Foster (Foster)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBeclomethasone + FormoterolBeclomethasone + Formoterol
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  • Foster
    aerosol d / inhal. 
    Kiesi Pharmaceuticals SpA     Italy
    • Dosage form: & nbsp

    Aerosol for inhalation dosed.

    Composition:

    1 dose of the drug contains:

    Active substances:

    beclomethasone dipropionate 0.100 mg

    formoterol fumarate 0.006 mg

    Excipients:

    hydrochloric acid 1M 0.014 mg, ethanol anhydrous 6.960 mg, norflurane (1,1,1,2-tetrafluoroethane) 50.92 mg.

    Description:Colorless or slightly yellow, clear solution in an aluminum can. The valve and the can should be free of visible corrosion.
    Pharmacotherapeutic group:Bronchodilator - (glucocorticosteroid local + β2-adrenomimetic selective)
    ATX: & nbsp

    R.01.A.D.01   Beclomethasone

    R.03.A.C.13   Formoterol

    Pharmacodynamics:

    The drug Foster contains beclomethasone dipropionate and formoterol. These two active substances of the drug 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 glucocorticosteroids (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 systemic SCS.

    Formoterol is a selective agonist β2-adrenergic receptors, causing 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 the drug Foster 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 the FVD of the preparation of Foster corresponds to that when using a combination of mono preparations beclomethasone dipropionate and formoterol and exceeds the effect on HPF of one beclomethasone dipropionate.

    Clinical efficacy of the drug Foster when used as a regular and facilitating therapy (Maintenance and Relief Therapy (MART)

    In a clinical study conducted in adults with uncontrolled bronchial asthma of moderate and severe severity, a comparison of the effectiveness of the drug Foster,(I inhalation 2 times a day) and according to the need to relieve asthma symptoms (up to 8 inhalations a day in total) and the effectiveness of the drug Foster, taken as a regular therapy (1 inhalation 2 times a day) plus the use of salbutamol as needed. It was shown that Foster's preparation, when used for regular therapy and for the removal of asthma symptoms, significantly increased the time until 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 the need for admission oral glucocorticosteroids for more than 3 days), compared with the use of the drug Foster 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 who received Foster as a regular therapy and to relieve asthma symptoms compared to the group of patients taking Foster as a regular therapy and salbutamol at symptoms of an asthma (0,1476 against 0,2239, accordingly).Patients in the Foster group as a regular therapy and for relieving 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 for asthma symptoms per day and the percentage of patients taking medications 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 the drug Foster at a dose of 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.

    Chronic obstructive pulmonary disease (COPD) In patients with severe COPD (with average FEV1 values ​​[the volume of forced expiration in the first second] of 42-43% of its calculated norm), the drug Foster at a dose of 100/6 μg twice a day caused an improvement in the FEV index determined in the morning before the application of a regular inhalation dose, comparable with the improvement of that with a fixed combination of budesonide / formoterol (400/12 μg 2 times a day),and greater efficacy compared with monotherapy with formoterol (12 mcg 2 times a day). With Foster, the average number of exacerbations per year, defined as a persistent increase in symptoms requiring oral 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 and formoterol. With regard to the frequency of exacerbations of COPD, Foster did not have an advantage over formoterol monotherapy.

