Full Prescribing Info
Antipyretic, analgesic.
Pharmacology: Paracetamol produces analgesia by raising the threshold of the pain center in the brain and by obstructing impulses at the pain-mediating chemoreceptors. The drug produces antipyresis by an action on the hypothalamus; heat dissipation is increased as a result of vasodilation and increased peripheral blood flow.
Pharmacokinetics: Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Following oral administration, peak plasma levels are attained in 10 min to 1 hr and the t½ is 75 min to 3 hrs.
Distribution of paracetamol to most body tissues and fluids is both rapid and uniform.
Paracetamol is excreted in the urine primarily as the glucuronide and smaller amounts as the sulfate, mercapturate and unchanged drug. Approximately 85% of a dose of paracetamol is excreted in the urine within 24 hrs after administration.
Pyrexia of unknown origin and for symptomatic relief of fever and pain associated with common childhood disorders, tonsillitis, upper respiratory tract infections, post-immunization reactions, after tonsillectomy and other conditions where patient is unable to take oral medications but where paracetamol can be administered with advantage. For prevention of febrile convulsion.
Headache, cold, sinusitis, muscle pain, arthritis and toothache.
Dosage/Direction for Use
Adults and Children ≥10 years: 2-3 mL. Children up to 10 years: 1-2 mL. Infants: ½-1 mL. Depending on severity of case, dose may be repeated 4-hourly till temperature returns to normal. In severe cases, dose may be administered IV very slowly.
Symptoms: Nausea, vomiting, abdominal pain, diaphoresis, generalized weakness and lethargy. If an overdosage of paracetamol is suspected, blood should be withdrawn immediately for paracetamol plasma assay, without regard to the presence or absence of symptomatology.
Treatment: The acute hepatotoxicity and nephrotoxicity of paracetamol can be overcome by the administration of sulfhydryl donors eg, N-acetylcysteine which should be given as soon as possible after ingestion. Treatment after 12 hrs is not effective.
Paracetamol overdosage should be treated with gastric lavage if the patient is seen within 4 hrs of ingestion of Aeknil.
Special Precautions
Paracetamol should be given with care to patients with impaired hepatic or renal function.
Adverse Reactions
Paracetamol has rarely been found to produce any adverse effects in therapeutic doses and is usually well tolerated by aspirin-sensitive patients. Toxicity may result from a single toxic dose of the drug or from chronic ingestion.
The following adverse reactions have been reported: Skin eruption, hematological toxicity eg, thrombocytopenia and leukopenia, methemoglobinemia which can result in cyanosis, and on long-term use, renal damage can result.
Drug Interactions
Paracetamol may enhance the activity of coumarin anticoagulants, but the effect is not generally of clinical significance.
ATC Classification
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Inj 150 mg/mL (amp) x 2 mL x 10's, 100's.
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