Index of drugs

Prevention and treatment of bronchoconstriction in patients with bronchial asthma, in addition to therapy with inhaled corticosteroids. Prevention of bronchial spasm caused by inhalation allergens, cold air or physical exercise. Prevention and treatment of bronchoconstriction in patients with reversible or irreversible chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The preparation improves the quality of life in patients with COPD.

1 capsule (1 inhalation dose) contains 12 μg of formoterol fumarate (as formoterol fumarate dihydrate). The preparation contains lactose.

A strong drug that stimulates selective β receptors₂-Adrenergic. Has a bronchodilator effect in patients with reversible airway obstruction. This effect occurs quickly (within 1-3 min) and persists for 12 hours after inhalation. In therapeutic doses, the action on the cardiovascular system is insignificant and occurs only in sporadic cases. Formoterol inhibits the release of histamine and leukotrienes, which are formed in the lungs as a result of an allergic reaction. The preparation is effective in preventing bronchoconstriction caused by inhalation allergens, exercise, cold air, histamine or methacholine. After inhalation of a single dose of 120 μg by healthy volunteers, formoterol was rapidly absorbed into the plasma and reached its maximum concentration within 5 min after inhalation. Most of the dose from the inhaler will be swallowed and then absorbed from the digestive tract. The drug is bound to plasma proteins in 61-64%. It is eliminated from the body, mainly in metabolic processes. The main biotransformation process is direct conjugation with glucuronic acid, another - O-demethylation followed by conjugation with glucuronic acid. There are many isoenzymes that catalyze the transformation, which indicates a low probability of drug interactions. The drug and its metabolites are completely eliminated from the body: about 2/3 of the oral dose is excreted in the urine and 1/3 - in the faeces.

Hypersensitivity to formoterol, lactose (which contains a small amount of milk proteins) or to any of the excipients.

Formoterol is not the first-line treatment for asthma. When treating patients with asthma, the product should only be used as an add-on to the inhaled corticosteroid in patients who are not adequately controlled by inhaled corticosteroid or in patients whose exacerbation is the basis for starting treatment with both an inhaled corticosteroid as well as a long-acting drug stimulating β receptors₂-Adrenergic. In a study with salmeterol, another long-acting drug that stimulates β receptors₂-adrenergic, a higher mortality rate due to asthma was observed in patients treated with salmeterol (13/13176) than in patients receiving placebo (3/13179); the appropriate studies for formoterol have not been performed. Formoterol should not be used in children up to 6 years of age due to the lack of sufficient clinical experience in this group of patients. In children aged 6-12 years, it is recommended to use a combination preparation containing an inhaled corticosteroid and a long-acting drug stimulating β-receptors₂-adrenergic, except when it is required to use these drugs separately. Do not use the preparation together with another long-acting drug stimulating β receptors₂-Adrenergic. Whenever a product is prescribed, patients should be evaluated for adequate anti-inflammatory therapy. Patients should be advised to continue taking anti-inflammatory medications after starting treatment, even if the symptoms resolve. If asthma symptoms are controlled, a gradual dose reduction may be considered; in the period of dose reduction it is important to regularly monitor the condition of patients; the lowest effective dose should be used. Clinical trials indicate a higher incidence of severe asthma exacerbations in patients taking the drug than in patients receiving placebo, in particular in children aged 5-12 years.If the symptoms persist or the number of doses of the preparation causing the relief of symptoms increases, it usually means that the disease process is exacerbated and the treatment of asthma should be re-considered. Do not start treatment with the product or increase the dose during exacerbation of asthma. Do not use the product to reduce the severity of acute asthma symptoms. The need for frequent medication to prevent exercise-induced bronchoconstriction several times during each week, despite adequate maintenance treatment, may be a symptom of inadequate asthma control, and may justify reassessment of asthma therapy and assessment of patient compliance. The preparation should be used with caution and under control and with particular attention to the recommended dosage in patients with the following diseases: ischemic heart disease, arrhythmias (especially at the third chamber block), tachyarrhythmia, severe heart failure or severe non-compensated heart failure, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm, pheochromocytoma, hypertrophic cardiomyopathy with narrowing of the outflow tract, hyperthyroidism, confirmed or suspected prolongation of the QT interval (QTc> 0.44 s). Due to the risk of hyperglycaemic reactions, additional blood Glucose control is recommended in diabetic patients. Due to the risk of hypokalemia, extreme caution is recommended in patients with severe asthma, as hypokalaemia may be exacerbated by hypoxia and concomitant therapy. In these situations, continuous monitoring of serum potassium is recommended. After administration of the preparation, paradoxical bronchospasm may occur - the drug should be stopped immediately and other treatment should be applied. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

