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Paracetamol solution for infusion 1gm/100ml
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory
Water for Injection USP
Paracetamol solution for infusion is a clear and slightly yellowish solution. It contains 10mg/mL of paracetamol. Paracetamol is a white crystalline solid or powder chemically described as 4 - acetamidophenol.
The precise mechanism of the analgesic and antipyretic properties of paracetamol has yet to be established; it may involve central and peripheral actions.
Paracetamol 10 mg/mL, solution for infusion provides onset of pain relief within 5 to 10 minutes after the start of administration. The peak analgesic effect is obtained in 1 hour and the duration of this effect is usually 4 to 6 hours. Paracetamol 10 mg/mL, solution for infusion reduces fever within 30 minutes after the start of administration with a duration of the antipyretic effect of at least 6 hours.
Absorption: Paracetamol pharmacokinetics are linear after a single administration of up to 2 g and after repeated administration during 24 hours.
The volume of distribution of paracetamol is approximately 1 L/kg.
Paracetamol is not extensively bound to plasma proteins.
Following infusion of 2g proparacetamol, (equivalent to 1g of paracetamol) significant concentrations of paracetamol (about 1.5 Ã‚Âµg/mL) were observed in the cerebrospinal fluid 20 minutes after infusion.
Paracetamol is metabolised mainly in the liver following two major hepatic pathways: glucuronic acid conjugation and sulphuric acid conjugation. The latter route is rapidly saturable at doses that exceed the therapeutic doses. A small fraction (less than 4%) is metabolised by cytochrome P450 to a reactive intermediate (N-acetyl benzoquinone imine) which, under normal conditions of use, is rapidly detoxified by reduced glutathione and eliminated in the urine after conjugation with cysteine and mercapturic acid. However, during massive poisoning, the quantity of this toxic metabolite is increased.