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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.
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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
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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. [email protected]. 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. [email protected]. FDA approved drug products. Results 10. US Food and Drug Administration. [email protected]. FDA approved drug products. Results
from query on “hydrocodone.” http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
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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. [email protected]. 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.
Your PreventiveRxSM Drug List: Expanded Plan PreventiveRx covers drugs that help keep you healthy because they prevent illness and other health conditions. You can get the products on this list at low or no cost to you. This list includes only prescription products. Brand-name drugs are listed with a first capital letter. Non-brand drugs (generics) are in lowercase letters. Brand-name drug
Guidelines of the German Society of Neurology (DGN) on Neurogenic Dysphagia (ND) Mario Prosiegel Neurologisches Krankenhaus München (NKM), Tristanstr. 20, D-80804 Munich, Germany The abovementioned guidelines were accepted by the DGN guidelines commission in September 2004 and will be published by the DGN in 2005. The main recommendations of these guidelines are as follows: ! Diagnosis o