Ultracet Overdosage

For management of a suspected drug overdose, contact the doctor immediately, even if there are no symptoms.
ULTRACET is a combination product. The clinical presentation of overdose may include the signs and symptoms of tramadol toxicity, paracetamol toxicity or both.
Accidental ingestion: Accidental ingestion of tramadol can result in respiratory depression and seizures due to an overdose of tramadol. Respiratory depression and seizures have been reported in a child following ingestion of a single tablet. Fatalities due to tramadol overdose have also been reported.
Symptoms: Tramadol: Serious potential consequences of overdosage are respiratory depression, serotonin syndrome, hyponatremia, lethargy, coma, seizure, cardiac arrest and death. In addition, cases of QT prolongation have been reported during overdose.
Fatalities have been reported in post-marketing in association with both intentional and unintentional overdose with tramadol. The initial symptoms of tramadol overdosage may include respiratory depression and/or seizures. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment.
Paracetamol: Serious potential consequences of overdosage with paracetamol are hepatic centrilobular necrosis, leading to hepatic failure and death. Renal tubular necrosis, hypoglycemia and coagulation defects also may occur. The initial symptoms seen within the first 24 hours following a paracetamol overdose are: gastrointestinal irritability, anorexia, nausea, vomiting, malaise, pallor and diaphoresis. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Emergency help should be sought immediately and treatment initiated immediately if overdose is suspected, even if symptoms are not apparent.
Treatment: A single or multiple overdose with ULTRACET may be a potentially lethal polydrug overdose, and consultation with doctor is recommended. The stomach should be emptied promptly and vigorous supportive therapy is required in severe intoxication.
In treating an overdose of ULTRACET, primary attention should be given to maintaining adequate ventilation along with general supportive treatment. Hypotension is usually hypovolemic in etiology and should respond to fluids. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation. Intubation should be considered before gastric lavage of the unconscious patient and when necessary, to provide assisted respiration.
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. Based on experience with tramadol, 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.
In the treatment of paracetamol overdosage, gastric decontamination should be administered just prior to paracetamol antidote N-acetylcysteine (NAC) to decrease systemic absorption if paracetamol ingestion is known or suspected to have occurred within a few hours of presentation. Serum paracetamol levels should be obtained immediately if the patient presents 4 or more hours after ingestion to assess potential risk of hepatotoxicity; paracetamol levels drawn less than 4 hours post-ingestion may be misleading. The antidote NAC should be administered as soon as possible by intravenous or oral route of administration.