tramadol + paracetamol




Concise Prescribing Info
Tramadol HCl 37.5 mg, paracetamol 325 mg
Short-term (≤5 days) management of moderate to severe pain.
Dosage/Direction for Use
Adult & childn >16 yr 1-2 tab every 4-6 hr for pain relief. Max: 8 tab/day. Elderly >75 yr Min interval doses should not be <6 hr.
May be taken with or without food.
Hypersensitivity. Acute intoxication w/ alcohol, hypnotics, narcotics, centrally-acting analgesics, opioids or psychotropic drugs. Patients on MAOI therapy. Severe hepatic or renal impairment. Impaired kidney function (CrCl <10 mL/min). Resp impairment. Acute alcoholism, delirium tremens & convulsive disorders. Suspected or known mechanical GI obstruction. Significant acute resp depression, elevated CO2 levels in the blood & cor pulmonale. Uncontrolled epilepsy. Severe CNS depression, increased cerebrospinal or intracranial pressure & head injury. Tonsillectomy &/or adenoidectomy in childn <12-18 yr
Special Precautions
Risk of hepatotoxicity, suicidal ideation, resp & CNS depression. Increased intracranial pressure or head trauma. May precipitate seizure & serotonin syndrome w/ MAOIs & SSRIs. Not to be used in opioid-dependent patients. May complicate clinical assessment of patients w/ acute abdominal conditions. Hepatic & renal impairment. Increased risk of misuse, abuse or diversion & overdosage. Avoid abrupt discontinuation. Tramadol: May impair ability to drive or operate machinery. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Abdominal pain, anorexia, constipation, diarrhea, dizziness, dry mouth, dyspepsia, fatigue, flatulence, headache, hot flushes, HTN, hypoesthesia, increased sweating, flu-like symptoms, insomnia, nausea, nervousness, prostatic disorder, pruritus, rash, somnolence, trembling & vomiting.
Drug Interactions
May alter effect of warfarin. Tramadol: Additive effects w/ other opioids (eg, fentanyl, pethidine) or illicit drugs causing CNS depression (eg, γ-hydroxybutyrate, flunitrazepam). Decreased analgesic effect & risk of tramadol-associated seizures w/ carbamazepine. Decreased plasma conc w/ CYP3A4 inducers eg, rifampicin, St. John's wort. Reduced metabolic clearance w/ CYP2D6 inhibitors (eg, amitriptyline, fluoxetine, paroxetine) &/or CYP3A4 inhibitors (eg, ketoconazole, erythromycin). Increased plasma conc w/ quinidine. Increased risk of serious adverse events including seizures & serotonin syndrome w/ serotonergic drugs (MAOIs, SSRIs, SNRIs, triptans, lithium). Paracetamol: Increased risk of hepatotoxicity w/ anticonvulsants eg, phenytoin, barbiturates, carbamazepine. Possible increased risk of hepatotoxicity w/ INH & severe hypothermia w/ phenothiazines. Additive effects w/ ethanol.
MIMS Class
Analgesics (Opioid)
ATC Classification
N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.
Algesia tab
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