Foradil caps for inhalation 12mcg #60

Foradil instruction

You can buy Foradil here

Foradil is a bronchodilating drug, beta2-adrenergic agonist.

Release form and composition

Foradil is available 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 pack of 3 or 6 blisters complete with an aerolizer (device for inhalation)].
1 capsule contains:
    active substance: formoterol fumarate dihydrate - 12 mcg;
    auxiliary component: lactose.

Pharmacodynamics

Foradil is a bronchodilator drug. Its active substance, formoterol, is a selective long-acting beta2-adrenoreceptor agonist. Formoterol has a bronchodilating effect, which manifests itself both in reversible and irreversible airway obstruction. Clinical effect occurs 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 inhibit the development of edema and the accumulation of inflammatory cells.
Efficacy has been established when using Foradil in order to prevent bronchospasm caused by physical exertion, inhalation of allergens / cold air, methacholine or histamine. In most patients with chronic lung diseases, the prolonged severity of the bronchodilator effect of the drug provides the necessary control of bronchospasm when prescribing a means for maintenance therapy 2 times a day.
With a stable course of chronic obstructive pulmonary disease (COPD), formoterol causes the onset of a bronchodilating effect quickly and for a long time, subjectively improving the patient's quality of life.

Pharmacokinetics

The range of therapeutic doses of formoterol is in the range from 12 μg to 24 μg, provided that it is used 2 times a day.
Formoterol fumarate after inhalation is rapidly absorbed into the plasma in the form of formoterol. The use of Foradil for 84 days at a dose of 12 or 24 mcg 2 times a day with COPD showed that the concentration of formoterol in plasma 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 used. Against the background of repeated inhalations, some cumulation of formoterol in plasma is noted.
Most inhaled formoterol is swallowed and absorbed from the gastrointestinal tract. Binding to plasma proteins - 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 glucuronidation. The metabolic process includes conjugation with sulfate and deformylation. Isoenzymes such as UGT1A1, 1A3, 1A6, 1A7, 1A8, 1A9, 1A10, 2B7, 2B15 are involved in the glucuronidation of formoterol, and CYP2A6, 2D6, 2C9, 2C19 in O-demethylation. Formoterol in therapeutic doses does not inhibit isoenzymes of the cytochrome P450 system. A low probability of drug interaction of the active substance through the inhibition of isoenzymes involved in metabolism is assumed.
In the urine of patients with bronchial asthma, unchanged formoterol is approximately 10%, in patients with COPD - 7%.
The active substance and its metabolites are completely excreted from the body. Through the kidneys –2/3 of the accepted dose, through the intestines - the rest.
Renal clearance of formoterol - 150 ml / min.
T1 / 2 (half-life) after a single inhalation at a dose of 120 mcg in healthy volunteers is 10 hours.
Correction of pharmacokinetic parameters is made according to body weight, the gender of the patient is not taken into account.
When using formoterol in children with bronchial asthma at the age of 5–12 years old at a dose of 12 or 24 mcg 2 times a day for 84 days, urinary excretion of unchanged formoterol increases by 18–84%. In the urine of children, approximately 6% of unchanged formoterol is determined.
There is no data on the pharmacokinetics of the drug in case of 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 obstruction in COPD in patients with chronic bronchitis, reversible or irreversible bronchial obstruction, pulmonary emphysema (prevention and treatment);
    prevention of bronchospasm due to inhalation of allergens, cold air or physical exertion - as an adjunct to treatment with inhaled corticosteroids.

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 coronary heart disease, impaired heart rhythm and conduction (especially with atrioventricular block III degree), hypertrophic cardiomyopathy, severe heart failure, severe arterial hypertension, idiopathic hypertrophic subaortic stenosis, aneurysm or aneurysm QTc interval (QT corrected for more than 0.44 seconds), pheochromocytoma, diabetes mellitus, individual neper lactose intolerance.
During pregnancy, the use of Foradil is indicated only in exceptional cases, when the expected therapeutic effect for the mother outweighs the potential threat to the fetus.

Instructions for use of Foradil: method and dosage

Foradil capsules cannot be taken orally by swallowing!
The powder inside the capsules is intended for inhalation, which is required only with the help of an aerolizer - a special device that is 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 the vertical position, push the blue buttons located on the sides 1 time to the end and release them. Do not click on these buttons several times!
    Take a full exhale, take the mouthpiece in your mouth, tightly clasping it with your lips, slightly tilt your head back, take a quick, as deep as possible even breath. With proper inhalation, a rattling, characteristic sound occurs that creates rotation of the capsule and spraying of the powder.
    Hearing a 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 residue 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. A dry cloth or soft brush is used 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 can cause its destruction and small pieces of gelatin during inhalation can get into the throat. Although gelatin is edible and will not cause much harm, nevertheless, strict adherence to capsule storage requirements is required. They are removed from the blister just before the procedure.
Before starting the use of 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 individually by taking into account the clinical need of the patient. Always use the lowest effective dose.
After achieving control of symptoms of bronchial asthma, consideration should be given to gradually reducing the dose of Foradil, which is carried out under close medical supervision of the patient's condition.
Recommended dosage for adults:
    bronchial asthma: maintenance therapy - 12-24 mcg (1-2 capsules) 2 times a day against the background of the simultaneous use of inhaled corticosteroids. 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 occurs more often than 2 times within 7 days, you should consult a doctor. With exacerbation of bronchial asthma, treatment cannot be started or the dose of the drug can not be changed. Do not use Foradil for the relief of acute attacks of bronchial asthma;
    COPD: maintenance therapy - 12-24 mcg 2 times a day;
    prevention of bronchospasm caused by physical exertion or exposure to a known allergen: 12 mcg (1 capsule) 15 minutes before the expected load or contact with the allergen. In severe cases of a history of bronchospasm, inhalation of the contents of 2 capsules may be required.
Recommended dosage for children over 5 years:
    bronchial asthma: maintenance therapy - 12 mcg 2 times a day only against the background of the simultaneous use of inhaled corticosteroids. The maximum daily dose is 24 mcg;
    prophylaxis of bronchospasm due to physical exertion or the inevitable exposure to an allergen: 15 mcg 15 minutes before exercise or presumptive contact with an allergen.

