TDL Plus Overdosage

Tramadol + Paracetamol is a combination product. The clinical presentation of overdose may include the signs and symptoms of Tramadol toxicity, paracetamol toxicity of both. The initial symptoms of Tramadol overdosage 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.
Human experience: Tramadol: Serious potential consequences of overdosage of the Tramadol component are respiratory depression, lethargy, coma seizure, cardiac arrest and death.
Paracetamol: Paracetamol in a 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 overdose with Tramadol + Paracetamol may be a potentially lethal polydrug overdose, and appropriate expert consultation, if available, 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. 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 treating an over dosage of Tramadol + Paracetamol, primary attention should be given to maintaining adequate ventilation along the general supportive treatment. Measures should be taken to reduce drug absorption. Vomiting should be induced mechanically, or with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the Vasopressors and others supportive measures should be employed on an unconscious patient and when necessary to provide assisted respiration. In adult and pediatric patients, any individual presenting with an unknown amount of paracetamol ingested or with a questionable or unreliable history about the time of ingestion should have a plasma paracetamol level drawn and be treated with acetylcysteine. If an assay cannot be obtained and the estimated paracetamol ingestion exceeds 7.5 to 110grams for adults and adolescents or 150mg/kg for children, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy.