Foradil Combi - Instructions For Use, Price, Reviews, 12 Mcg And 400 Mcg

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Foradil Combi

Foradil Combi: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Foradil Combi

ATX code: R03AK07

Active ingredient: budesonide (budesonide), formoterol (formoterol)

Producer: Novartis Pharma Stein (Switzerland), Pharmachemie (Netherlands)

Description and photo updated: 22.11.2018

Prices in pharmacies: from 968 rubles.

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Foradil Combi is a combined bronchodilator drug with anti-inflammatory, antiallergic, bronchodilatory, glucocorticoid, β ₂ -adrenomimetic and immunosuppressive action.

Release form and composition

Foradil Combi is available as a set of capsules with powder for inhalation, which includes:

• capsules with formoterol (12 mcg): size No. 3, colorless, transparent, marked in black ink: “CG” on the cap, “FXF” on the body (or vice versa); filler - free-flowing white powder;
• capsules with budesonide (200 mcg): size No. 3, gelatinous solid, lid - light pink, body - colorless, transparent; the capsule is marked "BUDE 200"; filler - white powder;
• capsules with budesonide (400 mcg): size No. 3, gelatinous solid, pink cap, body colorless, transparent; the capsule is marked "BUDE 400"; filler - white powder.

The Foradil Combi package contains formoterol capsules (12 mcg) and budesonide capsules (200 mcg or 400 mcg). Capsules are packaged in 10 pcs. in blisters, in a cardboard box complete with an inhalation device (aerolizer), 3 or 6 blisters of capsules containing formoterol (12 μg), and 1, 3, 6 or 12 blisters of capsules containing budesonide (200 μg or 400 μg).

Composition of 1 capsule with formoterol (12 mcg):

• active ingredient: formoterol fumarate dihydrate - 12 μg;
• auxiliary ingredients: lactose monohydrate (milk sugar) - up to 25,000 mcg;
• capsule shell: gelatin 100%.

Composition of 1 capsule with budesonide (200 mcg):

• active ingredient: budesonide - 200 mcg;
• auxiliary ingredients: lactose monohydrate (milk sugar) - 24,770 mcg;
• capsule shell: red iron oxide (E172), titanium dioxide (E171), water, gelatin.

Composition of 1 capsule with budesonide (400 mcg):

• active ingredient: budesonide - 400 mcg;
• auxiliary ingredients: lactose monohydrate (milk sugar) - 24 540 mcg;
• capsule shell: red iron oxide (E172), black iron oxide (E172), ponceau 4R crimson dye, titanium dioxide (E171), water, gelatin.

Pharmacological properties

Pharmacodynamics

The therapeutic properties of Foradil Combi are due to the pharmacodynamic characteristics of the active substances in its composition:

• formoterol: selective β ₂ agonist-adrenergic receptors, which has 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 practically excludes 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). In the course of clinical studies, it was found that formoterol effectively prevents bronchospasm provoked by physical activity, inhaled allergens, cold air, histamine or methacholine. Thanks to,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 to provide the required control of bronchospasm in patients with chronic lung diseases both during the day and at night. With a stable course of chronic obstructive pulmonary disease (COPD), formoterol also provides a rapid onset of bronchodilation and improves quality of life;With a stable course of chronic obstructive pulmonary disease (COPD), formoterol also provides a rapid onset of bronchodilation and improves quality of life;With a stable course of chronic obstructive pulmonary disease (COPD), formoterol also provides a rapid onset of bronchodilation and improves quality of life;
• budesonide: glucocorticosteroid (GCS), intended for inhalation use, has practically no systemic effect. Like other inhaled corticosteroids, its pharmacological efficacy is provided through interaction with intracellular glucocorticosteroid receptors and manifests itself as 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,suppresses the formation of chemotaxis substance (which ensures the effectiveness of the drug in stopping delayed-type allergic reactions); slows down the release of inflammatory mediators from mast cells (immediate allergic reactions). Budesonide promotes 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), the edema of the bronchial mucosa, the production of mucus and sputum decreases, the hyperresponsiveness of the respiratory tract decreases, and mucociliary clearance increases. A clinically significant therapeutic effect after the start of therapy for patients requiring GCS develops on average within 10 days. Regular use of budesonide for bronchial asthma reduces the severity of chronic inflammation in the lungs,thus improving their function, relieves the symptoms of bronchial asthma, inhibits bronchial hyperreactivity, preventing the development of an exacerbation of the disease.

