Oxycodone 10 325
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Analgesic Efficacy and Safety of Oxycodone 10 mg/Acetaminophen 325 mg
Introduction to Oxycodone 10 mg/Acetaminophen 325 mg
Oxycodone 10 mg/Acetaminophen 325 mg, commonly known as Percocet®, is a combination medication used to manage moderate to severe pain. This formulation combines the opioid oxycodone with the non-opioid analgesic acetaminophen, leveraging their complementary mechanisms to enhance pain relief while potentially reducing the required dose of each component.
Analgesic Efficacy in Postsurgical Pain
A randomized, controlled trial compared the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg with controlled-release (CR) oxycodone 20 mg in patients experiencing acute pain following oral surgery. The study found that the combination agent was significantly superior to CR oxycodone in four out of five measures of pain intensity and relief, providing faster onset of pain relief and a 24% reduction in treatment-related adverse events1. This suggests that the combination of oxycodone and acetaminophen not only enhances analgesia but also improves the safety profile compared to higher doses of oxycodone alone.
Preoperative Administration for Ambulatory Surgery
In a study examining the preoperative administration of CR oxycodone 10 mg for pain management after ambulatory laparoscopic tubal ligation surgery, patients who received the medication reported lower postoperative pain scores, reduced need for additional analgesics, and a shorter time to discharge compared to those who received a placebo2. This indicates that preoperative administration of CR oxycodone can effectively manage postoperative pain and facilitate earlier discharge.
Effectiveness in Chronic Low Back Pain
A prospective, open-label trial evaluated the new formulations of oxycodone 7.5 mg and 10 mg/acetaminophen 325 mg in patients with chronic low back pain. The study demonstrated significant reductions in pain intensity and improvements in quality of life over a four-week period. The treatment was well-tolerated, with most adverse events being mild to moderate in intensity3. This supports the use of oxycodone/acetaminophen combinations in managing chronic pain conditions.
Pharmacokinetics and Safety Profile
A pharmacokinetic study compared three dose levels of oxycodone/acetaminophen (5 mg/325 mg, 7.5 mg/500 mg, and 10 mg/650 mg) in healthy volunteers. The study found that oxycodone's maximum concentration (Cmax) and area under the curve (AUC) were dose-dependent, while the time to reach maximum concentration (tmax) and half-life (t1/2) were not. Adverse events were predictable based on the opioid's pharmacologic actions, with dizziness being the most common dose-related side effect5. This information is crucial for understanding the dose-response relationship and managing potential side effects.
Subjective and Psychomotor Effects
A study comparing the subjective, psychomotor, and physiological effects of hydrocodone/acetaminophen and oxycodone/acetaminophen combinations found that the 10 mg oxycodone combination produced a wider spectrum of subjective effects and greater psychomotor impairment than the 10 mg hydrocodone combination6. This highlights the importance of monitoring patients for potential impairments and advising them on activities that require full cognitive and motor function.
Conclusion
Oxycodone 10 mg/Acetaminophen 325 mg is an effective analgesic for managing both acute and chronic pain. It offers enhanced pain relief with a potentially improved safety profile compared to higher doses of oxycodone alone. Preoperative administration can facilitate better postoperative outcomes, and the combination is well-tolerated in chronic pain management. Understanding its pharmacokinetics and potential side effects is essential for optimizing its use in clinical practice. Further studies are warranted to fully characterize its long-term efficacy and safety.
Sources and full results
Most relevant research papers on this topic
Randomized, 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.
RCTPreoperative administration of controlled-release oxycodone for the management of pain after ambulatory laparoscopic tubal ligation surgery.
Preoperative controlled-release oxycodone 10 mg effectively manages pain after ambulatory laparoscopic tubal ligation surgery, potentially facilitating earlier postoperative discharge.
RCTEffectiveness and safety of new oxycodone/acetaminophen formulations with reduced acetaminophen for the treatment of low back pain.
New oxycodone/acetaminophen formulations with reduced acetaminophen are effective in treating moderate-to-severe chronic low back pain, with most patients reporting significant pain relief and tolerable side effects at a TID dosing frequency or less.
Comparison of the Pharmacokinetics of Oxycodone Administered in Three Percocet® Formulations
Increasing dose levels of oxycodone/acetaminophen proportionally increase oxycodone Cmax and AUC, with most adverse events being mild and self-limiting, except for dizziness.
RCTSubjective, psychomotor, and physiological effects profile of hydrocodone/acetaminophen and oxycodone/acetaminophen combination products.
The 10-mg oxycodone/650 mg acetaminophen combination produces more significant subjective effects than the 5-mg hydrocodone combination, and both drugs impair psychomotor performance.
RCTControlled-release oxycodone relieves neuropathic pain: a randomized controlled trial in painful diabetic neuropathy
Controlled-release oxycodone is effective and safe for managing painful diabetic neuropathy and improving quality of life.
RCT
Highly CitedPooled post hoc analysis of population pharmacokinetics of oxycodone and acetaminophen following a single oral dose of biphasic immediate-release/extended-release oxycodone/acetaminophen tablets
The single-dose population pharmacokinetics of biphasic immediate-release/extended-release oxycodone/acetaminophen tablets are not clinically relevant, with race and meal consumption having small pharmacokinetic effects.
Rigorous JournalSingle dose oral oxycodone and oxycodone plus paracetamol (acetaminophen) for acute postoperative pain in adults.
Single dose oxycodone is effective in acute postoperative pain at doses over 5 mg, and when combined with paracetamol, provides good analgesia to half of those treated, comparable to commonly used non-steroidal anti-inflammatory drugs.
Systematic Review
Very Rigorous JournalHighly CitedSingle dose oxycodone and oxycodone plus paracetamol (acetominophen) for acute postoperative pain.
Single-dose oral oxycodone, with or without paracetamol, is comparable to intramuscular morphine and non-steroidal anti-inflammatory drugs for acute postoperative pain, but central nervous system adverse effects are common.
Meta-Analysis