    Pharmacokinetics:
    Systemic exposure of active substances (beclomethasone dipropionate and formoterol) in a fixed combination of the drug Foster was compared with that of monotherapy with beclomethasone dipropionate and formoterol.
    In healthy volunteers who took a single dose of Foster's preparation (4 doses of 100/6 μg) or one-time beclomethasone dipropionate with propellant chlorofluorocarbon (CFCs) (4 doses of 250 μg each) and formoterol with propellant hydrofluoroalkane (HFA) (4 doses of 6 μg each), the area under the pharmacokinetic concentration-time curve (AUC) of the main active metabolite beclomethasone(B-17-MP) and its maximum plasma concentration (Cmax) with the use of the preparation Foster were accordingly 35% and 19% lower than with the use of the drug form beclomethasone dipropionate with propellant CFC and non-extramelodispersed the particle size distribution of the aerosol, and, conversely, the rate of its absorption was higher (0.5 h against 2 h) with Foster as compared to using only one beclomethasone dipropionate with CFC propellant in a dosage form with an extrinsic-dispersed particle size distribution of the aerosol.
    Following the use of a fixed combination (Foster's preparation) or a combination of monotherapy with beclomethasone dipropionate and formoterol (from two separate metered-dose inhalers), the maximum plasma concentrations of formoterol were similar, and its systemic exposure was slightly higher after Foster than with two separate beclomethasone dipropionate inhalers and formoterol in a free combination. No data have been obtained confirming the presence of pharmacokinetic or pharmacodynamic (systemic) interaction between beclomethasone dipropionate and formoterol.
    In healthy volunteers, the use of the spacer "Aero Chambers Plus" in comparison with the use of a standard actuator increased the intake of the active metabolite B-17-MP and formoterol by 41% and 45%, respectively, into the lungs. 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 the unchanged beclomethasone dipropionate increased.
    Pharmacokinetaka beclomethasone dipropionate
    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 beclomethasone dipropionate prodrug. After inhalation of beclomethasone, dipropionate is rapidly absorbed from the lungs; its absorption is preceded by an intensive conversion of beclomethasone dipropionate into its active metabolite B-17-MP. Systemic bioavailability of B-17-MP is composed of its absorption from the lungs (36%) and from the gastrointestinal tract (GIT) (from the swallowed part of the inhalation dose). Bioavailability swallowed part of the dose of beclomethasone dipropionate is negligible, but the pre-systemic conversion of beclomethasone dipropionate to 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 about 2% and 62% of the nominal dose, respectively. After intravenous administration of beclomethasone, dipropionate and its active metabolite B-17-MP are characterized by high plasma clearance (150 l / h and 120 l / h, respectively), a small volume distribution in the state of reaching equilibrium blood concentrations in beclomethasone dipropionate (20 L) and a large amount of distribution of its active metabolite B-17-MP (42 liters). The main product metabolism of beclomethasone dipropionate is its active metabolite B-17-MP. Less active metabolites beclomethasone dipropionate are beclomethasone-21-monopropionate (B-21-MP) and beclomethasone, but their role in systemic action of beclomethasone dipropionate is very low. Connection with plasma proteins moderately high.
    Excretion
    The bulk of beclomethasone dipropionate is withdrawn through intestines with feces in the form of polar metabolites. Renal beclomethasone excretion dipropionate and its metabolites is insignificant. Period half-life (tl/2) beclomethasone dipropionate and B-17-MP is 0.5 h and 2.7 h, respectively.
    Special patient groups
    Pharmacokinetics of beclomethasone dipropionate in patients with renal or hepatic Insufficiency has not been studied. However, with hepatic insufficiency, changes in the pharmacokinetics and safety profile of beclomethasone dipropionate are not expected, since it undergoes very rapid metabolism under the influence of the enzymes of esterases present in the liquid contents of the small intestine, serum, lungs and liver, with the formation of more polar products: B-21- MP, B-17-MP and beclomethasone. It is not supposed to increase the system exposure of beclomethasone dipropionate and its metabolites in patients with renal insufficiency, since they are practically not excreted by the kidneys.
    Pharmacokinetics of formoterol
    Absorption and distribution
    After inhalation formoterol absorbed, both from the lungs and from the digestive tract. From the digestive tract absorbed is the swallowed part of the inhalation dose, which may be depending on the type of inhalation device and inhalation technique from 60% to 90% of the inhalation dose, at the same time it is absorbed from the digestive tract as at least 65% of the swallowed part dose. After oral administration maximum plasma concentration of unchanged formoterol is reached within 0.5-1 hour. The connection of formoterol with proteins of blood plasma is 61 - 64 %, with 34% binding to albumin. Not observed saturation of formoterol with plasma proteins in the range plasma concentrations, achieved with therapeutic doses. Period half-life after oral administration is 2-3 hours. Absorption formoterol in the dose range formoterol fumarate from 12 μg to 96 μg is linear.
    Metabolism
    Formoterol intensively is metabolized, mainly, in the liver, the main way of it metabolism is conjugation with glucuronic acid with inactive metabolite. The second important pathway of metabolism is O-demethylation followed by conjugation.O-demethylation of formoterol involves cytochrome P450 isoenzymes CYP2D6, CYP2C19 and CYP2C9. Formoterol in 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 inhalation of a single dose of 120 μg, the plasma half-life was 10 hours. The right-handed and levorotatory enantiomers of unchanged formoterol released by the kidneys were approximately 40% and 60%, respectively. The relative proportion of two enantiomers remained constant throughout the range of doses studied, and after repeated doses are not applied a relative accumulation of one enantiomer by compared with another enantiomer. After taking formoterol orally (40- 80 mcg) in healthy volunteers 6% - 10% of the dose was detected in the urine in the form of unchanged formoterol and up to 8% dose was detected in the urine in the form of glucuronides. A total of 67% of the dose formoterol for oral administration is excreted by the kidneys in the form of metabolites), and the rest is allocated through intestines with feces. Renal the clearance of formoterol is 150 ml / min.
    Special patient groups
    Hepatic / Renal failure: pharmacokinetics formoterol in patients with hepatic or renal Insufficiency has not been studied.

