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