Oxycodone/APAP

Oxycodone is a semisynthetic, moderately potent, orally available opioid that is widely used for acute or chronic management of moderate- or moderately severe pain either alone or in combination with acetaminophen.

Information about Oxycodone

• Oxycodone (ox” i koe’ done) is a semisynthetic derivative of thebaine, a natural alkaloid found in the resin of poppy seeds (Papaver somniferum).
• Oxycodone alone or in combination with acetaminophen has been shown to be effective in ameliorating moderate- to moderately severe pain and is widely used for temporary as well as chronic management of pain states.

Liver safety of Oxycodone

• Despite wide scale use for many decades, oxycodone has not been convincingly linked to instances of clinically apparent acute liver injury.
• However, oxycodone and other opioid-acetaminophen combinations have become a common cause of acute liver injury, which is usually the result of excessive use of the medication for the opioid effect, which leads secondarily and unintentionally to an overdose of acetaminophen.
• In 2014, the FDA warned against the use of opioid combinations in which the dose of acetaminophen is greater than 325 mg per tablet or unit dose.
• Because of their potential for hepatotoxicity, opioid combinations in which the dose of acetaminophen is greater than 325 mg per tablet or capsule were discontinued.

Usage

Oxycodone alone or in combination with acetaminophen has been shown to be effective in ameliorating moderate- to moderately severe pain and is widely used for temporary as well as chronic management of pain states.

Approval

• Oxycodone has been in use since its first synthesis in 1917, but was formally approved for use in the United States in 1991.
• Since then, it has become one of the most commonly prescribed drugs in medical practice.

Dosage and administration for Oxycodone

• Oxycodone is available in multiple formulations including oral tablets of 5, 7.5, 10 and 20 mg, as well as capsules of 5 mg, suppositories of 10 and 20 mg and oral solution in various concentrations generically.
• Higher dose oral formulations of 10 to 80 mg are also available generically and under the brand name OxyContin for therapy of persistent, moderate- to moderately severe pain that requires 24 hour opioid therapy.
• Oxycodone is also available in fixed combinations with other analgesics, including aspirin, ibuprofen, but particularly acetaminophen.
• These combinations are commonly used and available generically and under the brand names such as Percocet, Tylox and Endocet. The dose of oxycodone is typically 5 to 10 mg and acetaminophen 300 to 600 mg per tablet.

Side effects

• Side effects of oxycodone include sedation, respiratory depression, mental clouding, euphoria, agitation, itching, constipation, diarrhea, abdominal bloating, nausea, vomiting, headache and dizziness.
• Severe adverse events include life-threatening respiratory depression, addiction, abuse, opioid withdrawal, serotonin syndrome (when used with serotonergic agents) and adrenal insufficiency.

Overdosing

• However, oxycodone and other opioid-acetaminophen combinations have become a common cause of acute liver injury, which is usually the result of excessive use of the medication for the opioid effect, which leads secondarily and unintentionally to an overdose of acetaminophen.
• In 2014, the FDA warned against the use of opioid combinations in which the dose of acetaminophen is greater than 325 mg per tablet or unit dose.
• Because of their potential for hepatotoxicity, opioid combinations in which the dose of acetaminophen is greater than 325 mg per tablet or capsule were discontinued.

Trade names

Oxycodone – Generic, OxyContin®

Drug class

Opioids

• Dailymed label info on Oxycodone/APAP
• FDA Oxycodone/APAP

Oxycodone/APAP Resources
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