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

Interactions
PK
Renal impairment
References

Paracetamol + tramadol

Generic name
Paracetamol + tramadol
Brand name
ATC Code
N02AJ13

Pharmacokinetics in children

No information is present at this moment.

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

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Available formulations

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Dosages

Moderate to severe pain
  • Oral
    • ≥ 12 years
      • Initial dose: 75 mg tramadolhydrochloride/650 mg paracetamol per dose (= 2 tablets), follow-up doses guided by pain, choosing the lowest effective dose possible. Repeat as needed every 6 hours, max. 300 mg tramadol/2600 mg paracetamol per day (= 8 tablets)

      • Directions for administration:

        Take the tablets whole with sufficient liquid; do not break or chew them. Dissolve the effervescent tablets in water and then drink the solution.

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Renal impaiment in children > 3 months

The excretion of tramadol is slowed in patients with kidney and/or liver function disorders. Extending the dosing interval should be considered carefully for these patients, according to their needs. Do not use if the creatinine clearance is < 10 ml/min)

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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

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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

Children have a higher risk of respiratory depression when using tramadol for all interventions / conditions where the airway could be obstructed in any way (FDA safety announcement 20-4-2017, Anderson et al 2017).

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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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References

  1. Grunenthal BV, SmPC Zaldiar (RVG 28113) 02-03-2017, www.geneesmiddeleninformatiebank.nl
  2. FDA., FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women,, https://www.fda.gov, 2017
  3. Anderson BJ et al., Tramadol: keep calm and carry on., Paediatr Anaesth, 2017, Aug;27(8), 785-788
  4. Grunenthal BV, SmPC Zaldiar (RVG 28113) 12-12-2024, www.geneesmiddeleninformatiebank.nl

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Changes

Changes