    Indications:
    - Basic therapy of bronchial asthma involving use of combined therapy (inhaled GCS + 32- long-term adrenomimetic actions): in patients, symptoms whose diseases are not enough are controlled by inhaled GCS and (32- adrenomimetics fast actions;
    - in patients already receiving effective supporting doses of inhaled glucocorticosteroids and (32- long-term adrenomimetics actions.
    - COPD:
    - treatment of bronchial obstruction <in patients with severe COPD (FEV1 <50% from its calculated normal value), which, despite the usual bronchodilating therapy, Significant symptoms persist this disease.

    Contraindications:

    - Hypersensitivity to active and auxiliary substances of the drug.

    - Children under 18 years.

    Carefully:

    - During pregnancy.

    - During the period of breastfeeding.

    - With pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system.

    - At a thyrotoxicosis.

    - With pheochromocytoma.

    - With diabetes.

    - With uncorrectable hypokalemia (as treatment β2-adrenomimetics alone 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 may have hypoxia potentiating effects, associated with gipokaliemia) (see section "Special instructions").

    - With idiopathic hypertrophic subaortic stenosis.

    - With hypertrophic obstructive cardiomyopathy.

    - With heart rhythm disturbances, especially with atrioventricular blockade of grade III and tachyarrhythmia.

    - With severe arterial hypertension.

    - In the presence of an aneurysm of any localization.

    - In the presence of other severe cardiovascular diseases (acute myocardial infarction, chronic ischemic heart disease, chronic heart failure,occlusive vascular lesions, especially atherosclerotic lesions).

    - With congenital or developed with the use of drugs, the lengthening of the interval QTc > 0.44 sec) (reception of formoterol may cause lengthening intervals and QTc).

    Pregnancy and lactation:

    Pregnancy

    There is no experience with the use of propylene GFA-134a (norflurane) or evidence of its safety during pregnancy and during breastfeeding in humans. However, studies on the effect of HFA-134a on reproductive function and development embriofetalnoe conducted on animals have not demonstrated any clinically relevant effects.

