Serious potential consequences of overdosage are respiratory depression, lethargy, coma, seizure, cardiac arrest and death. (See WARNINGS .) Fatalities have been reported in post marketing in association with both intentional and unintentional overdose with tramadol. 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, 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.

Tramadol Hydrochloride should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or other opioids. Tramadol Hydrochloride is contraindicated in any situation where other opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol Hydrochloride may worsen central nervous system and respiratory depression in these patients.

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