Foradil
Foradil: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. Use in the elderly
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Foradil
ATX code: R03AC13
Active ingredient: formoterol (formoterol)
Producer: Novartis Pharma AG (Switzerland)
Description and photo updated: 2018-26-11
Prices in pharmacies: from 496 rubles.
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Foradil is a bronchodilator, beta 2 -adrenomimetic.
Release form and composition
Foradil is produced in the form of capsules with powder for inhalation: size No. 3, transparent, colorless, black ink on the cap is marked CG, on the body - FXF or, conversely, inside the capsules - white powder free flowing [10 pcs. in blisters, in a cardboard box 3 or 6 blisters complete with an aerolizer (device for inhalation)].
1 capsule contains:
- active substance: formoterol fumarate dihydrate - 12 μg;
- auxiliary component: lactose.
Pharmacological properties
Pharmacodynamics
Foradil is a bronchodilator. Its active ingredient, formoterol, is a long-acting selective beta 2 -adrenoceptor agonist. Formoterol has a bronchodilatory effect, which manifests itself in both reversible and irreversible airway obstruction. The clinical effect occurs within 1-3 minutes after inhalation of the drug. Therapeutic doses of the active substance have a minimal effect on the cardiovascular system, which is noted in rare cases.
The bronchodilator effect of Foradil is due to the ability of formoterol to inhibit the release of leukotrienes and histamine from mast cells. In addition, its anti-inflammatory properties are manifested in the ability to prevent the development of edema and the accumulation of inflammatory cells.
Efficacy has been established when using Foradil to prevent bronchospasm caused by exercise, inhalation of allergens / cold air, methacholine or histamine. In most patients with chronic lung diseases, the prolonged severity of the bronchodilating effect of the drug provides the necessary control of bronchospasm when prescribing a drug for maintenance therapy 2 times a day.
With a stable course of chronic obstructive pulmonary disease (COPD), formoterol causes the onset of a bronchodilatory effect quickly and for a long time, subjectively improving the patient's quality of life.
Pharmacokinetics
The therapeutic dose range for formoterol is from 12 mcg to 24 mcg, provided that it is used 2 times a day.
Formoterol fumarate after inhalation is rapidly absorbed into plasma in the form of formoterol. Using Foradil for 84 days in a dose of 12 or 24 mg 2 times a day in COPD found that formoterol concentration in the plasma after 1 / 6 hours after inhalation is in the range of 11,5-25,7 pmol / l, and in the range from 2 to 6 hours is 23.3-50.3 pmol / l. In the systemic circulation, the amount of formoterol increases in proportion to the dose applied. Against the background of multiple inhalations, there is some accumulation of formoterol in the plasma.
Most of the dose of formoterol by inhalation is swallowed and absorbed from the gastrointestinal tract. Plasma protein binding - 61-64%, of which 34% - with albumin. Saturation of binding sites in the range of levels observed after application of therapeutic doses of Foradil is not achieved.
The main pathway of formoterol metabolism is direct glucuronidation, the additional one is O-demethylation followed by glucuronization. The metabolic process includes sulfate conjugation and deformylation. In the process of glucuronization of formoterol, isozymes such as UGT1A1, 1A3, 1A6, 1A7, 1A8, 1A9, 1A10, 2B7, 2B15 are involved, and CYP2A6, 2D6, 2C9, 2C19 are involved in O-demethylation. Formoterol in therapeutic doses does not inhibit cytochrome P450 isozymes. A low probability of drug interaction of the active substance is assumed through inhibition of isoenzymes involved in metabolism.
In the urine of patients with bronchial asthma in unchanged form, formoterol is approximately 10%, in patients with COPD - 7%.
The active substance and its metabolites are completely removed from the body. After kidney - 2 / 3 of the dose, through the bowel - the rest.
The renal clearance of formoterol is 150 ml / min.
T 1/2 (half-life) after a single inhalation at a dose of 120 mcg in healthy volunteers is 10 hours.
