Index of drugs

Bronchodilatory supportive treatment in adult patients with chronic obstructive pulmonary disease (COPD).

1 capsule contains 150 μg or 300 μg of indacaterol in the form of maleate. 1 delivered dose (release from the mouthpiece of the inhaler) contains respectively 120 μg or 240 μg of indacaterol in the form of maleate.

A long-acting β-receptor agonist₂-renergic for inhalation use. Has a bronchodilator effect. It is characterized by a fast start and a long time of action. After a single or repeated inhalation, it reaches its maximum concentration in the blood after about 15 minutes. Absolute bioavailability is about 43-45%. Steady state is achieved within 12-14 days. Plasma protein binding is approximately 95%. UGT1A1 is the only UGT isoform that metabolizes indacaterol to phenol-O-glucuronide. CYP3A4 is the dominant isoenzyme responsible for the hydroxylation of indacaterol. It is excreted mainly with faeces. Serum indacaterol levels decrease in multiphase with mean T_0,5 from 45.5-126 h. Effective T_0,5 after repeated administration, the preparation is 40-52 hours.

Hypersensitivity to the active substance, lactose or to any of the excipients.

The preparation should not be used in the treatment of asthma due to the lack of relevant data in this indication (long-acting β-receptor agonists₂-adrenergic agents may increase the risk of serious adverse events associated with asthma). In case of symptoms of allergic reactions or paradoxical bronchoconstriction, treatment should be discontinued immediately and alternative therapy should be applied. The preparation is not indicated for the treatment of acute bronchospasm. Caution should be exercised when using indacaterol in patients with cardiovascular disease (coronary heart disease, acute myocardial infarction, arrhythmia, hypertension), patients with a history of seizures, thyrotoxicosis, and patients who generally do not respond to treatment β-receptor agonists₂adrenergic. If clinically significant effects on the cardiovascular system occur (increased heart rate, blood pressure and / or other symptoms), it may be necessary to stop treatment. Caution should be exercised when using long-acting β-receptor agonists₂-adrenergic in patients who have been or are suspected to have QT prolongation and in patients who are taking medicines that affect the QT interval. Β-receptor agonists₂ they can cause clinically significant hypokalemia; in patients with severe COPD, hypoxia and concomitant medication may increase hypokalaemia, which may increase susceptibility to arrhythmia. Due to the risk of increased blood Glucose when starting treatment with diabetic patients, the serum glucose should be monitored even more closely. The preparation has not been studied in patients with inadequately controlled diabetes. It is not appropriate to use the preparation in children and adolescents under 18 years of age.

The preparation can be used during pregnancy only if the expected benefit outweighs the potential risk. Indacaterol may inhibit labor during relaxation due to the relaxation of the uterine smooth muscles. It is not known whether indacaterol or its metabolites are excreted in human milk. A decision should be made whether to discontinue breast-feeding or discontinue the preparation, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Common: upper respiratory tract infection, nasopharyngeal inflammation, sinusitis, headache and dizziness, cough, mouth and throat pain (including throat irritation), watery discharge from the nose, muscle spasms, chest pain, peripheral edema.Uncommon: hypersensitivity, diabetes, hyperglycemia, paresthesia, ischemic heart disease, atrial fibrillation, palpitations, tachycardia, paradoxical bronchospasm, pruritus / rash, muscle pain, musculoskeletal pain. When using 600 μg / day, the safety profile was essentially similar to the profile for the recommended doses; An additional side effect was tremor (often). On average, 17-20% of patients have an occasional cough that usually appears 15 s after inhalation and lasts an average of 5 s (about 10 sec in active smokers). Cough was observed more often in women than in men and more often in active smokers than in former smokers. There is no evidence that coughing after inhalation is associated with bronchospasm, exacerbation, deterioration of the disease or loss of efficacy.

Inhalation. Adults: the recommended dose is inhalation of 1 capsules of 150 μg once a day with the Onbrez Breezhaler inhaler. It has been shown that inhalation of a capsule content of 300 μg once a day provides additional clinical benefit in the control of dyspnea, especially in patients with severe COPD. The maximum dose is 300 μg once a day. The product should be administered at the same time each day. If you miss a dose, take the Next dose at the usual time the next day. No dosage adjustment is necessary in the elderly, in patients with impaired renal function, or in patients with mild or moderate hepatic impairment. Data on the use of the preparation in patients with severe hepatic impairment are not available. Do not swallow capsules of the preparation. Patients should be instructed how to use the preparation properly. Patients who do not have respiratory function improvement should be asked if they are swallowing the product instead of taking it by inhalation.