Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Oxycodone

Generic name
Oxycodone
Brand name
ATC Code
N02AA05

Pharmacokinetics in children

The following pharmacokinetic parameters (ranges (median)) were found after single intravenous administration of 0,1 mg/kg:

Age n= t½ (min) Cl (ml/min/kg) Vd (ml/kg) References
< 1 week (GA 33-36 weeks) 4 432-846 2,3-5,7 2400-3800 Pokela 2005
< 1 week (GA 37-40 weeks)  6 144-306 9,5-17,2 1900-4700 Pokela 2005
1 week to 2 month 6 96-696 (216) 3,7-40,4 (20,1) 1300-8500 (5600) Pokela 2005
2 to 6 months 6 48-234(120) 14,8-80,2 (15,4) 1800-6000 (3200) Pokela 2005
6 months to 9,8 years 39 73-208 8,5-21,2 1200-4100 Olkkola 1994,
Kokki 2004, Kokki 2017

Kokki 2004 additionally describes large interindividual variation; a Cmax of 1,7 to 14,5 ng/ml (mean±SD 9,2±4,9 ng/ml) was achieved after 60 to 360 minutes (mean±SD 193±137 minutes) in 9 children aged 6 months to 7 years after a single administration of 0,1 mg/kg via orogastric tube.

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

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Dosages

Severe pain
  • Oral
    • Extended release tablet
      • 6 years up to 12 years
        • (Oxycontin (Oxycodon hydrochloride)) 0.6 - 1.2 mg/kg/day in 2 doses.

        • Increase based on pain and the occurrence of tolerance. There is no maximum in malignant pain when dosing is done on the basis of pain. The dose can be increased by 50-100% per 24 hours.

          When switching from controlled-release oral morphine to controlled-release oxycodone, a guideline for the required dose is: 10 mg oxycodone is equivalent to approximately 20 mg morphine.

          Because of individual differences in sensitivity to different opioids, it is recommended to start with 1/2 -2/3 of this calculated dose

      • 6 years up to 12 years
        [5] [6] [11]
        • (Oxycontin (Oxycodon hydrochloride)) 0.6 - 1.2 mg/kg/day in 2 doses.

        • Increase based on pain and the occurrence of tolerance. There is no maximum in malignant pain when dosing is done on the basis of pain. The dose can be increased by 50-100% per 24 hours.

          When switching from controlled-release oral morphine to controlled-release oxycodone, a guideline for the required dose is: 10 mg oxycodone is equivalent to approximately 20 mg morphine.

          Because of individual differences in sensitivity to different opioids, it is recommended to start with 1/2 -2/3 of this calculated dose

    • Normal preparation (immediate release)
      • 12 years up to 18 years
        • (Oxynorm (Oxycodon hydrochloride)) 20 - 30 mg/day in 4 - 6 doses.

        • Increase based on pain and the occurrence of tolerance. There is no maximum in malignant pain when dosing is done on the basis of pain. The dose can be increased by 50-100% per 24 hours.

  • Intravenous
    • Extended release tablet
      • 12 years up to 18 years
        • Oxycodonhydrochloride: 1 - 10 mg/dose, bolus in 1-2 minutes. Repeat every 4 hours if indicated.

        • ALTERNATIVE:
          Continuous infusion: 2 mg/hour
          PCA: 0,03 mg/kg/dose with a lock-out interval of 5 minutes.

  • Subcutaneous
    • Extended release tablet
      • 12 years up to 18 years
        • Oxycodonhydrochloride: 5 mg/dose, bolus. Repeat every 4 hours if indicated..

        • ALTERNATIVE:
          Infusion in opioid-naive patients: 7,5 mg/day, titrate stepwise until sufficient pain relief is achieved.

      • 12 years up to 18 years
        • Oxycodonhydrochloride: 5 mg/dose, bolus. Repeat every 4 hours if indicated..

        • ALTERNATIVE:
          Infusion in opioid-naive patients: 7,5 mg/day, titrate stepwise until sufficient pain relief is achieved.

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The frequency, type and severity of adverse events in patients under 12 years of age are not expected to differ from those in adults and adolescents over 12 years of age.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In obese children, based on limited data, dosing based on adjusted body weight (ABW) is recommended (Ross et al. 2015). This can be calculated as follows:

ABW = ideal body weight + 0.25 x (total body weight-ideal body weight)

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Natural opium alkaloids
N02AA03
N02AA01
N02AA59
Phenylpiperidine derivatives
N02AB03
N02AB03
N02AB02
Diphenylpropylamine derivatives
N02AC06
N02AC03
Oripavine derivatives
N02AE01
Morphinan derivatives
N02AF02
Other opioids
N02AX06
N02AX01
N02AX02
Opioids in combination with non-opioid analgesics
N02AJ13

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References

  1. CBO, Richtlijn postoperatieve pijn, www.diliguide.nl, 2012, http://www.diliguide.nl/document/2995/postoperatieve-pijnstilling.html
  2. Mundipharma Pharmaceuticals BV, SPC Oxynorm (RVG 27509 / 27939) 26-04-2019, www.geneesmiddeleninformatiebank.nl
  3. Mundipharma Pharmaceuticals BV, SmPC Oxycontin (RVG 22107) 06-02-2020, www.geneesmiddeleninformatiebank.nl
  4. Kokki, M., et al., Maturation of oxycodone pharmacokinetics in neonates and infants: Oxycodone and its metabolites in plasma and urine., Br J Clin Pharmacol, 2017, 83 (4), 791-800
  5. Sharar, S. R., et al., A comparison of oral transmucosal fentanyl citrate and oral oxycodone for pediatric outpatient wound care, J Burn Care Rehabil, 2002, 23 (1), 27-31
  6. Koller, D. M., et al., Effectiveness of oxycodone, ibuprofen, or the combination in the initial management of orthopedic injury-related pain in children, Pediatr Emerg Care, 2007, 23 (9, 627-33
  7. Kokki, H., et al., Pharmacokinetics of oxycodone after intravenous, buccal, intramuscular and gastric administration in children, Clin Pharmacokinet, 2004, 43 (9), 613-22
  8. Olkkola, K. T., et al., Pharmacokinetics and ventilatory effects of intravenous oxycodone in postoperative children, Br J Clin Pharmacol, 1994, 38 (1), 71-6
  9. Ross, E. L., et al., Development of recommendations for dosing of commonly prescribed medications in critically ill obese children., Am J Health Syst Pharm, 2015, 72 (7), 542-56
  10. Pokela, M. L., et al., Marked variation in oxycodone pharmacokinetics in infants., Paediatr Anaesth, 2005, 15 (7), 560-5
  11. Charney, R. L., et al., Oxycodone versus codeine for triage pain in children with suspected forearm fracture: a randomized controlled trial, Pediatr Emerg Care, 2008, 24 (9), 595-600
  12. Mundipharma, SmPC Oxygesic® injekt 10 mg/ml Injektionslösung/Konzentrat zur Herstellung einer Injektions-/Infusionslösung (57886.00.00), 02/2022

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Changes

Changes