Oksikodonas 40 mg

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

• 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

• Hardened Matrix: Resists crushing (OxyContin OP)

• Gel Formation: Snorting prevention

• 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

• Brand (OxyContin): Round bi-convex tablets

• Generics: Must include FDA-approved AD properties

• Identification:
  • “OP” on one side, “40” on reverse
  • Color varies by manufacturer