Paracetamol Kabi Special Precautions

It is recommended to use a suitable analgesic oral treatment as soon as this route of administration is possible.
In order to avoid the risk of overdose, check that no other medicinal products administered do contain paracetamol or propacetamol hydrochloride.
Doses higher than those recommended entail the risk of very serious liver damage. Clinical signs and symptoms of hepatic damage (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis) are not usually seen until two days, and up to a maximum of 4-6 days, after administration. Treatment with antidote should be given as soon as possible (see Overdosage).
Paracetamol can cause serious skin reactions. Patients should be informed about the early signs of serious skin reactions, and the use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition or other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.
If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended.
The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
If flucloxacillin is continued after cessation of paracetamol, it is advisable to ensure that there are no signals of HAGMA, as there is a possibility of flucloxacillin maintaining the clinical picture of HAGMA (see Interactions).
As for all solutions for infusion presented in vials or bags, close monitoring is needed notably at the end of the infusion to avoid air embolism (see Special precautions for disposal and other handling under Cautions for Usage).
Paracetamol should be used with particular caution under the following circumstances: Abnormal Liver Function and Hepatocellular insufficiency (Child-Pugh ≤9).
Hepatobiliary disorders.
Meulengracht Gilbert Syndrome (familial non-haemolytic jaundice).
Severe renal insufficiency (creatinine clearance ≤30 ml/min), see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions.
Chronic alcohol abuse.
Chronic malnutrition (low reserves of hepatic glutathione).
Total parenteral nutrition (TPN) use.
Use of enzyme inducers.
Use of hepatotoxic agents
In patients suffering from a genetically caused G-6-PD deficiency (favism) the occurrence of a haemolytic anaemia is possible due to the reduced allocation of glutathione following the administration of paracetamol.
Dehydration.
Effects on laboratory tests: Paracetamol can affect tests for uric acid using phosphotungstic acid and blood sugar tests using glucose-oxidase-peroxidase.
Effects on ability to drive and use machines: Paracetamol Kabi has no influence on the ability to drive and use machines.