Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • 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.

  • April 1, 2011

    Uses:

    Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients 4 years of age and older

    A 40 mg/mL oral suspension of rufinamide has been approved by FDA. This suspension is equivalent to the already available 200 mg and 400 mg rufinamide tablets on a mg-per-mg basis. The suspension should be dosed with the supplied calibrated oral dosing syringe and adapter. Key counseling points for patients using this new formulation include shaking the medication before each use, replacing the cap securely after opening, keeping the suspension in an upright position at room temperature, and using the product within 90 days of first opening the bottle.

  • 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.

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