    There are no clinical data on the use of the drug Foster during pregnancy. Studies conducted on animals with the combination of beclomethasone dipropionate and formoterol, reproductive toxicity showed the presence only after their high systemic exposure. In connection with the tocolytic action of beta2-adrenomimetic drugs, special care should be taken during labor. Formoterol Do not recommend for use during pregnancy and, especially, late in pregnancy or during labor. If possible, another (more safe in pregnancy) therapy should be used.

    During pregnancy, the drug Foster should be used only in those cases when the benefit of using the drug exceeds 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.

    Breastfeeding period

    There is not enough clinical data on the use of the drug Foster during breastfeeding in humans.

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

    The drug Foster can be used in nursing women only in those cases when the expected therapeutic effect for the mother exceeds the potential risk for the child.

    Dosing and Administration:The drug Foster is designed for inhalation.
    Bronchial asthma
    The drug Foster is not intended for the initial treatment of bronchial asthma. Selection of the doses of active substances that make up the preparation Foster, occurs individually, depending on the severity of the disease.This need to be taken into account not only at the beginning of treatment with combined preparations, but also when their dose is changed. In the event that individual patients require different doses of a combination of active substances than that in the preparation Foster, it should take appropriate dose (32- agonists and / or SSC in separate inhalers.
    Beclomethasone dipropionate in Foster's preparation is characterized by an extra-fine dispersion of the particle size of the aerosol, which leads to a more pronounced effect than beclomethasone dipropionate in a dosage form with a non-extramelic dispersion of the particle size of the aerosol (for example, 100 μg of beclomethasone dipropionate with an extrapolated dispersion of aerosol particle sizes in the Foster preparation are equivalent to 250 mcg of beclomethasone dipropionate in a dosage form with neekstramelkodispersnym size distribution ca aerosol). Therefore, the total daily dose of beclomethasone dipropionate, used in the preparation Foster, should be lower than the total dose of beclomethasone dipropionate, used in dosage form neekstramelkodispersnym distribution of aerosol particle sizes.This should be taken into account when the patient is transferred from beclomethasone dipropionate in a dosage form with an unextremally dispersed aerosol particle size distribution to the Foster preparation: the dose of beclomethasone dipropionate in the Foster preparation should be lower, and its selection should be tailored to the individual needs of the patients.
    There are two approaches for the treatment of bronchial asthma with the drug Foster: regular therapy: Foster is used as a regular therapy with the addition of an additional fast-acting bronchodilator as needed; regular therapy and use as needed to relieve asthma symptoms: Foster is taken as a regular therapy and in response to the development of asthma symptoms as needed. Regular therapy Patients should be advised to have a separate inhaler with a fast-acting bronchodilator that they can use to relieve asthma symptoms at any time.
    Recommendations for dosing regimens for adults (18 years and older)
    One or two inhalations twice a day. The maximum daily dose is 4 inhalations per day.
    Regular therapy and application as needed to relieve asthma symptoms
    Patients take their regular daily dose of the drug Foster and additionally take the drug Foster as needed to relieve the symptoms of asthma. Patients should be advised to always carry Foster's medication to relieve asthma symptoms. Consider the need to use Foster as a regular therapy and as needed to relieve the symptoms of asthma especially follows in the following patients:
    - in patients with incompletely controlled bronchial asthma and needing drugs to relieve asthma symptoms;
    - in patients with exacerbation of bronchial asthma in the past, requiring medical intervention.
    Patients who often take a large amount of Foster's drug as needed to relieve asthma symptoms need careful monitoring for the development of dose-related undesirable effects.
    Recommendations for dosing regimens in patients aged 18 years and older
    The recommended dose for regular therapy is 1 inhalation 2 times a day (one inhalation in the morning and a second inhalation in the evening).In response to the development of asthma symptoms, patients can take one additional inhalation of the drug Foster. If symptoms persist after a few minutes, a second additional inhalation of the drug Foster should be performed. The maximum daily dose is 8 inhalations of the drug Foster.
    Patients who require frequent use of inhalations to relieve symptoms of bronchial asthma should be strongly advised to consult a doctor. It is necessary to overestimate the severity of bronchial asthma in these patients and revise their basic therapy.
    Recommendations for dosing regimens for children and adolescents under 18 years of age
