Psychiatry - November 2008 - (Page 32)

TABLE 5. AEs leading to discontinuation in rivastigmine trials (%)* ORAL CAPSULE ADVERSE EVENT Placebo n/a (n=868) Any AE Anorexia Dizziness Nausea Vomiting 5t/4m† <1 <1 1 <1 Rivastigmine 6–12mg/day (n=1189) 15t/6m† 3 2 8 5 TRANSDERMAL PATCH Placebo n/a (n=302) 5 1 <1 Rivastigmine 9.5mg/day (n=291) 10 9mg/day), compared to six percent women and four percent men taking placebo. It is not clear how much weight loss was associated with other gastrointestinal problems, such as anorexia, diarrhea, nausea, and vomiting. A case of severe vomiting, including esophageal rupture, was reported following improper reinitiation of treatment (4.5mg/day) after interruption of eight weeks. In clinical trials, nausea, vomiting, and weight loss were more frequent in women than in men. In patients with hepatic impairment and moderate renal impairment, clearance of orally administered rivastigmine is decreased by up to 65 percent. For unexplained reasons, patients with severe renal impairment have a 43percent higher clearance of the drug than healthy subjects. Dose adjustments are reportedly not necessary in patients with renal or hepatic impairment, since the drug dose should be individually titrated to tolerability. No specific pharmacokinetic studies were conducted to investigate the effect of gender and race on the disposition of rivastigmine; however, clearance is not affected by race or sex. The majority of participants in the rivastigmine patch trials had either no skin irritation or it was of a mild to moderate degree (it should be noted that the same site for patch application should not be used within 14 days). The incidence of severe skin irritation was very low and unrelated to the dose. No studies involving subjects with renal or hepatic impairment were conducted for the rivastigmine patch, but the PI document maintains the note that dosage adjustment is not necessary since the dose of the drug is individually titrated to tolerability. Caution should be exercised in patients with low body weight (<50kg) as these patients may experience more AEs and may be more likely to discontinue due to AEs; monitoring of patient weight is also recommended during rivastigmine patch therapy. For all methods of rivastigmine application, the drug should be titrated as prescribed, and reinitiated at the lowest dose if treatment is interrupted for more than a few days. NMDA receptor antagonists. Memantine. Memantine is an uncompetitive inhibitor of NMDA receptors, with a half-life of 60 to 80 hours. It is administered orally twice a day, with the recommended daily dose of 20mg.12 In clinical trials, there were no AEs that were associated with the discontinuation of treatment in one percent or more of memantine-

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Psychiatry - November 2008 Editor's Message Editorial Advisory Board Contents PsychRx Letters to the Editor Measuring Adverse Events in Psychiatry Nonsuicidal Self Injury in Adolescents Relative Tolerability of Alzheimer's Disease Treatments Biracial Identity Development and Recommendations in Therapy Depression and Cardiovascular Disease: Just an Urban Legend? Three Risk Management Basics Journal Watch Classified Advertising Information for Authors

Psychiatry - November 2008

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