Oxycodone 20 mg
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Oxycodone 20 mg: Pharmacokinetics, Efficacy, and Safety
Pharmacokinetics of Oxycodone 20 mg Controlled-Release Tablets
Bioavailability and Absorption
A pharmacokinetic study comparing a single 20 mg controlled-release (CR) oxycodone tablet with two 10 mg CR tablets found them to be bioequivalent. The 20 mg tablet had a Cmax of 109% and an AUC0-infinity of 107% relative to the two 10 mg tablets, indicating similar rates and extents of absorption1. Another study confirmed that the CR formulation allows for effective plasma concentrations to be reached quickly and maintained for a longer period compared to immediate-release (IR) formulations6.
Pharmacodynamic Correlations
Significant correlations were observed between plasma oxycodone concentrations and pharmacodynamic measures such as pupil size and subjective drug effect, with changes in plasma concentration accounting for over 25% of the observed changes in these variables1. This supports the reliability of CR oxycodone in maintaining consistent therapeutic effects.
Analgesic Efficacy in Postoperative Pain
Comparison with Other Formulations
In a randomized controlled trial, CR oxycodone 20 mg was compared with a combination of oxycodone 10 mg/acetaminophen 325 mg (Percocet®) for postsurgical pain. Both treatments were superior to placebo, but the combination agent provided faster onset and better pain relief, with fewer adverse events2. Another study on postoperative pain after breast surgery demonstrated that CR oxycodone 20 mg significantly reduced the need for additional IV opioid rescue medication and provided effective pain control with mild side effects3.
Dose-Response Relationship
A study comparing different doses of CR oxycodone (10, 20, and 30 mg) found a clear dose-response relationship. The 20 mg dose provided significant pain relief and had a duration of action of 10 to 12 hours, which was longer than that of IR oxycodone and oxycodone plus acetaminophen10.
Safety and Side Effects
Gastrointestinal Effects
Oxycodone 20 mg significantly prolonged gastrointestinal (GI) transit time, which can lead to constipation. However, co-administration with naloxone in a prolonged-release combination reduced this effect, suggesting a potential strategy for managing opioid-induced bowel dysfunction4 8.
Respiratory Effects
In a study comparing the respiratory effects of oxycodone 20 mg with tapentadol, oxycodone was found to have a more significant respiratory depressant effect. This highlights the need for careful monitoring of respiratory function in patients receiving oxycodone9.
Impulsivity and Cognitive Effects
Oxycodone 20 mg did not alter behavioral measures of impulsivity in healthy volunteers, indicating that it may not significantly impact cognitive functions related to impulsivity7.
Conclusion
Oxycodone 20 mg controlled-release tablets are bioequivalent to two 10 mg tablets and provide effective and sustained pain relief for postoperative pain. While they are associated with typical opioid side effects such as constipation and respiratory depression, these can be managed with appropriate co-medications and monitoring. The pharmacokinetic and pharmacodynamic profiles support its use in clinical settings where consistent and prolonged analgesia is required.
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Most relevant research papers on this topic
A pharmacokinetic/pharmacodynamic study of controlled-release oxycodone.
Two 10 mg and one 20 mg controlled-release oxycodone tablets are bioequivalent, with significant correlations between plasma concentrations and pharmacodynamic effects in normal volunteers.
RCTRandomized, Double‐Blind, Placebo‐Controlled Comparison of the Analgesic Efficacy of Oxycodone 10 mg/Acetaminophen 325 mg versus Controlled‐Release Oxycodone 20 mg in Postsurgical Pain
The new oxycodone 10mg/acetaminophen 325mg formulation (Percocet) provides enhanced analgesia, an opioid-sparing effect, and an improved side effect and safety profile for postsurgical pain compared to double the dose of oxycodone alone.
RCTClinical efficacy of controlled-release oxycodone 20 mg administered on a 12-h dosing schedule on the management of postoperative pain after breast surgery for cancer*
Controlled-release oxycodone 20 mg on a 12-hour dosing schedule effectively reduces postoperative opioid consumption and prevents pain after breast surgery for cancer with only mild side-effects.
RCTNaloxone as part of a prolonged release oxycodone/naloxone combination reduces oxycodone-induced slowing of gastrointestinal transit in healthy volunteers
A single dose of oxycodone 20 mg significantly prolonged gastrointestinal transit time, but this effect was reduced by co-administration of naloxone in healthy volunteers.
RCTPharmacokinetic‐pharmacodynamic relationships of controlled‐release oxycodone
Oxcodone, not oxymorphone, is primarily responsible for pharmacodynamic and analgesic effects in controlled-release oxycodone tablets.
Non-RCT
Highly CitedCharacterization and validation of a pharmacokinetic model for controlled-release oxycodone.
Controlled-release oxycodone tablets provide faster and longer-lasting pain relief compared to immediate-release oxycodone oral solution, allowing for twice-a-day dosing.
RCTHighly CitedThe prescription opioid, oxycodone, does not alter behavioral measures of impulsivity in healthy volunteers
Oxycodone does not affect impulsivity in healthy volunteers, despite producing dose-related mood changes.
RCTSingle- and multiple-dose pharmacokinetic evaluation of oxycodone and naloxone in an opioid agonist/antagonist prolonged-release combination in healthy adult volunteers.
The fixed-dose combination oxycodone/naloxone (OXN) is an effective analgesic treatment with reduced risk of opioid-induced constipation in healthy adult volunteers.
RCTAn experimental study comparing the respiratory effects of tapentadol and oxycodone in healthy volunteers
Tapentadol 100 mg has a modest respiratory advantage over oxycodone 20 mg, but not 150 mg, in healthy volunteers.
RCT
Very Rigorous JournalAnalgesic Efficacy of Controlled‐Release Oxycodone in Postoperative Pain
Controlled-release oxycodone is a safe and effective treatment for moderate to severe postoperative pain, with 20 and 30 mg doses providing better relief than 10 mg doses.
RCTHighly Cited