    There is no experience of using Foster in children and adolescents under 18 years of age. Therefore, before receiving additional clinical data, it is not recommended for patients under 18 years of age. The condition of patients should be regularly re-evaluated by a doctor, since the dosage regimen of the drug Foster is maintained at the optimal level and changes only on the advice of a doctor. The dose should be titrated to the minimum dose, against which optimal control over the symptoms of bronchial asthma remains.When the control over the symptoms of bronchial asthma is reached, consideration can be given to the gradual reduction in the dose of the drug Foster. In case of dose reduction, regular examination of the patient is important. The lowest effective dose of the drug should be used. When full control over the symptoms of bronchial asthma is achieved against the background of the minimum recommended dose of the drug, in the next step one can try to transfer the patient to taking one inhaled GCS. The patient should be warned about the need for daily use of the drug Foster, even in the absence of symptoms of bronchial asthma.
    COPD
    Recommendations on the regimen of dosing in adults (18 years and older)
    Two inhalations 2 times a day.
    Special patient groups
    There is no need for a special dose selection for elderly patients.
    There is no data on the taking of Foster's drug by patients with renal or hepatic insufficiency (see the section "Pharmacokinetics").
    Instructions for use of the inhaler
    A doctor or other health care provider should teach the patient to use the inhaler correctly and periodically check the techniqueinhalation. Proper use of a metered inhaler is a prerequisite for successful treatment. The patient should be advised to carefully read the instructions for use and follow the recommendations therein. Before the first use of the inhaler or after 14 days or more after a break in its use, the first dose must be sprayed into the air to make sure that it works. Whenever possible, patients should be inhaled from the inhaler while standing upright (standing or sitting).
    The order of inhalation
    1. Take the inhaler with your thumb and forefinger, as shown in the figure.
    2. Remove the protective cap from the inhaler mouthpiece and check that the mouthpiece is clean and contains no foreign objects.
    3. Exhale as slowly and deeper as possible.
    4. Hold the can upright with its body pointing upwards, and grasp the mouthpiece with your lips. Do not grasp the mouthpiece with your teeth. Take a long deep breath through the mouth, at the same time pressing the end of the balloon with your index finger after the inspiration has begun.
    5.After inhaling, hold the breath as long as possible, then remove the mouthpiece from the mouth and make a slow exhalation. Do not exhale into the inhaler.
    For the second dose, while holding the inhaler in an upright position, wait for about 30 seconds and then repeat steps 3 through 5.
    After use, firmly seal the mouthpiece with a protective cap.
    Attention! Performing steps 3 and 4, you can not hurry. Start inhaling as slowly as possible, immediately before pressing the inhaler dosing device. If the aerosol partially exits from the top of the inhaler or from the corners of the patient's mouth, repeat the sequence from step 3.
    Patients with weak hands are more comfortable to keep the inhaler with both hands. Therefore, the upper part of the inhaler should be held by two index fingers, and its lower part by two thumbs. After inhalation, rinse your mouth and throat with water or brush your teeth (see section "Special instructions").
    Cleaning the inhaler
    Patients should be advised to read the instructions for use carefully to receive instructions for cleaning the inhaler.For regular cleaning of the inhaler, patients should remove the protective cap from the mouthpiece and wipe the inner and outer surfaces of the mouthpiece with a dry cloth. They should not use water or other liquids to clean the mouthpiece. Patients who have difficulty in synchronizing aerosol spraying and inhaling can use the Aerochamber Plus Plus spacer device. The attending physician, pharmacist or nurse should instruct such patients how to properly use and care for the inhaler and the spacer device and to test their inhalation technique to ensure the optimal delivery of the inhaled drug to the lungs. When using the Aerochamber plus Plus spacer device, the optimal inhalation technique is achieved by carrying out one continuous slow and deep inspiration through the spacer without delay between pressing the inhaler and initiating inspiration.
    Side effects:

    The drug Foster contains beclomethasone dipropionate and formoterol fumarate, and therefore one should expect that it can cause side effects 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 in the preparation of Foster and when used as separate preparations 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 and <1/10), infrequently (> 1/1000 and <1/100), rarely (> 1/10000 and < 1/1000) and very rarely (<1/10000), an unknown frequency - according to the 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.

