Percocet 7.5/500mg – High-Dose Acetaminophen Opioid Combination
(Now Withdrawn from US Market – Safety Alert)
⚠️ Critical Prescribing Notice:
This formulation was discontinued in 2011 as part of the FDA-mandated acetaminophen dose reduction initiative to prevent liver toxicity. The current maximum allowable APAP in combo opioids is 325mg per unit dose.
If You Have This Medication:
-
STOP USE IMMEDIATELY – Risk of accidental hepatotoxicity
-
Contact Your Pharmacist – For proper disposal
-
Ask Your Doctor About Alternatives:
-
Percocet 7.5/325mg (current standard)
-
Oxycodone IR 7.5mg + separate APAP
-
Non-APAP options (e.g., oxycodone alone)
-
Why This Formula Was Dangerous:
• 500mg APAP per tablet → Exceeds 4g/day limit with just 8 doses
• Unintentional overdose risk when combined with other APAP products
• No therapeutic advantage over 325mg formulations
Current Guidelines for Equivalent Pain Control:
Option 1:
• Percocet 7.5/325mg 1-2 tabs q6h
• Max: 6 tabs/day (1,950mg APAP)
Option 2:
• Oxycodone 7.5mg IR + Tylenol 325mg PRN
• Allows better APAP monitoring
Option 3 (Chronic Pain):
• Oxycodone ER + APAP-free rescue med
FDA-Approved Alternatives:
| Product | Oxycodone | APAP | Status |
|---|---|---|---|
| Percocet | 2.5-10mg | 325mg | Available |
| Primlev | 7.5-10mg | 325mg | Available |
| Roxicet | 5mg | 325mg | Available |
Patient Advisory:
If you were previously prescribed 7.5/500mg:
✓ Request liver function tests
✓ Review all medications for hidden APAP
✓ Obtain naloxone rescue kit if continuing opioids
Pharmacist Note:
All legacy 7.5/500mg prescriptions should be:
❌ Rejected (invalid dosage form)
❌ Reported to state PDMP if encountered
❌ Replaced with safer alternatives
Consult pain management specialists for therapeutic alternatives tailored to your needs.
