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Duragesic : ウィキペディア英語版
Duragesic

Duragesic and Durogesic are trade names of fentanyl transdermal patches, used for relief of moderate to severe pain. The patches release fentanyl, a potent opioid, slowly through the skin. One patch may provide 72 hours of pain relief. Initial onset of effectiveness after a patch has been applied is typically 8–12 hours under normal conditions; thus, Duragesic patches are often prescribed with another opioid (such as morphine sulfate) to handle breakthrough pain.
==Approval and usage==
Duragesic was first approved by the College ter Beoordeling van Geneesmiddelen, the Medicines Evaluation Board in the Netherlands, on 17 July 1995 as 25, 50, 75 and 100 µg/h formulations after a set of successful clinical trials, and on October 27, 2004 the 12 µg/h formulation was approved as well.
On Jan 28, 2005, the U.S. Food and Drug Administration approved first-time generic formulations of 25, 50, 75, and 100 µg/h fentanyl transdermal systems (made by Mylan Technologies, Inc.; brand name Duragesic, made by Alza Corp.) through an FTC consent agreement derailing the possibility of a monopoly in the treatment of Breakthrough Chronic Pain by Alza Corp. In some cases, physicians instruct patients to apply more than one patch at a time, giving a much wider range of possible dosages. For example, a patient may be prescribed a 37.5 µg dosage by applying one 12 µg patch and one 25 µg patch simultaneously, or contingent on the large size of the (largest) 100 μg/h patch, multiple patches are commonly prescribed for doses exceeding 100μg/h, such as two 75 μg/h patches worn to afford a 150 μg/h dosage regimen. Although the commonly referred to dosage rates are 12/25/50/75/100 µg/h, the "12 µg" patch actually releases 12.5 µg/h.〔http://www.duragesic.com/duragesic/shared/pi/duragesic.pdf Official Duragesic Full Prescribing Information〕 It is designed to release half the dose of the 25 µg/h dose patch.
Duragesic is manufactured by ALZA Corporation and marketed by Janssen Pharmaceutica (both subsidiaries of Johnson & Johnson). During the period of June 2002 through June 2003, Duragesic sales totaled over one billion.
As of July 2009, construction of the Duragesic patch had been changed from the gel pouch and membrane design to "a drug-in-adhesive matrix designed formulation", as described in the prescribing information.〔 This construction eliminates the possibility of leakage and leakage-related accidental overdosing, and makes illicit use of the fentanyl more difficult.

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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