Oksikodonas 20 mg

Oxycodone HCl 20mg – High-Dose Opioid for Severe Pain Management
(Extended-Release Formulation – For Opioid-Tolerant Patients Only)

⚠️ Critical Safety Alert

• NOT FOR OPIOID-NAÏVE PATIENTS

• Minimum Requirement: ≥40mg MEDD (morphine equivalent daily dose) for ≥1 week

• ABSOLUTELY NEVER crush, chew, or dissolve

Therapeutic Profile

• Schedule II controlled substance (DEA)
• Duration: 12-hour controlled release
• Peak Effect: 4-5 hours post-dose
• Metabolism: Liver (CYP3A4/2D6 dependent)

FDA-Approved Indications

✔ Around-the-clock cancer pain
✔ Chronic severe pain (with documented tolerance)
✔ Palliative care when lower doses fail

Dosing Protocol

• Conversion from Other Opioids:
  20mg oxycodone ER q12h = 60mg oral morphine/day

• Renal Impairment:
  Reduce dose by 50% if CrCl <30mL/min

• Hepatic Caution:
  Start with 50% dose in cirrhosis

Abuse-Deterrent Features

• Hardened Tablet Matrix (resists crushing)

• Gel-Forming Technology if manipulated

• Brand Examples: OxyContin OP, Xtampza ER

Black Box Warnings

🛑 HIGH ADDICTION POTENTIAL – Abuse may cause overdose/death
🛑 LIFE-THREATENING RESPIRATORY DEPRESSION (especially with CNS depressants)
🛑 ACCIDENTAL INGESTION – One tablet can kill a child

Prescribing Requirements

• Documented Opioid Tolerance
• Pain Management Agreement signed
• Naloxone Co-Prescription mandatory
• Monthly PDMP Checks

Product Identification

• OxyContin OP 20mg:
  • Round, pink tablets
  • “OP” on one side, “20” on reverse

• Generic ER:
  • Varies by manufacturer (all must have FDA-approved AD properties)

Clinical Protocol:

1. Confirm opioid tolerance

2. Calculate prior 72-hour MEDD

3. Start at 50-75% conversion dose

4. Reassess every 3-7 days