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Daliresp (roflumilast) 

Indications 

Daliresp is indicated for: 

• Reducing the risk of COPD exacerbations in patients with severe COPD 
• Treating COPD associated with chronic bronchitis 
• Patients with a history of exacerbations 

Dosage and Administration 

• Take Daliresp exactly as prescribed by your healthcare provider. 
• Swallow the tablet whole with a glass of water, with or without food. 
• Take the medication at the same time every day for the best results. 
• Inform your doctor about any other medications you are taking. 
• Do not crush, chew, or break the tablet. 
• Do not take more than the recommended dose. 
• Avoid using this medication if you have moderate to severe liver impairment. 
• Do not abruptly stop taking Daliresp without consulting your healthcare provider. 

Mechanism of Action 

Daliresp works by inhibiting the enzyme phosphodiesterase 4 (PDE4) in the body. This action helps reduce inflammation in the lungs, which can improve breathing and decrease the frequency of COPD exacerbations. 

Contraindications 

Moderate to severe liver impairment (Child-Pugh B or C) 

Side Effects 

Common Side Effects: 

• Headache 
• Nausea 
• Diarrhea 
• Weight loss 
• Insomnia 

Serious Side Effects: 

• Severe weight loss 
• Mood changes, including depression and suicidal thoughts 
• Severe allergic reactions 

Precautions 

• Acute Bronchospasm: Do not use Daliresp for the relief of acute bronchospasm.
• Psychiatric Events: Monitor for signs of depression, anxiety, suicidal thoughts, or other mood changes. Contact a healthcare provider if these occur.
• Weight Decrease: Regularly monitor your weight. If significant weight loss occurs, consult your doctor to evaluate and possibly discontinue Daliresp.
• Drug Interactions: Avoid using Daliresp with strong cytochrome P450 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin).

Storage Instructions 

• Store Daliresp tablets at room temperature between 20° – 25°C (68° – 77°F). You can also keep them between 15° – 30°C (59° – 86°F). 
• Keep the medication in its original container tightly closed. 
• Keep out of reach of children and pets. 

References 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022522s009lbl.pdf