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

Interactions
PK
Renal impairment
References

Pethidine

Generic name
Pethidine
Brand name
ATC Code
N02AB02

Pharmacokinetics in children

After a single intravenous administration of 1 mg/kg, Pokela et al. 1992 and Hamunen et al. 1993 found the following pharmacokinetic parameters:

Age n= t½ (hour) Cl (ml/min/kg) Vd (l/kg) Reference
6 hours -5 months
(including 5 preterme neonates)		 21 3,3-31,7 4,1-34,9 3,3-11,0 Pokela et al. 1992
4-6 years 20 3,0 10,4 2,8 Hamunen et al. 1993

In addition, Jacobsen et al. 1988 found after single intravenous administration of 1 mg/kg to 10 children 7-13 years of age a mean Cmax of 2800 nmol/L reached after an average of 5 minutes (tmax). Based on the concentration time curves, a t½ of 3-4 hours was estimated.

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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

No information is present at this moment.

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Dosages

Severe pain
  • Intravenous
    • Term neonate
      • Occasionally: 1 mg/kg/dose, once only.
  • Oral
    • 1 year up to 18 years
      • 0.6 - 1.2 mg/kg/dose, once only.
      • Duration of treatment:

        For the treatment of acute pain a single dose is often sufficient.

      • 1 drop of Dolantin contains about 2.5 mg pethidine hydrochloride
Post-operative shivering
  • Intravenous
    • 1 month up to 18 years
      • 0.125 - 0.25 mg/kg/dose, once only. May be repeated once if needed..

      • Should only be applied under cardiorespiratory monitoring in the Post Anesthesia Care Unit (PACU).

    • 1 month up to 18 years
      • 0.125 - 0.25 mg/kg/dose, once only. May be repeated once if needed..

      • Should only be applied under cardiorespiratory monitoring in the Post Anesthesia Care Unit (PACU).

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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

Risk of respiratory depression, vasodilatation and hypotension

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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

Do not give for prolonged periods because of the accumulation of a metabolite that causes central stimulation.

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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
N02AA05
N02AA59
Phenylpiperidine derivatives
N02AB03
N02AB03
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. Rademaker C.M.A. et al, Geneesmiddelen-formularium voor Kinderen, 2007
  2. Teva BV, SmPC Pethidine (RVG 03561) 29 oktober 2020, www.geneesmiddeleninformatiebank.nl
  3. Sanofi-Aventis, SmPC Dolantin® Tropfen 50 mg/ml; Tropfen zum Einnehmen (6820849.00.00), 02/2019
  4. Hamunen, K., et al, Pharmacokinetics of i.v. and rectal pethidine in children undergoing ophthalmic surgery, Br J Anaesth, 1993, 71 (6), 823-6
  5. Jacobsen, J., et al, Comparative plasma concentration profiles after i.v., i.m. and rectal administration of pethidine in children, Br J Anaesth, 1988, 60 (6), 623-6
  6. Kranke, P., et al, Postoperative shivering in children: a review on pharmacologic prevention and treatment, Paediatr Drugs, 2003, 5 (6, 373-83
  7. Pokela, M. L., et al, Pharmacokinetics and pharmacodynamics of intravenous meperidine in neonates and infants, Clin Pharmacol Ther, 1992, 52 (4, 342-9

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Changes

Changes