FDA approved OxyContin (oxycodone) for Severe Pain in Adults and Pediatric PatientsFDA approved new opioid painkiller OxyContin for severe pain.

Oxycodone is an opioid agonist. The label does not provide specific mechanism details beyond its opioid agonist activity.

OxyContin is indicated for management of severe and persistent pain that requires an opioid analgesic and cannot be adequately treated with alternative options, including immediate-release opioids, in adults and opioid-tolerant pediatric patients 11 years and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. Limitations include reserving use for patients with inadequate alternatives and not for as-needed analgesia.

OxyContin should be prescribed only by healthcare professionals knowledgeable about extended-release/long-acting opioids and risk mitigation. The 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 patients with established opioid tolerance. Opioid-tolerant patients are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Use the lowest effective dosage for the shortest duration. Administer orally every 12 hours. Instruct patients to swallow tablets intact; do not cut, break, chew, crush, or dissolve. For adults not opioid-tolerant, initiate with 10 mg orally every 12 hours. For pediatric patients 11 years and older, use only in those already receiving and tolerating opioids for at least 5 consecutive days with a minimum of 20 mg per day of oxycodone or equivalent for at least two days immediately preceding dosing. In debilitated, opioid non-tolerant geriatric patients and patients with hepatic impairment, initiate at one third to one half the recommended starting dosage and titrate carefully.

Trial data not available in label.

Risks include addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration. Respiratory depression can occur at any time, especially during initiation and dose increases. Discuss opioid overdose reversal agents with patients and caregivers. Do not rapidly reduce or abruptly discontinue in physically dependent patients. OxyContin 60 mg and 80 mg tablets, single doses >40 mg, or total daily doses >80 mg are only for opioid-tolerant patients.

OxyContin is reserved for patients with severe and persistent pain requiring an opioid analgesic when alternative treatments are ineffective, not tolerated, or otherwise inadequate. It is not for as-needed use. Use the lowest effective dose for the shortest duration.