Dolcet Mini

Dolcet Mini Overdosage

tramadol + paracetamol

Manufacturer:

Janssen

Distributor:

Zuellig

Marketer:

Johnson & Johnson
Full Prescribing Info
Overdosage
This drug is a combination product. In case of drug overdose, tramadol toxicity, paracetamol toxicity or symptoms and signs of toxicity of both drugs may appear.
In case of overdose of tramadol, respiratory suppression, lethargy, coma, convulsion, cardioplegia, and serious symptoms of death may appear. The initial symptoms of tramadol overdosage may include respiratory depression and/or seizures. In addition, cases of QT prolongation have been reported during overdose. 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 children following ingestion of a single tablet. Fatalities due to tramadol overdose have also been reported.
In case of overdose of paracetamol, hepatic centrilobular necrosis resulting in liver failure and death may occur and renal tubular necrosis, hypoglycemia and coagulation disorder may occur. 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.
A single or multiple overdose with this drug may be a potentially lethal polydrug overdose. In case of overdose, contact institutions or hospitals where emergency care is available, and maintain a proper airway with general treatment. Symptoms resulted from overdose of tramadol due to administration of naloxone may be partially recovered, but risk of seizure will increase. As 7% of dosage was eliminated by 4-hour hemodialysis from experience of using tramadol, it is not beneficial for therapy for overdose. In case of overdose of paracetamol, administer N-acetylcysteine within 10 - 12 hours to protect the liver. 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 10 grams for adults and adolescents or 150 mg/kg for children, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy.
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