Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • 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.

  • 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:

    Treatment of head lice infestations in patients 4 years of age and older

    This new prescription 0.9% topical suspension lice product is derived from a soil microbe. In two Phase III clinical trials involving 1,038 patients, 84.6% (study 1) and 86.7% (study 2) of patients treated with spinosad were lice free 14 days after the last treatment, compared with 44.9% (study 1) and 42.9% (study 2) of patients treated with permethrin 1% (Nix—Insight), FDA said. The most commonly reported adverse events with spinosad were application-site erythema (3%), ocular hyperemia (2%), and application-site irritation (1%). Spinosad is recommended to be applied to dry scalp and hair, left in place for 10 minutes, and rinsed off with warm water. No nit combing is required. Repeat applications are needed only if live lice are seen 7 days after the first treatment. ParaPRO expects spinosad to launch in the first half of 2011.

  • February 1, 2011

    Uses:

    Treatment of major depressive disorder (MDD) in adults

    Vilazodone has a unique mechanism of action because it is a selective serotonin reuptake inhibitor (SSRI) and a partial agonist at the 5HT1A receptor. Although the net result of this action on serotonergic transmission is not fully understood, experts have theorized that the partial agonist activity of vilazodone may decrease the occurrence of sexual adverse effects that are commonly associated with SSRIs. FDA approved the antidepressant based on two Phase III, 8-week, placebo-controlled trials involving 869 patients with MDD age 18 to 70 years showed that treatment with vilazodone 40 mg once daily was superior to placebo in the improvement of depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale total score. Some of the most common adverse events with vilazodone were diarrhea, nausea, vomiting, and insomnia

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