    Violations of the blood and lymphatic system

    Infrequently: granulocytopenia.

    Rarely: thrombocytopenia.

    Immune system disorders

    Infrequently: allergic dermatitis.

    Rarely: hypersensitivity reactions, including erythema, swelling of the lips, face, eyes and pharynx.

    Disorders from the endocrine system

    Rarely: oppression of adrenal function.

    Disorders from the metabolism and nutrition

    Infrequently: hypokalemia, hyperglycemia.

    Disorders of the psyche

    Infrequently: dysphoria.

    Rarely: deviations in behavior, sleep disturbances, hallucinations.

    Disturbances from the nervous system

    Often: headache.

    Infrequently: tremor, dizziness.

    Disturbances on the part of the organ of sight

    Rarely: glaucoma, cataract.

    Hearing disorders and labyrinthine disorders

    Infrequently: tubo-otitis.

    Heart Disease

    Infrequently: palpitation, lengthening of the interval QTC, ECG changes, tachycardia, tachyarrhythmia.

    Rarely: ventricular extrasystoles, angina pectoris.

    Rarely: atrial fibrillation.

    Vascular disorders

    Infrequently: hyperemia, "tides" of blood to the skin of the face.

    Disturbances from the respiratory system, chest and mediastinal organs

    Often: dysphonia.

    Infrequently: rhinitis, cough, productive cough, painful sensitivity of the pharynx, decreased effectiveness or inefficiency previously usually helped the patient with a bronchospasm attack of drugs and measures.

    Rarely: paradoxical bronchospasm.

    Rarely: shortness of breath, exacerbation of bronchial asthma.

    Disorders from the gastrointestinal tract

    Infrequently: diarrhea, dryness of the oral mucosa, dyspepsia, dysphagia, burning sensation in the lips, nausea, dysgeusia (perversion of taste).

    Disturbances from the skin and subcutaneous tissues

    Infrequently: itching, rash, hyperhidrosis.

    Rarely: urticaria, angioedema.

    Disturbances from musculoskeletal and connective tissue

    Infrequently: muscle spasms, myalgia.

    Rarely: growth retardation in children and adolescents.

    Disorders from the kidneys and urinary tract

    Rarely: nephritis.

    General disorders and disorders at the site of administration

    Rarely: peripheral edema.

    Unknown frequency: fatigue.

    Violations from laboratory and instrumental studies

    Infrequently: an increase in C-reactive protein, an increase in the number of platelets in the peripheral blood, an increase in the concentrations of free fatty acids, insulin, ketone bodies, glycerol in the blood.

    Rarely: increased blood pressure, lower blood pressure.

    Rarely: decreased bone density.

    As with any other inhaled therapy, it is possible to develop paradoxical bronchospasm (see section "Special instructions").

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

    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 applying the drug. Candidiasis, taking place with clinical symptoms, can be treated with local antifungal therapy while continuing treatment with Foster.

    When using inhaled glucocorticosteroids, 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 bone mineral density, slow growth in children and adolescents, development of cataracts and glaucoma (cf.See also "Special instructions").

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

    Overdose:

    Inhalation doses of the preparation Foster up to 12 cumulative doses of aerosol (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, and no serious or severe adverse effects were observed.

    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.

