Tracy

Moderate to severe acute pain.

Adult & childn >16 yr 1-2 tab every 4-6 hr. Max: 8 tab daily. Patient w/ CrCl <30 mL/min Dosing interval is recommended to be increased not to exceed 2 tab every 12 hr.

May be taken with or without food.

Hypersensitivity. Cases of acute intoxication w/ alcohol, hypnotics, narcotics, centrally acting-analgesics, opioids or psychotropic.

Discontinue use at 1st appearance of skin rash or any sign of hypersensitivity. Not to be received by patients w/ history of anaphylactoid reactions to codeine & other opioids. Not to be co-administered w/ other tramadol or paracetamol-containing products. Not to be used in opioid-dependent patients. Caution in patients at risk for resp depression; w/ increased ICP or head injury. W/drawal symptoms may be relieved by tapering the medication. Use w/ caution & in reduced dosages when administered to patients receiving CNS depressant (eg, alcohol, opioids, anesth agents, phenothiazines, tranquilizers or sedative hypnotics). Monitor for signs & symptoms of hyponatremia in patients w/ predisposing risk factors. Concomitant use w/ MAOIs or SSRIs. Use has not been studied in patients w/ impaired renal function. Not recommended in patients w/ severe hepatic impairment. Safe use in pregnancy has not been established. Not recommended for nursing mothers. Tramadol: Risk of seizures. Risk of convulsions may be increased in patients w/ epilepsy, w/ history of seizures, or w/ recognized risk for seizure (eg, head trauma, metabolic disorders, alcohol & drug w/drawal, CNS infections). Concomitant use increases seizure risk in patients taking SSRIs antidepressants or anorectics, TCAs, & other tricyclic compd (eg, cyclobenzaprine, promethazine), or opioids. May enhance seizure risk in patients taking MAOIs, neuroleptics or other drugs that reduce seizure threshold. Paracetamol: Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive paracetamol use.

Paracetamol: Haematological reactions (including thrombocytopenia, leucopenia, pancytopenia, neutropenia, agranulocytosis); skin rashes, & other hypersensitivity reactions. Tramadol: Nausea, vomiting, constipation, drowsiness, confusion; micturition, ureteric/biliary spasm; dry mouth, dizziness, sweating, facial flushings, headache, vertigo, bradycardia, tachycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood, decreased libido or potency, hallucinations, miosis; raised ICP; muscle rigidity (following high doses).

Increased risk of adverse events including seizure & serotonin syndrome w/ MAOIs or SSRIs. Tramadol: Increased metabolism & significantly reduced analgesic effect w/ carbamazepine. Increased conc w/ quinidine. Increased INR w/ warfarin-like compd. Inhibited metabolism w/ CYP2D6 inhibitors (eg, fluoxetine, paroxetine, amitriptyline).

Analgesics (Opioid)

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

Rx