Published: June 2010

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Tramadol - key points for prescribing

Information on this subject has been updated. Read the most recent information.

Prescriber Update 31(2): 12
June 2010

Tramadol will be fully funded in New Zealand for the first time from 1 June 2010. Medsafe wishes to take this opportunity to provide a summary of key points for prescribers who are considering treatment with tramadol.

Prescribers are encouraged to familiarise themselves with the complete prescribing information for tramadol available on the Medsafe website at: www.medsafe.govt.nz/Medicines/infoSearch.asp

Tramadol is a synthetic opioid analgesic indicated for the treatment of moderate to severe pain at step 2 of the WHO analgesic ladder. Importantly tramadol inhibits the reuptake of serotonin and noradrenaline in addition to its opioid action.

The maximum daily dose of tramadol should not exceed 400 mg per day; however the elderly (over 75 years of age) and those with renal or hepatic impairment usually require lower doses.

Tramadol should not be used in patients:

• With acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic medicinal products.
• Who are receiving monoamine oxidase inhibitors (MAOIs) or have taken them in the past 14 days.
• With epilepsy not adequately controlled by treatment.
• With severe renal impairment (creatinine clearance <10 mL/min).

Although tramadol causes less respiratory depression and addiction than codeine or morphine, it may increase the risk of nausea and vomiting, sedation and dizziness.¹ Tramadol can induce convulsions and increase the potential for selective serotonin re-uptake inhibitors, tricyclic antidepressants, antipsychotics and other seizure threshold lowering agents to cause convulsions.²

Tramadol is also known to cause Serotonin Syndrome when used concomitantly with other medicines that increase serotonin levels. A list of such medicines was provided in a previous Prescriber Update article.³

As at 14 April 2010, the Centre for Adverse Reactions Monitoring (CARM) had received a total of 162 reports associated with tramadol use. These reports include cases of Serotonin Syndrome, seizures, hyponatraemia, respiratory depression and hypotension in association with tramadol use. There have also been reports of increased INR and/or bleeding when used concomitantly with warfarin.

As with all medicines and vaccines, healthcare professionals are encouraged to report all suspected serious and unexpected adverse reactions associated with tramadol treatment to CARM.

References

1. Best Practice Advocacy Centre. (2008). WHO analgesic ladder: Which weak opioid to use at step two? Best Practice Journal. 18: 20-23.
2. Arrow Pharmaceuticals (NZ) Limited. 14 January 2010. Arrow-Tramadol (tramadol hydrochloride) data sheet. www.medsafe.govt.nz/profs/Datasheet/a/arrowtramadolcap.pdf (Adobe PDF file 108 KB)
3. Savage R. (2007). Serious reactions with tramadol: Seizures and Serotonin Syndrome. Prescriber Update. 28(1): 11-13. www.medsafe.govt.nz/profs/PUArticles/TramSerious.htm