Paracetamol + tramadol

Generic name
Paracetamol + tramadol
Brand name
ATC Code
N02AJ13
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Paracetamol + tramadol

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information is present at this moment.

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

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.

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)

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

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).

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
N02AA03
N02AA01
N02AA05
N02AA59
Phenylpiperidine derivatives
N02AB03
N02AB03
N02AB02
Diphenylpropylamine derivatives
N02AC06
N02AC03
Oripavine derivatives
N02AE01
Morphinan derivatives
N02AF02
Other opioids
N02AX06
N02AX01
N02AX02

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

Changes

Therapeutic Drug Monitoring


Overdose