Foradil Combi 12mcg/400mcg #120

Foradil Combi instruction

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Release form and composition

Foradil Combi is produced in the form of a set of capsules with powder for inhalation, which includes:
    capsules with formoterol (12 mcg): size No. 3, colorless, transparent, marked in black ink: on the lid - “CG”, on the body - “FXF” (or vice versa); filler - free-flowing white powder;
    capsules with budesonide (400 mcg): size No. 3, hard gelatin, the cap is pink, the body is colorless, transparent; the capsule is marked "BUDE 400"; filler - white powder.
The packaging of Foradil Combi contains capsules with formoterol (12 mcg) and capsules with budesonide (200 mcg or 400 mcg). Capsules packed in 10 pieces. in blisters, in a cardboard bundle complete with an inhalation device (aerolizer), 3 or 6 capsule blisters containing formoterol (12 mcg), and 1, 3, 6 or 12 capsule blisters containing budesonide (200 mcg or 400 mcg).
Composition 1 capsule with formoterol (12 mcg):
    active component: formoterol fumarate dihydrate - 12 mcg;
    auxiliary ingredients: lactose monohydrate (milk sugar) - up to 25,000 mcg;
    capsule shell: 100% gelatin.
Composition 1 capsule with budesonide (400 mcg):
    active component: budesonide - 400 mcg;
    auxiliary ingredients: lactose monohydrate (milk sugar) - 24 540 mcg;
    capsule shell: red iron oxide (E172), black iron oxide (E172), ponceau crimson dye 4R, titanium dioxide (E171), water, gelatin.

Pharmacodynamics

The therapeutic properties of Foradil Combi are due to the pharmacodynamic characteristics of the active substances in its composition:
    formoterol: a selective β2-adrenergic receptor agonist that exerts a bronchodilating effect in patients with reversible airway obstruction. The effect occurs quickly (from 1 to 3 minutes) and persists after inhalation for 12 hours. The use of therapeutic doses of formoterol virtually eliminates its effect on the function of the cardiovascular system (noted in exceptional cases). By inhibiting the release of histamine and leukotrienes from mast cells, it exhibits anti-inflammatory efficacy, preventing the development of edema and the accumulation of inflammatory cells (confirmed in animal experiments). During clinical studies, it was found that formoterol effectively prevents bronchospasm caused by physical exertion, inhaled allergens, cold air, histamine or methacholine. Due to the fact that the bronchodilatory effect of formoterol after inhalation for 12 hours remains pronounced, the use of Foradil Combi 2 times a day with long-term maintenance treatment in most cases allows us to provide the required control of bronchospasm in patients with chronic lung diseases both in the daytime and at night . With a stable course of chronic obstructive pulmonary disease (COPD), formoterol also provides a rapid onset of bronchodilation and improves the quality of life;
    budesonide: glucocorticosteroid (GCS), intended for inhalation use, practically does not have a systemic effect. Like other inhaled corticosteroids, its pharmacological effectiveness is ensured through interaction with intracellular glucocorticosteroid receptors and is manifested by anti-inflammatory, anti-allergic and immunosuppressive effects. Budesonide increases the production of lipocortin (an inhibitor of phospholipase A2), inhibits the release of arachidonic acid and the synthesis of its metabolic products - prostaglandins and cyclic endoperoxides; prevents marginal accumulation of neutrophils, reduces inflammatory exudation, inhibits the production of cytokines, slows down the migration of macrophages, reduces the severity of infiltration and granulation, inhibits the formation of chemotaxis substance (which ensures the effectiveness of Foradil Combi when stopping allergic reactions of a delayed type); slows the release of inflammatory mediators from mast cells (immediate allergic reactions). Budesonide contributes to an increase in the number of active β-adrenergic receptors, as a result of which the patient's response to bronchodilators is restored (allowing to reduce the frequency of their use), edema of the bronchial mucosa, mucus and sputum production are reduced, airway hyperreactivity is reduced, mucociliary clearance is enhanced. The clinically significant therapeutic effect after the initiation of therapy for patients in need of taking corticosteroids, on average, develops within 10 days. Regular use of budesonide in bronchial asthma reduces the severity of the chronic inflammatory process in the lungs, thereby improving their function, eases the symptoms of bronchial asthma, inhibits bronchial hyperreactivity, preventing the development of exacerbation of the disease.

