안녕하십니까.
대한신경정신의학회의 법률고문변호사로서 일하게 되었음을 기쁘게 생각하며, 본 법률상담란을 통해 회원분들을 만나게 되어 반갑습니다. 의료영역은 그 직무의 특수성으로 인하여 많은 법령에서 규제를 받고 있으며, 이러한 특수성에서 오는 법률리스크는 경제적 손실은 물론 행정처분과도 직결되고 있습니다. 의료영역은 물론 일반 법률상의 궁금한 사항에 대한 즉시적인 자문을 통해 회원분들에게 작지만 도움이 될 수 있도록 최선을 다하겠습니다. 감사합니다.
법무법인 세승 대표변호사 김선욱 배상
[최신의학정보] [노인정신]노인우울증
The Food and Drug Administration as of Feb 28 2006 approved Emsam (selegiline), the first skin (transdermal) patch for use in treating major depression. The 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.

The Emsam patch will be made available in three sizes that deliver 6, 9, or 12 mg of selegiline per 24 hours. The patch is a matrix containing three layers consisting of a backing, and adhesive drug layer, and a release liner that is placed against the skin.

Emsam has been shown safe and effective for treatment of major depressive disorder in 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 rule 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 mild 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 seen less commonly was light-headedness related to a drop in blood pressure.

EMSAM was developed by Somerset Pharmaceuticals, Inc. In December 2004, Bristol-Myers Squibb and Somerset entered into an agreement that provides Bristol-Myers Squibb with distribution rights to market EMSAM after approval in the United States. Selegiline was initially approved in capsule form for use in Parkinson's Disease.

Adapted from: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01326.html

Suggested reading for more information:
Patkar AA, Pae CU, Masand PS. Transdermal selegiline: the new generation of monoamine oxidase inhibitors. CNS Spectr. 2006 May;11(5):363-75.
가톨릭대학교 정신과 배치운

배치운 작성일:2006년 08월 03일 00:29
 
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김병만 답변 감사합니다~ 2011-03-29 19:50
김병만 답변 감사합니다~ 2011-03-29 19:50  
김병만 답변 감사합니다ㅇㅀㄴㄹ홇ㅎㅎㅎㅎㅎㅎㅎㅎㅎㅎㅎㅎㅎㅎㅎㅎㅎㅎ홍록 ㅅ ㅛㄴㄱㅇㅀㄹ윦ㄹㅇ류ㅗㅇ슐호 2011-03-29 19:50  
김병만 답변 감사합니다~ 2011-03-29 19:50  
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