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COMMONLY USED ORAL OPIOIDS — Comparison of Characteristics and Abuse Labeling
MOLECULE
BRAND NAMES
AVAILABLE
INDICATION(S)a
INTERVAL
DEA SCHEDULEc
ABUSE-DETERRENT LABELING
IMMEDIATE-RELEASE OPIOIDS
Management of breakthrough pain in cancer Fentanyl citrate
patients 16d-18e years of age and older who transmucosal
are already receiving and who are tolerant to around-the-clock opioid therapy for their SHORT-ACTING OPIOIDS
Hydromorphone
Morphine sulfate, None (formerly
and chronic pain where an opioid analgesic is appropriate.8 Management of acute and chronic moderate to severe pain where the use of an opioid Oxycodone HCl,
Relief of moderate to moderately severe pain.11 in patients where use of an opioid analgesic Oxymorphone, IR
Relief of moderate to severe acute pain where Tapentadol
Tramadol
COMBINATION SHORT-ACTING OPIOIDS (+ ACETAMINOPHEN)
Relief of mild to moderately severe pain.20 Hydrocodone
Vicodin: Relief of moderate to moderately Percocet: Management of acute and chronic Oxycodone
moderate to severe pain where the use of an LONG-ACTING OPIOIDS (EXCLUDING METHADONE)
Management of pain severe enough to require daily, around-the-clock (ATC), long-term opioid treatment for which alternative treatment Hydrocodone
bitartrate
• Reserve for use in patients for whom alternative treatment options (eg, nonopioid analgesics or IR opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Management of moderate to severe pain in Hydromorphone
opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an Morphine sulfate
when a continuous, around-the-clock opioid analgesic is needed for an extended period when a continuous, around-the-clock opioid Oxycodone ER
analgesic is needed for an extended period of time. Not for use on an as-needed basis or in the immediate post-operative period.33Relief of moderate to severe pain in patients Oxymorphone ER
requiring continuous around-the-clock opioid treatment for an extended period of time.34 Moderate to severe chronic pain in adults; Tapentadol ER
neuropathic pain associated with diabetic Tramadol
severe chronic pain in adults who require around-the-clock treatment of their pain for LONG-ACTING COMBINATION OPIOIDS
Morphine
Management of moderate to severe pain when sulfate and
a continuous, around-the-clock opiod analgesic naltrexone HCl
is needed for an extended period of time.37 aExcept for Zohydro™, indications listed are as per respective package inserts as of November 3, 2013, and do not reflect FDA labeling regulations announced on September 10, 2013.38 bMean values. cFederal (DEA) schedule. Schedules may vary by state. dActiq. eFentora. fDose dependent. gTramadol.
hM1 metabolite. iNot currently available or marketed due to voluntary recall, but still approved.6
REFERENCES
1.
Actiq [package insert]. Frazer, PA: Cephalon Inc; December 2011.
15. Nucynta [package insert]. Titusville, NJ: Janssen Pharmaceuticals Inc; September 2013.
30. Kadian [package insert]. Morristown, NJ: Actavis Kadian LLC; July 2012.
2. Fentora [package insert]. North Wales, PA: Teva Pharmaceuticals USA Inc; February 2013.
16. US Food and Drug Administration. Orange Book: Approved Drug Products with
31. Avinza [package insert]. Bristol, TN: King Pharmaceuticals Inc; May 2013.
3. US Food and Drug Administration. Orange Book: Approved Drug Products With
Therapeutic Equivalence Evaluations. Active ingredient search results from “OB_Rx” table 32. MS Contin [package insert]. Stamford, CT: Purdue Pharma LP; September 2012.
Therapeutic Equivalence Evaluations. Active ingredient search results from “OB_Rx” table for query on “tapentadol.” http://www.accessdata.fda.gov/Scripts/cder/ob/docs/tempai.
33. OxyContin [package insert]. Stamford, CT: Purdue Pharma LP; July 2013.
for query on “fentanyl citrate.” http://www.accessdata.fda.gov/Scripts/cder/ob/docs/ 34. Opana ER [package insert]. Malvern, PA: Endo Pharmaceuticals Inc; June 2013.
tempai.cfm. Accessed October 14, 2013.
17. Ultram [package insert]. Titusville, NJ: Janssen Pharmaceuticals Inc; March 2008.
35. Nucynta ER [package insert]. Titusville, NJ: Janssen Pharmaceuticals Inc; September 2013.
4. Dilaudid [package insert]. Stamford, CT: Purdue Pharma LP. www.drugs.com/pro/dilaudid.
18. US Food and Drug Administration. Orange Book: Approved Drug Products With
html?printable=1. Accessed October 2, 2013.
