Finished product reference
Acetaminophen / Tramadol Hydrochloride
Tablet · Oral · 325 mg/37.5 mg
- List code
- 53402
- Pharmacologic class
- Compound opioid analgesic (paracetamol / tramadol)
What it is and how it works
Tramadol is a centrally acting analgesic that is a weak mu-opioid agonist (mainly via its O-desmethyl metabolite formed by CYP2D6) and inhibits noradrenaline and serotonin reuptake; paracetamol adds a complementary central analgesic effect.
Indications
Symptomatic treatment of moderate to severe pain when the combination is considered necessary.
Dosage and administration (summary)
Oral; for tablets of 37.5 mg/325 mg, usually 2 tablets initially, then as required at intervals of at least 6 hours, up to a maximum of 8 tablets daily.
Contraindications
Acute intoxication with alcohol, hypnotics, opioids or psychotropic drugs; use with or within 14 days of MAO inhibitors; uncontrolled epilepsy; severe hepatic impairment; hypersensitivity.
Warnings and precautions
Risk of seizures, serotonin syndrome (with SSRIs, SNRIs, tricyclics), respiratory depression, dependence and misuse. Avoid other paracetamol-containing products; caution with CNS depressants, in renal impairment and in CYP2D6 ultra-rapid metabolisers.
Pregnancy
Not recommended in pregnancy; chronic use may cause neonatal withdrawal.
Storage and supply
Store below 25 °C.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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