Medication Monitor

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Generic Name (Trade Name—Company)
  • May 27, 2011


    Treatment of fecal incontinence in adult patients who have failed previous therapies such as modifications in diet, fiber therapy, or antimotility medications 

    Solesta 1 mL injectable gel consists of dextranomer microspheres (50 mg/mL) and stabilized sodium hyaluronate (15 mg/mL) in a phosphate-buffered 0.9% sodium chloride solution. It is injected into the deep submucosal layer in the proximal part of the high pressure zone of the anal canal. A total of four submucosal injections are administered at each treatment session. The injections are designed to build up tissue in that area so that the opening of the anus narrows allowing patients to have better control of their muscles. Only physicians experienced in performing anorectal procedures and who have successfully completed the Solesta injection procedure training program can administer the gel.


  • May 27, 2011


    Treatment of adult patients with Clostridium difficile-associated diarrhea 

    Fidaxomicin, formerly known as OPT-80, is primarily active against species of clostridia, including C. difficile, and works by inhibiting bacterial protein synthesis via transcription inhibition. A key advantage of fidaxomicin over currently available treatments is that this agent is thought to have less deleterious effects on intestinal microbiota, resulting in a lower rate of recurrent infections. The recommended dose is 200 mg twice daily for 10 days. When compared with vancomycin, fidaxomicin was found to be noninferior in terms of clinical response, but was associated with a better sustained response.    

  • May 23, 2011


    Treatment of chronic hepatitis C genotype 1 infection

    Telaprevir is another oral agent approved by FDA for the treatment of chronic hepatitis C genotype 1 infection in adult patients with compensated liver disease, including those with cirrhosis. As with boceprevir, it must be given in combination with peginterferon alfa and ribavirin and can be used in patients who are previously untreated or those who have failed previous interferon and ribavirin therapy. Telaprevir’s mechanism of action is identical to boceprevir. The recommended dose is 750 mg (two 375-mg tablets) given orally three times daily (approximately every 7 to 9 hours) with food. It is given in combination with peginterferon alfa and ribavirin for the first 12 weeks. When added to peginterferon alfa and ribavirin, sustained viral response rates was as high as 79% in trials.

  • May 20, 2011


    Treatment of HIV-1 in treatment-naive adults 

    Rilpivirine is the newest nonnucleoside reverse transcriptase inhibitor (NNRTI) for use in combination with other antiretroviral agents in treatment-naive adults. The recommended dose is one 25-mg tablet once daily with a meal. Approval was based on 48-week data from two Phase III trials and 96-week data from a Phase IIb trial that showed efficacy comparable to regimens that added efavirenz (Sustiva—Bristol-Myers Squibb). The most common adverse events of at least moderate to severe intensity were depression, insomnia, headache, and rash.


  • May 13, 2011


    Treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adult patients with compensated liver disease, including those with cirrhosis

    Boceprevir, the first HCV protease inhibitor to reach the U.S. market, is used only in combination with peginterferon alfa and ribavirin. In clinical studies of patients poorly responsive to interferon, oral boceprevir administered three times daily (every 7–9 hours) with food improved the sustained virologic response (SVR) rate by threefold (up to 66%, compared with 23% with placebo). In treatment-naive patients, the SVR was also in the 66% range, compared with 38% for patients in a control group. In combination boceprevir therapy, the most commonly reported adverse reactions (greater than 35%) have been fatigue, anemia, nausea, headache, and dysgeusia.