Side effects

    from the gastrointestinal tract: infrequently - dry mouth; very rarely - nausea;
    from the nervous system: often - tremor, headache; infrequently - dizziness; very rarely - violation of taste sensations;
    from the immune system: very rarely - hypersensitivity reactions in the form of itching, rash, urticaria, lowering blood pressure (BP), angioedema;
    mental disorders: infrequently - increased irritability, agitation, anxiety, insomnia;
    on the part 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, the following adverse reactions were identified during post-marketing observations:
    from the respiratory system, chest and mediastinal organs: cough;
    on the part of the heart: angina pectoris, arterial hypertension, atrial fibrillation, tachyarrhythmia, ventricular extrasystoles and other heart rhythm disturbances;
    dermatological reactions: rash;
    laboratory and instrumental data: increased blood pressure, lengthening the QT interval on the electrocardiogram, hypokalemia, hyperglycemia.

Overdose

Symptoms of an overdose of Foradil are nausea, vomiting, weakness, drowsiness, dry mouth, anxiety, headache, dizziness, tremors, nervousness, hyperglycemia, metabolic acidosis, hypokalemia, cramps, 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, if necessary hospitalization. Providing control of indicators of cardiac activity, conducting supportive measures. The use of beta-blockers is recommended with caution because of the increased risk of bronchospasm.

special instructions

During the use of Foradil, patients with diabetes need to carefully and regularly monitor their blood glucose levels.
It should be borne in mind that with the use of other drugs belonging to the class of long-acting beta2-adrenoreceptor agonists, an increase in the frequency of fatal outcomes was noted in patients with bronchial asthma.
Foradil inhalation in patients with COPD improves their quality of life.
Before prescribing a drug for bronchial asthma, the doctor must make sure that the anti-inflammatory therapy being carried out is fully consistent with the clinical condition of the patient. Foradil should be used only as an adjunct to the 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 beta2-adrenoreceptor agonist. You can not stop treatment with inhaled corticosteroids, including with improvement. The simultaneous use of other long-acting beta2-adrenoreceptor agonists is contraindicated. The need for frequent additional doses may indicate a worsening of 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 result of therapy with Foradil may be hypokalemia. In severe 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 paradoxical bronchospasm. In case of its occurrence, 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 Foradil inhalations, disorders of the nervous system, including dizziness, are noted, the patient is advised to avoid potentially dangerous activities, including driving vehicles or complex mechanisms, during the period of use of the drug.

Pregnancy and lactation

The safety of the use of formoterol during pregnancy and breastfeeding has not been established.
In the period of 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 beta2-adrenergic agonist can slow the process of childbirth.
The use of the drug during lactation is contraindicated; if it is necessary to use inhalations of formoterol, breast-feeding should be stopped.
The effect of Foradil on female fertility has not been established.

Use in childhood

According to the instructions, Foradil is contraindicated for the treatment of children under the age of 5 years.
For children over 5 years of age, the drug is prescribed according to the indications.
For children aged 5 to 12 years, it is recommended to prescribe combination preparations containing an inhaled GCS and a long-acting beta2-adrenergic receptor agonist, except when it is necessary to use them separately.

Use in old age

For patients over 65 years of age, correction of the dosage regimen of Foradil is not required.

Drug interaction

    quinidine, disopyramide, procainamide, phenothiazines, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and other drugs that prolong the QT interval: increase the effect of adrenostimulants on the cardiovascular system, increasing the risk of ventricular arrhythmias;
    sympathomimetic drugs: can cause aggravation of side effects of formoterol;
    xanthine derivatives, diuretics or corticosteroids: increase the risk of enhancing the potential hypokalemic effect of beta2-adrenergic agonist;
    anesthesia using hydrocarbons: the risk of developing arrhythmias increases;
    beta-blockers, including eye drops: contribute to weakening the action of Foradil, therefore, their combination with formoterol should not be allowed.

Terms and conditions of storage

Keep out of the reach of children.
Store at temperatures up to 25 ° C in a dry place.
Shelf life is 2 years.

Reviews

Reviews about Foradil are mostly positive. Indicating the effectiveness of the drug, patients noted a significant decrease in the frequency of seizures. The advantages of Foradil also include its long-term effect.
As disadvantages, a not very convenient device for inhalation is noted. There are reports of the development of unwanted adverse reactions.

Terms of sell

You don't need a prescription to buy Foradil.