Correction of pharmacokinetic parameters is carried out by body weight, the patient's gender is not taken into account.
When using formoterol in children with bronchial asthma at the age of 5–12 years at a dose of 12 or 24 μg 2 times a day for 84 days, the urinary excretion of unchanged formoterol increases by 18–84%. In the urine of children, approximately 6% of formoterol is determined unchanged.
There are no data on the pharmacokinetics of the drug in impaired liver and / or kidney function, and in elderly patients.
Indications for use
- bronchial asthma - for the prevention and treatment of bronchospasm, only in combination with inhaled glucocorticosteroids (GCS);
- violation of bronchial patency in COPD in patients with chronic bronchitis, reversible or irreversible bronchial obstruction, pulmonary emphysema (prevention and treatment);
- prevention of bronchospasm caused by inhalation of allergens, cold air or physical exertion - as an adjunct to the treatment of inhaled GCS.
Contraindications
- age up to 5 years;
- breast-feeding;
- hypersensitivity to the components of the drug.
Caution should be exercised when prescribing Foradil to patients with ischemic heart disease, heart rhythm and conduction disturbances (especially with atrioventricular block of the III degree), hypertrophic cardiomyopathy, severe heart failure, severe arterial hypertension, idiopathic hypertrophic subaortic stenosis, aneurysm, or lengthening QTc interval (QT corrected for more than 0.44 seconds), pheochromocytoma, diabetes mellitus, individual lactose intolerance.
During pregnancy, the use of Foradil is indicated only in exceptional cases when the expected therapeutic effect for the mother exceeds the potential threat to the fetus.
Instructions for the use of Foradil: method and dosage
Foradil capsules should not be taken orally by swallowing!
The powder inside the capsules is intended for inhalation, which must be carried out only with the help of an aerolizer - a special device included in the package.
The sequence of actions during inhalation:
- Take the aerolizer, remove the cap, firmly holding the device by the base, turn the mouthpiece in the direction of the arrow.
- Remove the capsule from the blister pack, place it in the cell (in the form of a capsule) located at the base of the inhaler, close the aerolizer by turning the mouthpiece.
- Activate (pierce) the capsule: while holding the aerolizer in an upright position to the end, press once on the blue buttons located on the sides and release them. You cannot press these buttons several times!
- Exhale fully, take the mouthpiece in your mouth, tightly clasping it with your lips, tilt your head back slightly, take a quick, deep, even breath. When the inhalation is performed correctly, a rattling characteristic sound is produced, which creates the rotation of the capsule and the atomization of the powder.
- Having heard the characteristic sound, it is necessary to hold your breath as long as possible, while simultaneously removing the mouthpiece from your mouth. Exhale and check for powder residues in the capsule. If the powder remains in the capsule, repeat the inhalation procedure.
- After inhalation, remove the empty capsule from the aerolizer, close it and the mouthpiece with a cap. Use a dry cloth or soft brush to remove powder residues from the mouthpiece and cell.
In the absence of a characteristic sound, the inhalation of the powder did not take place. Therefore, you should check the condition of the capsule by opening the aerolizer. If the capsule is stuck in the cell, it must be carefully removed. At the same time, it is strictly forbidden to try to release the capsule by repeatedly pressing the blue buttons.
Repeated piercing of the capsule body may cause the capsule to break and small pieces of gelatin may enter the throat when inhaled. While gelatin is edible and will not cause much harm, strict adherence to capsule storage requirements is required. They are taken out of the blister just before the procedure.
Before starting to use Foradil, the doctor must explain to the patient and make sure that he understands the rules for using the inhalation device.
The dose of the drug is prescribed by the individual selection method, taking into account the clinical need of the patient. The lowest effective dose should always be used.
After achieving control of the symptoms of bronchial asthma, a gradual reduction in the dose of Foradil should be considered, which is carried out under close medical supervision of the patient's condition.
