Roflumilast (Daliresp)

Roflumilast is a selective, highly potent phosphodiesterase 4 inhibitor with greater affinity for PDE4 than other PDE4 inhibitors.

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.
Roflumilast cream is associated with higher rates of diarrhea, headache, and pain at the application site compared with vehicle, but represents an effective topical therapy on all psoriasis areas of the body, face and inter-triginous areas.

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