Alaxan FR

Alaxan FR Overdosage

ibuprofen + paracetamol

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Full Prescribing Info
Overdosage
Paracetamol in massive overdosage may cause hepatotoxicity in some patients. In adults and children >12 years, hepatotoxicity may occur following ingestion of >7.5-10 g over a period of ≤8 hrs. Fatalities are infrequent (<3-4% of untreated cases) and have rarely been reported with overdoses of <15 g. In children <12 years, acute overdosage with paracetamol dose of <150 mg/kg body weight have not been associated with hepatotoxicity. Early symptoms following a potentially hepatotoxic overdose may include: Nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatotoxicity may not be apparent until 48-72 hrs after ingestion. In adults and children >12 years, 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 N-acetylcysteine. Do not wait for the results of assays for plasma paracetamol levels before initiating treatment with N-acetylcysteine. The following additional procedures are recommended: Promptly initiate gastric decontamination of the stomach. A plasma paracetamol assay should be obtained as early as possible, but no sooner than 4 hrs following ingestion. Liver function studies should be obtained initially and repeated at 24-hr intervals.
Serious toxicity or fatalities have been extremely infrequent following acute paracetamol overdose in young children, possibly because of differences in the way they metabolize paracetamol. In children, the maximum potential amount ingested can be more easily estimated. If >150 mg/kg or an unknown amount of paracetamol was ingested, obtain a plasma paracetamol level as soon as possible, but no sooner than 4 hrs following ingestion. If an assay cannot be obtained and the estimated paracetamol ingestion exceeds 150 mg/kg, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy.
Alcohol Information: Chronic, heavy alcohol abusers may be at risk of liver toxicity from excessive paracetamol use, although reports of this event are rare. Reports usually involve cases of severe chronic alcoholics and the dosage of paracetamol most often exceed recommended doses and often involve substantial overdose. Healthcare professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of paracetamol.
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