Recommended dosage for adults:
- bronchial asthma: supportive therapy - 12-24 μg (1-2 capsules) 2 times a day against the background of the simultaneous use of inhaled GCS. The maximum daily dose is 48 mcg. To relieve symptoms of bronchial asthma, occasional additional use of 12-24 mcg per day is allowed. If the need for additional use of the drug arises more often than 2 times within 7 days, you should consult a doctor. In case of exacerbation of bronchial asthma, it is impossible to start treatment or change the dose of the drug. Foradil should not be used to relieve acute attacks of bronchial asthma;
- COPD: supportive therapy - 12-24 mcg 2 times a day;
- prevention of bronchospasm caused by physical activity or exposure to a known allergen: 12 μg (1 capsule) 15 minutes before the expected load or contact with the allergen. In case of a history of severe bronchospasm, inhalation of the contents of 2 capsules may be required.
Recommended dosage for children over 5 years of age:
- bronchial asthma: maintenance therapy - 12 mcg 2 times a day only against the background of the simultaneous use of inhaled GCS. The maximum daily dose is 24 mcg;
- prevention of bronchospasm caused by physical activity or the inevitable exposure to an allergen: 15 minutes before exercise or expected contact with an allergen - 12 μg.
Side effects
- from the gastrointestinal tract: infrequently - dryness of the oral mucosa; very rarely - nausea;
- from the nervous system: often - tremor, headache; infrequently - dizziness; very rarely - a violation of taste;
- on the part of the immune system: very rarely - hypersensitivity reactions in the form of itching, rash, urticaria, lowering blood pressure (BP), angioedema;
- mental disorders: infrequently - increased excitability, agitation, anxiety, insomnia;
- from the side of the heart: often - a feeling of palpitations; infrequently - tachycardia; very rarely - peripheral edema;
- from the respiratory system, chest and mediastinal organs: infrequently - bronchospasm, paradoxical bronchospasm;
- from the musculoskeletal and connective tissue: infrequently - muscle spasm, myalgia;
- general disorders: infrequently - irritation of the mucous membrane of the pharynx and larynx.
In addition, in the course of post-marketing observations, the following adverse reactions were established:
- from the respiratory system, chest and mediastinal organs: cough;
- from the heart: angina pectoris, arterial hypertension, atrial fibrillation, tachyarrhythmia, ventricular extrasystoles and other cardiac arrhythmias;
- dermatological reactions: rash;
- laboratory and instrumental data: increased blood pressure, prolongation of the QT interval on the electrocardiogram, hypokalemia, hyperglycemia.
Overdose
Symptoms of a Foradil overdose are nausea, vomiting, weakness, drowsiness, dry mouth, anxiety, headache, dizziness, tremor, nervousness, hyperglycemia, metabolic acidosis, hypokalemia, convulsions, muscle cramps. Decrease or increase in blood pressure, palpitations, ventricular arrhythmias, tachycardia, possibly cardiac arrest, death.
The appointment of symptomatic therapy is recommended. Careful monitoring of the patient's condition, hospitalization if necessary. Ensuring control of indicators of cardiac activity, carrying out supportive measures. The use of beta-blockers is recommended with caution due to the increased risk of bronchospasm.
special instructions
During the period of application of Foradil, patients with diabetes mellitus need to be especially careful and regularly monitor blood glucose levels.
It should be borne in mind that against the background of the use of other drugs belonging to the class of long-acting beta 2 -adrenoreceptor agonists, an increase in the frequency of deaths was noted in patients with bronchial asthma.
Inhalation of Foradil in patients with COPD helps to improve their quality of life.
Before prescribing a medication for bronchial asthma, the doctor must make sure that the anti-inflammatory therapy is fully consistent with the patient's clinical condition. Foradil should be used only as an additional agent to anti-inflammatory drugs used in cases where monotherapy with inhaled GCS does not provide sufficient control of the symptoms of the disease or a severe form of the disease requires a combination of inhaled GCS and a long-acting beta 2 -adrenoreceptor agonist. You can not stop treatment with inhaled corticosteroids, including when the condition improves. Concomitant use of other beta 2 agonists is contraindicatedlong-acting adrenergic receptors. The need for frequent intake of additional doses may indicate a worsening of the course of bronchial asthma.
