⚠️ Critical Safety Alert
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NOT AVAILABLE in U.S. since 2014 – All opioid/APAP combos now limited to ≤325mg APAP per unit
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Extreme Hepatotoxicity Risk:
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Just 6 tablets = 3,900mg APAP (exceeds daily max)
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8 tablets = 5,200mg (acute liver failure range)
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If Encountering This Product:
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DO NOT ADMINISTER – Likely counterfeit/foreign
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REPORT to FDA MedWatch
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SWITCH IMMEDIATELY to safer alternatives
Current FDA-Approved Alternatives
| Product | Hydrocodone | APAP | Status |
|---|---|---|---|
| Norco | 5/7.5/10mg | 325mg | Available |
| Hysingla ER | 10-120mg | 0mg | No APAP risk |
| Zamicet | 10mg | 300mg | Rare specialty product |
Why 650mg APAP Was Banned:
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#1 Cause of Acute Liver Failure in U.S. (2000s)
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Fatal Overdoses from unintentional APAP stacking
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No Therapeutic Benefit over 325mg formulations
Proper 10mg Hydrocodone Dosing Today
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Standard 10/325mg:
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Max 6 tabs/day (1,950mg APAP)
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APAP-Free Options:
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Hysingla ER (pure hydrocodone)
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Combine hydrocodone IR with separate APAP
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Patient Counseling Points
✔ Never combine with other APAP products
✔ Watch for hidden APAP in cold/flu meds
✔ Early OD signs: Nausea, RUQ pain, confusion
Need legitimate pain management?
Consult a physician for:
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Non-APAP opioids
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Multimodal therapies
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Personalized risk assessment
