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DALIRESP™ (roflumilast) tablet

CLINICAL PHARMACOLOGY
Mechanism of Action
Roflumilast and its active metabolite (roflumilast N-oxide) are selective inhibitors of phosphodiesterase 4 (PDE4). Roflumilast and roflumilast N-oxide inhibition of PDE4 (a major cyclic-3',5'-adenosine monophosphate (cyclic AMP)-metabolizing enzyme in lung tissue) activity leads to accumulation of intracellular cyclic AMP. While the specific mechanism(s) by which DALIRESP exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in lung cells.

INDICATIONS AND USAGE
DALIRESP™ is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Limitations of Use
DALIRESP is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION
The recommended dose of DALIRESP is one 500 microgram (mcg) tablet per day, with or without food.

HOW SUPPLIED
DALIRESP is supplied as white to off-white, round tablets, embossed with 'D' on one side and '500' on the other side. Each tablet contains 500 mcg of roflumilast

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

phosphodiesterase 4 (PDE4) inh