Pharmacokinetics

Pharmacokinetic characteristics of formoterol

    absorption: the substance is rapidly absorbed by inhalation. As a result of a single dose of formoterol (120 μg), Cmax (maximum plasma concentration) is reached in 5 minutes and amounts to 266 pmol / L. Due to ingestion, absorption in the gastrointestinal tract (GIT) also occurs rapidly, up to 65%. In the treatment of COPD for 12 weeks, 2 times a day at a dose of 12 or 24 μg of formoterol, its plasma concentration, measured 10, 120 and 360 minutes after inhalation, is 11.5–25.7 pmol / L and 23, 3-50.3 pmol / L, respectively; the concentration in the systemic circulation increases in proportion to the dose (12–96 mcg);
    distribution by organs and tissues: formoterol binds to plasma proteins by 61–64%, of which 34% is associated with serum albumin. Within the concentrations recorded after the use of Foradil Combi in therapeutic doses, saturation of the binding sites is not achieved;
    metabolism: the main pathway of formoterol metabolism is direct binding to glucuronic acid, another pathway is O-demethylation with further glucuronidation. Secondary metabolic processes include conjugation of formoterol with sulfate followed by their deformation. Many isoenzymes of formoterol are involved in the processes of glucuronidation (UGT1A1, 1A3, 1A6-10, 2B7, 2B15) and O-demethylation (CYP2D6, CYP2A6, CYP2C9, CYP2C19), this suggests a small possibility of drug interaction by inhibiting any of the isofer in the metabolism of formoterol. In the therapeutic dose range, formoterol does not inhibit isoenzymes of the cytochrome P450 system;
    excretion: in case of bronchial asthma and COPD with doses of 12 or 24 mcg applied 2 weeks a day in unchanged form in the urine, ~ 10% or 7%, respectively, was determined. Formoterol and its metabolites are excreted completely from the body: with urine - 70%, with feces - 30%. Renal clearance - 150 ml / min. The elimination half-life (T1 / 2) is 120–180 minutes.

Pharmacokinetic characteristics of budesonide

    absorption: the substance is completely and quickly absorbed by inhalation, Cmax is achieved immediately. Given the sedimentation of budesonide on the mucosa of the oropharynx, its absolute bioavailability is 73%. Due to oral administration, absorption in the digestive tract is ± 10%;
    distribution to organs and tissues: distribution volume (Vd) - 3 l / kg. According to studies, budesonide accumulates in the lymph nodes, spleen, thymus, reproductive organs, adrenal cortex, bronchi, and also crosses the placental barrier;
    metabolism: in the lungs, budesonide is not metabolized; its systemic clearance with inhalation is 0.5 l / min. Plasma protein binds to 88%. After absorption, about 90% of the substance is metabolized in the liver, forming several inactive metabolites (in comparison with budesonide, their biological activity is one hundred times less), including 6β-hydroxybudesonide and 16α-hydroxyprednisolone. The main pathway of the metabolism of a substance in the liver by using the CYP3A4 isoenzyme of the P450 system can vary under the action of inhibitors / inducers of the CYP3A4 isoenzyme;
    excretion: T1 / 2 budesonide - 120–168 min, systemic clearance is high (1.4 l / min). The substance is excreted in the form of metabolites with feces - 10%, with urine - 70%. In liver diseases, the plasma concentration of budesonide increases.

Indications for use

    bronchial asthma, insufficiently controlled by the use of short-acting β2-agonists and inhaled GCS (therapy on demand);
    bronchial asthma adequately controlled by the use of long-acting β2-agonists and inhaled corticosteroids;
    COPD with proven efficacy of the use of GCS.

