Medication Monitor



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

    Data from one Phase II and three Phase III studies involving more than 3,300 infants showed that two doses of the vaccine given 3 months apart elicited a robust immune response against the serogroups in the vaccine. In addition, data from these studies showed that the measles-mumps-rubella-varicella vaccine and pneumococcal conjugate vaccine can be administered at the same as Menactra in children. The most common adverse events included injection-site reactions (i.e., swelling and tenderness) and irritability.

  • April 1, 2011

    Uses:

    Prevention of herpes zoster (shingles) in patients 50 to 59 years of age

    Zostavax was originally approved for patients 60 years and older. Data from a placebo-controlled, double-blind study involving 22,439 patients who were 50 to 59 years of age showed that administration of the vaccine reduced the risk of developing zoster by 69.8% over a median monitoring period of 1.3 years. Injection-site reactions were the most commonly observed adverse events in this patient population.

  • April 1, 2011

    Uses:

    Treatment of HIV-1 infection in children and adults in combination with other antiretroviral agents and prevention of mother-to-child HIV transmission

    Water-dispersible zidovudine 100 mg tablets, a generic version of ViiV Healthcare’s Retrovir, have been approved under the President’s Emergency Plan for AIDS Relief. This first and only water-dispersible zidovudine tablet allows for easy administration of the medication to patients who cannot swallow. A news release by the manufacturer stated that the company developed the formulation for use in treating children with HIV/AIDS and for prevention of mother-to-child HIV transmission.

  • 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.

  • April 1, 2011

    Uses:

    Treatment of external genital and perianal warts in patients 12 years of age and older

    Approval of Zyclara was based on data from two Phase III, double-blind studies that evaluated the complete clearance of warts across several anatomical locations with imiquimod 3.75% cream. Approximately 28.3% of patients using once-daily imiquimod cream for up to 8 weeks had complete clearance of all warts compared with 9.4% of those given placebo cream. In addition, only 15% of patients treated with imiquimod experienced a recurrence within 12 weeks. The product was originally approved for the treatment of actinic keratoses of the face or balding scalp in immunocompetent patients.

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