Paracetamol IV (Orthopaedic — Opioid-Sparing)

SCOPE: this is the whole of the adult regimen in the SPC for the intravenous product, which is this page's primary route. The SPC doses paracetamol infusion by BODY WEIGHT and risk factors only - it contains no orthopaedic-specific, opioid-sparing or multimodal-analgesia regimen, so no indication-specific dose is published. Posology table, verbatim: '> 50 kg with additional risk factors for hepatotoxicity 1 g 100 ml 100 ml 3 g'; '> 50 kg and no additional risk factors for hepatotoxicity 1 g 100 ml 100 ml 4 g'; '> 33 kg to <= 50 kg 15 mg/kg 1.5 ml/kg 75 ml 60 mg/kg not exceeding 3 g'. 'The dose to be administered and the bottle size to be used depend exclusively on the patient`s weight. The volume to be administered must not exceed the determined dose.' The 100 ml bottle 'is restricted to adults, adolescents and children weighing more than 33 kg'. RISK OF MEDICATION ERRORS (§4.4): 'Take care to avoid dosing errors due to confusion between milligram (mg) and milliliter (ml), which could result in accidental overdose and death'; 'When writing prescriptions, include both the total dose in mg and the total dose in volume.' The solution may be diluted 'up to one tenth (one volume Paracetamol into nine volumes diluent)'; if diluted, 'use the diluted solution within the hour following its preparation (infusion time included)'. Single use only; inspect visually and use 'only if solution is clear, colourless or slightly pinkish-orangish'.

NOT A SINGLE PER-KG PER-DOSE FIGURE - dosePerKg is deliberately null because the SPC dose per administration changes across the weight bands (7.5 mg/kg at or below 10 kg, 15 mg/kg above 10 kg); do not calculate a weight-based dose from one number. §4.2 weight table, verbatim: '10 ml ampoule ... <= 10 kg* 7.5 mg/kg 0.75 ml/kg [maximum volume] 7.5 ml [maximum daily dose] 30 mg/kg'; '50 ml bottle ... > 10 kg to <= 33 kg 15 mg/kg 1.5 ml/kg 49.5 ml 60 mg/kg not exceeding 2 g'; '100 ml bottle ... > 33 kg to <= 50 kg 15 mg/kg 1.5 ml/kg 75 ml 60 mg/kg not exceeding 3 g'. Presentation is fixed by weight: 'The 10 ml ampoule is restricted to term newborn infants, infants and toddlers weighing up to 10 kg. The 50 ml bottle is restricted to toddlers and children weighing more than 10 kg and up to 33 kg. The 100 ml bottle is restricted to adults, adolescents and children weighing more than 33 kg.' '*Preterm newborn infants: No safety and efficacy data are available for premature newborn infants.' Patients weighing 10 kg or less: 'The volume to be administered should be withdrawn from the ampoule and diluted in a sodium chloride 9 mg/ml (0.9%) solution or glucose 50 mg/ml (5%) solution or a combination of both solutions up to one tenth (one volume Paracetamol into nine volumes diluent) and administered over 15 minutes'; 'A 5 or 10 ml syringe should be used ... However, this should never exceed 7.5 ml per dose'. 'The volume to be administered must not exceed the determined dose.' RISK OF MEDICATION ERRORS: 'Take care when prescribing and administering Paracetamol to avoid dosing errors due to confusion between milligram (mg) and millilitre (ml), which could result in accidental overdose and death ... When writing prescriptions, include both the total dose in mg and the total dose in volume.' Concentration is 10 mg/ml, stated verbatim in the product name and dosing table. Verify the paediatric dose against a children's formulary.