1、醫藥新知【36】 公告日期: 95/04/11摘錄藥師: 唐乙民¡ 主題: FDA Approves Emsam (Selegiline) as First Drug Patch for DepressionEmsam (Selegiline) FDA核準第一個用於抗憂鬱之藥物貼片¡ 內容摘要:The Food and Drug Administration today approved Emsam (selegiline), the first skin (transdermal) patch for use in treating major depression. T

2、he once a day patch works by delivering selegiline, a monoamine oxidase inhibitor or MAOI, through the skin and into the bloodstream. At its lowest strength, Emsam can be used without the dietary restrictions that are needed for all oral MAO inhibitors that are approved for treating major depression

3、. Major depressive disorder is a common psychiatric condition in the U.S. population. Symptoms of depression include general emotional dejection, withdrawal and restlessness that interfere with daily functioning, such as loss of interest in usual activities; significant change in weight and/or appet

4、ite; insomnia; increased fatigue; feelings of guilt or worthlessness; slowed thinking or impaired concentration; and a suicide attempt or suicidal ideation. MAO inhibitors usually require specific dietary restrictions because when combined with certain foods they can cause a sudden, large increase i

5、n blood pressure, or “hypertensive crisis”. A hypertensive crisis can lead to a stroke and death. Symptoms of a hypertensive crisis include sudden onset of severe headache, nausea, stiff neck, a fast heartbeat or a change in the way your heart beats (palpitations), sweating, and confusion. Patients

6、who have these symptoms should get medical care right away.The lowest dose of the MAOI patch, which delivers 6 milligrams (mg) of the medication over a 24 hour period, can be used without such dietary restrictions.Emsam has been shown safe and effective for treatment of major depressive disorder in

7、two 6-8 week studies and also in a longer-term study of patients. The data for EMSAM 6mg/24hr support the recommendation that a modified diet is not required at this dose. Patients are advised to change the patch once a day. The more limited data available for EMSAM 9mg/24hr and 12mg/24hr do not rul

8、e out food effects so that patients receiving these higher doses should follow dietary restrictions that advise them to avoid certain foods or beverages. This includes foods and beverages such as aged cheese and wine. The only common side effect of Emsam detected in placebo-controlled trials was a m

9、ild skin reaction where the patch is placed. There may be mild redness at the site when a patch is removed. If the redness does not go away within several hours after removing the patch or if irritation or itching continues, patients are advised to contact their doctor.Another side effect that was s

10、een less commonly was light-headedness related to a drop in blood pressure.Although the effects of heat on the patch are not known, the drug labeling advises health care professionals and patients about the possible effects of direct heat applied to the Emsam patch. Direct heat may result in an incr

11、eased amount of the drug absorbed from the patch. Patients should avoid exposing the patch to heating pads, electric blankets, heat lamps, saunas, hot tubs, or prolonged sunlight. Like all approved antidepressants, this product carries a warning of increased suicidality in children and adolescents.

12、Selegiline was initially approved in capsule form for use in Parkinson's Disease.中文摘要FDA核準Emsam (selegiline)為第一個用於抗憂鬱的皮膚貼片。Selegiline為一種單胺氧化酶抑制劑(MAOIs)，貼片劑型為經皮吸收後釋放到血液中，一天使用一片。Emsam貼片在最低效力下即具有治療嚴重憂鬱癥的能力，且優於其他口服MAOIs為不需飲食方面的限制。嚴重憂鬱癥在美國是一種常見的精神疾病。嚴重憂鬱癥的癥狀包括：感情沮喪、消極和坐臥不寧影響到日常作息、興趣喪失、體重或胃口有顯著的改變、失眠、

13、疲勞增加、無價值的感覺、思考變慢或注意力減弱、及有自殺傾向或自殺念頭。MAOIs通常需特殊的飲食限制，因為和某些食物併用時可能會導致血壓增加或高血壓危象。高血壓危象可能導致中風或死亡。當病人有高血壓危象癥狀出現時（如突然劇烈的頭痛、噁心、脖子僵硬、心跳加快或者心悸、出汗、精神混亂）時要馬上給予治療。Emsam貼片為24小時6mg最低有效劑量之持續釋放劑型，且不需飲食限制。研究顯示：嚴重憂鬱癥病人使用emsam為期兩次6-8週的治療是安全且有效，長期使用病人亦有相似的效果。研究資料證實：使用emsam6mg/24hr/片劑型者不需要飲食限制，但是有關於emsam 9mg/24hr/片和12mg/24hr/片不受食物影響的確實可用資料有限，所以當病人必須使用高劑量emsam時，應建議病人避開某些食物及飲料(例如：陳年的乳酪和葡萄酒)。Emsam在安慰組對照試驗中常見副作用為輕微的皮膚反應。可能為貼片撕去時產生輕微的發紅。假如發紅在撕去貼片幾小時之後沒消失、過敏、持續發癢時，建議病患應與開方的醫生聯繫。另一個不常發生的副作用與血