Tramapan Overdosage

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 and signs: TRAMAPAN is a combination product. The clinical presentation of overdose may include the signs and symptoms of tramadol toxicity, paracetamol toxicity or both. The initial symptoms of tramadol overdose may include respiratory depression and/or seizures. The initial symptoms seen within the first 24 hours following a paracetamol overdose may include: 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.
Tramadol: Serious potential consequences of overdosage of the tramadol component are respiratory depression, lethargy, coma, seizure, cardiac arrest and death. In addition, cases of QT prolongation have been reported during overdose.
Paracetamol: Paracetamol in massive overdosage may cause hepatic toxicity in some patients. Early symptoms following a potentially hepatotoxic overdosage may include: 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.
Treatment: A single or multiple overdoses with TRAMAPAN may be a potentially lethal polydrug overdose, and immediate consultation with a regional poison control center or transfer to a hospital is recommended.
While naloxone will reverse some, but not all, symptoms caused by overdosage with tramadol, the risk of seizures is also increased with naloxone administration. Naloxone is not recommended in treating convulsions, since tramadol-induced convulsions were adversely affected by naloxone in animal experiments. In such cases diazepam should be given intravenously. Hemodialysis or hemofiltration is not expected to be helpful in an overdose because it removes less than 7% of the administered tramadol dose in a 4-hour dialysis period. In treating an overdosage of TRAMAPAN, primary attention should be given to maintaining adequate ventilation along with general supportive treatment. Keep open the respiratory tract (aspiration); maintain respiration and circulation depending on the symptoms. Because strategies for the management of overdose are continually evolving, it is advisable to contact a poison control center (where available) to determine the latest recommendations for the management of an overdose. Hypotension is usually hypovolemic in etiology and should respond to fluids. Vasopressors and other supportive measures should be employed as indicated. A cuffed endo-tracheal tube should be inserted, when necessary, to provide assisted respiration.
In adults and adolescents, hepatic toxicity may occur following ingestion of 7.5-10 grams in a period of eight hours or less. Regardless of the quantity of paracetamol reported to have been ingested, the paracetamol antidote n-acetylcysteine should be administered orally or intravenously as soon as possible, if possible within 10 hours after intoxication. Plasma samples to determine paracetamol plasma levels should be taken but results of assays should not be awaited before initiating treatment with n-acetylcysteine.