive deterioration in the control of asthma or COPD symptoms is potentially life threatening, and the patient should undergo an urgent medical examination. Consideration should be given to the need to increase the dose of GCS (or inhalation, or oral), and if there is a suspicion of infection - about the need for antibiotics.

Patients should not begin treatment with a combination of beclomethasone + formoterol during exacerbation of bronchial asthma, or with significant weighting or acute deterioration of its course. During treatment with a combination of beclomethasone + formoterol, serious adverse effects and complications associated with bronchial asthma may occur. If symptoms of bronchial asthma can not be controlled or worsen after treatment, patients are advised to continue treatment, but consult a doctor.

As with any other inhaled therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after inhalation of the dose of the combination beclomethasone + formoterol. Paradoxical bronchospasm should be stopped immediately with the help of fast acting inhalation bronchodilators. It is necessary to stop therapy with a combination of beclomethasone + formoterol, review treatment tactics and, if necessary, transfer the patient to alternative therapy. The combination of beclomethasone + formoterol should not be used for the initial treatment of bronchial asthma.

To treat an acute attack of bronchial asthma, patients should always be advised to have a fast-acting bronchodilator with a combination of beclomethasone + formoterol (for patients who use it as regular therapy and as needed to relieve asthma symptoms) or a separate rapid bronchodilator (for patients using the combination Beclomethasone + formoterol only as a regular therapy).

The patient should be cautioned about the need for a daily combination of beclomethasone + formoterol in accordance with the recommendations given by the doctor, even if they do not have any manifestations of bronchial asthma. Inhalations for the removal of symptoms of bronchial asthma should be performed in response to the development of asthmatic symptoms, but they are not intended for regular preventive use, for example, before physical exertion. To do this, consider the possibility of using a separate rapid bronchodilator.

When the control over the symptoms of bronchial asthma is achieved, consideration can be given to the gradual decrease in the dose of the combination beclomethasone + formoterol. In case of a dose reduction, it is important to conduct a regular examination of the patient. The lowest effective dose should be used.

Any inhaled GCS can cause systemic effects, especially with prolonged use in high doses, but it should be noted that the likelihood of these effects when using inhaled GCS is much lower than when treated with oral GCS. Possible systemic effects include Cushing's syndrome, cushingoid, oppression of adrenal function, growth retardation in children and adolescents, decreased BMD, cataract and glaucoma. Therefore, it is important that such patients are regularly observed by a doctor and the dose of inhaled glucocorticosteroids decreases to the lowest, at which effective control over the symptoms of bronchial asthma is maintained.

Long-term treatment of patients with high doses of inhaled glucocorticosteroids may lead to suppression of adrenal function and the development of acute adrenal insufficiency. The group of special risk includes children under 16 years of age taking inhalation doses of beclomethasone dipropionate exceeding the recommended ones. Situations that could potentially be the starting point for the development of acute adrenal insufficiency include trauma, surgery, infection, or any rapid reduction in the dose of beclomethasone dipropionate taken. Symptoms of adrenal insufficiency are usually nonspecific - anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, lowering blood pressure, confusion, hypoglycemia and convulsions. During stress periods and with planned surgical interventions, consideration should be given to the additional use of systemic GCS.

If there is reason to believe that, against the background of previous systemic therapy of GCS, adrenal function was disrupted, caution should be exercised in transferring patients to treatment with a combination of beclomethasone + formoterol. Patients who are transferred from the reception of GCS inside by inhalation can be at a risk of decreasing the adrenal reserve. Patients who required high doses of emergency GCS in the past or who received long-term treatment with high doses of inhaled glucocorticosteroids may also be at risk. This possibility of residual disturbance of the function of the adrenal gland should always be borne in mind in urgent and planned stressful situations, and in these cases the question of appropriate treatment of the SCS should be considered. If the adrenal gland function is severe, it may be necessary to consult a specialist before the planned procedures.

It is recommended to instruct the patient about the need to rinse the mouth and throat with water or brush your teeth after inhalation in order to minimize the risk of candida infection of the oral and pharyngeal mucosa.

Impact on the ability to drive vehicles and engage in other potentially hazardous activities. The effect of the combination beclomethasone + formoterol on the ability to drive vehicles and engage in other potentially hazardous activities has been unfaithful.

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