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Daliresp 500mcg Tab 1x30 mfg by Forest Pharma

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Daliresp 500mcg Tab 1x30 mfg by Forest Pharma

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Mfg. By Forest Pharmaceuticals This Item Requires A Valid Order From A Physician Licensed in The USA. Item No.:Item Profile
Item No.:RXD4437547/RXB10097013/RXI5128798/A
NDC No. 00456009530
Generic Name:Roflumilast
. Trade Name: Daliresp
Additional Description:Strength: 500Mcg
Form Tabs
Size 30 Each
Unit of Measure Each
Unit of Sale Each
Unit Dose
Schedule No. 0
Private Label 999
Multi-Source N
Active Status Active
Generic Ind. Branded Drug
Drug Class Rx
Vendor Name Fores UPC

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Daliresp (500 mcg) is a selective PDE4 inhibitor that is indicated as a treatment to reduce the risk of exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Daliresp is a once-daily oral tablet and is the first and only selective PDE4 inhibitor approved by the FDA.

While the specific mechanism 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. Daliresp is not a steroid, is not a bronchodilator, and is not indicated for the relief of acute bronchospasm.

Daliresp will be available nationwide in the second calendar quarter of 2011. In August 2009 Forest Laboratories and Nycomed entered into a definitive collaboration and distribution agreement pursuant to which Forest acquired an exclusive license for Daliresp in the United States.

Indication

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.

About COPD

COPD is an under-diagnosed, progressive, irreversible lung disease and is the third leading cause of death in the U.S. Approximately 12 million people in the U.S. are currently diagnosed with COPD and an additional 12 million are likely to have the disease and not know. Approximately half of COPD patients treated by a physician with controller medications have severe COPD. Of the patients diagnosed with severe COPD, almost three quarters, or 2.8 million, have chronic bronchitis.

Symptoms of COPD include breathlessness, chronic cough and excessive production of phlegm. A significant worsening of symptoms called an exacerbation can last several weeks and often requires substantial medical intervention, including hospitalization. Exacerbations can result in worsening health status, lung function decline, and increased risk of death.

Important Safety Information

Contraindications

Daliresp is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Warnings and Precautions

Acute Bronchospasm

Daliresp is not a bronchodilator and should not be used for the relief of acute bronchospasm.

Psychiatric Events including Suicidality

Treatment with Daliresp is associated with an increase in psychiatric adverse reactions (5.9% of patients treated with Daliresp versus 3.3% treated with placebo). Instances of suicidal ideation and behavior, including completed suicide, have been observed in clinical trials. Three patients treated with Daliresp experienced suicide-related adverse reactions (one completed suicide and two suicide attempts) compared to one patient (suicidal ideation) treated with placebo. 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 weigh the risks and benefits of treatment with Daliresp in patients with a history of depression and/or suicidal thoughts or behavior and evaluate the risks and benefits of continuing treatment if such events occur.

Weight Decrease

Weight loss was a common adverse reaction in Daliresp clinical trials (7.5% of patients treated with Daliresp vs 2.1% treated with placebo). In addition to being reported as adverse reactions, weight was prospectively assessed in two 1-year trials. In these studies, 20% of patients receiving Daliresp experienced moderate weight loss (5-10% of body weight) vs 7% receiving placebo and 7% receiving Daliresp vs 2% receiving placebo experienced severe weight loss (>10% body weight). During follow-up after treatment discontinuation, the majority of patients with weight loss regained some of the weight they had lost while receiving Daliresp. Patients treated with Daliresp should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated, and discontinuation of Daliresp should be considered.

Drug Interactions

Use of Daliresp with strong cytochrome P450 enzyme inducers (eg, rifampicin, phenobarbital, carbamazepine, phenytoin) is not recommended. The risk of using Daliresp with inhibitors of CYP3A4 and/or CYP1A2 enzymes should be weighed carefully against benefit.

Adverse Reactions

The most common adverse reactions observed with Daliresp (incidence greater-than or equal to 2% and greater than placebo) were diarrhea (10% vs 3%), weight decreased (8% vs 2%), nausea (5% vs 1%), headache (4% vs 2%), back pain (3% vs 2%), influenza (3% vs 3%), insomnia (2% vs 1%), dizziness (2% vs 1%), decreased appetite (2% vs 0%).

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