Pharmacokinetics

Pharmacokinetic characteristics of formoterol:

• absorption: the substance is rapidly absorbed by inhalation. As a result of the use of a single dose of formoterol (120 μg), C _max (maximum plasma concentration) is reached in 5 minutes and is 266 pmol / l. Due to ingestion, absorption in the gastrointestinal tract (GIT) also occurs quickly, in a volume of up to 65%. When treating COPD for 12 weeks, 2 times a day at a dose of 12 or 24 μg of formoterol, its concentration in blood plasma, 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 μg);
• distribution over organs and tissues: formoterol binds to plasma proteins by 61–64%, of which 34% is associated with serum albumin. Saturation of binding sites is not achieved within the limits of concentrations recorded after application of the drug in therapeutic doses;
• metabolism: the main pathway of formoterol metabolism is direct binding to glucuronic acid, another pathway is O-demethylation with further glucuronization. Secondary metabolic processes include the conjugation of formoterol with sulfate, followed by their deformation. Many isoenzymes of formoterol are involved in the processes of glucuronization (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 iso in the metabolism of formoterol. In the range of therapeutic doses, formoterol does not inhibit cytochrome P ₄₅₀ isozymes;
• excretion: in bronchial asthma and COPD, when applied for 12 weeks, doses of 12 or 24 μg 2 times a day unchanged in the urine were determined by ~ 10% or 7%, respectively. Formoterol and its metabolites are completely excreted from the body: with urine - 70%, with feces - 30%. Renal clearance - 150 ml / min. The half-life (T _1/2) is 120-180 minutes.

Pharmacokinetic characteristics of budesonide:

• absorption: the substance is completely and quickly absorbed by inhalation, C _{max is} achieved immediately. Taking into account the sedimentation of budesonide on the mucous membrane of the oropharynx, its absolute bioavailability is 73%. Due to ingestion, absorption in the gastrointestinal tract is ± 10%;
• distribution to organs and tissues: volume of distribution (V _d) - 3 l / kg. According to studies, budesonide accumulates in the lymph nodes, spleen, thymus, reproductive organs, adrenal cortex, bronchi, and also penetrates the placental barrier;
• metabolism: in the lungs, budesonide is not metabolized; its systemic clearance with inhalation is 0.5 l / min. Plasma proteins bind up 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 metabolism of a substance in the liver using the isoenzyme CYP3A4 of the P ₄₅₀ system can vary under the influence of inhibitors / inducers of the isoenzyme CYP3A4;
• excretion: T _{1/2 of} budesonide - 120-168 min, high systemic clearance (1.4 l / min). The substance is excreted in the form of metabolites with feces - 10%, with urine - 70%. In liver disease, the plasma concentration of budesonide increases.

Indications for use

• bronchial asthma, insufficiently controlled by the use of short-acting β ₂ -agonists and inhaled corticosteroids (therapy on demand);
• bronchial asthma, adequately controlled by the use of long-acting β ₂ -agonists and inhaled GCS;
• COPD with proven effectiveness of GCS use.

Contraindications

Absolute:

• period of breastfeeding;
• pulmonary tuberculosis in active form;
• lactase deficiency, hereditary galactose intolerance, glucose-galactose malabsorption syndrome (lactose is present in the capsules);
• children under 6 years of age;
• hypersensitivity to formoterol, budesonide, any other components of the inhalation kit.

