Index of drugs

Maintenance treatment, in combination with inhaled glucocorticoids, symptoms of airway obstruction and prevention of symptoms caused by exercise in patients with asthma, if treatment with glucocorticosteroids is not sufficient. Treatment of airway obstruction symptoms in patients with chronic obstructive pulmonary disease (COPD).

1 delivered dose contains 4.5 μg or 9 μg of formoterol fumarate dihydrate. 1 metered dose contains 6 μg or 12 μg of formoterol fumarate dihydrate. The preparation contains lactose.

Selective β₂-mimetyk. Has a bronchodilator effect in patients with reversible airway obstruction. This effect occurs quickly (within 1-3 minutes after inhalation) and lasts approximately 12 hours after a single dose. Inhaled formoterol is rapidly absorbed, and C_max in serum occurs about 15 minutes after inhalation. The average dose of the drug entering the lungs after inhalation from the Turbuhaler inhaler is 28-49% of the delivered dose (21-37% of the metered dose). The absolute systemic bioavailability is about 61% of the delivered dose (corresponding to 46% of the metered dose). The degree of binding to plasma proteins is about 50%. Formoterol is metabolized by direct glucuronidation and O-demethylation. 8-13% of the dose of formoterol delivered (corresponding to 6-10% of the metered dose) is excreted in the urine in unchanged form. Final T_0,5 after inhalation is 17 hours.

Hypersensitivity to formoterol or lactose administered by inhalation (which contains small amounts of milk proteins).

Asthma treatment with formoterol should not be started because it is not sufficient for this purpose. Patients with asthma who should be treated for long-acting β₂- mimetics, should simultaneously receive anti-inflammatory treatment with optimally selected doses of glucocorticoids. Patients should be advised to continue anti-inflammatory therapy after initiation of the treatment, even if symptoms are relieved. Although the preparation may be included in treatment when the use of inhaled glucocorticosteroids does not provide adequate control of asthma symptoms, it should not be initiated in patients during ACUTE, severe asthma exacerbation or if there is significant deterioration of the patient during the exacerbation. Instruct patients who are starting treatment so that if they do not get asthma-like or get worse, they continue treatment and contact their physician. When symptoms of asthma remain under control, a gradual dose reduction may be considered. It is important to regularly monitor the patients' condition while reducing the doses used. The lowest effective doses of the drug should be used. The preparation should be used with caution in patients with pheochromocytoma, thyrotoxicosis, hypertrophic cardiomyopathy with narrowing of the outflow tract, severe hypertension, subvalvular aortic stenosis of unknown origin, aneurysm and in patients with other serious cardiovascular diseases, eg ischemic heart disease, tachyarritis or severe heart failure. Patients with prolonged QTc interval or taking QTc prolongation medication should be observed because formoterol may prolong the QTc interval. In diabetic patients, blood Glucose control is recommended at the beginning of treatment because β₂-mimetic can increase its concentration. Particular caution is recommended in patients with acute severe asthma who are at increased risk of hypokalemia (through hypoxia). Hypokalemic effects may increase xanthine, steroids and diuretics. In these situations, monitoring of serum potassium is recommended. In the case of paradoxical bronchoconstriction, treatment should be stopped immediately and alternative therapy instituted. The lactose content of the preparation is usually not clinically relevant in patients with lactose intolerance; It should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose. Children under 6 years of age should not be used because of insufficient data on the use of this drug in this age group. The influence of factors such as old age, hepatic and renal dysfunction on the pharmacokinetics of formoterol is unknown. In case of severe liver cirrhosis, an increase in serum formoterol concentration should be expected.

The safety of use in pregnant women has not been established - special care is recommended in this group of patients, especially during the first trimester of pregnancy and just before delivery. The drug should not be used in women who are breastfeeding.

Common: palpitations, headache, muscle tremors. Uncommon: tachycardia, muscle spasms, agitation, restlessness, sleep disorders. Rarely: cardiac arrhythmia (eg atrial fibrillation, supraventricular tachycardia, extra spasms), nausea, hypersensitivity reactions (eg eczema, urticaria, pruritus, bronchospasm), hypokalaemia. Very rare: angina pectoris, QTc prolongation, hyperglycemia, taste disturbances, dizziness, changes in blood pressure, paradoxical bronchospasm. During β treatment₂-sympatics can lead to an increase in the concentration of insulin, free fatty acids, glycerol, ketone compounds in the blood. The lactose contained in the preparation contains small amounts of milk proteins that may cause allergic reactions.

Inhalation. The need to use additional doses of the drug, in addition to those used in maintenance treatment, more than twice a week indicates that the treatment is not sufficient - you should then consider changing the treatment.Asthma. Adults. Ad hoc application: 4.5-9 μg to reduce symptoms of airway obstruction. Maintenance dose: 4.5-9 μg 1 or 2 times daily (some patients may need 18 μg 1 or 2 times a day). Prevention of symptoms of airway obstruction caused by exercise: 9 μg before exercise; the maximum daily dose: 36 μg, however, it is allowed to administer up to 54 μg daily; the maximum single dose: 27 μg.Children from 6 years. Ad hoc application: 4.5-9 μg to reduce symptoms of airway obstruction. Maintenance dose: 9 μg 1 or 2 times a day. Prevention of symptoms of airway obstruction caused by exercise: 4.5-9 μg before exercise; maximum daily dose: 18 μg, however, up to 36 μg per day is allowed; the maximum single dose: 9 μg.Chronic obstructive pulmonary disease. Maintenance dose: 9 μg 1 or 2 times a day. The maximum maintenance dose should not exceed 18 μg. In patients treated with the preparation to control symptoms, additional doses (inhalations) may be used if necessary in addition to those used as maintenance treatment. The maximum daily dose: 36 μg; the maximum single dose: 18 μg.Special groups of patients. No dosage adjustment is necessary for patients with impaired liver or kidney function or elderly patients.