Extended-release (ER) opioid with FDA-approved labeling describing abuse-deterrent properties (ADP)1-3
- In vitro demonstrate that OxyContin has physicochemical properties expected to make abuse via injection difficult
- Data from a clinical abuse potential study, along with support from the in vitro data, indicate that OxyContin has physicochemical properties that are expected to reduce abuse via the intranasal route
- Abuse-deterrent properties do not prevent or reduce the risk of addiction4
- Abuse of OxyContin by injection and intranasal routes, as well as by the oral route, is still possible
- All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use
- With parenteral abuse, the inactive ingredients in OxyContin can be expected to result in local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, valvular heart injury, embolism, and death. Cases of thrombotic microangiopathy (a condition characterized clinically by thrombocytopenia and microangiopathic hemolytic anemia) associated with parenteral abuse have been reported. Parenteral drug abuse is commonly associated with transmission of infectious diseases, such as hepatitis and HIV
Food has no significant effect on extent of oxycodone absorption
- OxyContin can be taken with or without food
7 tablet strengths
For dosage flexibility and to help titrate to a dosage that provides adequate analgesia and minimizes adverse reactions
- OxyContin is dosed orally every 12 hours
- Cutting, breaking, crushing, chewing, or dissolving the tablet will result in uncontrolled delivery of oxycodone and can lead to overdose or death
References: 1. US Department of Health and Human Services. FDA Supplemental Approval Letter. April 2013. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022272Orig1s014Ltr.pdf. Accessed February 21, 2018. 2. US Food and Drug Administration. Opioid medications—abuse-deterrent opioids. August 21, 2017. https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337066.htm. Accessed February 21, 2018. 3. US Food and Drug Administration. Drugs@FDA: FDA approved drug products. NDA 022272. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022272. Accessed February 21, 2018. 4. US Food and Drug Administration. Remarks delivered before FDA's scientific meeting on opioids. July 10, 2017. https://www.fda.gov/NewsEvents/Speeches/ucm566189.htm. Accessed February 21, 2018.