OXYCONTIN

The activity of OXYCONTIN is primarily due to the parent drug oxycodone. OXYCONTIN is designed to provide delivery of oxycodone over 12 hours. Cutting, breaking, chewing, crushing or dissolving OXYCONTIN impairs the controlled-release delivery mechanism and results in the rapid release and absorption of a potentially fatal dose of oxycodone. Oxycodone release from OXYCONTIN is pH independent. The oral bioavailability of oxycodone is 60% to 87%. The relative oral bioavailability of oxycodone from...

Adult Clinical Study A double-blind, placebo-controlled, fixed-dose, parallel group, two-week study was conducted in 133 patients with persistent, moderate to severe pain, who were judged as having inadequate pain control with their current therapy. In this study, OXYCONTIN 20 mg, but not 10 mg, was statistically significant in pain reduction compared with placebo. Pediatric Clinical Study OXYCONTIN has been evaluated in an open-label clinical trial of 155 opioid-tolerant pediatric patients with moderate to severe chronic pain. The mean duration of therapy was 20.7 days (range 1 to 43 days). T...

The following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Interactions With Benzodiazepines and Other CNS Depressants [see Warnings and Precautions (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7) ] Adrenal Insufficiency ...

OXYCONTIN is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.13) ] Hypersensitivity (e.g., ...

Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation. ( 5.7 ) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Regularly evaluate, particularly during i...

7 DRUG INTERACTIONS Table 4 includes clinically significant drug interactions with OXYCONTIN.

Table 4Clinically Significant Drug Interactions with OXYCONTIN Inhibitors of CYP3A4 and CYP2D6 Clinical Impact: The concomitant use of OXYCONTIN and CYP3A4 inhibitors can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more prono...