The results of clinical studies indicate a slight increase in the frequency of severe exacerbations of bronchial asthma, especially in children aged 5–12 years.
The consequence of therapy with Foradil may be hypokalemia. In severe bronchial asthma, it is important for the patient to ensure regular monitoring of the level of potassium concentration in the blood serum.
There is a risk of developing paradoxical bronchospasm. If it occurs, it is necessary to stop inhalation and prescribe alternative therapy.
Influence on the ability to drive vehicles and complex mechanisms
If, against the background of inhalations of Foradil, disorders of the nervous system, including dizziness, are noted, the patient is advised to avoid potentially hazardous activities, including driving vehicles or complex mechanisms, during the period of use of the drug.
Application during pregnancy and lactation
The safety of using formoterol during pregnancy and breastfeeding has not been established.
During gestation, Foradil can be used only in exceptional cases, when the expected therapeutic effect for the mother exceeds the potential threat to the fetus. It should be borne in mind that the tocolytic effect of beta 2 -adrenomimetic can slow down the process of childbirth.
The use of the drug during lactation is contraindicated; if it is necessary to use inhalations of formoterol, breastfeeding must be stopped.
The effect of Foradil on female fertility has not been established.
Pediatric use
According to the instructions, Foradil is contraindicated for the treatment of children under the age of 5 years.
For children over 5 years old, the drug is prescribed according to indications.
Children aged 5 to 12 years are recommended to prescribe combined preparations containing inhaled corticosteroids and a long-acting beta 2 -adrenergic receptor agonist, unless their separate use is necessary.
Use in the elderly
For patients over 65 years of age, correction of the dosage regimen of Foradil is not required.
Drug interactions
- quinidine, disopyramide, procainamide, phenothiazines, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and other drugs that prolong the QT interval: cause an increase in the effect of adrenostimulants on the cardiovascular system, increasing the risk of ventricular arrhythmias;
- sympathomimetic agents: may aggravate the side effects of formoterol;
- derivatives of xanthine, diuretics or corticosteroids: increase the risk of increasing the potential hypokalemic action of beta 2 -adrenomimetic;
- anesthesia using hydrocarbons: the risk of arrhythmia increases;
- beta-blockers, including eye drops: help to weaken the action of Foradil, therefore, they should not be combined with formoterol.
Analogs
Foradil's analogs are Oxis Turbuhaler, Ascoril, Berotek, Formoterol, Stopussin, Salbutamol, Formoterol-Nativ, Fenoterol, Ventolin, Onbrez Breezhaler, etc.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C, protected from moisture.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Foradil
Reviews about Foradil are mostly positive. Pointing to the effectiveness of the drug, patients notice a significant decrease in the frequency of attacks. The advantages of Foradil also include its long-term effect.
The disadvantages are not very convenient inhalation device. There are reports of the development of undesirable side reactions.
Price for Foradil in pharmacies
The price of Foradil for a package containing 30 capsules can range from 427 rubles; 60 capsules - from 850 r.
Foradil: prices in online pharmacies
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Drug name Price Pharmacy |
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Foradil 12 mcg capsules with powder for inhalation complete with inhaler Aerolizer 30 pcs. 496 r Buy |
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Foradil powder capsules for inhalation. 12μg 30 pcs. RUB 510 Buy |
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Foradil 12 mcg capsules with powder for inhalation complete with inhaler Aerolizer 60 pcs. RUB 624 Buy |
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Foradil powder capsules for inhalation. 12μg 60 pcs. 736 RUB Buy |
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Foradil Combi 200 mcg + 12 mcg capsules with powder for inhalation set 120 pcs. RUB 968 Buy |
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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!
