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Pulmonary - Phosphodiesterase 4 (PDE4) inhibitors

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
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Disclaimer

Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.    [  Read the disclaimer    |   <<Back    |    New drug index   ]
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