Oxycodone/paracetamol

Oxycodone/paracetamol
Combination of
Oxycodone Opioid analgesic
Paracetamol Anilide analgesic
Clinical data
Trade names Depalgos
Endocet
Percocet
Ratio-Oxycocet
Roxicet
Tylox
AHFS/Drugs.com percocet
License data
Pregnancy
category
  • C
Routes of
administration
Oral
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
 NYesY (what is this?)  (verify)

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.[1]

History

The U.S. Food and Drug Administration first approved Percocet in 1976, under application ANDA 085106.[2]

Formulation

As of August 2014, Endo International produces Percocet in the following dosages.[3] 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:[3][4]

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 .[5]

Oxycodone Hydrochloride (mg) Paracetamol (Acetaminophen) (mg) Tablet Color Tablet Shape Tablet Number
2.5 325 pink oval 2.5
5 325 blue round 0027
7.5 325 peach round 229
10.0 325 white round M2A4

Implicated in deaths

On June 30, 2009, an FDA advisory panel recommended that Percocet, Vicodin, and every other combination of acetaminophen with narcotic analgesics[6] 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.[7]

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.[8][9][10]

In March 2017, US President Trump initiated the President’s Commission on Combating Drug Addiction and the Opioid Crisis.[11] In July 2017, an interim report was published. Some excerpts:[12]

As we have all seen, opioids are a prime contributor to our addiction and overdose crisis. In 2015, nearly two-thirds of drug overdoses were linked to opioids like Percocet, OxyContin, heroin, and fentanyl. [...] Americans consume more opioids than any other country in the world. In fact, in 2015, the amount of opioids prescribed in the U.S. was enough for every American to be medicated around the clock for three weeks.
Since 1999, the number of opioid overdoses in America have quadrupled according to the CDC. Not coincidentally, in that same period, the amount of prescription opioids in America have quadrupled as well. This massive increase in prescribing has occurred despite the fact that there has not been an overall change in the amount of pain Americans have reported in that time period. We have an enormous problem that is often not beginning on street corners; it is starting in doctor’s offices and hospitals in every state in our nation. [...]
In 2016, specific states witnessed an escalating number of overdose deaths due to heroin and/or fentanyl(s), in some states vastly exceeding deaths due to prescription opioids.
In 2015, 27 million people reported current use of illegal drugs or abuse of prescription drugs. Despite this self-reporting, only 10 percent of the nearly 21 million citizens with a substance use disorder (SUD) receive any type of specialty treatment according to the most recent National Survey on Drug Use and Health. This is contributing greatly to the increase of deaths from overdose.

See also

References

  1. "PERCOCET (Oxycodone and Acetaminophen Tablets, USP)" (PDF). Endo Pharmaceuticals. Archived from the original (PDF) on 20 July 2011.
  2. "Drugs@FDA. FDA approved drug products (searchable database)". U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Retrieved 2009-03-30.
  3. 1 2 "Percocet oxycodone and acetaminophen tablets USP" (PDF). Endo Pharmaceuticals. May 2011. Retrieved October 20, 2012.
  4. "PERCOCET- oxycodone hydrochloride and acetaminophen tablet". Endo Pharmaceuticals. August 2014.
  5. FDA Black Box warning and prescribing information
  6. "FDA May Restrict Acetaminophen". WebMD.
  7. Harris, Gardiner (2009-07-01). "Ban Is Advised on 2 Top Pills for Pain Relief". The New York Times. Retrieved 2010-05-22.
  8. 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
  9. 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. PMC 2789122Freely accessible. PMID 19969577. doi:10.1503/cmaj.091791.
  10. "Deaths from opioid use have doubled; five-fold increase in oxycodone deaths". Canadian Medical Association Journal. ScienceDaily. December 7, 2009. Retrieved May 31, 2012.
  11. www.whitehouse.gov
  12. PDF
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