Conditions / diseases in which Foradil Combi should be used with extreme caution, under close medical supervision due to the presence of active ingredients in its composition:

• formoterol (especially in the process of dose reduction): with ischemic heart disease (IHD), heart rhythm and conduction disorders, especially with atrioventricular block of the III degree, severe chronic heart failure (CHF), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, aeurysm of the aeurysm, 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), liver cirrhosis, glaucoma; taking into account the possibility of the development of fungal pathologies, caution is observed with bronchiectasis and pneumoconiosis.

For the relief of an acute attack of bronchospasm, budesonide is not effective, therefore it should not be prescribed for status asthmaticus, 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 are advised to carry out regular additional monitoring of blood glucose levels.

Instructions for the use of Foradil Combi: method and dosage

Foradil Combi is intended for inhalation injection: capsules containing formoterol and budesonide should be used only using 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 it to a dose sufficient to maintain the therapeutic effect.

After achieving control of bronchial asthma symptoms against the background of inhalations with formoterol, the possibility of a gradual reduction in its dose should be considered, which must be carried out under regular medical supervision. During an exacerbation of bronchial asthma, you should not start treatment with formoterol or change its dose. Formoterol should also not be used for the relief of acute attacks of bronchial asthma.

Inhalation of β-adrenomimetics, 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 maintenance treatment of bronchial asthma and COPD are used in the following order:

1. Capsules containing formoterol.
2. 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 relieve 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 issue of correcting the treatment regimen, since this may indicate a worsening of the course of the disease;
• budesonide: the minimum dose (it is also the least effective) in the inhalation set is 200 mcg (1 capsule), therefore Foradil Combi is not prescribed when a single dose of budesonide is required less than 200 mcg. The maintenance dose for the treatment of mild bronchial asthma is 400-800 mcg per day, divided into 2 doses of 200-400 mcg. In case of exacerbation of bronchial asthma when switching from oral dosage forms of GCS to inhalation or when reducing the dose for oral administration, the maximum permissible daily dose of budesonide can be 1600 mcg, divided into 2-4 doses.

Treatment for children 6 years of age and older:

• formoterol: regular maintenance dose - 12 mcg (1 capsule) 2 times a day; the maximum daily dose is 24 μg (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, the dose of budesonide can be increased to a maximum daily dose of 800 mcg.

Inhalation rules

In order to ensure the correct use of Foradil Combi, a doctor or other healthcare professional should explain to the patient how to use the inhaler, tell that inhalation should be carried out only with an aerolizer, and warn against swallowing capsules intended for inhalation use. For children and adolescents, the procedure is carried out under the supervision of adults to make sure that the inhalation technique is performed correctly.

When a gelatin capsule breaks down during inhalation, small pieces of gelatin can enter the mouth and then down the throat. To minimize the likelihood of such a hit, do not pierce the capsule more than once.

The capsule is removed from the blister pack 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 developing unwanted systemic reactions.

There are isolated reports of unintentional swallowing of whole capsules. In most of these cases, the development of undesirable effects was not observed. If, after inhalation, the patient's breathing does not improve, the doctor must re-explain to him the scheme of the correct use of the drug.

Aerolizer Application:

1. Remove the protective cap from the mouthpiece of the aerolizer.
2. Holding the aerolizer firmly by the base, turn the mouthpiece in the direction of the arrow.
3. Place the capsule in the capsule-shaped cell opened at the base of the aerolizer, which must be removed from the blister just before the procedure.
4. Close the aerolizer by turning the mouthpiece to its original position.
5. While holding the aerolizer strictly vertically, press the blue buttons located on its sides once until the end, and then release them.
6. Take a deep breath.
7. Throwing your head back slightly, take the mouthpiece in your mouth, clasping it tightly with your lips. Make a uniform, fast, deepest breath, which should be accompanied by a characteristic rattling sound created by the rotation of the capsule when spraying the powder.
8. Hold your breath for as long as possible, while simultaneously removing the mouthpiece from your mouth, and then exhale. Open the aerolizer, make sure no powder remains in the capsule. Otherwise, repeat the manipulations described in paragraphs 6-8.
9. Having finished inhalation, open the aerolizer, remove the empty capsule, turn the mouthpiece to its original position and cover the aerolizer with a cap.

