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

    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.

  • 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%).

  • February 1, 2011

    Uses:

    Treatment of breakthrough pain in adult patients 18 years of age or older with cancer who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medication

    A new formulation of fentanyl, sublingual immediate-release tablets, has been FDA approved in six different strengths: 100, 200, 300, 400, 600, and 800 µg; the 100-µg strength is recommended to be taken as the initial dose. Because serious adverse reactions, including death, have been reported with other immediate-release fentanyl transmucosal products, this product is available only through a Risk Evaluation and Mitigation Strategy program, which requires pharmacies, distributors, health care providers, and patients to enroll.

  • February 1, 2011

    Clonidine extended-release tablets and suspension have been approved by FDA. Both formulations are indicated to be taken once daily, either alone or in combination with other antihypertensive agents. The tablets will be marketed in two strengths—0.17 mg and 0.26 mg—and the suspension will be available in a 0.09 mg/mL formulation.

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