The combination oxycodone/paracetamol (North American trade name Percocet, generic Endocet and Ratio-Oxycocet in Canada) is a combined opioid/non-opioid pain reliever used to treat moderate to severe acute (short-term) pain, marketed by Endo International plc, formerly Endo Pharmaceuticals.
The U.S. Food and Drug Administration first approved Percocet in 1976, under application ANDA 085106.
As of August 2014, Endo Pharmaceuticals produces Percocet in the following dosages. Percocet tablets are available in four combinations of oxycodone hydrochloride with 325 mg of paracetamol / acetaminophen, each having different appearances and usual maximum daily doses:
Due to the liver toxicity of paracetamol the manufacturer and FDA dosage guidelines suggest no more than 4000mg total of paracetamol be taken per day, which would be 12 or fewer Percocet tablets per day as each one contains 325mg.
|Oxycodone Hydrochloride (mg)||Paracetamol (Acetaminophen) (mg)||Tablet Color||Tablet Shape|
Implicated in deaths
On June 30, 2009, an FDA advisory panel recommended that Percocet, Vicodin, and every other combination of acetaminophen with narcotic analgesics be limited in their sales because of their contributions to an alleged 400 acetaminophen-related deaths in the United States each year, that were attributed to acetaminophen overdose and associated liver damage.
In December 2009, the Canadian Medical Association Journal reported a study finding a fivefold increase in oxycodone-related deaths in Ontario (mostly accidental) between 1991 and 2007 that led to a doubling of all opioid-related Ontario deaths over the same period.
- "PERCOCET® (Oxycodone and Acetaminophen Tablets, USP)" (PDF). Endo Pharmaceuticals. Archived from the original (PDF) on 20 July 2011.
- "Drugs@FDA. FDA approved drug products (searchable database)". U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Retrieved 2009-03-30.
- "Percocet oxycodone and acetaminophen tablets USP" (PDF). Endo Pharmaceuticals. May 2011. Retrieved October 20, 2012.
- "PERCOCET- oxycodone hydrochloride and acetaminophen tablet". Endo Pharmaceuticals. August 2014.
- FDA Black Box warning and prescribing information
- "FDA May Restrict Acetaminophen". WebMD.
- Harris, Gardiner (2009-07-01). "Ban Is Advised on 2 Top Pills for Pain Relief". The New York Times. Retrieved 2010-05-22.
- Irfan A. Dhalla, Muhammad M. Mamdani, Marco L.A. Sivilotti, Alex Kopp, Omar Qureshi, David N. Juurlink. Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone. Canadian Medical Association Journal, 2009; 181 (12): 891 DOI: 10.1503/cmaj.090784
- Benedikt Fischer, Jürgen Rehm. Deaths related to the use of prescription opioids. Canadian Medical Association Journal, 2009; Fischer, B.; Rehm, J. (2009). "Deaths related to the use of prescription opioids". Canadian Medical Association Journal. 181 (12): 881–882. doi:10.1503/cmaj.091791. PMC 2789122. PMID 19969577.
- "Deaths from opioid use have doubled; five-fold increase in oxycodone deaths". Canadian Medical Association Journal. ScienceDaily. December 7, 2009. Retrieved May 31, 2012.