FORMULATION:

Each mL contains Paracetamol........................................................................................................10 mg

PHARMACOLOGY:

Paracetamol produces analgesia by raising the threshold of the pain center in the brain and by obstructing impulses at the pain mediatingchemoreceptors. The drug produces antipyresis by an action oh the hypothalamus; heat dissipation is increased as a result of vasodilation andincreased peripheral blood flow.

PHARMACOKINETICS:

Distribution of Paracetamol to most body tissues and fluids is both rapid and uniform. Paracetamol is excreted in the urine primarily as the glucoronideand smaller amounts as the sulphate, mercapturate and unchanged in the urine within 24 hours after administration.

INDICATION:

Paracetamol, a para-aminophenol derivative, has analgesic and antipyretic properties and weak anti-inflamatory activity. It may be given byintravenous infusion for the short-term treatment of moderate pain, particularly following surgery, and fever. Parcetamol is often the analgesic orantipyretic of choice, especially in the elderly and in patients in whom salisylates or other NSAIDs are contraindicated. Such patients includeashmatics,l those with a history of peptic ulcer, and children.

DOSAGE AND ADMINISTRATION:

Paracetamol is given by intravenous infusion to adults and children over 10 kg in weight as follow:

· patients weighing over 50 kg, single doses of 1 g every 4 or more hours, to a maximum of 4 g daily

· from 33 to 50 kg, single doses of 15mg/kg every 4 or more hours, to a maximum of 60 mg/kg or 3 g daily (whichever is less)

· between 10 and 33 kg, single dose of 15 mg/kg or 2 g daily (whichever is less)

The paracetamol solution is administered as a 15-minute intravenous infusion.

CONTRAINDICATIONS:

Nephrotoxicity.

ADVERSE REACTIONS:

Paracetamol has rarely been found to produce any side effects in therapeutic doses and is usually well tolerated by aspirin sensitive patients. Toxicitymay result from a single toxic dose of the drug or from chronic ingestion. The following adverse reactions have been reported; skin eruption,haematological toxicity eg. thrombocytopenia and leucopenia, methaemoglobinaemia which can result in cyanosis, and on long-term use, renaldamage can result.

PRECAUTION:

Paracetamol should be given with care to patients with impaired kidney or liver function. Not to be given to neonates.

INTERACTIONS:

Paracetamol may enhance the activity of coumarin anticoagulants, but the effect is hot generally of clinical significance.

OVERDOSAGE/SYMPTOMS:

Symptoms of overdosage may include 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 symptomology.

TREATMENT:

The acute hepatotoxicity and nephrotoxicity of Paracetamol can be overcome by th'e administration of sulphydryl donors eg. N-acetylcysteine which should be given as soon as possible after congestion. Treatment after 12 hours is not effective. Paracetamol overdosage should be treated with gastriclavage if the patient is seen within 24 hours of ingestion of the drug.

STORAGE CONDITION:

Store at temperatures not exceeding 30°C.

CAUTION:

FOODS, DRUGS, DEVICES AND COSMETICS ACT, prohibits dispensing without prescription.

AVAILABILITY: USP Type I Clear Glass Bottle x 100 mL (Box of 1’s)