Zuellig Pharma
Concise Prescribing Info
Short-term treatment of moderate pain syndrome post-op; hyperthermic response in adults. Symptomatic treatment of pain & hyperthermia in the post-op period in childn.
Dosage/Direction for Use
Administer by IV infusion. Duration: 15 min. Adult & adolescent >50 kg 1,000 mg max single dose. Max daily dose: 4 g. Min interval between each administration should not be <4 hr. 1-4 infusions during the first 24 hr since the onset of pain syndrome (post-op). May be extended, if necessary, but should not exceed total duration of 72 hr & total of 12 infusions. Childn 10-50 kg 15 mg/kg. Max daily dose: 60 mg/kg. Min interval between each administration daily dose must not be <4 hr. Do not exceed infusion/day. Renal insufficiency (CrCl ≤30 mL/min) Interval must be increased up to 6 hr & max duration must not exceed 48 hr.
Hypersensitivity to paracetamol or sulfite. Severe hepatocellular insufficiency. Bronchial asthma.
Special Precautions
Hepatocellular & severe renal insufficiency (CrCl <30 mL/min); chronic alcoholism; nutritional dystrophy (reduced reserves of hepatic gluthatione); dehydration. Alcoholic liver disease. May alter the levels of serum glucose & serum uric acid. Monitor liver function & peripheral blood cell count in case of prolonged treatment. Pregnancy & lactation.
Adverse Reactions
Malaise, arterial hypotension, increase in hepatic transaminase level.
Drug Interactions
Reduced clearance w/ probenecid. Prolonged elimination t½ w/ salicylates. May enhance severe toxicity w/ liver microsomal oxidation inducing agents (eg, phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, TCAs).
MIMS Class
Analgesics (Non-Opioid) & Antipyretics
ATC Classification
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Infulgan soln for infusion 10 mg/mL
(glass) 100 mL x 1's;20 mL x 1's
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