Duragesic
From Wikipedia, the free encyclopedia
Duragesic and Durogesic (IPA: [ˌdɚə'dʒiʒɪk]) are the trade names of fentanyl transdermal therapeutic systems, and are used for moderate to severe pain relief. Since Duragesic/Durogesic release fentanyl, a potent opioid, slowly through the skin, one patch may provide 72 hours of pain relief. Though its initial onset after a patch has been applied is roughly (under normal conditions) 8-12 hours, thus Duragesic patches are often prescribed with another opioid (such as morphine sulfate) to handle breakthrough-pain.
Durogesic was first approved by the CBG in the Netherlands on 17 July 1995 as 25, 50, 75 and 100 µg/hour formulations, and on 27 October 2004 the 12 µg/hour formulations 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/hour fentanyl transdermal systems (made by Mylan Technologies, Inc.; brand name Duragesic, made by Alza Corp.) The generic bioequivalent of Duragesic is available in 12, 25, 50, 75, and 100 µg dosages, while the trade names Duragesic and Durogesic are available in 12.5, 25, 50, 75, and 100 µg dosages. During the period of June 2002–June 2003, Duragesic sales totaled over one billion dollars.
It is manufactured by ALZA Corporation and marketed by Janssen Pharmaceutica (both subsidiaries of Johnson & Johnson). Fentanyl, developed by Janssen Pharmaceutica.
[edit] Warnings
Since Duragesic and Durogesic are highly potent, there are many black box warnings in Duragesic's and Durogesic's prescribing information (PDF file). Additionally, due to the risk of serious adverse drug reactions, it is highly important that the patches be applied correctly and as prescribed.
[edit] Recalls
Janssen Pharmaceutica Products, L.P., initiated a series of Class II Recalls in March 2004 due to a potentially life-threatening manufacturing defect. At least one fatality, possibly due to the defect, has been reported to the American FDA. The 25 mcg/hr Duragesic patches manufactured by ALZA Corporation were also recalled in February 2008 due to a concern that small cuts in the gel reservoir could result in accidental exposure of patents or health care providers to the fentanyl gel.[1]
[edit] External links
- [1] - Manufacturers's productlist for Europe, including Durogesic
- FDA recall notice
- FDA petition - classification of different transdermal systems
- Duragesic.com - Manufacturer's Duragesic website
- Duragesic.com - Prescribing Information in the United States
|
||||||||||||||||||||||||||||||||||||||||
