Oksikodonas 30 mg

Oxycodone HCl 30mg – High-Potency Opioid for Severe Chronic Pain
(Extended-Release Formulation – Reserved for Opioid-Tolerant Patients Only)

⚠️ Critical Safety Notice

• STRICTLY CONTRAINDICATED for opioid-naïve individuals

• FOR USE ONLY in patients already taking ≥45mg MEDD (morphine equivalent daily dose)

• TAMPERING RISK: Must prescribe with abuse-deterrent formulation

Therapeutic Profile

• Schedule II controlled substance (DEA)
• Duration: 12-hour controlled release
• Peak Effect: 4-6 hours post-dose
• Metabolism: Hepatic (CYP3A4/2D6)

FDA-Approved Indications

✔ Around-the-clock cancer pain management
✔ Chronic severe pain in opioid-adapted patients
✔ Palliative care when lower doses fail

Dosing Protocol

• Minimum Tolerance Requirement:
  ≥45mg oral morphine equivalents/day for ≥1 week

• Conversion Guide:
  30mg oxycodone ER q12h = 60mg oral morphine/day

• Administration:
  Swallow whole – never crush, chew, or dissolve

• Renal Adjustment:
  Reduce frequency to q24h if CrCl <30mL/min

Abuse-Deterrent Features

• Hardened Tablet Matrix (resists crushing)

• Viscous Gel Formation if manipulated

• Brand Examples: OxyContin OP, Xtampza ER

Black Box Warnings

🛑 HIGH ADDICTION POTENTIAL – Abuse may lead to overdose/death
🛑 LIFE-THREATENING RESPIRATORY DEPRESSION
🛑 NEONATAL OPIOID WITHDRAWAL SYNDROME

Prescribing Requirements

• Documented Opioid Tolerance in medical record
• Pain Management Contract signed
• Naloxone Co-Prescription mandatory
• Monthly PDMP Checks required

Identification & Packaging

• Tablet Markings:
  • OxyContin OP: “OP” on one side, “30” on other
  • Colors vary by manufacturer (e.g., green, gray)

• Dispensing Limits:
  • 30-day supply maximum
  • No automatic refills