Cedars-Sinai Medical Center

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A BI-WEEKLY PUBLICATION FROM THE CEDARS-SINAI CHIEF OF STAFF Sept. 26, 2014 | Archived Issues

P and T Approvals, Details About Tramadol Change

Pharmacy Focus

See highlights of the Aug. 5 meeting of the Pharmacy and Therapeutics Committee. Also, more details are available about tramadol's new status as a controlled substance.

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Meetings and Events


Grand Rounds

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Upcoming CME Conferences

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CME Newsletter - September (PDF)


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P and T Approvals, Details About Tramadol Change

Pharmacy Focus

Highlights of the Aug. 5 meeting of the Pharmacy and Therapeutics Committee are summarized in the PDF link below. Also, more details are available about tramadol's new status as a controlled substance. 

P and T Committee Approvals - Aug. 5, 2014 (PDF)

Details About Tramadol's Classification as a Controlled Substance

Tramadol has been used as a substitute for other opioids. In 2013, 43.8 million prescriptions for tramadol were dispensed in the United States. Tramadol is a synthetic opioid analgesic used for the management of moderate to moderately severe pain.

Tramadol has traditionally and incorrectly been considered a drug of little abuse potential. Similar to other opioids, it binds µ-opioid receptors while also inhibits norepinephrine and serotonin reuptake.

As of Aug. 18, 2014, U.S. Drug Enforcement Administration placed tramadol (also known by the brand name Ultram) into Schedule IV of the Controlled Substances Act due to an increase in abuse of tramadol products over the last few years.

Tramadol is extensively metabolized by N- and O-demethylation, glucuronidation or sulfation, and CYP3A4 and CYP2D6:

  • Higher tramadol concentrations in poor metabolizers of CYP2D6
  • Multiple significant drug-drug interactions

Similar to opioid withdrawal, abrupt discontinuation may lead to symptoms such as anxiety, insomnia, sweating and tremors. Tapering tramadol may be prudent to avoid withdrawal symptoms.

For discharge prescription, a prescription written on secure paper or called in to a pharmacist is required before the medication can be dispensed.

The usual dosage range:

Immediate release50-100 mg every 4-6 hours (maximum dose 400 mg/day)
Orally disintegrating tablet50-100 mg every 4-6 hours (maximum dose 400 mg/day)
Extended release100-300 mg once daily (maximum dose 300 mg/day)

 


References

  • Ultram (tramadol) package insert. Raritan, New Jersey: Ortho-McNeil Pharmaceutical Inc.; revised March 2008.
  • Ultram ER (tramadol extended release) package insert. Titusville, New Jersey: Janssen Pharmaceuticals Inc.; revised July 2014.
  • Rybix ODT (tramadol) package insert. Florham Park, New Jersey: Shionogi Inc.; revised August 2011.
  • Schedules of Controlled Substances: Placement of Tramadol into Schedule IV. Drug Enforcement Administration. Federal Register. 2014;79(127):37623-30.

Previously in Medical Staff Pulse:

Tramadol Is Now Managed as a Controlled Substance (Pharmacy Focus, Aug. 15, 2014)