In step 1-5, the capsule may be damaged if pierced, allowing small pieces of gelatin to penetrate the mouth and throat. Gelatin is a food ingredient and is not harmful when absorbed. But in order to avoid complete destruction of the capsule, it should not be pierced more than once, it is also recommended to observe the storage conditions and remove the capsule from the blister immediately before inhalation.

In step 7, if no characteristic sound was heard, the aerolizer must be opened to find out what happened to the capsule. If it is stuck in the cell, it must be carefully removed without trying to release it by repeatedly pressing the blue buttons on the sides of the inhaler.

Wipe the mouthpiece and aerolizer compartment with a dry cloth or soft brush to remove powder residues.

Side effects

The 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 rare - 0.0001% or less, including individual messages; with an unknown frequency - post-marketing observation data, the frequency of which cannot be reliably estimated.

Undesirable side reactions when using formoterol:

• immune system: extremely rarely - such hypersensitivity reactions as urticaria, arterial hypotension, angioedema, rash, itching;
• mental disorders: infrequently - anxiety, agitation, insomnia, increased irritability;
• nervous system: often - tremor, headache; infrequently - dizziness; extremely rare - dysgeusia (taste disturbance);
• cardiovascular system: often - palpitations; infrequently - tachycardia; extremely rare - peripheral edema; with an unknown frequency - angina pectoris, heart rhythm disturbance, 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 rare - nausea;
• musculoskeletal system: infrequently - myalgia, muscle spasms;
• data from laboratory and instrumental studies: with an unknown frequency - a decrease in serum potassium concentration, an increase in blood glucose levels, an extension of 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 - rash.

Undesirable side reactions when using budesonide:

• endocrine system: rarely - suppression of the function of the adrenal cortex, Itsenko-Cushing's syndrome, hypercortisolism / hypocorticism, growth retardation in childhood and adolescence;
• organ of vision: rarely - cataract, glaucoma;
• immune system: rarely - such hypersensitivity reactions as angioedema, rash, urticaria, itching; with an unknown frequency - contact dermatitis [HRT (delayed-type hypersensitivity), IV type of 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 an unknown frequency - dysgeusia;
• musculoskeletal system: rarely - a decrease in bone mineral density;
• respiratory system, chest and mediastinal organs: often - cough; rarely - candidiasis of the oral mucosa / larynx, paradoxical bronchospasm, pharyngeal irritation, dysphonia (after a dose reduction or cessation of therapy with budesonide, it goes away 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 specified in the instructions, you must inform your doctor about them.

Overdose

Symptoms of an overdose of formoterol can be reactions characteristic of β ₂ -adrenomimetics, such as headache, nausea, vomiting, drowsiness, tremors, palpitations, ventricular arrhythmia, tachycardia, metabolic acidosis, hyperglycemia, hypokalemia, arterial hypertension.

Supportive and symptomatic treatment is recommended, and hospitalization is necessary for serious disorders. Cardioselective β-blockers may be used only under close medical supervision, with extreme caution, as this can cause bronchospasm.

Since budesonide has a low acute toxicity, a single high-dose inhalation can cause 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

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 insufficient control of symptoms during the period of monotherapy with inhaled corticosteroids or with a severe disease requiring a combination of inhaled corticosteroid and long-acting β ₂ -adrenomimetics. It is contraindicated to use formoterol simultaneously with other long-acting β ₂ -agonists. Before starting treatment, it is necessary to assess the patient's condition regarding the adequacy of the anti-inflammatory therapy used. After the start of inhalations with formoterol, it is recommended to continue the ongoing anti-inflammatory therapy without changes, even with a clinically significant improvement in the condition.

