APA Daily Bulletin - Day 4, 2008 - (Page 6) Wednesday/Thursday The Daily BULLETIN May 7-8, 2008 REMARKABLE MEMBERS Working to reduce psychiatric disability in the workplace Andrea G. Stolar, M.D., is a strong advocate for occupational psychiatry to members of the APA. As chair of the APA’s Corresponding Committee on Psychiatry in the Workplace, Dr. Stolar, and the committee, are presenting four workshops during this meeting to emphasize the importance of workplace mental health, and help psychiatrists consider their patients’ work history and environment when evaluating mental health needs. “Psychiatric disability is a growing issue and cost to society, business and patients. Job loss or job withdrawal caused by psychiatric illness should be viewed as a psychiatric emergency warranting prompt psychiatric assessment. As physicians, we need to be thinking about function when we ask about symptoms — exploring how they translate to function and targeting restoration or maintenance of function to our treatment plans,” Stolar said. Wednesday morning, Dr. Stolar will be a participant in Issue Workshop 64 “What Time Does Not Heal: Achieving Functional Recovery in Psychiatric Illness,” which takes place from 11:00 a.m. to 12:30 p.m. in Room 149 A/B, Level One of the convention center. On Thursday, Issue Workshop 86 titled “The Clinician’s Role in Changing the Light Bulb” will help participants assess and modify barriers to mental and role function resulting from identity shifts. It will take place from 9:00 to 10:30 a.m. in Room 151A, Level One of the convention center. The Corresponding Committee on Psychiatry in the Workplace is a small one, comprised of seven members and meets once a year with the mission of educating psychiatrists on the importance of assessing function as a component of psychiatric evaluation and treatment. They seek to remind physicians to ask about a patients work, work history, work function as part of their routine psychiatric evaluation. Under the leadership of Dr. Stolar, the corresponding committee has accomplished impressive goals with limited resources. This year, they worked to draft position statements on employment-related psychiatric examinations and discriminatory disability insurance coverage; assisted with MentalHealthWorks, a quarterly publication on workplace mental health; and participated on the Taskforce on Disability and Return to Work. Dr. Stolar is the medical director for the Professionals in Crisis Program at the Menninger Clinic and associate professor of psychiatry in the Menninger Department of Psychiatry & Behavior Sciences at Baylor College of Medicine. Brief Summary—see package insert for full prescribing information. ARICEPT® (Donepezil Hydrochloride Tablets) ARICEPT® ODT (Donepezil Hydrochloride) Orally Disintegrating Tablets INDICATIONS AND USAGE ARICEPT® is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild to moderate Alzheimer’s Disease, as well as in patients with severe Alzheimer’s Disease. CONTRAINDICATIONS ARICEPT® is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. WARNINGS Anesthesia: ARICEPT®, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. Cardiovascular Conditions: Because of their pharmacological action, cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes. This effect may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of ARICEPT®. Gastrointestinal Conditions: Through their primary action, cholinesterase inhibitors may be expected to increase gastric acid secretion due to increased cholinergic activity. Therefore, patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers, e.g., those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDS). Clinical studies of ARICEPT® have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. ARICEPT®, as a predictable consequence of its pharmacological properties, has been shown to produce diarrhea, nausea and vomiting. These effects, when they occur, appear more frequently with the 10 mg/day dose than with the 5 mg/day dose. In most cases, these effects have been mild and transient, sometimes lasting one to three weeks, and have resolved during continued use of ARICEPT®. Genitourinary: Although not observed in clinical trials of ARICEPT®, cholinomimetics may cause bladder outflow obstruction. Neurological Conditions: Seizures: Cholinomimetics are believed to have some potential to cause generalized convulsions. However, seizure activity also may be a manifestation of Alzheimer’s Disease. Pulmonary Conditions: Because of their cholinomimetic actions, cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease. PRECAUTIONS