Opana ER (oxymorphone hydrochloride extended-release) 5mg is a semi-synthetic opioid analgesic classified as a Schedule II controlled substance. This lowest available strength of extended-release oxymorphone is indicated for around-the-clock management of moderate to severe chronic pain in opioid-tolerant patients. With twice the potency of oxycodone, it provides sustained pain relief but carries significant risks of abuse, misuse, and life-threatening respiratory depression.
Opana ER 5 mg
Medical Uses & Indications
FDA-Approved Uses
Chronic pain management requiring continuous opioid therapy
Pain uncontrolled by other opioids
Alternative to other extended-release opioids
Key Clinical Features
• Formulation: Tamper-resistant extended-release tablets
• Onset: 30-60 minutes
• Duration: 12-hour dosing interval
• Potency: 5mg ≈ 10mg oral oxycodone
• DEA Classification: Schedule II (High abuse potential)
Pharmacology & Mechanism
Neurochemical Action
• Pure μ-opioid receptor agonist
• No active metabolites
• Minimal histamine release
Metabolic Profile
• Hepatic metabolism: Glucuronidation (UGT2B7)
• No CYP450 involvement (Fewer drug interactions)
• Elimination half-life: 7-12 hours
Dosing & Administration
Standard Dosing Protocol
• Opioid-naïve patients: NOT recommended
• Opioid-tolerant patients:
-
Initial dose: 5mg q12h
-
Titration: Increase by 5-10mg q12h every 3-7 days
-
Swallow whole; never crush/chew
Conversion Guidelines
| Current Opioid | Opana ER 5mg Equivalent |
|---|---|
| Oxycodone 10mg daily | 5mg q12h |
| Morphine 20mg daily | 5mg q12h |
| Hydrocodone 15mg daily | 5mg q12h |
Safety Profile
Common Adverse Effects
• Constipation (prophylaxis required)
• Nausea/vomiting (30-40%)
• Pruritus (20-25%)
• Sedation/dizziness
Black Box Warnings
Addiction, abuse, and misuse
Life-threatening respiratory depression
Accidental exposure risk
Neonatal opioid withdrawal syndrome
Risk Mitigation Strategies
Prescribing Safeguards
-
Assess opioid tolerance before initiation
-
Start low, go slow titration
-
Regular PDMP monitoring
-
Naloxone co-prescribing