Therapeutic Equivalence Evaluations. Active ingredient search results from “OB_Rx” table 36. Ultram ER [package insert]. Titusville, NJ: Janssen Pharmaceuticals Inc; July 2013.
5. US Food and Drug Administration. Orange Book: Approved Drug Products with
for query on “tramadol.” http://www.accessdata.fda.gov/Scripts/cder/ob/docs/tempai.cfm. 37. Embeda [package insert]. New York, NY: Pfizer Inc; November 2013.
Therapeutic Equivalence Evaluations. Active ingredient search results from “OB_Rx” table 38. United States Food and Drug Administration. FDA announces safety labeling changes and
for query on “hydromorphone.” http://www.accessdata.fda.gov/Scripts/cder/ob/docs/ 19. Drug Enforcement Administration. Office of Diversion Control. Drug & Chemical Evaluation
postmarket study requirements for extended-release and long-acting opioid analgesics. tempai.cfm. Accessed October 20, 2013.
Section. Tramadol. August 29, 2013. http://www.deadiversion.usdoj.gov/drug_chem_info/ http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367726.htm. 6. ER/LA opioid analgesics REMS. Updated September 20, 2013. http://www.er-la-opioidrems.
tramadol.pdf. Accessed October 20, 2013.
com/IwgUI/rems/products.action. Accessed November 3, 2013.
20. Tylenol with codeine. http://www.rxlist.com/tylenol-codeine-drug.htm. Accessed
7. US Food and Drug Administration. Orange Book: Approved Drug Products With
Therapeutic Equivalence Evaluations. Active ingredient search results from “OB_Rx” table 21. US Food and Drug Administration. Drugs@FDA.com. FDA approved drug products. Results
for query on “morphine sulfate.” http://www.accessdata.fda.gov/Scripts/cder/ob/docs/ from query on “acetaminophen.” http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ tempai.cfm. Accessed October 20, 2013.
index.cfm. Accessed October 27, 2013.
8. Morphine sulfate [package insert]. Columbus, OH: Roxane Laboratories; January 2012.
22. Vicodin [package insert]. North Chicago, IL: AbbVie Inc; August 2013.
9. Oxecta [package insert]. Bristol, TN: King Pharmaceuticals Inc; June 2013.
23. US Food and Drug Administration. Drugs@FDA.com. FDA approved drug products. Results
10. US Food and Drug Administration. Drugs@FDA.com. FDA approved drug products. Results
from query on “hydrocodone.” http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ turntheconversation.com
from query on “oxycodone.” http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ index.cfm. Accessed October 27, 2013.
index.cfm. Accessed October 21, 2013.
24. Percocet [package insert]. Malvern, PA: Endo Pharmaceuticals Inc; August 2013.
11. OxyIR [package insert]. Stamford, CT: Purdue Pharma, LLC. February 2007. http://www.
25. Roxicet [package insert]. Columbus, OH: Roxane Laboratories Inc; August 2012.
indianapainsociety.org/fileuploads/OxyIR.pdf. Accessed October 21, 2013.
26. Zohydro [package insert]. San Diego, CA: Zogenix Inc; October 2013.
12. Roxicodone [package insert]. Bristol, TN: King Pharmaceuticals Inc; June 2013.
27. US Food and Drug Administration. Drugs@FDA.com. FDA approved drug products. Results
13. Opana [package insert]. Malvern, PA: Endo Pharmaceuticals Inc; March 2013.
from query on “hydrocodone bitartrate.” http://www.accessdata.fda.gov/scripts/cder/ 14. US Food and Drug Administration. Orange Book: Approved Drug Products with
drugsatfda/index.cfm. Accessed November 3, 2013.
Mallinckrodt, the “M” brand mark and the Mallinckrodt Therapeutic Equivalence Evaluations. Active ingredient search results from “OB_Rx” 28. FDA approves extended release, single entity hydrocodone product. Silver Spring, MD: US
Pharmaceuticals logo are trademarks of a Mallinckrodt company. table for query on “oxymorphone.” http://www.accessdata.fda.gov/Scripts/cder/ob/docs/ Food and Drug Administration; October 25, 2013. Other brands are trademarks of their respective owners.
tempai.cfm. Accessed October 20, 2013.
29. Exalgo [package insert]. Hazelwood, MO: Mallinckrodt Brand Pharmaceuticals Inc; March 2013.

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