The relief of acute attacks of bronchial asthma is carried out with the help of short-acting β ₂ -adrenomimetics. A sudden deterioration in the patient's condition requires immediate medical attention.

In patients receiving formoterol in placebo-controlled clinical trials, there was an increase in the incidence of severe exacerbations of bronchial asthma. But the results of these studies do not allow for a quantitative assessment of this complication in various groups.

As a result of the use of β ₂ -adrenomimetics, including formoterol, potentially serious hypokalemia can develop, which can increase the risk of arrhythmias. This condition can be potentiated by hypoxia and concomitant therapy, which requires special care in severe bronchial asthma. It is recommended that such patients regularly monitor serum potassium levels.

Paradoxical bronchospasm can develop as a result of the use of formoterol, as with any other inhalation treatment, this condition requires immediate discontinuation of the drug and the appointment of alternative therapy.

Budesonide

To ensure the delivery of budesonide to 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, not for relief of seizures. Inhalation in compliance with the recommended dosage regimen is continued even in the absence of symptoms of bronchial asthma.

The development of paradoxical bronchospasm requires immediate discontinuation of budesonide, assessment of the patient's condition and, if necessary, the appointment of another drug. Paradoxical bronchospasm is immediately stopped with short-acting β ₂ -adrenomimetics, an inhaler with which the patient should always have at his disposal.

If the patient's condition worsens, the need for short-acting bronchodilators increases, and dyspnea attacks intensify, it is necessary to immediately consult a specialist for examination and consideration of the possibility of increasing the dose of inhaled corticosteroids or corticosteroids 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 thoroughly rinse the mouth with water, and with the development of such an infection, local antifungal treatment is possible without stopping the inhalations with budesonide.

In case of exacerbation of bronchial asthma, the dose of budesonide is increased or, if necessary, a short course of therapy with systemic corticosteroids is carried out and / or antibiotic therapy is prescribed when an infection develops.

Regular monitoring of the growth dynamics of children and adolescents is required during long-term therapy with inhaled GCS, and if it is delayed, correction of the dosage regimen with the appointment of a minimum effective dose and consultation of an allergist is required.

The question of the long-term consequences of growth retardation (the effect on the patient's final growth) in children when using inhaled GCS has not been studied. There were also no adequate studies of the possibility of compensating for the arising growth retardation in children after discontinuation of therapy with oral GCS.

As a rule, budesonide does not affect the function of the adrenal glands, but sometimes, as a result of prolonged inhalation of the recommended daily doses, its systemic action may develop.

The use of high doses of inhaled corticosteroids or prolonged therapy can contribute to the development of systemic undesirable effects, manifested by suppression of the 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 disorders, agitation, depression or aggressiveness, especially in childhood. It should be noted that such reactions with inhalation use of GCS develop less frequently than with their oral administration.

In 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 inhalation at the beginning of the course may be supplemented with a short intake of GCS inside, no more than two weeks.

In patients with hormone-dependent bronchial asthma, it is necessary to stabilize the condition during the transition to inhalation therapy with budesonide with oral corticosteroids.

The first 10 days of switching to budesonide by inhalation, it is used in high doses simultaneously with oral corticosteroids, previously used, in the same dose, after which the daily dose of corticosteroids for oral administration is gradually reduced to the minimum therapeutic. Each month, the dose of corticosteroids should be reduced by 2.5 mg in terms of prednisone. You can not abruptly interrupt treatment with GCS, 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 recovers sufficiently to ensure an adequate patient response to stressful situations, such as trauma, surgery, or severe infections. During this period, regular monitoring of the indicators of the function of the hypothalamic-pituitary-adrenal system is required.

In case of dysfunction of the adrenal cortex in stressful situations, some patients may need an additional dose of GCS for oral administration. They are advised to keep a warning card with such information with them at all times.

