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

Bioavailability approximately 90%. Children metabolize benzodiazepine agonists more quickly than adults and adolescents.

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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

Sedation
  • Intravenous
    • 1 month up to 18 years
      [1]
      • 0.2 - 0.4 mg/kg/day in 4 doses. Max single dose: 3 mg/dose.
  • Oral
    • 1 month up to 18 years
      [1] [12]

      • 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
      [3] [11]
      • 0.1 mg/kg/dose, bolus. Max single dose: 4 mg/dose.
Acute anxiety (short use)
  • Oral
    • 6 years up to 18 years
      [2]
      • 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
      [4] [5] [8] [9]
      • 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
      [4] [9]
      • 1 - 4 mg/dose, once only. 1 to 2 hours before the procedure.

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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

Paradoxical reactions can occur in children in particular, with acute agitation, confusion and changes in the mental condition, and disinhibition. Epileptic seizures and myoclonia have been reported in neonates with very low birthweights. Sedation, concentration/memory problems, tolerance/dependency in longer-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

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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
N05BA01

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References

  1. Landelijk Kenniscentrum Kind-enJeugdpsychiatrie (Ketelaars), Anxiolytica/hypnotica, 2009
  2. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  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

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Changes

Changes