Drug Topics - November 10, 2008 - (Page 16)

FDA CERTIFICATION capsules was studied in a randomized, double-blind, placebo-controlled trial that was six months in duration, with an initial four-week dose-escalation phase. In this trial, patients were assigned to one of three treatment groups: galantamine ER in a ﬂexible dose of 16 to 24 mg once daily, galantamine ER in a ﬂexible dose of 8 to 12 mg twice daily, and placebo. The primary efﬁcacy measures in this study were the Alzheimer’s Disease Assessment Scale (ADAS-cog) and Alzheimer’s Disease Assessment Scale (ADAS-cog) Clinician’s Interview-Based Impression of Change plus the Caregiver Interview (CIBIC-plus). On the protocol-speciﬁed primary efﬁcacy analysis at month six, a statistically signiﬁcant improvement favoring galantamine ER over placebo was seen for the ADAS-cog, but not for the CIBIC-plus. Galantamine ER showed a statistically signiﬁcant improvement when compared with placebo on the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, a measure of function, and a secondary efﬁcacy measure in this study. Per the product labeling, the recommended starting dose of Galantamine ER is 8 mg/day and increasing to the initial maintenance dose of 16 mg/day after a minimum of four weeks. A further increase to 24 mg/day should be attempted after a minimum period of four weeks at 16 mg per day. The manufacturer recommends administering Galantamine “Assuming the ER once daily in the morning, preferably price is less with food. Patients than any of the and caregivers should branded drugs in be advised to ensure this class, generic adequate ﬂuid intake Razadyne ER will during treatment. If be a more costtherapy has been ineffective option terrupted for several for most patients days or longer, the manufacturer recomwho respond to mends the patient be cholinesterase restarted at the lowinhibitors. ” est dose and the dose — Robert J. Cluxton Jr., escalated until the PharmD, MBA, CGP patient is again taking the desired dose. Galantamine plasma concentrations may be increased in patients with moderate to severe hepatic impairment. In patients with moderately impaired hepatic function (Child-Pugh score of seven to nine), the product label states that the dose should generally not exceed 16 mg per day. The manufacturer does not recommend the use of Galantamine ER in patients with severe hepatic impairment (Child-Pugh score of 10 to 15). For patients with moderate renal impairment the dose should generally not exceed 16 mg per day. In patients with severe renal impairment (creatinine clearance < 9 mL per min), the manufacturer does not recommended the use of Galantamine ER. Galantamine ER capsules will be available in 8 mg, 16 mg, and 24 mg form and will be packaged in bottles of 30 and 500 capsules. Cluxton believes galantamine ER offers a less expensive option for a class of drugs that provides only modest and temporary improvement in cognition function. “As pharmacists we should educate caregivers and patients that a less expensive generic drug in this class is available. However, the decision to change should be made by the patient’s physician after careful consideration,” Cluxton said. JULIO FERNANDEZ is a PharmD based in New Jersey. http://www.nationaltechexam.org http://www.nationaltechexam.org

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Drug Topics - November 10, 2008 Contents Up Front Up Front in Depth Letters Rx Care Government Community Practice First Responders Clinical Practice Self-Care FDA Safety Page Weighing the Complications of Obesity New Products Viewpoint

Drug Topics - November 10, 2008

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