Roflumilast (Daliresp)

Oral agent indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe disease associated with chronic bronchitis and a history of exacerbations.

Roflumilast (Daliresp) is an oral phosphodiesterase-4 inhibitor that inhibits the breakdown of cyclic AMP and may improve FEV1 when taken with bronchodilators.

Roflumilast (Daliresp) reduces exacerbations in patients treated with corticosteroids by 15-20% in severe to very severe COPD and a history of exacerbations.

Roflumilast (Daliresp) side effects include nausea diarrhea, anorexia, headache, weight loss, and alterations in sleep.

Not a bronchdilator agent.

Contraindicated in patients with moderate to severe liver disease (Child-Pugh B or C).

May be associated with insomnia, anxiety, depression, suicidal ideation and other mood changes.

Psychiatric adverse reactions in controlled clinical trials 5.9% versus such reactions in 3.3% of placebo patients.

Weight loss a common adverse reaction, 7.5% versus 2.1% in placebo patients.

Use with strong cytochrome P450 agents is not recommended, and includes phenytoin, carbamazine, phenobarbital and rifampin.

Most common clinical adverse reactions are diarrhea (9.5%), weight loss (7.5%), nausea (4.7%), headache (4.4%), an back pain (3.2%).

Roflumilast cream, a topical PDE-4 inhibitor administered once daily for plaque psoriasis was superior to vehicle cream in leading to the state of clear almost clear lesions at six weeks.

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