    When symptoms of an overdose of formoterol are shown, it supports the basic functions of the body and symptomatic treatment. In severe cases - hospitalization. Can be considered the use of cardioselective beta-blockers with extreme caution, since the use of beta-adrenoblockers can cause bronchospasm. It is necessary to monitor the potassium content in the blood plasma.Single inhalation of doses of beclomethasone dipropionate, which significantly exceed the recommended dose, can lead to a temporary depression 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 manifest itself: a significant inhibition of the adrenal cortex can occur up to the adrenal crisis. 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 Foster.

    With a chronic overdose of beclomethasone dipropionate, there is a risk of suppressing the function of the adrenal cortex (see Fig.section "Special instructions"). In chronic overdose, it is recommended to monitor the reserve function of the adrenal cortex. Treatment should be continued in a dose sufficient to achieve control over the symptoms of bronchial asthma.

    Interaction:

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

    With the joint administration of the drug Foster and other β-adrenergic drugs, the side effect of formoterol may be increased, so caution should be exercised when simultaneously using formoterol theophylline or other β-adrenergic drugs.

    The combined use of the drug Foster and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase (MAO) inhibitors and tricyclic antidepressants may prolong QTc-Interval and increase the risk of ventricular arrhythmias.

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

    Joint use of MAO inhibitors, as well as drugs with similar properties, such as furazolidone and procarbazine, can cause an increase in blood pressure.

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

    As a result of the use of β2-adrenomimetics hypokalemia may occur, which can be intensified by concomitant treatment with xanthine derivatives, mineralocorticosteroids, glucocorticosteroids and diuretics (see section "Specific guidance"), hypokalemia may increase the predisposition to arrhythmia in patients taking cardiac glycosides.

    Because of the small amount of ethanol in the Foster preparation, there is a theoretical possibility of interaction in patients taking disulfiram or metronidazole, which have increased sensitivity to ethanol.

    Special instructions:

    If patients have such accompanying diseases as heart rhythm disturbances,especially atrio-ventricular blockade of the third degree and tachyarrhythmia, idiopathic hypertrophic subaortal stenosis, hypertrophic obstructive cardiomyopathy, severe heart diseases: acute myocardial infarction, chronic ischemic heart disease, chronic heart failure, occlusive vascular lesions, especially atherosclerotic, aneurysm, arterial hypertension, and also hypertrophy of the prostate, glaucoma, it is necessary to exercise special care with the use of the drug Foster, as well as such patients may need to monitor their condition.

    Treatment of patients with known lengthening or suspected prolongation of the QTc interval, both congenital and drug-induced medication (QTc> 0.44 sec), should be performed with caution, since the use of formoterol may induce prolongation of the QTc interval.

    Caution is also required when Foster is used in patients with thyrotoxicosis, diabetes, pheochromocytoma and uncorrected hypokalemia. In the treatment of (32-adrenomimetics, potentially severe hypokalemia can occur.

    Particular caution should be observed in patients with severe bronchial asthma, since undesirable effects associated with hypokalemia may be potentiated by hypoxia. Hypokalemia may also be potentiated with simultaneous treatment with other medications that can cause hypokalemia, such as xanthine derivatives, mineralocorticosteroids, glucocorticosteroids and diuretics (see "Interactions with Other Drugs").

    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.

    Inhaling high doses of formoterol can lead to an increase in the concentration of glucose in the blood. In patients with diabetes mellitus during the application of the drug Foster should monitor the concentration of glucose in the blood. If general anesthesia is planned with preparations of halogenated hydrocarbons, it is necessary to warn the patient not to perform Foster's inhalation for at least 12 hours before the anesthesia begins (due to the risk of heart rhythm disturbances).

    As with other preparations containing inhaled CEN, the need to apply and dose of the drug Foster 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 Foster can not be abruptly stopped, the dose should be reduced gradually and under the supervision of a doctor.

