Severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis

Active Ingredient: Roflumilast

Indication for Roflumilast

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

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:

250 ug once daily for 28 days and thereafter 500 ug once daily for several weeks until effect is achieved

Dosage regimens

Oral, 250 micrograms roflumilast, once daily, over the duration of 28 days. Afterwards, oral, 500 micrograms roflumilast, once daily.

Detailed description

Starting dose

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

Maintenance 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.

Dosage considerations

It should be swallowed with water and taken at the same time every day. It can be taken with or without food.

Active ingredient


Roflumilast is a PDE4 inhibitor, a non-steroid, anti-inflammatory active substance designed to target both the systemic and pulmonary inflammation associated with COPD.

Read more about Roflumilast

Related medicines

Develop a tailored medication plan for your case, considering factors such as age, gender, and health history

Ask the Reasoner

Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.