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

Interactions
PK
Renal impairment
References

Ropivacaine

Generic name
Ropivacaine
Brand name
ATC Code
N01BB09

Pharmacokinetics in children

 

Age group V
(l/hour/kg)
 		 CL
(l/hour/kg)
t½
(hours)
Neonate 21.86 0.096 6.3
1 month 25.94 0.143 5.0
6 months 41.71 0.320 3.6
1 year 52.60 0.451 3.2
4 years 65.24 0.633 2.8

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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

Pain relief: epidural (caudal)
  • Epidural
    • 12 years up to 18 years
      • Initial dose: 20 - 40 mg/dose, bolus.
      • Maintenance dose: 12 - 28 mg/hour, continuous infusion.  .

      • Alternative: Single injections, intermittent (lumbar): 20-30 mg/dose
Epidural anaesthesia
  • Caudal, lumbal, thoracal
    • Term neonate
      • Initial dose: Max. 2 mg/kg/dose, once only.
      • Maintenance dose: 0.2 mg/kg/hour, continuous infusion.  .
    • 1 year up to 18 years
      [1] [2]
      • Initial dose: Max. 2.5 mg/kg/dose, once only. Max: 40 mg/dose.
      • Maintenance dose: 0.4 mg/kg/hour, continuous infusion.  .
    • 1 month up to 3 months
      • Initial dose: Max. 2.5 mg/kg/dose, once only.
      • Maintenance dose: 0.2 mg/kg/hour, continuous infusion.  .
    • 3 months up to 1 year
      • Initial dose: Max. 2.5 mg/kg/dose, once only.
      • Maintenance dose: 0.3 mg/kg/hour, continuous infusion.  .
    • 1 year up to 18 years
      • Initial dose: Max. 2.5 mg/kg/dose, once only. Max: 40 mg/dose.
      • Maintenance dose: 0.4 mg/kg/hour, continuous infusion.  .
    • 1 year up to 18 years
      • Initial dose: Max. 2.5 mg/kg/dose, once only. Max: 40 mg/dose.
      • Maintenance dose: 0.4 mg/kg/hour, continuous infusion.  .
(Peripheral) nerve block
  • Perineural
    • 1 month up to 3 months
      • Max.  2.5 mg/kg/dose Repeat if needed.

      • Alternative: 0,2 mg/kg/uur, continuous infusion.

    • 3 months up to 1 year
      • Max.  2.5 mg/kg/dose Repeat if needed.

      • Alternative: 0,4 mg/kg/uur, continuous infusion 

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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

It may be assumed that the frequency, type and severity of side effects in children are the same as in adults, with the exceptions of hypotension, which occurs less frequently in children (< 1 in 10) and vomiting, which occurs more frequently in children (> 1 in 10).
It is difficult to detect early symptoms of local anaesthetic toxicity in children as they are unable to express this verbally.

(SmPC Naropin)

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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

Regular toxicity monitoring is needed until after stopping an epidural infusion in neonates because elimination is slow and their metabolism is not mature enough. There is no documentation about use in premature children.

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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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Amides
N01BB08
N01BB01
N01BB10
N01BB02
N01BB52
N01BB20
N01BB52
N01BB03
N01BB04
Esters of benzoic acid
N01BC01
ESTERS OF BENZOIC ACID
N01BC01

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References

  1. Aspen Pharma Trading Limited, SmPC Naropin 0,2% (RVG 18437) 07-09-2023, www.geneesmiddeleninformatiebank.nl
  2. Editorial board, Extrapolation of (levo)bupivacaine data to ropivacain, Dec 18, 2023

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Changes

Changes