As a result of the transition from systemic corticosteroids to inhalation of budesonide, the manifestation of such side reactions as eczema, allergic rhinitis, lethargy, muscle and joint pain, nausea / vomiting, which were stopped earlier by oral administration of corticosteroids, is possible. Therapy of these conditions is carried out with antihistamines or GCS for local use.

Influence on the ability to drive vehicles and complex mechanisms

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

Application during pregnancy and lactation

According to the instructions, Foradil Combi during pregnancy is allowed to be used only if the intended 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 β ₂ -agonists, it is able to suppress labor due to its relaxing effect on the smooth muscles of the uterus;
• budesonide: if it is necessary to carry out GCS therapy during pregnancy, it is preferable to use it in the form of inhalation. Its systemic effect with this method of administration is much weaker in comparison with taking the drug inside.

Budesonide is excreted during lactation, whether formoterol penetrates into breast milk is unknown, therefore, breastfeeding should be discarded when Foradil Kombi is prescribed.

Pediatric use

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 efficacy of inhalation therapy in this age group.

With impaired renal function

There is no need for dose adjustment of Foradil Combi in patients with renal failure.

For violations of liver function

There is no need for dose adjustment of Foradil Combi in patients with hepatic impairment. But given that budesonide is excreted mainly by the liver, in severe hepatic impairment, it should be used with caution.

Use in the elderly

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

Drug interactions

Possible interaction of formoterol with simultaneously used drugs:

• phenothiazines, quinidine, procainamide, disopyramide, antihistamines, monoamine oxidase (MAO) inhibitors, macrolide antibiotics, tricyclic antidepressants, as well as other drugs that can prolong the QT interval: caution should be exercised when using formoterol, since they increase the effect of adrenomimetics on cardiac system; drugs that can prolong the QT interval increase the likelihood of ventricular arrhythmias;
• other sympathomimetics: may aggravate the side effects of formoterol;
• xanthine derivatives, corticosteroids, diuretics: able to increase the potential hypokalemic efficacy of β ₂ -adrenomimetics;
• halogenated hydrocarbons (during anesthesia): increase the risk of arrhythmia;
• β-adrenergic receptor blockers: can weaken the effect of formoterol, simultaneous use is contraindicated if there are no vital indications.

Possible interaction of budesonide with concomitantly used drugs:

• inhibitors of the isoenzyme CYP3A4 (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 budesonide dosage regimen;
• inducers of the isoenzyme CYP3A4 (rifampicin, phenytoin, phenobarbital): can accelerate the metabolism of budesonide, reducing its systemic concentration and effectiveness;
• methandrostenolone, estrogens: enhance the effect of budesonide.

Analogs

Foradil Combi's analogs are: Foster, Duoresp Spiromax, Sabacomb, Salmecort, Zenheil, Seretid, Seretid Multidisk, Symbicort Turbuhaler, Tevacomb, etc.

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.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Foradil Combi

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

The disadvantages include the high cost of the product, the large size of the aerolizer, which makes it inconvenient to carry with you, and the frequent absence of the drug in the pharmacy. A single case of breakdown of the aerolizer is described.

Price for Foradil Combi in pharmacies

Approximate prices for Foradil Combi:

• Foradil Combi 12 + 200 mcg (capsules with formoterol 12 mcg + capsules with budesonide 200 mcg), 10 pcs. in blisters, in a package of 6 blisters of each type of capsule complete with a device for inhalation - 1090–1176 rubles;
• Foradil Combi 12 + 400 mg (capsules with formoterol 12 mcg + capsules with budesonide 400 mcg), 10 pcs. in blisters, in a package of 6 blisters of each type of capsule, complete with a device for inhalation - 1200-1400 rubles.

Foradil Combi: prices in online pharmacies

Drug name Price Pharmacy

Foradil Combi 200 mcg + 12 mcg capsules with powder for inhalation set 120 pcs. RUB 968 Buy

Foradil Combi 400 mcg + 12 mcg capsules with powder for inhalation set 120 pcs. 1205 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!