Contraindications

Absolute:
    period of breastfeeding;
    active pulmonary tuberculosis;
    lactase deficiency, hereditary galactose intolerance, glucose-galactose malabsorption syndrome (lactose is present in capsules);
    children under 6 years old;
    hypersensitivity to formoterol, budesonide, any other components of the inhalation kit.
Conditions / diseases in which, with extreme caution, under careful medical supervision, Foradil Combi should be used because of the presence of active components in its composition:
    formoterol (especially in the process of dose reduction): with coronary heart disease (CHD), cardiac arrhythmias and conduction disorders, in particular with atrioventricular block III degree, severe chronic heart failure (CHF), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, aneurysm aortic thyrotoxicosis, known or suspected prolongation of the QT interval (QT corrected for more than 0.44 seconds), hypokalemia, hypocalcemia and pheochromocytoma;
    budesonide: with inactive pulmonary tuberculosis, respiratory tract infections (fungal, viral, bacterial etiology), cirrhosis, glaucoma; taking into account the possibility of the development of fungal pathologies, caution is observed for bronchiectasis and pneumoconiosis.
For stopping an acute attack of bronchospasm, budesonide is not effective, therefore, it should not be prescribed for asthmatic status, as well as other acute asthmatic conditions, as the main therapy.
β-adrenergic agonists, including formoterol, have a hyperglycemic effect, and therefore patients with diabetes mellitus are advised to conduct regular additional monitoring of blood glucose levels.

Instructions for use of Foradil Combi: method and dosage

Foradil Combi is intended for inhalation injection: capsules containing formoterol and budesonide should be used only with the help of a special device - an aerolizer, a single-dose capsule powder inhaler included in the kit.
The combined bronchodilator drug is prescribed individually, in the minimum effective dose. When using an aerolizer, the dose is selected gradually, bringing to a dose sufficient to maintain a therapeutic effect.
After achieving control of the symptoms of bronchial asthma against the background of inhalation with formoterol, the possibility of a phased reduction in its dose, which must be carried out under regular medical supervision, should be considered. During exacerbation of bronchial asthma, one cannot start treatment with formoterol or change its dose. Formoterol should also not be used to stop acute attacks of bronchial asthma.
Inhalation administration of β-adrenergic agonists, including formoterol, expands the bronchi, which improves the penetration of budesonide into the respiratory tract, enhancing its therapeutic effect. In this regard, Foradil Combi capsules for the supportive treatment of bronchial asthma and COPD are used in this order:
    Capsules containing formoterol.
    Capsules containing budesonide.
Treatment of adult patients:
    formoterol: maintenance dose - 12-24 mcg (1-2 capsules) 2 times a day; the maximum daily dose is 48 mcg. To alleviate the symptoms of bronchial asthma, if necessary, the dose can be increased by 12-24 mcg per day. When the need ceases to be episodic (occurs more often 2 times a week), a doctor’s consultation is necessary to consider the correction of the treatment regimen, since this may indicate a worsening of the course of the disease;
    budesonide: the minimum dose (it is also minimally effective) in the inhalation kit is 200 μg (1 capsule), so Foradil Combi is not prescribed when a single dose of budesonide less than 200 μg is required. The maintenance dose for the treatment of mild asthma is 400-800 mcg per day, divided into 2 doses of 200-400 mcg. In case of exacerbation of bronchial asthma during the transition from oral dosage forms of GCS to inhalation or when the dose for oral administration is reduced, the maximum allowable daily dose of budesonide can be 1600 μg, divided into 2–4 doses.
Treatment for children 6 years and older:
    formoterol: regular maintenance dose - 12 mcg (1 capsule) 2 times a day; the maximum daily dose is 24 mcg (2 capsules);
    budesonide: the initial daily dose for the treatment of mild bronchial asthma is 200 mcg. The maintenance dose for regular therapy is 100-200 mcg 2 times a day. If necessary, increase the dose of budesonide to the maximum daily allowance of 800 mcg.

