OVERDOSE

Cases of overdose with tramadol have been reported. Estimates of ingested dose in foreign fatalities have been in the range of 3 to 5 g. A 3 g intentional overdose by a patient in the clinical studies produced emesis and no sequelae. The lowest dose reported to be associated with fatality was possibly between 500 and 1000 mg in a 40 kg woman, but details of the case are not completely known.

Serious potential consequences of overdosage are respiratory depression and seizure. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment. While naloxone will reverse some, but not all, symptoms caused by overdosage with tramadol HCl the risk of seizures is also increased with naloxone administration. In animals convulsions following the administration of toxic doses of tramadol could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice. Hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.

CONTRAINDICATIONS

Tramadol should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. It is also contraindicated in cases of acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.