Properties
What is it?
International Nonproprietary Name - fluticasone propionate, salmeterol Clinical-pharmacological group: Glucocorticoids → Inhaled glucocorticosteroid preparations Pharmaceutical form Inhalation powder Indication Asthma (reversible obstructive airway disease) The medication is indicated for the regular treatment of asthma (reversible obstructive airway disease). This may include: Patients who are on an effective long-term maintenance dose of a long-acting beta-agonist and are using inhaled corticosteroids. Patients who experience symptoms despite current inhaled corticosteroid therapy. Patients who are receiving regular bronchodilator therapy and require inhaled corticosteroids. Chronic Obstructive Pulmonary Disease (COPD) The medication is indicated for the regular treatment of chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. It has been shown to reduce mortality. Dosage and Administration The preparation is intended for inhalation use only. Patients should be advised to use it regularly for optimal effect, even when asymptomatic. Regular patient assessment by a doctor is necessary to ensure the dose remains optimal and is only changed on medical advice. Asthma (reversible obstructive airway disease) Dose titration is required down to the lowest dose that controls symptoms. When symptom control is maintained with twice-daily use of the medication, titration may proceed to once-daily use at the lowest effective dose. Patients should receive an adequate amount containing the appropriate dose of fluticasone propionate for their disease severity. If a patient is inadequately controlled on inhaled corticosteroid therapy alone, substitution with therapeutically effective doses of the medication may lead to improvement in asthma control. For patients whose asthma is controlled on inhaled corticosteroid therapy alone, substitution with the medication may allow for a reduction in the corticosteroid dose for asthma control. Recommended doses: Adults and adolescents aged 12 years and older One inhalation (50 mcg salmeterol or 100 mcg fluticasone propionate) twice daily or One inhalation (50 mcg salmeterol or 250 mcg fluticasone propionate) twice daily or One inhalation (50 mcg salmeterol or 500 mcg fluticasone propionate) twice daily. Children aged 4 years and older One inhalation (50 mcg salmeterol or 100 mcg fluticasone propionate) twice daily There are no data on the use of the medication in children under 4 years of age. Chronic Obstructive Pulmonary Disease (COPD) The recommended dose for adult patients is one inhalation of 50/250 micrograms - 50/500 micrograms salmeterol/fluticasone propionate twice daily. The dose of 50/500 micrograms twice daily reduces mortality. Special patient populations Dose adjustment is not necessary in patients with renal or hepatic impairment.