    If the patient considers treatment ineffective, he should consult a doctor. The increased need for bronchodilators to relieve asthma symptoms indicates a worsening of the course of the disease and requires a reassessment of the treatment of 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 suspected infection, the need for antibiotics.

    Patients should not begin treatment with Foster during an exacerbation of bronchial asthma, or if they have a significant weighting of its course or acute deterioration of the course of bronchial asthma. During treatment with Foster, serious adverse effects and complications associated with bronchial asthma may occur. If the symptoms of bronchial asthma can not be controlled or they deteriorate after starting treatment with Foster, patients are advised to continue treatment, but consult a doctor.

    As with any other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after inhalation of the drug dose. Paradoxical bronchospasm should be stopped immediately with the help of fast acting inhaled bronchodilators. It is necessary to stop Foster's therapy, review treatment tactics and, if necessary, transfer the patient to alternative therapy.

    The drug Foster 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: Foster (for patients,using Foster as a regular therapy and as needed to relieve asthma symptoms), or a separate fast-acting bronchodilator (for patients using Foster as a regular therapy only). The patient should be warned about the need for daily intake of the drug Foster according to the recommendations given by the doctor, even if they do not have manifestations of bronchial asthma. Inhalation of the drug Foster for the removal of symptoms of bronchial asthma should be carried out 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 you achieve control over the symptoms of bronchial asthma, you can consider the gradual decrease in the dose of the drug Foster. In case of a dose reduction, it is important to conduct a regular examination of the patient. The lowest effective dose of the drug Foster should be used (see section "Method of administration and dose").

    Any inhaled GCS can cause systemic effects, especially with prolonged use in high doses; it should be noted, however, 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, reduction of bone mineral density, cataract and glaucoma. Therefore, it is important that such patients are regularly observed by a doctor and the dose of inhaled glucocorticosteroids is reduced to the lowest dose 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 the age of 16 who take 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.Symptoms of adrenal insufficiency are usually nonspecific: anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, lowering of blood pressure, confusion, hypoglycemia and convulsions. During stress periods and with planned surgical interventions, additional use of systemic corticosteroids should be considered. If there is reason to believe that against the background of previous systemic therapy of GCS, adrenal function has been disrupted, care should be taken when transferring patients to Foster's treatment. Patients who are transferred from the reception of GCS inside by inhaled GCS may 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 glands 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.In case of severe adrenal insufficiency, specialist consultation may be required before planning procedures.

    It is recommended that the patient be instructed to rinse the mouth and throat with water or brush his teeth after inhalation in order to minimize the risk of developing candidiasis of the oral and pharyngeal mucosa.

    Patients should be informed that Foster contains a small amount of ethanol (approximately 7 mg in a single dose), but with therapeutic doses, the amount of ethanol is very low and does not pose a risk to patients.

    The can is under pressure: do not expose it to high temperatures (above 50 ° C), do not pierce, do not throw into the fire, even empty.

    Within the indicated shelf life, patients can store the drug they use at room temperature (not above 25 ° C) for 5 months. The date of storage at room temperature should be marked on the package. Storage of the drug in the refrigerator is unacceptable!

    Effect on the ability to drive transp. cf. and fur:

    The effect of the drug Foster on the ability to control transpositic agents and engage in other potentially hazardous activities is notoriously unfaithful.

    Form release / dosage:

    Aerosol for inhalation dosed 100 + 6 μg / dose.

    Packaging:Aluminum balloon with a metering valve, containing 120 doses of the drug. 1 bottle with an inhaler and instruction is placed in a cardboard box.
    Storage conditions:

    At a temperature of + 2-8 ° C, in a place protected from the sun, away from heating appliances. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    20 months. Do not use after the date shown on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000876/09
    Date of registration:09.02.2009
    The owner of the registration certificate:Kiesi Pharmaceuticals SpAKiesi Pharmaceuticals SpA Italy
    Manufacturer: & nbsp
    Information update date: & nbsp20.10.2014
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