Rules for inhalation

In order to ensure the correct use of Foradil Combi, a doctor or other medical professional should explain to the patient how to use the inhaler, tell that inhalation should be carried out only with the help of an aerolizer, and warn that capsules intended for inhalation cannot be swallowed. For children and adolescents, the procedure is carried out under the supervision of adults to ensure the correct implementation of the inhalation technique.
If the gelatin capsule is destroyed during the inhalation process, small pieces of gelatin can enter the mouth and then the throat. To minimize the likelihood of such a hit, do not pierce the capsule more than once.
From the blister pack, the capsule is removed immediately before inhalation.
After inhalation of budesonide, it is recommended to rinse your mouth with water, this can prevent irritation of the oral mucosa and pharynx and reduce the risk of unwanted systemic reactions.
There are some reports of unintentional ingestion of whole capsules. In most of these cases, the development of undesirable effects was not observed. If, after inhalation, the patient does not improve breathing, the doctor should re-explain to him the scheme for the correct use of Foradil Combi.
Application of an aerolizer:
    Remove the protective cap from the mouthpiece of the aerolizer.
    Firmly holding the aerolizer by the base, turn the mouthpiece in the direction of the arrow.
    In the capsule-shaped cell that opens at the base of the aerolizer, place the capsule that needs to be removed from the blister immediately before the procedure.
    By turning the mouthpiece to its original position, close the aerolizer.
    While holding the aerolizer strictly vertically, press on the blue buttons located on its sides once to the end, and then release them.
    Take a deep breath.
    Throwing his head back slightly, take the mouthpiece into his mouth, tightly clasping his lips. Make a uniform, quick, as deep breath as possible, which should be accompanied by a characteristic rattling sound created by the rotation of the capsule when spraying the powder.
    Hold your breath for as long as possible while taking the mouthpiece out of your mouth and then exhale. Open the atomizer, make sure that no powder remains in the capsule. Otherwise, repeat the manipulations described in paragraphs 6–8.
    After inhalation, open the aerolizer, remove the empty capsule, turn the mouthpiece to its original position and cover the aerolizer with a cap.
At stage 1–5, the capsule can be damaged when pierced, which is why small pieces of gelatin can penetrate the mouth and then into the throat. Gelatin is a food ingredient; its absorption does no harm. But in order to avoid complete destruction of the capsule, it should not be punctured more than once, it is also recommended to observe storage conditions and remove the capsule from the blister just before inhalation.
At step 7, if you did not hear a characteristic sound, you need to open the aerolizer to find out what happened to the capsule. If it is stuck in a cell, it needs to be carefully removed without trying to release it by repeatedly pressing the blue buttons on the sides of the inhaler.
The mouthpiece and the cell of the aerolizer are wiped with a dry cloth or soft brush to remove powder residue.

