tramadol + paracetamol


Cadila Healthcare


Metro Drug


Zydus Healthcare Phils
Concise Prescribing Info
Paracetamol 325 mg, tramadol HCl 37.5 mg
Symptomatic treatment of moderate to severe pain.
Dosage/Direction for Use
Initially 2 tab. May take additional dose as needed. Max: 8 tab/day. Dose interval: Should not be <6 hr.
Should be taken on an empty stomach: Swallow whole, do not chew/crush.
Hypersensitivity. Acute intoxication w/ alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs. Patients taking MAOIs or w/in 2 wk w/drawal; epilepsy uncontrolled by treatment. Severe resp insufficiency; hepatic & renal impairment (CrCl <10 mL/min). Concomitant use of opioid agonists-antagonists (nalbuphine, buprenorphine, pentazocine). Pregnancy & lactation. Childn <12 yr.
Special Precautions
Do not exceed the recommended dose. Avoid prolonged dosage interval. Not suitable as substitute in opioid-dependent patients. Convulsions may occur in patients susceptible to seizures or taking other drugs that lower seizure threshold especially SSRIs, TCAs, antipsychotics, centrally-acting analgesics or local anesth; increased risk when exceeded the recommended upper dose limit. Opioid-dependent patients or those w/ cranial trauma, prone to convulsive disorder, biliary tract disorders, in a state of shock, in an altered state of consciousness for unknown origin, w/ problems affecting the resp center/function, or w/ increased intracranial pressure. Potential to cause w/drawal symptoms. Cases of dependence & abuse may occur (rare). May affect ability to drive or operate machinery.
Drug Interactions
Risk of serotonergic syndrome (diarrhea, tachycardia, sweating, trembling, confusion, even coma) w/ selective-A, nonselective, selective-B MAOIs; delay treatment w/ MAOIs for 2 wk before treatment. Central excitation symptoms evocative of serotonergic syndrome. Increased sedative effect w/ alcohol. Risk of reduced efficacy & shorter duration of carbamazepine & other enzyme inducers. Decreased analgesic effect of opioid agonists-antagonists (buprenorphine, nalbuphine, pentazocine) by competitive blocking effect at the receptors w/ the risk of occurrence of w/drawal syndrome.
ATC Classification
N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.
Trap FC tab
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