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

Interactions
PK
Renal impairment
References

Levobupivacaine

Generic name
Levobupivacaine
Brand name
ATC Code
N01BB10

Pharmacokinetics in children

The pharmacokinetic properties of levobupivacaine are similar to that of bupivacaine; both extensively metabolized in the liver, and excreted in the urine and faeces [SmPC Levobupicavaine RVG 115877]

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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

Spinal anesthesia
  • Intrathecal
    • 5 up to 10 kg
      • 1 mg/kg/dose, once only.
    • 10 up to 15 kg
      • 0.8 mg/kg/dose, once only.
    • 15 up to 20 kg
      • 0.6 mg/kg/dose, once only.
    • 20 up to 35 kg
      • 0.4 mg/kg/dose, once only.
    • ≥ 35 kg
      • 0.3 mg/kg/dose, once only.
Epidural anaesthesia
  • Caudal, lumbal, thoracal
    • 1 month up to 3 months
      • Initial dose: Max. 2.5 mg/kg/dose, once only.
      • Maintenance dose: Max. 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: Max. 0.3 mg/kg/hour, continuous infusion.
    • 1 year up to 18 years
      • Initial dose: Max. 2.5 mg/kg/dose, once only.
      • Maintenance dose: Max. 0.4 mg/kg/hour, continuous infusion.
(Peripheral) nerve block
  • Perineural
    • 1 month up to 18 years
      • Max  2.5 mg/kg/dose Repeat if needed..
Local anesthesia, field block
  • Infiltration
    • 1 month up to 18 years
      • Max  2.5 mg/kg/dose Repeat if needed..

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Renal impaiment in children > 3 months

No data are available regarding patients with renal insufficiency. Levobupivacaine is extensively metabolized and unchanged levobupivacaine is not excreted in the urine [SmPC Bupivacaine RVG 115877].

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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

Levobupivacaine can cause the same side effects as racemic bupivacaine and other local anesthetics. However, it may result in lower cardiac toxicity, neurological injury after peripheral nerve blockade, and adverse CNS effects compared to bupivacaine [Verma 2014, Gupta 2014, Patel 2006].

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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

Monitoring using a saturation meter, respiration ECG monitor, and blood pressure measurement, as well as a bladder catheter for micturition disorders.
To avoid excessive dosage in obese patients, dose should be calculated on the basis of ideal body-weight. 

 

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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
N01BB02
N01BB52
N01BB20
N01BB52
N01BB03
N01BB04
N01BB09
Esters of benzoic acid
N01BC01
ESTERS OF BENZOIC ACID
N01BC01

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References

  1. AbbVie BV, SmPC Chirocaine (RVG 24617) 19 nov 2014, www.cbg-meb.nl
  2. Wiegele, M.,et al., Caudal epidural blocks in paediatric patients: a review and practical considerations, British journal of anaesthesia, 2019, 122(4), 509–517
  3. Luz, G.,et al, Bupivacaine plasma concentrations during continuous epidural anesthesia in infants and children., Anesthesia and analgesia, 1996, 82(2), 231–234
  4. Verma, D.,et al., Spinal anesthesia in infants and children: A one year prospective audit, Anesthesia, essays and researches, 2014, 8(3), 324–329
  5. Rochette, A. et al., Cerebrospinal fluid volume in neonates undergoing spinal anaesthesia: a descriptive magnetic resonance imaging study, BJA, 2016, 117(2), 214–219
  6. L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., SmPC Levobupivacaine 2.5/5.0 mg/ml oplossing voor injectie. (RVG 115877/115878) 16-07-2020, www.geneesmiddeleninformatiebank.nl
  7. López, T., et al., Spinal anesthesia in pediatric patient, Minerva anestesiologica, 2012, 78(1), 78–87
  8. Patel, D., Epidural analgesia for children, Continuing Education in Anaesthesia Critical Care & Pain, 2006, 6(2), 63–66
  9. Jöhr M., Regional anaesthesia in neonates, infants and children: an educational review., European journal of anaesthesiology, 2015, 32(5), 289–297
  10. Suresh, S., et al.., The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia., Regional anesthesia and pain medicine, 2018, 43(2), 211–216
  11. Meunier, J. F., et al., Pharmacokinetics of bupivacaine after continuous epidural infusion in infants with and without biliary atresia., Anesthesiology, 2001, 95(1), 87–95
  12. Calder, A. et al, Pharmacokinetic profiles of epidural bupivacaine and ropivacaine following single-shot and continuous epidural use in young infants, Paediatric anaesthesia, 2012, 22(5), 430–437
  13. Luz, G.,et al, Free and total bupivacaine plasma concentrations after continuous epidural anaesthesia in infants and children, Paediatric anaesthesia, 1998, 8(6), 473–478
  14. Mazoit, J. X., et al., Pharmacokinetics of bupivacaine following caudal anesthesia in infants., Anesthesiology, 1988, 68(3), 387–391
  15. Ecoffey, C. et al, Bupivacaine in children: pharmacokinetics following caudal anesthesia., Anesthesiology, 1985, 63(4), 447–448
  16. Shah, R. D., et al, Applications of regional anaesthesia in paediatrics. , British journal of anaesthesia,, 2013, 111(1), i114–i124
  17. Gupta A, et al, Spinal anesthesia in children: A review., J Anaesthesiol Clin Pharmacol., 2014, 30(1), 10-8
  18. Patel D., Epidural analgesia for children., Continuing Education in Anaesthesia Critical Care & Pain, 2006, 6(2), 63-6
  19. Meunier, J. F., et al., Pharmacokinetics of bupivacaine after continuous epidural infusion in infants with and without biliary atresia., Anesthesiology, 2001, 95(1), 87–95
  20. Ecoffey, C. et al, Bupivacaine in children: pharmacokinetics following caudal anesthesia., Anesthesiology, 1985, 63(4), 447–448
  21. Shah, R. D., et al, Applications of regional anaesthesia in paediatrics., British journal of anaesthesia,, 2013, 111(1), i114–i124

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Changes

Changes