| Initial U.S. Approval: 2011
The active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors.
The drug substance is a white to off-white non-hygroscopic powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol and freely soluble in acetone.
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.
Each tablet of DALIRESP for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, povidone and magnesium stearate.
| 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
| WARNINGS AND PRECAUTIONS
USE IN SPECIFIC POPULATIONS
| Most common adverse reactions (≥ 2%) are diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite.
To report SUSPECTED ADVERSE REACTIONS, Contact Forest Laboratories, Inc. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
|The recommended dose of DALIRESP is one 500 microgram (mcg) tablet per day, with or without food.|
| DOSAGE FORMS AND STRENGTHS
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
| Package Insert data:
Production Site Oranienburg
Lehnitzstrasse 70 – 98
Component Code Number:
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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