Avoid using the product during pregnancy if there is a more secure alternative medicine. Formoterol can inhibit labor during the relaxation of the uterine muscle. It is not known if formoterol is excreted in human milk. Mothers taking the preparation should not breastfeed.

Clinical trials indicate a higher incidence of severe asthma exacerbations in patients taking the drug than in patients receiving placebo, in particular in children aged 5-12 years. Common: headache, muscle tremors, palpitations. Uncommon: agitation, anxiety, nervousness, insomnia, dizziness, tachycardia, bronchospasm (including paradoxical bronchospasm), irritation of the mucous membrane of the throat, muscle spasms, muscle pain. Rarely: hypersensitivity reactions (such as hypotension, bronchospasm, urticaria, angioedema, pruritus, skin rash), hypokalaemia, arrhythmia (eg atrial fibrillation, supraventricular tachycardia, additional spasms), nausea. Very rare: hyperglycemia, taste disturbances, peripheral edema, angina pectoris, prolonged QT interval in ECG. In addition, the following side effects (frequency unknown) have been reported post-marketing: cough, rash, increased blood pressure, including hypertension. The use of drugs that stimulate β receptors₂-adrenergic may cause an increase in insulin, free fatty acids, glycerol and ketones in the blood. Excipient lactose contains a small amount of milk proteins that can cause allergic reactions.

Inhalation. Bronchodilatory activity is maintained for 12 h after inhalation of the preparation. Maintenance treatment, based on the use of the drug twice a day, contributes in most cases to the resolution of bronchoconstriction, associated with chronic conditions, both during the day and at night.Adults. Bronchial asthma. Maintenance treatment: inhalation of 1-2 capsules twice daily. The preparation should only be prescribed as an add-on medicine used together with an inhaled corticosteroid. The maximum recommended maintenance dose is 48 μg per day. If necessary, an additional 1-2 capsules per day may be used to reduce the severity of symptoms unless the maximum recommended daily dose (48 μg) is exceeded. If the need for additional doses is more common (e.g.more than 2 days a week), a change in treatment should be considered, as it may indicate a worsening of the disease process. It should not be used to reduce the severity of acute asthma symptoms. In the event of an attack of asthma, a short-acting drug stimulating β-receptors should be used₂-Adrenergic.Prevention of bronchial spasm caused by exercise or allergens: inhaling the contents of 1 capsule at least 15 minutes before exercise or exposure to an allergen. In order to prevent bronchoconstriction in patients with a history of severe bronchospasm, it may be necessary to use 2 capsules. In patients with chronic asthma, clinically indicated to be used to prevent exercise or allergen-induced bronchoconstriction, asthma treatment should also include therapy using an inhaled corticosteroid.Chronic obstructive pulmonary disease. Maintenance treatment: inhalation of 1-2 capsules twice daily.Children over 6 years old. Bronchial asthma. Maintenance treatment: inhalation of 1 capsule 2 times a day. The preparation should only be prescribed as an add-on medicine used together with an inhaled corticosteroid. The maximum recommended dose is 24 micrograms per day. Do not use the product to reduce the severity of acute asthma symptoms. In the event of an acute attack of asthma, a short-acting drug stimulating β-receptors should be used₂-Adrenergic.Prevention of bronchial spasm caused by exercise or allergens: inhaling the contents of 1 capsule at least 15 minutes before exercise or exposure to an allergen. In patients with chronic asthma, the use of the preparation to prevent exercise or allergen-induced bronchoconstriction is clinically indicated, but treatment of asthma should also include treatment with an inhaled corticosteroid.