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

Interactions
PK
Renal impairment
References

Lorazepam

Generic name
Lorazepam
Brand name
ATC Code
N05BA06

Pharmacokinetics in children

Age

Distribution (L/kg)

Half-life (h)

Elimination (mL/min/kg)

Reference

Term neonates

(Mean ± SD)

0.76 ± 0.37

40.2 ± 16.5 

0.232 ± 0.110 

McDermott

Adults

1.3 

12-16

 

1-1.2

After IV administration 

SmPC

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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

Acute anxiety (short use)
  • Oral
    • 6 years up to 18 years
      • 0.02 - 0.1 mg/kg/day in 2 - 3 doses.

      • Start with a low initial dose and slowly increase, depending on the clinical picture.
Premedication in dental or surgical procedures
  • Oral
    • 6 years up to 13 years
      • 0.5 - 1 mg/dose, once only. Max: 0.05 mg/kg/dose. 1 to 2 hours before the procedure.
    • 13 years up to 18 years
      • 1 - 4 mg/dose, once only. 1 to 2 hours before the procedure.
Iatrogenic benzodiazepine dependency, weaning after prolonged use of midazolam
  • Oral
    • Preterm and Term neonate
        • Initial dose lorazepam: daily dose of midazolam, divided by 12
          • Daily dose of lorazepam in 4 doses
        • The intravenous midazolam is tapered over 24 hours as lorazepam is introduced:
          • The midazolam dose is halved after the second administration of lorazepam (6 hours after lorazepam initiation)
          • The midazolam dose is again halved after the third administration of lorazepam (12 hours after lorazepam initiation)
          • Midazolam is stopped after the fourth administration of lorazepam
        • Tapering of lorazepam: in steps of 10% of the initial dose
          • Every 24 hours after 6-9 days of midazolam treatment
          • Every 48 hours after ≥ 10 days of midazolam treatment
        • If symptoms of iatrogenic withdrawal syndrome (IWS) occur:
          • Rescue dose of 0.1 mg/kg midazolam or
          • Increase lorazepam dose to the previous step
    • 1 month up to 18 years

      • Oral administration only while phasing out intravenous medication to prevent withdrawal symptoms after intravenous sedation. Oral therapy is started after which intravenous medication is phased out. Dose dependent on the intravenous dose used
Sedation
  • Oral
    • 1 month up to 18 years

      • Oral administration only while phasing out intravenous medication to prevent withdrawal symptoms after intravenous sedation. Oral therapy is started after which intravenous medication is phased out. Dose dependent on the intravenous dose used
Status epilepticus
  • Intravenous
    • 1 month up to 18 years
      • 0.1 mg/kg/dose, bolus max 2 mg/min. Max single dose: 4 mg/dose.

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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

Especially in children paradoxical reactions with acute excitement, confusion and change of mental status, disinhibition may occur. In term and preterm neonates with both normal and very low birth weight, epileptic seizures, myoclonus, hypotension and respiratory depression have been reported. Sedation, concentration/memory problems, tolerance/dependence with long-term use.

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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

The liquid for injection contains propylene glycol and benzyl alcohol. Premature infants, neonates with a low birthweight and children who are receiving high doses are susceptible to the effects of benzyl alcohol, propylene glycol and macrogol.
Adverse events have been observed at IV doses as low as 0.07 mg/kg in both term and preterm neonates. The precise relationship between dose and risk remains uncertain.

