Oxycet (Oxycodone/Acetaminophen) Dosing
The recommended starting dose of Oxycet for opioid-naïve patients with acute moderate-to-severe pain is oxycodone 5-15 mg (with acetaminophen 325 mg) every 4-6 hours as needed, starting at the lower end of this range (5 mg) to minimize adverse effects. 1, 2
Initial Dosing Strategy
- Start with oxycodone 5 mg/acetaminophen 325 mg, one tablet every 4-6 hours as needed for pain. 1, 2
- The FDA-approved dosing range for opioid-naïve patients is 5-15 mg oxycodone every 4-6 hours, but starting at 5 mg is safest. 2
- Prescribe as "as needed" (PRN) rather than scheduled dosing to minimize total opioid exposure and side effects. 1, 3
- Maximum of 12 tablets per 24 hours to avoid exceeding 3,900 mg acetaminophen daily (though 4,000 mg is the absolute maximum). 1
Dose Titration Principles
- Titrate based on individual patient response, pain severity, and tolerability. 2
- Real-world data shows that 97% of patients achieving pain relief required only 1.61 doses of oxycodone 5 mg combined with acetaminophen 325 mg, with pain scores reduced from 5.68 to 2.49 within approximately 21 days. 4
- If 5 mg is inadequate, increase to 10 mg per dose rather than increasing dosing frequency. 2
- Avoid exceeding 50 morphine milligram equivalents (MME) per day without careful reassessment, as overdose risk escalates while pain relief plateaus. 3
Critical Safety Considerations
- Explicitly counsel patients to avoid all other acetaminophen-containing products (over-the-counter cold medications, other pain relievers) to prevent hepatotoxicity. 3, 5
- The acetaminophen component is now limited to 325 mg or less per tablet in combination products. 1
- For elderly patients (≥65 years), start with lower doses and extend dosing intervals due to increased risk of respiratory depression. 3, 2
- For patients with hepatic or renal impairment, reduce starting doses and monitor closely. 3
Duration and Context of Use
- Limit prescribing to the shortest duration necessary for acute pain, typically 3-5 days. 3, 5
- Oxycodone/acetaminophen is appropriate for severe traumatic injuries, invasive surgeries, and other severe acute pain when NSAIDs are contraindicated or ineffective. 3
- Nonopioid therapies (NSAIDs, acetaminophen alone) are equally or more effective for many common acute pain conditions including low back pain, musculoskeletal injuries, minor surgeries, and dental pain. 3, 6
- If used around-the-clock for more than a few days, implement a gradual taper (10-25% dose reduction) to minimize withdrawal symptoms. 3, 5
Common Pitfalls to Avoid
- Do not use opioid-acetaminophen combinations as first-line therapy when nonopioid alternatives may be effective. 3, 5
- Do not prescribe on a scheduled basis rather than as-needed, as this unnecessarily increases opioid exposure. 3, 5
- Do not fail to account for total acetaminophen from all sources when calculating daily limits. 3, 5
- Do not prescribe extended-release oxycodone formulations for acute pain—these are for opioid-tolerant patients with chronic pain only. 1, 2
Comparative Efficacy
- Oxycodone 10 mg plus acetaminophen 650 mg provides good analgesia to approximately half of treated patients, with a number-needed-to-treat (NNT) of 2.7 and duration of effect up to 10 hours. 7
- Oxycodone/acetaminophen combinations show similar efficacy to hydrocodone/acetaminophen for acute low back pain. 6
- Single-dose oxycodone 15 mg alone has an NNT of 4.6, demonstrating that combination therapy with acetaminophen improves efficacy. 7