Index of drugs

Regular, symptomatic treatment supporting reversible airflow obstruction in patients with bronchial asthma (also with nocturnal symptoms) who have not been adequately controlled for asthma symptoms with inhaled corticosteroids, according to current therapeutic guidelines. Treatment of chronic obstructive pulmonary disease (COPD). Prevention of exercise asthma.

1 metered dose contains 25 μg of salmeterol in the form of xinafoate.

Selective, long-acting drug stimulating β receptors₂-renergic, with a long side chain, which is associated with an extra-cardiac site. The preparation prevents the histamine-induced bronchoconstriction and causes bronchial dilatation lasting at least 12 h. Salmeterol inhibits the early and late phase of the response to inhalation allergens, and the effect on the late phase persists for 30 h after a single dose of drug, when the bronchodilatory action has already subsided . A single dose of salmeterol reduces the hyperresponsiveness of the bronchi. The drug works locally in the lungs.

Hypersensitivity to salmeterol xinafoate or to any of the excipients. The product contains soya lecithin - is contraindicated in patients with allergy to peanut or soya.

The patient's response to treatment must be monitored based on the clinical status and lung function tests. Salmeterol should not be used (and is not sufficient) to start treatment for bronchial asthma. Salmeterol should not be used to treat acute asthma symptoms. Salmeterol should not be initiated during a severe asthma exacerbation or when there has been a significant or severe worsening of its course. Patients should be advised to continue treatment and seek medical advice if they did not have asthma control or deterioration at the start of salmeterol. For maintenance treatment of asthma, salmeterol should be used in combination with inhaled or oral corticosteroids. In the maintenance therapy for asthma, long-acting bronchodilators should not be used as a sole or essential drug. In the case of paradoxical bronchoconstriction, a fast-acting inhaler bronchodilator should be used immediately, salmeterol should be immediately discontinued, the patient's condition assessed and other treatment instituted if necessary. Salmeterol should be used with caution in patients with hyperthyroidism and in patients with existing cardiovascular diseases. There are very rare reports of increased blood Glucose, which should be taken into account when prescribing salmeterol to patients with a history of diabetes. Due to the risk of severe hypokalemia, extreme caution is recommended in patients with acute severe asthma, as this effect may be exacerbated by hypoxia and concomitant use of xanthine, steroids and diuretic agents. In these cases, serum potassium should be monitored. Due to the increased risk of serious respiratory events or death of patients of African or Afrocaribiban origin, treatment should be advised and medical advice should be sought if they did not control asthma symptoms or deteriorate at the beginning of salmeterol use. The concomitant use of ketoconazole or other strong CYP3A4 inhibitors should be avoided unless the benefits of salmeterol treatment outweigh the potential for increased risk of systemic side effects. There are no data available on the use of salmeterol in patients with hepatic impairment. The safety and efficacy of the preparation has not been demonstrated in children, therefore it should not be used in children aged 12 years and younger.

Due to limited data, the use of salmeterol during pregnancy should be avoided. Salmeterol is excreted in breast milk - the risk for a breastfed infant can not be ruled out.The decision on whether to stop breastfeeding or to stop (or not take) salmeterol treatment should be made on the basis of the assessment of the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Common: tremor and headache, palpitations, muscle spasms. Uncommon: rash (pruritus and redness), nervousness, tachycardia. Rarely: hypokalemia, insomnia, dizziness. Very rare: anaphylactic reactions (including edema and angioneurotic edema, bronchospasm and anaphylactic shock), hyperglycaemia, arrhythmia (including atrial fibrillation, supraventricular tachycardia and additional spasms), irritation of the mouth and throat and paradoxical bronchospasm, nausea, joint pain, nonspecific chest pain.

Inhalation. The product should be used regularly; full therapeutic effect will be felt after taking several doses of the drug.Bronchial asthma. Adults and adolescents over 12 years: 2 inhalation doses of 25 μg twice a day. In patients with asthma with more severe airway obstruction, up to 4 inhalations of 25 μg twice daily may be beneficial. After monitoring the symptoms of asthma, a gradual decrease in the dose of salmeterol should be considered. It is important to regularly monitor the patient's condition while reducing the dose. The lowest effective dose of salmeterol should be used.COPD. Adults: 2 inhalation doses of 25 μg twice a day.
No dose adjustment is necessary in the elderly or in patients with impaired renal function.