The Problem: Acetaminophen (APAP) Effective but Potentially Hazardous

Daily exposure >4000 mg is associated with liver toxicity*1,3,4

  • APAP poses increased risk for special populations, including:
    • Patients with kidney or liver disease1,5
    • Patients on multiple-drug regimens6
  • APAP overdoses have been linked to acute liver failure and death:
    • Acute liver failure: APAP is the leading cause of acute liver failure in the United States1,7

In January 2011, the FDA mandated limiting the amount of APAP to 325 mg per dose in all prescription APAP-containing products by 2014

Indications and Usage

PrimlevTM (oxycodone/acetaminophen tablets) is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

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