New Drug Update 2009-2010 - LAFP

Dizziness 16% 22% 31% 30% 5%
Somnolence 12% 13% 21% 10% 1%
Headache 12% 11% 12% 14% 7%
Pruritus 3% 9% 17% 12% 1%
Hyperhidrosis 0% 5% 4% 6% 1%
Pyrexia 1% 6% 0% 2% 3%
Table 9. Adverse Reactions Reported in the Tapentadol vs Oxycodone in the 10-Day
Uncontrolled Osteoarthritis Pain Study 22
Tapentadol
50 mg
(n = 157)
Tapentadol
75 mg
(n = 168)
Oxycodone
10 mg
(n = 172)
Dizziness 18% 26% 23% 5%
Nausea 18% 21% 41% 5%
Vomiting 7% 14% 34% 4%
Somnolence 6% 10% 12% 1%
Headache 6% 8% 3% 6%
Constipation 4% 7% 26% 2%
Pruritus 2% 5% 15% 1%
Diarrhea 1% 5% 1% 3%
Fatigue 1% 7% 10% 1%
Placebo
(n = 169)
Table 10. Tapentadol and Oxycodone Tolerability Over 90 Days in
Patients With Lower Back Pain or Osteoarthritis 24
Tapentadol
Oxycodone
Nausea 18.4% 29.4%
Dizziness 18.1% 17.1%
Vomiting 16.9% 30%
Constipation 12.8% 27.1%
Headache 11.5% 10%
Somnolence 10.2% 9.4%
Pruritus 4.3% 11.8%
DRUG INTERACTIONS: Tapentadol use is contraindicated with or within 14 days of using an MAOI.
Tapentadol should be used with caution in patients using other centrally acting agents or alcohol.
Tapentadol does not inhibit or induce cytochrome P450 enzymes; therefore, CYP-mediated interactions
are unlikely. Drug interactions were not observed with coadministration with acetaminophen,
acetylsalicylic acid, metoclopramide, naproxen, omeprazole, or probenecid.
RECOMMENDED MONITORING: Patients should be monitored for analgesic response, respiratory
depression, and impaired CNS function during tapentadol therapy.
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