paracetamol + tramadol: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
paracetamol + tramadol: clinical details
Prescribing considerations
- Confirm that pain requires both components and assess other medicines for duplicate ingredients.
- Review ongoing benefit and harms and establish a discontinuation plan before repeated use.
- Assess respiratory disease, seizure risk, head injury, renal or hepatic impairment, frailty, substance-use history, mental-health history and concurrent sedatives.
- Consider CYP2D6 variability if analgesia is unexpectedly poor or opioid toxicity occurs.
- The combination is not established for children younger than 12 years.
Contraindications and cautions
- Hypersensitivity to either active ingredient or an excipient.
- Acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic medicines.
- Current or recent MAOI treatment within the product-specified washout period.
- Severe hepatic impairment.
- Epilepsy not controlled by treatment.
Monitoring
- Pain response, function and continuing need.
- Sedation, respiratory depression and sleep-related breathing disturbance.
- Constipation, nausea, confusion, seizures and serotonin toxicity.
- Tolerance, hyperalgesia, dependence, opioid-use disorder or withdrawal.
- Renal and hepatic status where relevant.
- INR when clinically indicated with warfarin-like anticoagulants.
Clinical pharmacology
Tramadol is a racemic, centrally acting analgesic with mu-opioid activity and effects on noradrenaline and serotonin signalling. Paracetamol has central and peripheral analgesic activity through incompletely defined mechanisms. Tramadol and its metabolites are mainly renally eliminated; paracetamol is chiefly hepatically conjugated.
Formulation and product differences
- The selected product is a pale-yellow film-coated tablet marked with a manufacturer logo and “T5”.
- It must be swallowed whole and should not be broken or chewed.
- The selected formulation contains lactose and is essentially sodium-free.
- Different manufacturers' tablets can have different excipients and appearances; check the product-specific SmPC and leaflet.
paracetamol + tramadol preparations and strengths
Tablet
Route: Oral
Strengths: 37.5 mg + 325 mg
paracetamol + tramadol interactions
Important interactions include:
Other paracetamol- or tramadol-containing products
Increase the risk of accidental overdose and serious liver or opioid toxicity.
Monoamine oxidase inhibitors (MAOIs)
Contraindicated during treatment and for the specified washout period because severe serotonergic or central nervous system reactions may occur.
SSRIs, SNRIs, tricyclic antidepressants, mirtazapine and other serotonergic medicines
May increase the risk of serotonin syndrome and, for some medicines, seizures.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.