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

Interactions
PK
Renal impairment
References

Diazepam

Generic name
Diazepam
Brand name
ATC Code
N05BA01

Pharmacokinetics in children

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

Status epilepticus
  • Rectal
    • 1 month up to 18 years
      [3] [19] [21]
      • In home setting OR if no IV access yet: 0.25 - 1 mg/kg/dose, once only. Max: 10 mg/dose. In the absence of effect, dosing can be repeated after 10 minutes..
  • Intravenous
    • 1 month up to 18 years
      [3] [20]
      • 0.1 - 1 mg/kg/dose, once only Dose may be repeated once after 10-15 minutes.. Max: 20 mg/dose.

      • Higher doses than the maximum dosage may be required depending on body weight and severity of symptoms.
Febrile convulsions
  • Rectal
    • 1 month up to 18 years
      [1] [19] [21]
      • 0.25 - 1 mg/kg/dose repeat after 10 minutes if indicated. Dose may be repeated once every 12 hours..
Weakening of the skeletal muscles
  • Oral
    • 1 month up to 18 years
      • 0.1 - 0.8 mg/kg/day in 4 doses. Max: 40 mg/day.
  • Intravenous
    • 1 month up to 18 years
      • Initial dose 0.05 - 0.2 mg/kg/dose, once only. Further dosing depending on the effect.

      • Administer intravenously with monitoring

  • Rectal
    • 10 up to 15 kg
      [4]
      • 5 mg/dose, as required. If there is no effect after 10 minutes, repeat the dose and then repeat if necessary every 12 hours..
    • ≥ 3 years and ≥ 15 kg
      [4]
      • 10 mg/dose, as required. If there is no effect after 10 minutes, repeat the dose and then repeat if necessary every 12 hours..
Acute anxiety (short use)
  • Oral
    • 6 years up to 12 years
      [2]
      • 0.1 - 0.3 mg/kg/day in 2 - 3 doses.

      • Start with a low initial dose and increase slowly, depending on the clinical picture

    • 12 years up to 18 years
      [2]
      • 3 - 10 mg/day in 2 - 3 doses.

      • Start with a low initial dose and increase slowly, depending on the clinical picture

  • Rectal
    • ≥ 6 years
      [4]
      • 10 mg/dose, as required. If there is no effect after 10 minutes, repeat the dose and then repeat if necessary every 12 hours..

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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

Can exacerbate respiratory depression by barbiturates. Paradoxical reactions can occur in children in particular, with acute agitation, confusion and changes in the mental condition. Increased secretion of saliva and bronchial secretions have been observed after rectal use, particularly in children (SmPC).

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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

Administer intravenously with monitoring. The antagonist flumazenil (Anexate) must be present: 0.01 mg/kg; repeat after 1 min if needed.

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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
N05BA06

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References

  1. Actavis BV, SPC Stesolid RVG 07045/07046/07047/07048/07049/07606/07607, www.cbg-meb.nl, Geraadpleegd 30 april 2010, http://db.cbg-meb.nl/IB-teksten/h07045.pdf
  2. Landelijk Kenniscentrum Kind-enJeugdpsychiatrie (Ketelaars), Anxiolytica/hypnotica, 2009
  3. Nederlandse Vereniging voor Kindergeneeskunde, Richtlijn status epilepticus kinderen ouder dan één maand., Nederlandse Vereniging voor Kindergeneeskunde, Juni 2012
  4. Allgen Pharmaceuticals & Generics B.V, SmPC Diazepam rectiole (RVG 19798) 20-11-2019, www.geneesmiddeleninformatiebank.nl
  5. MMI, Gelbe Liste | Online, 05/2018
  6. STADA, SmPC Diazepam 5mg/10mg Tabletten (515.01.00-02.00), 07/2013
  7. Ratiopharm, SmPC Diazepam 5mg Tabletten (17447.00.00), 10/2013
  8. Ratiopharm, SmPC Diazepam 2mg Tabletten (1036.00.00), 10/2013
  9. Ratiopharm, SmPC Diazepam 10mg/ml Tropfen zum Einnehmen (16605.00.00), 03/2015
  10. Ratiopharm, SmPC Diazepam 10mg Zäpfchen (6776953.00.00), 10/2013
  11. Ratiopharm, SmPC Diazepam 10mg Tabletten (17447.01.00), 10/2013
  12. Puren, SmPC Stesolid 10mg/2ml Emulsion zu Injektion (22929.00.01), 04/2018
  13. Krewel Meuselbach, SmPC Valocordin-Diazepam 10mg/ml Tropfen zum Einnehmen (6270981.00.00), 08/2016
  14. Rotexmedica, SmPC Diazepam 5mg/ml Injektionslösung (4012.00.01), 06/2015
  15. AbZ, SmPC Diazepam 10mg/2ml Ampullen (6143573.00.00), 04/2014
  16. Puren, SmPC Stesolid Rectal Tube 5mg/10mg Rektallösung (22929.00.00-01), 10/2016
  17. Desitin, SmPC Diazepam rectal tube 5mg/10mg Rektallösung (15919.00.00-01.00), 05/2018
  18. Braun, SmPC Diazepam Lipuro 10mg/2ml Emulsion zur Injektion (6148.00.00), 04/2014
  19. Aurobindo, SmPC Stesolid rectiole (RVG 07606/07607) 26-20-2020, www.geneesmiddeleninformatiebank.nl
  20. Centrafarm B.V., SmPC Diazapam IV (RVG 56691) 26-10-2020, www.geneesmiddeleninformatiebank.nl
  21. Actavis Group PTC ehf, SmPC Stesolid Prefill 5 mg/ml rektalvæske, oppløsning. , https://www.legemiddelsok.no/_layouts/15/Preparatomtaler/Spc/0000-06290.pdf, 14.09.2018

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Changes

Changes