Index of drugs

Long-term symptomatic treatment of moderate to severe chronic bronchial asthma in patients who require regular bronchodilator therapy in combination with long-term anti-inflammatory therapy (inhaled and / or oral glucocorticosteroids). Treatment with glucocorticosteroids should be continued. Relief of symptoms of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD).

1 metered dose contains 12 μg of formoterol fumarate dihydrate, which corresponds to the dose delivered 10.1 μg.

A selective β-receptor agonist₂adrenergic. It expands the bronchi in patients with reversible obstructive airways diseases. The onset of action occurs within 1-3 min, significant bronchodilation is maintained for 12 h after inhalation of the drug. It effectively prevents the contraction caused by methacholine. After inhalation 90% of the dose is swallowed and then absorbed from the gastrointestinal tract. In patients with asthma, the maximum plasma concentration occurs 15 minutes after inhalation. Plasma protein binding is 61-64% (34% with albumin). Formoterol is mainly metabolised by direct glucuronidation and O-demethylation, followed by conjugation with glucuronic acid. Many CYP450 isoenzymes (2D6, 2C19, 2C9 and 2A6) are the catalysts for transformation, and therefore the probability of drug-drug interaction is low. Formoterol excretion appears to be multi-phase, and therefore described as T_0,5 depends on the time periods considered. Based on plasma or blood levels measured 6, 8 or 12 h after oral administration, it was determined that T_0,5 in the phase of elimination is 2-3 hours. Based on the rate of excretion through the kidneys, marked between 3 and 16 h after inhalation of the drug, it was calculated that T_0,5 is 5 hours. The active substance and metabolites are completely eliminated, 2/3 of the oral dose is excreted in the urine and 1/3 in the faeces; on average, 6-9% of the substance is excreted unchanged in the urine.

Hypersensitivity to the active substance or any of the excipients.

The drug should not be used as a first-line treatment for asthma. Patients with asthma who require long-acting β treatment₂- they should simultaneously receive anti-inflammatory treatment with optimally selected doses of corticosteroids. The drug is not intended for the relief of acute asthma attacks. In the event of an acute attack of dyspnea, use a fast-acting β₂ -agonistę. Do not start treatment with formoterol during worsening asthma symptoms or worsening or worsening asthma symptoms. If the symptoms of asthma persists or worsen after starting treatment, a doctor should be consulted. Caution should be exercised when treating patients with atrioventricular block IIIst, refractory to diabetes mellitus, thyrotoxicosis, pheochromocytoma, hypertrophic cardiomyopathy with narrowing of the outflow tract, spontaneous subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorder, such as such as ischemic heart disease, tachyarrhythmia or severe heart failure and occult vascular diseases, especially atherosclerosis. Caution should be exercised when treating patients with QT prolongation. e.g. congenital or drug-induced (QTc> 0.44 s) and patients undergoing drug therapy affecting the QT interval. Due to the hyperglycemic effect of β₂It is recommended that additional monitoring of blood Glucose in the initial phase of treatment in diabetic patients is recommended. If general anesthesia is planned with halogenated anesthetics, make sure that you have not been taking your medicine for at least 12 hours before starting anesthesia. In the case of paradoxical bronchoconstriction, treatment should be stopped immediately and alternative therapy should be started. Β treatment₂can lead to potentially severe hypokalemia.Special caution is recommended in patients with severe acute asthma, as the risk of hypokalemia may be increased by hypoxia. Simultaneous use with xanthine derivatives, steroids and diuretics may potentiate hypokalemic effects. Therefore, it is recommended to monitor serum potassium, especially in patients with low initial potassium levels or who are particularly at risk for low levels of potassium in the blood. Such control should also be carried out when, during previous treatment, short-acting β₂-sympatics with no reduction in potassium in the blood. If necessary, potassium deficiency should be topped up. Due to the decreased serum potassium, the action of digitalis-containing glycosides is increased. It must not be used in children under 12 years of age for the treatment of asthma.

There are no adequate data on the use of formoterol in pregnant women. Treatment can be considered at all stages of pregnancy if it is necessary to manage asthma symptoms and if the expected benefit to the mother outweighs the potential risk to the fetus. It is not known if formoterol is excreted in human milk. The use of formoterol in breastfeeding women should only be considered if the expected benefit to the mother outweighs the potential risk to the child.

Common: tremor, headache, palpitations, coughing. Uncommon: hypokalemia, hyperglycemia, agitation, anxiety (especially motor), sleep disturbances, dizziness, taste disturbances, tachycardia, throat irritation, nausea, excessive sweating, muscle spasms, muscle pain. Rarely: hypersensitivity reactions (eg angioneurotic edema, bronchospasm, eruptions, urticaria, pruritus), arrhythmia (eg atrial fibrillation, supraventricular tachycardia, additional spasms), angina pectoris, changes in blood pressure, paradoxical bronchospasm, nephritis. Very rare: thrombocytopenia, improper behavior, hallucinations, overeating, QT prolongation, dyspnoea, exacerbation of asthma, peripheral edema. Occasionally after inhalation β₂-sympathomimetics have been reported to have stimulatory effects o.u.n., which is manifested by hyperactivity - these effects were observed mainly in children up to 12 years. Application of β₂can lead to increased levels of insulin in the blood, free fatty acids, glycerol and ketone bodies.

Inhalation.Asthma. Adults and adolescents from 12 years: 1 dose twice a day, morning and evening (24 μg / day). In severe cases, a maximum of 2 doses 2 times a day, in the morning and in the evening (48 μg / day). The maximum daily dose is 4 doses (48 μg).Chronic obstructive pulmonary disease (COPD). Adults (from 18 years of age): usually 1 dose twice a day (morning and evening, 24 μg / day). If indicated for regular use, do not use more than 2 doses per day. If necessary, additional doses may be taken to relieve symptoms, in addition to the doses prescribed for regular use, so that the maximum total daily dose is 4 doses (regular plus additional). Do not use more than 2 doses at the same time.
After controlling the symptoms of asthma, a gradual dose reduction should be considered. The patient's condition should be regularly monitored during dose reduction. The lowest effective dose should be used. Patients should be advised not to interrupt or change their previous treatment with steroids after starting treatment. No data available suggesting the need to adjust the dose in patients with renal or hepatic impairment (there are no clinical data on the use of these drugs in these patient groups). Patients should not use the inhaler for more than 3 months from the date on which the pharmacist issued it.