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

Interactions
PK
Renal impairment
References

Tapentadol

Generic name
Tapentadol
Brand name
ATC Code
N02AX06

Pharmacokinetics in children

Parameters based on the final tapentadol paediatric popPK model (SmPC)

Age Apparent Vd (L) Mean +/- SD Apparent clearance (L/h) Mean +/- SD
2 to 6 year 286 +/- 78 79 +/- 20
6 to 12 year 545 +/- 148 148 +/- 42
12 to 18 year 958 +/- 241 217 +/- 45

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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

Chronic moderate to severe pain
  • Oral
    • Depotpreparat (modifisert frisetting av virkestoff)
      • ≥ 6 years
        • Initial dose: 3 mg/kg/day in 2 doses. Max: 100 mg/day.
        • Maintenance dose: Titrate starting dose every 2 days to effect with 25 mg increments for children < 40 kg and 25-50 mg increments for children ≥ 40 kg to max 7 mg/kg/day in 2 doses. Max: 500 mg/day.

        • If discontinued, phase out gradually to avoid withdrawal symptoms.
Moderate to severe pain
  • Oral
    • Normal preparation (immediate release)
      • ≥ 2 years
        • 1.25 mg/kg/dose, as required, max. 6 times daily. Max: 7.5 mg/kg/day.

        • If discontinued, phase out gradually to avoid withdrawal symptoms

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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

Frequency, type and severity of adverse reactions in children and adolescents treated with
Palexia are expected to be the same as in adults treated with tapentadol (SmPC Palexia)

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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

Physicians should be vigilant for symptoms of withdrawal after repeated administration of tapentadol and its abrupt cessation.

In obese children, monitor treatment carefully due to lack of data. The maximum dose for children and adolescents with a high BMI (body mass index) must not exceed the calculated maximum dose for a body weight at the 97.5 percentile for the given age (SmPC Palexia oral solution)

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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
N02AB02
Diphenylpropylamine derivatives
N02AC06
N02AC03
Oripavine derivatives
N02AE01
Morphinan derivatives
N02AF02
Other opioids
N02AX01
N02AX02
Opioids in combination with non-opioid analgesics
N02AJ13

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References

  1. Grünenthal B.V., SmPC Palexia Retard (RVG 110724, 110728, 110729, 110730, 110731) 20-3-2024, www.geneesmiddelinformatiebank.nl
  2. Grünenthal B.V., SmPC Palexia drank ( RVG 120265 / 120266) 15-07-2024, www.geneesmiddelinformatiebank.nl

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Changes

Changes