Hydromorfon

Generic name
Hydromorfon
Brand name
ATC Code
N02AA03
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Hydromorfon

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The following pharmacokinetic parameters were observed:

Age n Dose Cmax (ng/ml) tmax (hour) Cl (ml/min/kg) Reference
7 years 1 4 mg/day in 2 doses controlled release 1,07 6 - Babul 1995
7 years 1 10 mg/day in 2 doses
controlled release		 1,48 4 - Babul 1995
Mean 15.3 years 5 1,4 microg/kg/hour continuous IV infusion - - 28,6-98,2 (mean 51,7) Collins 1996

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Severe pain
  • Oral
    • Normal preparation (immediate release)
      • ≥ 1 month and ≥ 10 kg
        • Initial dose: 30 - 80 microg./kg/dose every 3-4 hours. Max: 2.6 mg/dose.
          • Adjust the dose based on effect
          • Intravenous formulation can be administerred orally [back-end comment only: check country specific specifications !]
          • The immediate release formulation may be converted to a extended release formulation. In this case the total daily dose should be divided in 2 administrations. 
  • Subcutaneous
    • ≥ 1 month and < 10 kg
      • Initial dose: 3 - 5 microg./kg/dose every 3-4 hours.
        • Adjust the dose based on effect
        • Alternatively: continuous infusion: 1-2 mcg/kg/hour
    • ≥ 1 month and 10 up to 50 kg
      • Initial dose: 10 - 15 microg./kg/dose every 3-4 hours.
        • Adjust the dose based on effect
        • Alternatively: continuous infusion: 3-5 mcg/kg/hour
    • ≥ 1 month and ≥ 50 kg
      • Initial dose: 1 - 1.5 mg/dose every 3-4 hours.
        • Adjust the dose based on effect
        • Alternatively: continuous infusion: 3-5 mcg/kg/hour, max 450 microg/hour.
  • Intravenous
    • Normal preparation (immediate release)
      • ≥ 1 month and < 10 kg
        • Initial dose: 3 - 5 microg./kg/dose every 3-4 hours.
          • Adjust the dose based on effect
          • Slow administration in at least 2-3 minutes
          • Alternatively: continuous infusion: 1-2 mcg/kg/hour
      • ≥ 1 month and < 10 kg
        • Initial dose: 3 - 5 microg./kg/dose every 3-4 hours.
          • Adjust the dose based on effect
          • Slow administration in at least 2-3 minutes
          • Alternatively: continuous infusion: 1-2 mcg/kg/hour
    • ≥ 1 month and 10 up to 50 kg
      • Initial dose: 10 - 15 microg./kg/dose every 3-4 hours.
        • Adjust the dose based on effect
        • Slow administration in at least 2-3 minutes
        • Alternatively: continuous infusion: 3-5 mcg/kg/hour
        • Alternatively: PCA pump bolus 3-4 microg/kg/dose, lockoutinterval 5-10 minutes.If needed combine with continuous background infusion start 3-5 microgram/kg/hour.
    • ≥ 1 month and ≥ 50 kg
      • Initial dose: 1 - 1.5 mg/dose every 3-4 hours.
        • Adjust the dose based on effect
        • Slow administration in at least 2-3 minutes
        • Alternatively: continuous infusion: 3-5 mcg/kg/hour, max. 450 microg/hour
        • Alternatively: PCA pump bolus 200 microg/dose, lockout interval 5-10 minutes.If needed combine with continuous background infusion: start 3-5 microgram/kg/hour.

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.

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

Side effects

No information is present at this moment.

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

Hydromorphon is a strong opoid and has a great variability in dosing between oral and intravenous administration. Caution is needed when switching from one route to the other. The bio-equivalent oral dose can be up to 3-5 times the intravenous dose. (NVK 2013, SmPC)

Interactions

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

OPIOIDS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Natural opium alkaloids
N02AA01
N02AA05
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

References

  1. Dunbar, P. J., et al., Use of patient-controlled analgesia for pain control for children receiving bone marrow transplant, J Pain Symptom Manage, 1995, 10(8), 604-11
  2. Zernikow, B., et al, Pediatric palliative care: use of opioids for the management of pain, Paediatr Drugs, 2009, 11(2), 129-51
  3. Mundipharma Pharmaceuticals B.V., ,, SmPC Palladon (RVG 26549, 26550, 22162, 22163, 22164, 22165, 104836, 104838) 06-04-2018, www.geneesmiddeleninformatiebank.nl
  4. Babul, N., et al, Hydromorphone and metabolite pharmacokinetics in children, J Pain Symptom Manage, 1995, 10(5), 335-7
  5. Collins, J. J., et al, Patient-controlled analgesia for mucositis pain in children: a three-period crossover study comparing morphine and hydromorphone., J Pediatr, 1996, 129(5), 722-8
  6. Friedrichsdorf, S. J., et al, The management of pain in children with life-limiting illnesses., Pediatr Clin North Am, 2007, 54(5), 645-72
  7. Karl, H. W., et al, Controlled trial of morphine vs hydromorphone for patient-controlled analgesia in children with postoperative pain, Pain Med, 2012, 13(12), 1658-9
  8. Nederlandse Vereniging voor Kindergeneeskunde , Richtlijn Palliatieve zorg voor kinderen. Versie 1, 2013
  9. Nederlandse Vereniging voor Kindergeneeskunde, Richtlijn Palliatieve zorg voor kinderen. Versie 1, 2013

Changes

Therapeutic Drug Monitoring


Overdose