Oxycodone/paracetamol

Oxycodone/acetaminophen, sold under the brand name Percocet among others, is a combination of the opioid oxycodone with acetaminophen, used to treat moderate to severe short-term pain.

Oxycodone/paracetamol
Combination of
OxycodoneOpioid analgesic
AcetaminophenAnilide analgesic
Clinical data
Trade namesDepalgos, Endocet, Percocet, Ratio-Oxycocet, Roxicet, others
AHFS/Drugs.compercocet
License data
Pregnancy
category
  • C
Routes of
administration
By mouth
ATC code
Legal status
Legal status
  • US: Schedule II
Identifiers
CAS Number
ChemSpider
 NY (what is this?)  (verify)

History

The U.S. Food and Drug Administration first approved Percocet in 1976, under application ANDA 085106.[1]

Formulation

As of August 2014, Endo International produces Percocet in the following dosages.[2] 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:[2][3]

Due to the liver toxicity of paracetamol the manufacturer and FDA dosage guidelines suggest no more than 4000 mg total of paracetamol be taken per day, which would be 12 or fewer Percocet tablets per day as each one contains 325 mg .[4]

Oxycodone hydrochloride (mg)Paracetamol (acetaminophen) (mg)Tablet colorTablet shapeTablet number
2.5325pinkoval2.5
5325whiteround0919
7.5325peachround229
10.0325whiteround44 104

Implicated in deaths

On June 30, 2009, an FDA advisory panel recommended that Percocet, Vicodin, and every other combination of acetaminophen with narcotic analgesics[5] 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.[6]

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.[7][8][9]

In March 2017, US President Donald Trump initiated the President's Commission on Combating Drug Addiction and the Opioid Crisis.[10] In July 2017, an interim report was published. Some excerpts:[11]

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. "Drugs@FDA. FDA approved drug products (searchable database)". U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Retrieved 2009-03-30.
  2. "Percocet oxycodone and acetaminophen tablets USP" (PDF). Endo Pharmaceuticals. May 2011. Archived from the original (PDF) on August 6, 2012. Retrieved October 20, 2012.
  3. "PERCOCET- oxycodone hydrochloride and acetaminophen tablet". Endo Pharmaceuticals. August 2014.
  4. "Percocet - FDA prescribing information, side effects and uses".
  5. "FDA May Restrict Acetaminophen". WebMD.
  6. Harris, Gardiner (2009-07-01). "Ban Is Advised on 2 TopPills for Pain Relief". The New York Times. Retrieved 2010-05-22.
  7. Dhalla, I. A; Mamdani, M. M; Sivilotti, M. L.A; Kopp, A; Qureshi, O; Juurlink, D. N (2009). "Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone". Canadian Medical Association Journal. 181 (12): 891–6. doi:10.1503/cmaj.090784. PMC 2789126. PMID 19969578.
  8. 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.
  9. "Deaths from opioid use have doubled; five-fold increase in oxycodone deaths". Canadian Medical Association Journal. December 7, 2009. Retrieved May 31, 2012.
  10. "Presidential Executive Order Establishing the President's Commission on Combating Drug Addiction and the Opioid Crisis". 29 March 2017.
  11. "PDF" (PDF).
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