Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • March 1, 2011

    Uses:

    Maintenance treatment of bipolar I disorder as an adjunct to either lithium or valproate

    Approval of this agent was based on data from a 52-week maintenance trial with 337 patients with bipolar I disorder. Patients on combination therapy had fewer mood events (n = 25) compared with those on either lithium or valproate alone (n = 43). This difference was primarily attributed to a reduction in manic episodes (7 vs. 19), not depressive episodes (14 vs. 18). Tremor occurred more frequently with combination therapy (6% vs. 2.4%).

  • March 1, 2011

    Azilsartan is a once-daily angiotensin II receptor blocker. The drug can be given as monotherapy or in combination with other antihypertensive agents to control blood pressure. According to the approved labeling, azilsartan has had a robust clinical trial program with almost 6,000 patients evaluated for efficacy and more than 4,800 evaluated for safety. When compared with valsartan (Diovan—Novartis) 320 mg/d and olmesartan (Benicar—Daiichi-Sankyo) 40 mg/d, treatment with azilsartan 80 mg/d resulted in superior blood pressure reductions. Diarrhea was the most commonly reported adverse event in placebo-controlled trials.

  • March 1, 2011

    Uses:

    Reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations

    Roflumilast is an oral agent that has a unique mechanism of action because it and the active metabolite roflumilast N-oxide are selective inhibitors of phosphodiesterase 4, the main cyclic adenosine monophosphate–metabolizing enzyme in inflammatory and immune cells. FDA said that roflumilast, given as a 500 µg tablet once daily to patients with severe COPD associated with chronic bronchitis, resulted in a significant reduction in the rate of moderate or severe exacerbations compared with placebo-treated patients; long-acting beta-2–adrenergic receptor agonists and short-acting muscarinics was used by approximately 40% of patients in both groups. In addition, roflumilast was also shown to be more efficacious in improving lung function when used concomitantly with salmeterol (Serevent—GlaxoSmithKline) or tiotropium (Spiriva—Boehringer Ingelheim) over a 6-month period compared with these agents alone. Use of this agent has been associated with psychiatric adverse events.

  • February 1, 2011

    Uses:

    Treatment of acetaminophen overdose to minimize hepatic injury

    Cumberland announced that it has a new formulation of injection that does not contain ethylene diamine tetraacetic acid or any other stabilization and chelating agents and is preservative free. This new formulation will also have an extended shelf life of 30 months compared with 24 months for the original formulation.

  • February 1, 2011

    Uses:

    Maintenance treatment of advanced follicular lymphoma in patients who responded to initial treatment with this agent plus chemotherapy (induction treatment)

    Approval was based on data from the PRIMA (Primary Rituxan and Maintenance) study (n = 1,217), which showed that continuing rituximab therapy every 2 months for 2 years in patients who responded to initial treatment with rituximab plus chemotherapy nearly doubled progression-free survival compared with patients who stopped therapy (hazard ratio 0.54 [95% CI 0.42–0.70], P = 0.0001). Rituximab is also indicated for treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia and, in combination with methotrexate, to reduce structural damage in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.

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