Roflumilast is indicated for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations.

Chronic Obstructive Pulmonary Disease (COPD)

The recommended dosage for patients with COPD is one 500 mcg tablet per day, with or without food.

The most common adverse reactions associated with roflumilast are-

• diarrhea
• weight loss
• nausea
• headache
• back pain
• influenza
• insomnia
• dizziness
• decreased appetite
• abdominal pain

Less common adverse reactions include suicidal ideation or behavior, allergic reactions, and hepatic events.

Diarrhea	Nausea	Headache
Back Pain	Influenza	Insomnia (Difficulty in Falling asleep)

• Suicidal behavior and ideation: Patients taking roflumilast should be monitored closely for suicidal ideation or behavior. Patients with a history of depression or suicidal thoughts should be monitored closely during treatment with roflumilast.
• Weight loss: Patients should be monitored for unintentional weight loss while taking roflumilast.
• Hepatic events: Liver function tests should be monitored regularly in patients taking roflumilast. Treatment should be discontinued in patients who develop significant liver function abnormalities.
• Allergic reactions: Patients should be advised to discontinue treatment and seek medical attention if they experience signs of an allergic reaction, such as rash, hives, or difficulty breathing.
• Concomitant use with strong CYP3A4 inhibitors: Concomitant use of roflumilast with strong CYP3A4 inhibitors should be avoided, as this may increase the risk of roflumilast toxicity.