Drug-Drug Interactions (see Clinical Pharmacology:Clinical Pharmacokinetics:Drug-drug Interactions) Effect of ARICEPT ® on the Metabolism of Other Drugs: No in vivo clinical trials have investigated the effect of ARICEPT® on the clearance of drugs metabolized by CYP 3A4 (e.g. cisapride, terfenadine) or by CYP 2D6 (e.g. imipramine). However, in vitro studies show a low rate of binding to these enzymes (mean Ki about 50-130 μM), that, given the therapeutic plasma concentrations of donepezil (164 nM), indicates little likelihood of interference. Whether ARICEPT® has any potential for enzyme induction is not known. Formal pharmacokinetic studies evaluated the potential of ARICEPT® for interaction with theophylline, cimetidine, warfarin, digoxin and ketoconazole. No effects of ARICEPT® on the pharmacokinetics of these drugs were observed. Effect of Other Drugs on the Metabolism of ARICEPT ®: Ketoconazole and quinidine, inhibitors of CYP450, 3A4 and 2D6, respectively, inhibit donepezil metabolism in vitro. Whether there is a clinical effect of quinidine is not known. In a 7-day crossover study in 18 healthy volunteers, ketoconazole (200 mg q.d.) increased mean donepezil (5 mg q.d.) concentrations (AUCO-24 and Cmax) by 36%. The clinical relevance of this increase in concentration is unknown. Inducers of CYP 2D6 and CYP 3A4 (e.g., phenytoin, carbamazepine, dexamethasone, rifampin, and phenobarbital) could increase the rate of elimination of ARICEPT®. Formal pharmacokinetic studies demonstrated that the metabolism of ARICEPT® is not significantly affected by concurrent administration of digoxin or cimetidine. Use with Anticholinergics: Because of their mechanism of action, cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications. Use with Cholinomimetics and Other Cholinesterase Inhibitors: A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol. Carcinogenesis, Mutagenesis, Impairment of Fertility No evidence of a carcinogenic potential was obtained in an 88-week carcinogenicity study of donepezil hydrochloride conducted in CD-1 mice at doses up to 180 mg/kg/day (approximately 90 times the maximum recommended human dose on a mg/m2 basis), or in a 104-week carcinogenicity study in Sprague-Dawley rats at doses up to 30 mg/kg/day (approximately 30 times the maximum recommended human dose on a mg/m2 basis). Donepezil was not mutagenic in the Ames reverse mutation assay in bacteria, or in a mouse lymphoma forward mutation assay in vitro. In the chromosome aberration test in cultures of Chinese hamster lung (CHL) cells, some clastogenic effects were observed. Donepezil was not clastogenic in the in vivo mouse micronucleus test and was not genotoxic in an in vivo unscheduled DNA synthesis assay in rats. Donepezil had no effect on fertility in rats at doses up to 10 mg/kg/day (approximately 8 times the maximum recommended human dose on a mg/m2 basis). Pregnancy Pregnancy Category C: Teratology studies conducted in pregnant rats at doses up to 16 mg/kg/day (approximately 13 times the maximum recommended human dose on a mg/m2 basis) and in pregnant rabbits at doses up to 10 mg/kg/day (approximately 16 times the maximum recommended human dose on a mg/m2 basis) did not disclose any evidence for a teratogenic potential of donepezil. However, in a study in which pregnant rats were given up to 10 mg/kg/day (approximately 8 times the maximum recommended human dose on a mg/m2 basis) from day 17 of gestation through day 20 postpartum, there was a slight increase in still births and a slight decrease in pup survival through day 4 postpartum at this dose; the next lower dose tested was 3 mg/kg/day. There are no adequate or well-controlled studies in pregnant women. ARICEPT® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether donepezil is excreted in human breast milk. ARICEPT® has no indication for use in nursing mothers. Pediatric Use There are no adequate and well-controlled trials to document the safety and efficacy of ARICEPT® in any illness occurring in children. Geriatric Use Alzheimer’s disease is a disorder occurring primarily in individuals over 55 years of age. The mean age of the patients enrolled in the clinical studies with ARICEPT® was 73 years; 80% of these patients were between 65 and 84 years old and 49% of the patients were at or above the age of 75. The efficacy and safety data presented in the clinical trials section were obtained from these patients. There were no clinically significant differences in most adverse events http://www.drugabuse.gov
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