Side effects

Scale for assessing the frequency of side effects: very often - 0.1% or more; often - more than 0.01%, but less than 0.1%; infrequently - more than 0.001%, but less than 0.01%; rarely - more than 0.0001%, but less than 0.001%; extremely rarely - 0.0001% or less, including individual messages; with unknown frequency - data from post-marketing observations, the frequency of occurrence of which cannot be reliably estimated.
Undesirable adverse reactions with the use of formoterol:
    immune system: extremely rare - hypersensitivity reactions such as urticaria, arterial hypotension, angioedema, rash, itching;
    mental disorders: infrequently - a sense of anxiety, agitation, insomnia, increased irritability;
    nervous system: often - tremor, headache; infrequently - dizziness; extremely rarely - dysgeusia (taste disorder);
    cardiovascular system: often - palpitations; infrequently - tachycardia; extremely rarely - peripheral edema; with an unknown frequency - angina pectoris, cardiac arrhythmias, including ventricular extrasystoles, atrial fibrillation, tachyarrhythmia;
    respiratory system, organs of the chest and mediastinum: infrequently - irritation of the mucous membrane of the larynx and pharynx, bronchospasm, including paradoxical; with an unknown frequency - cough;
    Gastrointestinal tract: infrequently - dryness of the oral mucosa; extremely rarely - nausea;
    musculoskeletal system: infrequently - myalgia, muscle cramps;
    data from laboratory and instrumental studies: with an unknown frequency - a decrease in serum potassium concentration, an increase in blood glucose, an increase in the QT interval on an ECG (electrocardiogram), an increase in blood pressure (blood pressure), including arterial hypertension;
    skin and subcutaneous tissue: with an unknown frequency - a rash.
Undesirable adverse reactions with the use of budesonide:
    endocrine system: rarely - inhibition of adrenal cortex function, Itsenko-Cushing's syndrome, hypercorticism / hypocorticism, growth retardation in childhood and adolescence;
    organ of vision: rarely - cataract, glaucoma;
    immune system: rarely - hypersensitivity reactions such as angioedema, rash, urticaria, itching; with unknown frequency - contact dermatitis [HRT (delayed-type hypersensitivity), type IV allergy according to Jell and Coombs];
    mental disorders: with an unknown frequency - sleep disorders, psychomotor hyperactivity, depression, anxiety, aggressive behavior, deviant behavior (especially in children);
    Gastrointestinal tract: often - difficulty swallowing; with unknown frequency - dysgeusia;
    musculoskeletal system: rarely - decrease in bone mineral density;
    respiratory system, chest and mediastinal organs: often - cough; rarely - candidiasis of the mucous membrane of the oral cavity / larynx, paradoxical bronchospasm, pharyngeal irritation, dysphonia (after a dose reduction or discontinuation of therapy with budesonide, it resolves on its own).
The use of budesonide for the treatment of patients with COPD increased the incidence of subcutaneous hematomas by 10% and pneumonia by 6%, compared with the placebo group, where these indicators were 4 and 3%, respectively.
In case of aggravation of these side effects or the appearance of any other negative reactions not listed in the instructions, you must inform your doctor about them.

Overdose

Symptoms of an overdose of formoterol can be reactions characteristic of β2-adrenergic agonists, such as headache, nausea, vomiting, drowsiness, tremor, palpitations, ventricular arrhythmia, tachycardia, metabolic acidosis, hyperglycemia, hypokalemia, arterial hypertension.
Supportive and symptomatic treatment is recommended, and for serious violations, hospitalization is necessary. Cardioselective β-blockers can be used exclusively under close medical supervision, with extreme caution, as this can cause bronchospasm.
Since budesonide has low acute toxicity, a single high-dose inhalation may cause a temporary suppression of the function of the hypothalamic-pituitary-adrenal system. This condition does not require emergency treatment. Moreover, in case of an overdose, it is allowed to continue treatment of the underlying disease with budesonide in doses sufficient to maintain its therapeutic effect.

Special instructions for Foradil Combi

Formoterol

The use of formoterol in patients with COPD improves their quality of life.
As an anti-inflammatory drug, formoterol in the treatment of patients with bronchial asthma should be used exclusively for concomitant treatment with inadequate control of symptoms during monotherapy with inhaled corticosteroids or in severe illness requiring a combination of inhaled corticosteroid and long-acting β2-adrenergic agonists. Formoterol is contraindicated to use simultaneously with other long-acting β2-agonists. Before starting treatment, it is necessary to assess the condition of the patient regarding the adequacy of the anti-inflammatory therapy used. After the start of inhalation with formoterol, ongoing anti-inflammatory therapy is recommended to continue unchanged even with a clinically significant improvement.
Relief of acute attacks of bronchial asthma is performed using short-acting β2-adrenergic agonists. A sudden deterioration in the patient's condition requires immediate medical attention.
In patients receiving formoterol during placebo-controlled clinical trials, there was an increase in the frequency of severe exacerbations of bronchial asthma. But the results of these studies do not allow us to quantify this complication in various groups.
As a result of the use of β2-adrenergic agonists, including formoterol, potentially serious hypokalemia can develop that can increase the risk of arrhythmias. This condition can be potentiated by hypoxia and concomitant therapy, which requires special caution in severe bronchial asthma. These patients are advised to regularly monitor the serum potassium content.
Paradoxical bronchospasm can develop due to the use of formoterol, as with any other inhaled treatment, this condition requires immediate withdrawal of Foradil Combi and the appointment of alternative therapy.

