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

Interactions
PK
Renal impairment
References

Promethazine

Generic name
Promethazine
Brand name
ATC Code
R06AD02

Pharmacokinetics in children

There is no data known about the kinetics of this drug in children.

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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

Travel sickness
  • Oral
    • Tablet
      • 8 years up to 18 years
        • Promethazine 25 mg/dose 30-60 minutes before the start of the journey – repeat after 8 hours if necessary.
    • Syrup
      • 2 years up to 18 years
        • Promethazine 0.2 mg/kg/dose, as required 2-4x daily.
        • Directions for administration:

          To prevent motion sickness, the syrup must be given 1 hour before the start of the journey and repeated after 6-8 hours if necessary.

        • Other antihistamines are preferred for this indication, due to the strong sedating properties of promethazine.
Nausea and vomiting (in palliativ care)
  • Intravenous
    • Syrup
      • 2 years up to 18 years
        • Promethazine 0.2 - 0.5 mg/kg/dose, as required, max. 4 dd. Max: 25 mg/dose.
  • Oral
    • Syrup
      • 2 years up to 18 years
        • Promethazine 0.2 - 0.5 mg/kg/dose, as required, max. 4 dd. Max: 25 mg/dose.
As an adjuvant with other sedatives
  • Intravenous
    • 2 years up to 18 years
      • Promethazine 0.5 mg/kg/dose, once only. Max: 50 mg/day. Max single dose: 25 mg/dose.
  • Intramuscular
    • 2 years up to 18 years
      • Promethazine 0.5 mg/kg/dose, once only. Max: 50 mg/day. Max single dose: 25 mg/dose.
  • Oral
    • 2 years up to 18 years
      • Promethazine 0.5 mg/kg/dose, once only. Max: 50 mg/day. Max single dose: 25 mg/dose.
Rescue treatment in acute psychiatric crises/agitation
  • Intramuscular
    • 12 years up to 18 years
      • Promethazine 25 - 50 mg/dose, once only. In combinatie met haloperidol.
        • Controleer effect na 45 minuten.
    • 12 years up to 18 years
      • Promethazine 25 - 50 mg/dose, once only. In combinatie met haloperidol.
        • Controleer effect na 45 minuten.
Prophylaxis and symptomatic treatment for allergic conditions in which non-sedating antihistamines have proved ineffective or insufficiently effective
  • Oral
    • 2 years up to 18 years
      • Promethazine 0.2 mg/kg/dose 2-4x daily. Max: 50 mg/day. Max single dose: 25 mg/dose. ALTERNATIVE: 0.5 mg/kg/dose (max 25 mg) once before bedtime.
        • Start met de laagst werkzame dosis.
        • De patiënt moet individueel ingesteld worden.
Insomnia (in-patient use)
  • Oral
    • Syrup
      • 2 years up to 18 years
        • Promethazine 0.5 mg/kg/day in 1 dose. Max: 50 mg/day.
Übelkeit und Erbrechen (GERMAN INDICATION ONLY)
  • Oral
    • 6 years up to 18 years
      • Initial dose: 10 mg/day in 1 dose
      • Maintenance dose: 10 - 30 mg/day in 3 doses. Max: 0.5 mg/kg/day.

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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 infants: respiratory depression, sleep apnoea, sudden infant death syndrome. Especially in children: paradoxical stimulation of the central nervous system with sleeplessness, nervousness, tachycardia, tremors and convulsions.[SmPC]

Agitation is reported in one study [Razieh 2013]

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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 in children

Children younger than 2 years (including preterm and term neonates) due to the risk of sedation, respiratory depression and the possible association with sudden infant death syndrome. [SmPC Atosil]

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

Be careful in children with sleep apnoea in their previous history, when sudden infant death syndrome has occurred in the family and when children wake up spontaneously less easily than normal. Use is not recommended in very ill or dehydrated children in case of acute infections due to the risk of dystonia, in case of symptoms of Reye’s syndrome and in case of symptoms of other liver conditions.

Other antihistamines are preferred for the indications ‘Allergic conditions based on the release of histamine’ and ‘Travel sickness’, due to the strong sedating properties of promethazine.

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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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Aminoalkyl ethers
R06AA04
R06AA52
R06AA02
Substituted alkylamines
R06AB03
Phenothiazine derivatives
R06AD01
R06AD08
Piperazine derivatives
R06AE07
R06AE03
R06AE09
R06AE05
Other antihistamines for systemic use
R06AX18
R06AX29
R06AX02
R06AX27
R06AX26
R06AX17
R06AX13
R06AX25
R06AX28

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References

  1. Hohenhaus SM., An informal discussion of emergency nurses\' current clinical practice: what\'s new and what worksDanger with use of intravenous promethazine in the emergency department, J Emerg Nurs, 2005, Oct;31(5), 465-7
  2. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  3. Ratiopharm Nederland BV, SPC Promethazine (RVG 17353, 17354), www.cbg-meb.nl, Geraadpleegd 03 juni 2010, http://db.cbg-meb.nl/IB-teksten/h50277.pdf
  4. Teva B.V., SmPC Promethazine Teva 1 mg/ml, stroop (RVG 50277), 12/2022
  5. Centrafarm B.V., SmPC Promethazine CF 25 mg, omhulde tabletten (RVG 50250), 08/2021
  6. Pharmachemie BV, SmPC Promethazine (RVG 50278) 10-04-2013, www.geneesmiddeleninformatiebank.nl
  7. Centrafarm BV, SmPC Promethazine CF oplossing voor injectie (RVG 50249) 05-08-2016, www.geneesmiddeleninformatiebank.nl
  8. NVK, Richtlijn Palliatieve Zorg voor Kinderen, 2013
  9. Razieh F et al., Efficacy of chloral hydrate and promethazine for sedation during electroencephalography in children: a randomised clinical trial., Iranian Journal of Pediatrics, 2013, 23, 27-31
  10. Kenniscentrum Kind,- en Jeugdpsychiatrie, Ingrijpmedicatie protocol , 2016
  11. O’Brien JF et al., Rectal thiopental compared with intramuscular meperidine, promethazine and chlorpromazine for pediatric sedation, Ann Emerg Med, 1991, 20(6), 664-7
  12. Xiang Z et al., Effects of promethazine or dexamethasone pretreatment on mivacurium-induced histamine release in children, Paediatr Anaesth, 2014, 24(3), 322-6
  13. Kenniscentrum Kind,- en Jeugdpsychiatrie, Expert opinie Slaapproblemen 15-11-2018
  14. Prinses Maxima Ziekenhuis., Expert opinie Palliatieve zorg in de oncologie 17-09-2018
  15. Kenniscentrum Kind,- en Jeugdpsychiatrie, Expert opinie ingrijpen bij acute psychotische crises 15-11-2018
  16. Desitin, SmPC Atosil® Injektionslösung N, 28,2 mg/ml (6245368.00.00), 10/2017
  17. Desitin, SmPC Atosil® 25mg Filmtabletten/Tropfen, 22,6 mg/ml (6245842.00.00), 10/2017
  18. Kenniscentrum Kind,- en Jeugdpsychiatrie, Ingrijpmedicatie protocol, 2016

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Changes

Changes