Tramadol

Indications

Moderate pain (includes fixed-dose combination with paracetamol). Acute or chronic pain

Adverse effects

See full list of Adverse Effects for opioid analgesics.

Specific to Tramadol

  • CNS stimulation, weakness, sweating, sleep disorder, rash
  • Depression, difficulty in concentration

Dose

IV/IM

  • 50–100 mg every 4–6 hours, up to a total daily dose of 600 mg (maximum 300 mg daily if >75 years).
  • Nausea and vomiting are more likely with IV bolus doses >50 mg

Oral-immediate release

  • 50–100 mg every 4–6 hours when necessary; maximum 400 mg daily (or 300 mg daily if >75 years).

Oral-12 hour controlled release

  • 50–200 mg every 12 hours; maximum 400 mg daily (or 300 mg daily if >75 years). Do not use controlled release product for initial stabilisation.

Oral-24 hour controlled release

  • Start with 100 mg once daily; usual dose 200 mg once daily (maximum 400 mg once daily). Do not use controlled release product for initial stabilisation.

Renal impairment

  • IV/IM/oral (immediate release product), initially 50–100 mg every 12 hours.
  • Oral (12 hour controlled release product), initially 50–200 mg every 24 hours.

Severe hepatic impairment

  • IV/IM/oral (immediate release product), 50-100 mg every 12 hours.

Fixed-dose combination with paracetamol

  • For adult, initially 2 tablets (of paracetamol 325mg and tramadol 37.5 mg), then 1 to 2 tablets every 6 hours if needed. Maximum of 8 tablets in 24 hours

Administration advice

  • Give IV injection over 2 to 3 minutes; nausea and vomiting are more likely after rapid injection.

Counselling

  • Swallow whole; do not crush or chew controlled release tablets

Precautions

Serotonin toxicity

  • Treatment with, or within 14 days of, a MAOI is contraindicated due to risk of serotonin toxicity.
  • Treatment with other drugs that may contribute to serotonin toxicity may increase likelihood; avoid combinations or monitor clinical course carefully.

Renal

  • Rate of excretion of tramadol and its active metabolite are decreased in renal impairment. Avoid if CrCl <10 mL/minute; reduce dose if CrCl <30 mL/minute (24 hour controlled release product is contraindicated in this situation).

Hepatic

  • In severe hepatic impairment reduce the dose of parenteral and immediate release oral products; do not use controlled release products.

Elderly

  • Avoid use in people >75 years; do not use 24 hour controlled release product.

Children

  • Limited data available. Although the manufacturer does not recommend use in children, it is used by some specialist paediatricians.

Practice considerations

  • analgesia starts within 1 hour of oral administration, peaks at 2–4 hours
  • do not use controlled release products for acute pain management as slow onset and offset make rapid, safe titration impossible
  • 6–10% of Caucasians and 1–2% of Asians lack the enzyme CYP2D6 (necessary for metabolism of tramadol to the active metabolite O‑desmethyltramadol); these people may obtain reduced analgesia with tramadol
  • if maximum doses are not fully effective, consider alternative opioid (e.g. morphine) and/or seek specialist advice
  • tramadol has relatively weak affinity for opioid receptors and the misuse potential appears to be low; it is designated as a Schedule 4 product and not a controlled substance
  • atypical withdrawal symptoms (e.g. severe anxiety, panic attacks, hallucinations, paraesthesia, tinnitus) have been reported
  • naloxone only partially antagonises tramadol overdose, and may increase the risk of seizures

Practice considerations (for fixed-dose combination with paracetamol)

  • Consider using paracetamol and tramadol separately to optimise analgesia, because the maximum recommended dosage of the fixed dose combination is only 2.6 g paracetamol and 300 mg tramadol daily

Available products

  • Tramadol hydrochloride 50, 100, 150, 200 mg – modified release tablets, twice daily (e.g. Zydol SR®, Tramal SR®)
  • Tramadol hydrochloride 100, 200, 300 mg - extended release, once daily (Durotram XR®), non PBS
  • Tramadol hydrochloride 100 mg/2 mL – injection
  • Tramadol hydrochloride 100 mg/mL – oral liquid