Budesonide

To ensure that budesonide enters the lungs, it is important to instruct patients on the need for proper inhalation, in accordance with the rules outlined above.
Budesonide is intended for systematic daily prophylactic use, and not for stopping attacks. Inhalations in compliance with the recommended dosage regimen continue even in the absence of symptoms of bronchial asthma.
The development of paradoxical bronchospasm requires the immediate cessation of the use of budesonide, an assessment of the patient's condition and, if necessary, the appointment of another drug. Paradoxical bronchospasm is immediately stopped with the help of short-acting β2-adrenergic agonists, the inhaler with which should always be at the disposal of the patient.
If the patient's condition worsens, the need for short-acting bronchodilators grows, attacks of shortness of breath intensify, you must immediately consult a specialist to conduct an examination and consider the possibility of increasing the dose of inhaled GCS or GCS for oral administration.
In order to reduce the likelihood of developing candidiasis of the oral cavity and pharynx after each inhalation of budesonide, it is necessary to rinse the mouth thoroughly with water, and with the development of such an infection, local antifungal treatment is possible without stopping inhalation of budesonide.
In case of exacerbation of bronchial asthma, increase the dose of budesonide or, if necessary, conduct a short course of therapy with systemic corticosteroids and / or prescribe antibiotic therapy for the development of infection.
Regular monitoring of the growth dynamics of children and adolescents is required during prolonged therapy with inhaled GCS, and if it is delayed, the dosage regimen should be corrected with a minimum effective dose and an allergist should be consulted.
The issue of the long-term consequences of growth retardation (effect on the final growth of the patient) in children using inhaled GCS has not been studied. Adequate studies have also not been conducted on the possibility of compensating for the resulting stunting in children after cessation of oral corticosteroids therapy.
As a rule, budesonide does not affect adrenal function, but sometimes, as a result of prolonged inhalation of the recommended daily doses, it is possible to develop its systemic effect.
The use of high doses of inhaled corticosteroids or prolonged therapy can contribute to the development of systemic undesirable effects, manifested by suppression of adrenal cortex function, hyperadrenocorticism / Itsenko-Cushing's syndrome, growth retardation in children and adolescents, decreased bone mineral density, hypersensitivity reactions, cataracts, glaucoma, in rare cases of a number of behavioral disorders, including psychomotor hyperactivity, sleep disturbances, agitation, depression or aggressiveness, especially in children's age. It should be noted that such reactions with inhaled use of GCS develop less frequently than with their oral administration.
With hormone-independent bronchial asthma, the therapeutic effect of budesonide develops on average within 10 days from the start of therapy. With increased bronchial secretion, budesonide inhalations at the beginning of the course may add a short intake of corticosteroids inside, no more than two weeks.
In patients with hormone-dependent bronchial asthma, it is necessary to stabilize the state during the transition to inhaled therapy with budesonide with the administration of corticosteroids inside.
The first 10 days of switching to budesonide inhalation are used in high doses simultaneously with oral GCS, which were used earlier, at the previous dose, after which the daily dose of GCS for oral administration is gradually reduced to the minimum therapeutic. Each month, the dose of corticosteroids in terms of prednisolone should be reduced by 2.5 mg. You can not abruptly interrupt the treatment of corticosteroids, including budesonide.
After the transition in the first months, the patient's condition should be strictly monitored until the function of the hypothalamic-pituitary-adrenal system is restored enough to ensure an adequate response of the patient to stressful situations, such as injuries, surgical interventions or severe infections. During this period, regular monitoring of indicators of the function of the hypothalamic-pituitary-adrenal system is required.
In case of impaired adrenal cortex function in stressful situations, some patients may need an additional dose of corticosteroids for oral administration. They are advised to keep with them a warning card containing this information.
The transition from systemic corticosteroids to budesonide inhalation may cause adverse reactions such as eczema, allergic rhinitis, lethargy, muscle and joint pain, nausea / vomiting, which were previously stopped by oral administration of corticosteroids. Therapy of these conditions is carried out with antihistamines or GCS for topical use.

