Medication Monitor



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

    Uses:

    Treatment of HIV-1 infection in adults in combination with other antiretroviral agents

    This new formulation is a once-daily 400-mg tablet. Approval was based on data that showed that nevirapine 400 mg extended-release tablets were noninferior to twice-daily dosing with the immediate-release 200-mg tablets over a 48-week period. For patients switching from immediate-release nevirapine to the extended-release formulation, the manufacturer recommends an immediate conversion with no lead-in dosing needed. For treatment-naive patients, therapy must be initiated with one 200-mg immediate-release tablet daily for the first 14 days; patients able to tolerate this therapy can then be switched to the 400-mg extended-release tablets.

  • 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.

  • March 1, 2011

    Uses:

    Reduce the risk of preterm birth in women with a singleton pregnancy and a history of singleton spontaneous preterm birth

    FDA originally approved hydroxyprogesterone caproate under the trade name Delalutin in 1956 for use in pregnant women; however, the original manufacturer requested withdrawal of the product from the market in 2000 for reasons unrelated to safety. This newly available synthetic progestin is given as a 250-mg intramuscular injection once weekly by a health professional beginning between 16 weeks, 0 days, and 20 weeks, 6 days gestation, and continuing until week 37 of gestation or delivery, whichever occurs first. Approval was based on data showing that women treated with weekly hydroxyprogesterone caproate injections were less likely to deliver babies before 32, 35, and 37 weeks of gestation compared with those given a vehicle injection. Injection site reactions, urticaria, pruritus, nausea, and diarrhea occurred more commonly with active therapy.

  • March 1, 2011

    Uses:

    Adjunctive therapy to stimulants for treatment of ADHD in children and adolescents 6–17 years of age

    Intuniv was originally approved as monotherapy for treatment of ADHD in the same age group. Approval was based on data from a 9-week, multicenter, double-blind, placebo-controlled trial involving 455 children who had a suboptimal response to stimulant therapy. Combination therapy with guanfacine and a stimulant resulted in significant improvements on the ADHD Rating Scale–IV, which includes hyperactive/impulsive and inattentive subscales, compared with stimulant monotherapy. In addition, combination therapy was associated with mild to moderate adverse events similar to those observed with either treatment alone.

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