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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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Benzodiazepine derivatives
N05BA12
N05BA08
N05BA09
N05BA01
N05BA04
Diphenylmethane derivatives
N05BB01
Azaspirodecanedione derivatives
N05BE01

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Landelijk Kenniscentrum Kind-enJeugdpsychiatrie (Ketelaars), Anxiolytica/hypnotica, 2009
  3. Waardenburg van DA, et al., Richtlijn status epilepticus kinderen ouder dan één maand., Nederlandse Vereniging voor Kindergeneeskunde, Augustus 2005
  4. Prolepha Research B.V, SmPC Lorazepam Prolepha (RVG 119556 en 119557) 25-10-2018, www.geneesmiddelinformatiebank.nl
  5. neuraxpharm, SmPC, Lorazepam-neuraxpharm® (7791.00.00/7791.01.00), 11/2013
  6. ratiopharm, SmPC, Lorazepam-ratiopharm® Tabletten (7431.00.00/7431.01.00), 04/2018
  7. Pfizer, SmPC, Tavor® pro injectione 2 mg Injektionslösung (7379.00.00), 07/17
  8. Pfizer, SmPC, Tavor® 0,5 mg/ 1,0 mg/ Tabs 2 mg/ 2,5 mg Tabletten (6174941.00.00), 07/17
  9. Pfizer, SmPC, Tavor® 1,0/ 2,5 mg Expidet Plättchen (6948.00.00), 07/17
  10. Uptodate: UpToDate®, Pediatric Drug information: Lorazepam Lexicomp® Topic 9573 Version 298.0, accessed 12/18
  11. Nederlandse Vereniging voor Neurologie, Richtlijn Epilepsie > Status Epilepticus > Bij kinderen, https://epilepsie.neurologie.nl/cmssite/index.php?pageid=610&tabid=20110429141709, Geraadpleegd 11 juli 2019
  12. Van der Vossen, AC. et al, Oral lorazepam can be substituted for intravenous midazolam when weaning paediatric intensive care patients off sedation, Acta Paediatr, 2018, Mar 23;107(9), 1594-1600
  13. Pfizer, SmPC Temesta 2 mg Amp. (1-20346), 02/2019
  14. Ng, E., et al., Safety of benzodiazepines in newborns, Ann Pharmacother,, 2002, 36(7-8), 1150-5
  15. McDermott, C.A., et al., J Pediatr,, Pharmacokinetics of lorazepam in critically ill neonates with seizures., 1992, 120(3), 479-83
  16. Maloley, P.A., et al., Lorazepam dosing in neonates: application of objective sedation scores, Dicp,, 1990, 24(3), 326-7
  17. Prolepha Research B.V, SmPC Lorazepam Prolepha (RVG 119556 en 119557) 09-03-2025, www.geneesmiddelinformatiebank.nl
  18. Maharaj, A.R.,et al., A workflow example of PBPK modeling to support pediatric research and development: case study with lorazepam, AAPS j, 2013, 15(2, 455-64
  19. Medochemie Ltd, SmPC Lorazepam IV 4 mg/ml (RVG 122954) 13-03-2024, www.geneesmiddelinformatiebank.nl
  20. Cummings, A.J. and A.G. Whitelaw., A study of conjugation and drug elimination in the human neonate., Br J Clin Pharmacol,, 1981, 12(4), 511-5
  21. van der Vossen, A.C., et al., Oral lorazepam can be substituted for intravenous midazolam when weaning paediatric intensive care patients off sedation., Acta Paediatr, 2018, 107(9), 1594-1600
  22. Dallefeld, S.H., et al., Comparative safety profile of chloral hydrate versus other sedatives for procedural sedation in hospitalized infants, J Neonatal Perinatal Med, 2020, 13(2), 159-165
  23. Lee, D.S., et al., Myoclonus associated with lorazepam therapy in very-low-birth-weight infants., Biol Neonate, 1994, 66(6), 311-5
  24. Reiter, P.D. and A.D. Stiles., Lorazepam toxicity in a premature infant., Ann Pharmacother,, 1993, 27(6), 727-9
  25. Chess, P.R. and C.T. D'Angio., Clonic movements following lorazepam administration in full-term infants., Arch Pediatr Adolesc Med, 1998, 152(1), 98-9
  26. Puia-Dumitrescu, M., et al., Assessment of 2-Year Neurodevelopmental Outcomes in Extremely Preterm Infants Receiving Opioids and Benzodiazepines., JAMA Netw Open, 2021, 4(7), e2115998

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Changes

Changes