Abuse Potential

• Oxycodone is an opioid agonist and a schedule II controlled substance with an abuse liability similar to morphine
• Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing this drug in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
• Patients at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g. major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids.
• All patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction.

Proper Patient Selection  

• Oxycodone (CR) is indicated for the management of moderate to severe pain when a continuous around-the-clock opioid analgesic is needed for an extended period of time.
• Oxycodone (CR) is not intended for use on an as needed basis.
• Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
• Oxycontin 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in opioid tolerant patients, as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant or sedating effects of opioids.

Proper Administration

• Swallow tablets whole. Must not be cut, broken, chewed, crushed or dissolved as this leads to rapid release and absorption may result in potentially fatal dose of oxycodone.

Drug Interactions with Cytochrome P450 3A4 Inhibitors

• The concomitant use of oxycodone with all cytochrome P450 3A4 inhibitors such as macrolide antibiotics (e.g., azithromycin), azole antifungal agents (e.g., ketoconazole), and protease inihbitors (e.g., ritonavir) may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse effects and may cause potentially fatal respiratory depression.
• Patients receiving oxycodone controlled release and a CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

• Black Box data revised July 2001 (FDA Safety Alert Posted)

FDA and Industry Communications

Approved Risk Evaluation and Mitigation Strategies (REMS)

Oxycontin (oxycodone hydrochloride) Controlled-Release Tablets (PDF - 288KB)

Medication Guides

Patient Medication Guide

Package Inserts

Oxycodone