Active Ingredient: Tiotropium
Tiotropium is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with severe asthma who experienced one or more severe asthma exacerbations in the preceding year.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Respiratory (Inhalation), 5 micrograms tiotropium, once daily.
The recommended dose is 5 microgram tiotropium once daily, at the same time of the day.
The recommended dose should not be exceeded.
In the treatment of asthma the full benefit will be apparent after several doses of the medicinal product. In adult patients with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (≥800 μg budesonide/day or equivalent) and at least one controller.
For:
Respiratory (Inhalation), 5 micrograms tiotropium, once daily.
The recommended dose for patients 6 to 17 years of age is 5 microgram tiotropium once daily, at the same time of the day.
In adolescents (12-17 years) with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (>800-1600 µg budesonide/day or equivalent) and one controller or in addition to inhaled corticosteroids (400-800 µg budesonide/day or equivalent) with two controllers.
For children (6-11 years) with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (>400 µg budesonide/day or equivalent) and one controller or in addition to inhaled corticosteroids (200-400 µg budesonide/day or equivalent) with two controllers.
The safety and efficacy of tiotropium in children aged 6-17 years with moderate asthma has not been established. The safety and efficacy of tiotropium in children below 6 years of age has not been established.
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