Treatment with Daliresp (Roflumilast) is associated with an increase in psychiatric adverse reactions. In 8 controlled clinical trials 5.9% (263) of patients treated with Daliresp (Roflumilast) 500 mcg daily reported psychiatric adverse reactions compared to 3.3% (137) treated with placebo. The most commonly reported psychiatric adverse reactions were insomnia, anxiety, and depression which were reported at higher rates in those treated with Daliresp (Roflumilast) 500 mcg daily (2.4%, 1.4%, and 1.2% for Daliresp (Roflumilast) versus 1.0%, 0.9%, and 0.9% for placebo, respectively) . Instances of suicidal ideation and behavior, including completed suicide, have been observed in clinical trials. Three patients experienced suicide-related adverse reactions (one completed suicide and two suicide attempts) while receiving Daliresp (Roflumilast) compared to one patient (suicidal ideation) who received placebo.
Before using Daliresp (Roflumilast) in patients with a history of depression and/or suicidal thoughts or behavior, prescribers should carefully weigh the risks and benefits of treatment with Daliresp (Roflumilast) in such patients. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Prescribers should carefully evaluate the risks and benefits of continuing treatment with Daliresp (Roflumilast) if such events occur.
The active ingredient in Daliresp (Roflumilast) tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is CHClFNO and the molecular weight is 403.22.
The chemical structure is:
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 (Roflumilast) 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 (Roflumilast) for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, povidone and magnesium stearate.
Daliresp (Roflumilast) 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.
Daliresp (Roflumilast) tablets are available:
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Treatment with Daliresp (Roflumilast) is associated with an increase in psychiatric adverse reactions. In clinical trials, 5.9% (263) of patients treated with Daliresp (Roflumilast) 500 mcg daily reported psychiatric adverse reactions compared to 3.3% (137) treated with placebo. The most commonly reported psychiatric adverse events were insomnia, anxiety, and depression which were reported at higher rates in those treated with Daliresp (Roflumilast) 500 mcg (2.4%, 1.4%, and 1.2% for Daliresp (Roflumilast) versus 1.0%, 0.9%, and 0.9% for placebo, respectively). Instances of suicidal ideation and behavior, including completed suicide, have been observed in clinical trials. Three patients experienced suicide-related adverse reactions (one completed suicide and two suicide attempts) while receiving Daliresp (Roflumilast) compared to one patient (suicidal ideation) who received placebo.
Before using Daliresp (Roflumilast) in patients with a history of depression and/or suicidal thoughts or behavior, prescribers should carefully weigh the risks and benefits of treatment with Daliresp (Roflumilast) in such patients. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Prescribers should carefully evaluate the risks and benefits of continuing treatment with Daliresp (Roflumilast) if such events occur
The administration of the cytochrome P450 enzyme inducer rifampicin resulted in a reduction in exposure which may result in a decrease in the therapeutic effectiveness of Daliresp (Roflumilast) . Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) with Daliresp (Roflumilast) is not recommended [].
Manufactured by:
Nycomed GmbHProduction Site OranienburgLehnitzstrasse 70 – 9816515 OranienburgGermany
Manufactured for:
Forest Pharmaceuticals, Inc.Subsidiary of Forest Laboratories, Inc.St. Louis, MO 63045, USA
Daliresp (Roflumilast) is a registered trademark of Nycomed GmbH.
© 2010, 2011 Forest Laboratories, Inc.
