Active Ingredient: Roflumilast
Roflumilast is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
For this indication, competent medicine agencies globally authorize below treatments:
Oral, 250 micrograms roflumilast, once daily, over the duration of 28 days. Afterwards, oral, 500 micrograms roflumilast, once daily.
The recommended starting dose is one tablet of 250 micrograms roflumilast to be taken once daily, for 28 days.
This starting dose is intended to reduce adverse events and patient discontinuation when initiating therapy, but it is a sub-therapeutic dose. Therefore, the 250-micrograms dose should be used only as a starting dose
After 28 days of treatment with the 250-micrograms starting dose, patients must be up-titrated to one tablet of 500 micrograms roflumilast, to be taken once daily.
Roflumilast 500 micrograms may need to be taken for several weeks to achieve its full effect. Roflumilast 500 micrograms has been studied in clinical trials for up to one year, and is intended for maintenance treatment.
It should be swallowed with water and taken at the same time every day. It can be taken with or without food.
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