Paediatric dosage recommendations (1 month to 12 years) The dose should be based on 15 mg/kg, with the understanding that dosing with solid dose products for this age group is less flexible than with liquid products. The total daily dose should not exceed 60 mg/kg without medical advice. Doses should be given every four to six hours as required with not more than four doses in 24 hours. The medicine should not be administered for more than 48 hours without seeking medical advice. Administration to children under one month is not recommended. Statements to this effect must appear on labels of the primary pack and the immediate container. Age Average body weight (kg) Single dose (mg) 1 - 3 months 4 6 60 - 90 – 3 - 6 months 6 8 90 - 120 – 6 - 12 months 8 10 120 - 150 – 1 - 2 years 10 12 150 - 180 – 2 - 3 years 12 14 180 - 210 – 3 - 4 years 14 16 210 - 240 – Age Average body weight (kg) Single dose (mg) 4 - 5 years 16 18 240 - 270 – 5 - 6 years 18 20 270 - 300 – 6 - 7 years 20 22 300 - 330 – 7 - 8 years 22 25 330 - 375 – 8 - 9 years 25 28 375 - 420 – 9 - 10 28 32 420 - 480 – 10 - 11 years 32 36 480 - 540 – 11 - 12 years 36 41 540 - 615 – Doses must be expressed in whole numbers and should be presented with age, weight and mL unless otherwise justified. The recommended dose should be able to be measured commonly available metric measuring devices. There may be instances where the dose needs to be slightly different than the recommended milligram dose given above, having regard to the paracetamol concentration of the product. Sponsors intending to supply measuring devices with the product should consult Australian Standard AS 2224.2 - 1986. Calibrations on measuring devices should be in metric units and correspond with the doses shown on the label where possible to minimise the need for calculation and guesswork. Product Strength and pack size Sponsors may supply any or all of the following strengths of paracetamol liquid without the need for justification: 24 mg/mL, 48 mg/mL, 50 mg/mL and 100 mg/mL. Deviation from these strengths requires justification. not prohibited, the introduction of pack sizes larger than 200 mL will require justification.
Paediatric dosage recommendations (1 month to 12 years) The dose should be based on 15 mg/kg, with the understanding that dosing with solid dose products for this age group is less flexible than with liquid products. The total daily dose should not exceed 60 mg/kg without medical advice. Doses should be given every four to six hours as required with not more than four doses in 24 hours. The medicine should not be administered for more than 48 hours without seeking medical advice. Administration to children under one month is not recommended. Statements to this effect must appear on labels of the primary pack and the immediate container. Age Average body weight (kg) Single dose (mg) 1 - 3 months 4 – 6 60 - 90 3 - 6 months 6 – 8 90 - 120 6 - 12 months 8 – 10 120 - 150 1 - 2 years 10 – 12 150 - 180 2 - 3 years 12 – 14 180 - 210 3 - 4 years 14 – 16 210 - 240 Age Average body weight (kg) Single dose (mg) 4 - 5 years 16 – 18 240 - 270 5 - 6 years 18 – 20 270 - 300 6 - 7 years 20 – 22 300 - 330 7 - 8 years 22 – 25 330 - 375 8 - 9 years 25 – 28 375 - 420 9 - 10 28 – 32 420 - 480 10 - 11 years 32 – 36 480 - 540 11 - 12 years 36 – 41 540 - 615 Doses must be expressed in whole numbers and should be presented with age, weight and mL unless otherwise justified. The recommended dose should be able to be measured commonly available metric measuring devices. There may be instances where the dose needs to be slightly different than the recommended milligram dose given above, having regard to the paracetamol concentration of the product. Sponsors intending to supply measuring devices with the product should consult Australian Standard AS 2224.2 - 1986. Calibrations on measuring devices should be in metric units and correspond with the doses shown on the label where possible to minimise the need for calculation and guesswork. Product Strength and pack size Sponsors may supply any or all of the following strengths of paracetamol liquid without the need for justification: 24 mg/mL, 48 mg/mL, 50 mg/mL and 100 mg/mL. Deviation from these strengths requires justification. not prohibited, the introduction of pack sizes larger than 200 mL will require justification.
otc-argom-121011.docx