Trabest

Tramadol HCl 37.5 mg, paracetamol 325 mg

Management of moderate to severe pain.

Adult & childn >16 yr 1-2 tab every 4-6 hr. Max: 8 tab daily.

May be taken with or without food: Swallow whole w/ sufficient liqd. Do not break/chew.

Hypersensitivity. Uncontrolled epilepsy. Acute alcohol, hypnotics, centrally-acting analgesics, opioids or psychotropic drugs intoxication. Concomitant or use of MAOI w/in 2 wk of w/drawal. Severe hepatic impairment.

Discontinue use if severe skin reactions occur. Not suitable as substitute in opioid-dependent patients. Not recommended in patients w/ severe resp insufficiency. Epileptic or patients susceptible to seizures. Patients w/ cranial trauma, prone to convulsive disorder, biliary tract disorders, in state of shock, altered state of consciousness for unknown reasons, resp centre or function problems, increased intracranial pressure. Tolerance, drug abuse, physical &/or psychological dependence. Avoid abrupt discontinuation. Not to be used concurrently w/ other paracetamol- or tramadol-containing drugs. Not recommended in concomitant use w/ opioid agonists-antagonists eg, nalbuphine, buprenorphine, pentazocine. Concomitant use w/ medications lowering seizure threshold eg, SSRIs, TCAs, antipsychotics, centrally-acting analgesics or local anaesth. May affect ability to drive & use machines. Not to be used in severe hepatic impairment. Not recommended in severe renal impairment (CrCl <10 mL/min). Hepatotoxicity; moderate hepatic impairment. Not to be used during pregnancy & lactation. Not recommended in childn <16 yr. Elderly >75 yr.

Dizziness & somnolence; nausea. Headache, trembling; confusion, mood changes (anxiety, nervousness, euphoria), sleep disorders; vomiting, constipation, dry mouth, diarrhoea, abdominal pain, dyspepsia, flatulence; sweating, pruritus. Tramadol: Postural hypotension, bradycardia, collapse. Paracetamol: Cutaneous hypersensitivity reactions eg, skin rashes, angioedema, SJS/TEN.

Increased risk of serotoninergic syndrome w/ MAOIs; SSRIs & triptans. Increased sedative effects w/ alcohol. Decreased tramadol plasma conc w/ carbamazepine & other enzyme inducers. Decreased analgesic effect w/ opioid agonists-antagonists eg, buprenorphine, nalbuphine, pentazocine. Increased risk of resp depression w/ other opioid derivatives, barbiturates & benzodiazepines. Increased central depression w/ CNS depressants eg, other opioid derivatives, barbiturates, benzodiazepines, other anxiolytics, hypnotics, sedative antidepressants & antihistamines, neuroleptics, centrally-acting antihypertensive drugs, thalidomide & baclofen. Increased INR w/ warfarin-like compds. Inhibition of tramadol metabolism w/ CYP3A4 inhibitors eg, ketoconazole & erythromycin. Increased risk of convulsions w/ bupropion, SSRIs, TCAs & neuroleptics. Increased paracetamol absorption w/ metoclopramide or domperidone. Reduced paracetamol absorption w/ cholestyramine. Increased tramadol requirement w/ pre- & post-op use of ondansetron in patients w/ post-op pain.

Analgesics (Opioid)

N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.

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