Oxycodone HCl 40mg – High-Potency Opioid for Severe Refractory Pain
(Extended-Release Formulation Only – Never for Immediate Use)
Critical Safety Alert
⚠️ ABSOLUTELY CONTRAINDICATED in opioid-naïve patients
⚠️ FOR USE ONLY in opioid-tolerant patients (≥60mg MEDD for ≥1 week)
⚠️ TAMPER-RESISTANT formulation required by FDA
Therapeutic Profile
• Schedule II controlled substance
• ER Mechanism: 12-hour controlled release
• Bioavailability: 60-87% (higher than morphine)
• Peak Effect: 4-5 hours post-dose
Strict Indications
✔ Cancer pain in opioid-adapted patients
✔ Chronic pain with documented tolerance
✔ Palliative care cases with failed lower doses
Dosing Protocol
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Must Confirm Tolerance:
≥60mg oral morphine equivalents daily for ≥1 week -
Initial Conversion:
30mg oxycodone ER q12h = 90mg oral morphine/day -
Never Crush/Chew:
Avoid deadly rapid release -
Renal Adjustment:
Reduce dose by 50% if CrCl <60mL/min
Abuse-Deterrent Features
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Hardened Matrix: Resists crushing (OxyContin OP)
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Gel Formation: Snorting prevention
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FDA-Mandated REMS: Prescriber/pharmacist certification
Black Box Warnings
🛑 ADDICTION/OVERDOSE: High abuse potential
🛑 NEONATAL WITHDRAWAL: Pregnancy risks
🛑 LIFE-THREATENING RESPIRATORY DEPRESSION
Patient Requirements
• Opioid Treatment Agreement signed
• Monthly Prescriptions (no refills)
• Naloxone Co-Prescription mandatory
• Urine Drug Screening compliance
Available Formulations
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Brand (OxyContin): Round bi-convex tablets
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Generics: Must include FDA-approved AD properties
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Identification:
• “OP” on one side, “40” on reverse
• Color varies by manufacturer
