Paracetamol Kabi

Short-term treatment of moderate pain (especially following surgery) & fever (for urgent need to treat pain or hyperthermia &/or when other routes of administration are not possible).

IV No >4 doses to be given in 24 hr. Min interval between each administration: 4 hr. Administer as 15-min IV infusion. Adult, adolescent, & childn weighing >50 kg & no additional risk factors for hepatotoxicity 1 g/100 mL. Max daily dose: 4 g, >50 kg w/ additional risk factors for hepatotoxicity 1 g/100 mL. Max daily dose: 3 g, >33 kg to ≤50 kg 15 mg/kg. Max daily dose: 60 mg/kg, not exceeding 3 g, >10 kg to ≤33 kg 15 mg/kg. Max daily dose: 60 mg/kg, not exceeding 2 g, ≤10 kg 7.5 mg/kg. Max daily dose: 30 mg/kg. Adult w/ chronic or compensated active hepatic disease, hepatocellular insufficiency, chronic alcoholism, chronic malnutrition, dehydration, Meulengracht Gilbert syndrome, weighing <50 kg Max daily dose: Not to exceed 3 g.

Hypersensitivity to paracetamol, propacetamol HCl (prodrug of paracetamol). Severe hepatocellular insufficiency (Child-Pugh >9).

Discontinue at 1st appearance of skin rash or any other sign of hypersensitivity; & closely monitor if high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis is suspected. Avoid dosing errors due to confusion between mg & mL, which could result in accidental overdose & death; risk of overdose, check that no other medicinal products containing paracetamol or propacetamol HCl are administered. Use of suitable analgesic oral treatment is recommended if possible. Risk of very serious liver damage in higher doses. Serious skin reactions. Early signs of serious skin reactions. HAGMA due to pyroglutamic acidosis in patients w/ severe illness eg, severe renal impairment & sepsis, or in patients w/ malnutrition or other sources of glutathione deficiency (eg, chronic alcoholism) who were treated w/ paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. Clinical signs & symptoms of hepatic damage (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis), usually seen until 2 days, & up to a max of 4-6 days, after administration. Abnormal liver function & hepatocellular insufficiency (Child-Pugh ≤9); hepatobiliary disorders; Meulengracht Gilbert syndrome (familial non-haemolytic jaundice); severe renal insufficiency (CrCl ≤30 mL/min); chronic alcohol abuse & malnutrition (low reserves of hepatic glutathione); TPN; use of enzyme inducers & hepatotoxic agents; in patients suffering from genetically caused G6PD deficiency (favism); dehydration. Closely monitor at the end of the infusion to avoid air embolism. Can affect uric acid tests using phosphotungstic acid & blood sugar tests using glucose-oxidase-peroxidase. Pregnancy; use lowest effective dose for the shortest possible time & at lowest possible frequency. Pre-term newborn infants.

Administration site reaction (pain & burning sensation).

Reduced clearance w/ probenecid. Prolonged elimination t_½ w/ salicylamide. Impaired metabolism w/ enzyme-inducing medicinal products eg, rifampicin, barbiturates, TCAs, INH & some antiepileptics (carbamazepine, phenytoin, phenobarb, primidone). Unexpected hepatotoxicity w/ alcohol or enzyme-inducing medicinal products. Enhanced tendency of neutropenia w/ zidovudine. Prolonged action of chloramphenicol. Reduced elimination t_½ w/ OCs. Slight variations of INR values w/ oral anticoagulants (paracetamol 4 g/day for at least 4 days). High anion gap metabolic acidosis w/ flucloxacillin.

Analgesics (Non-Opioid) & Antipyretics

N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.

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