Influence on the ability to drive vehicles and complex mechanisms

Due to the likelihood of developing neuropsychiatric symptoms as a result of treatment with budesonide and formoterol (dizziness) and other disorders of the central nervous system, the use of Foradil Combi requires caution when performing potentially hazardous activities. It is recommended that you refuse to drive vehicles while using formoterol.

Pregnancy and lactation

According to the instructions, Foradil Combi during pregnancy is allowed to be used only if the expected benefit to the mother exceeds the potential risk to the fetus. In this case, the following properties of the components should be taken into account:
    formoterol: like other β2-agonists, it is able to suppress labor activity due to the relaxing effect on the smooth muscles of the uterus;
    budesonide: if necessary, therapy for corticosteroids during pregnancy is preferably used in the form of inhalation. Its systemic effect with this method of administration is much weaker in comparison with taking Foradil Combi inside.
Budesonide is excreted during lactation, whether formoterol passes into breast milk - it is not known, therefore, when appointing Foradil Combi, breastfeeding should be abandoned.

Use in childhood

In pediatric practice, Foradil Combi is contraindicated in children under 6 years of age due to the lack of clinical experience, as well as data on the safety and effectiveness of inhalation therapy in this age group.

With impaired renal function

There is no need to adjust the dose of Foradil Combi in patients with renal failure.

With impaired liver function

There is no need to adjust the dose of Foradil Combi in patients with liver failure. But given that budesonide is excreted primarily by the liver, with severe impaired hepatic function, it should be used with caution.

Use in old age

There is no data on the need to adjust the dosage regimen of Foradil Combi in old age (after 65 years).

Drug interaction

Possible interaction of formoterol with simultaneously used drugs:
    phenothiazines, quinidine, procainamide, disopyramides, antihistamines, monoamine oxidase inhibitors (MAOs), macrolide antibiotics, tricyclic antidepressants, as well as other drugs that can extend the QT interval: care should be taken when using with formoterol, since they increase the effect of cardiovascular adrenomimetics system drugs that can extend the QT interval increase the likelihood of ventricular arrhythmias;
    other sympathomimetics: may exacerbate side effects of formoterol;
    xanthine derivatives, corticosteroids, diuretics: able to increase the potential hypokalemic effectiveness of β2-adrenergic agonists;
    halogenated hydrocarbons (during anesthesia): increase the risk of arrhythmias;
    β-adrenergic receptor blockers: can weaken the effect of formoterol, concomitant use is contraindicated if there are no vital indications.
Possible interaction of budesonide with simultaneously used drugs:
    CYP3A4 isoenzyme inhibitors (amiodarone, ketoconazole, itraconazole, nelfinavir, ritonavir, clarithromycin): can reduce the metabolism of budesonide, thereby increasing its systemic concentration; when used together, regular monitoring of the function of the adrenal cortex is required and, if necessary, correction of the dosage regimen of budesonide;
    CYP3A4 isoenzyme inducers (rifampicin, phenytoin, phenobarbital): can accelerate the metabolism of budesonide, reducing its systemic concentration and effectiveness;
    methandrostenolone, estrogens: enhance the effect of budesonide.

Terms and conditions of storage

Store at a temperature not exceeding 25 ° C in a dry place. Keep out of the reach of children.
Shelf life is 2 years.

Reviews

Foradil Combi, according to patients, is a very effective combination drug for long-term treatment and prevention of bronchopulmonary diseases, fast-acting and reliable, which does not require special storage conditions. Users also note the transparency of the capsules, which allows you to see if all the medicine is taken in one inhalation.

Terms of sell

You don't need a prescription to buy Foradil Combi.