Dexamethasone

Generic name
Dexamethasone
Brand name
ATC Code
H02AB02
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Dexamethasone

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

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Meningitis
  • Intravenous
    • 1 month up to 18 years
      [1]
      • 0.6 mg/kg/day in 4 doses. Max: 40 mg/day.
      • Duration of treatment:

        4 days
Nausea and vomiting in chemotherapy
  • Oral
    • 1 month up to 18 years
      [4]

      • < 0.6 m2: 2 mg/dose, twice daily
        ≥ 0.6 m²: 4 mg/dose, twice daily

      • If ondansetron/granisetron alone is not effective enough and other causes of vomiting have been eliminated. Start before administering the cytostatic agent.

  • Intravenous
    • 1 month up to 18 years
      [4]

      • < 0.6 m2: 2 mg/dose, twice daily
        ≥ 0.6 m²: 4 mg/dose, twice daily

      • If ondansetron and granisetron are not effective enough and other causes of vomiting have been eliminated. Start before administering the cytostatic agent.
Nausea and vomiting, post-operative
  • Intravenous
    • 1 year up to 18 years
      [1]
      • 0.1 mg/kg/dose, once only. Max single dose: 4 mg/dose.
Prophylaxis of post-detubation stridor
  • Intravenous
    • Premature infants, Gestational age < 37 weeks
      [7] [16]
      • Initial dose: At least 4 hours before extubation: 0.25 mg/kg/dose, once only.
      • Maintenance dose: 0.25 mg/kg/dose 8 hours and 16 hours AFTER initial dose (3 doses in total).
    • Term neonate
      [7] [16]
      • Initial dose: At least 4 hours before extubation: 0.25 mg/kg/dose, once only.
      • Maintenance dose: 0.25 mg/kg/dose 8 hours and 16 hours AFTER initial dose ( 3 doses in total).
    • 1 month up to 18 years and < 40 kg
      [1] [6] [10] [12] [16] [19]
      • Prior to extubation: 0.5 mg/kg/dose repeat if necessary. Max: 40 mg/day.
    • 1 month up to 18 years and ≥ 40 kg
      [6] [10] [12] [16]
      • Prior to extubation 20 mg/dose repeat if necessary. Max: 40 mg/day.
Treatment of post-detubation stridor
  • Intravenous
    • Prematures neonates Gestational age < 37 weeks
      • 0.25 mg/kg/dose, once only repeat if necessary.
    • Term neonate
      • 0.25 mg/kg/dose, once only Repeat if necessary.
    • 1 month up to 18 years and < 40 kg
      [10]
      • 0.5 mg/kg/dose, once only repeat if necessary. Max: 40 mg/day.
    • 1 month up to 18 years and ≥ 40 kg
      [10]
      • 20 mg/dose, once only repeat if necessary. Max: 40 mg/day.
Stress dosing if oral administration is not possible in the home situation
  • Intramuscular
    • 1 month up to 1 year
      [1]
      • 1 mg/dose, once only.

      • See warnings and precautions for a description of stress situations

    • 1 year up to 6 years
      [1]
      • 2 mg/dose, once only.

      • See warnings and precautions for a description of stress situations

    • ≥ 6 years
      [1]
      • 4 mg/dose, once only.

      • See warnings and precautions for a description of stress situations

    • Term neonate
      [1]
      • 1 mg/dose, once only.

      • See warnings and precautions for a description of stress situations
Phasing-out schedule
  • Oral
    • 1 month up to 18 years
      [1]

      • Phase out when used for longer than 10 days
        0.5 mg dexamethasone is equivalent to approx. 15 mg hydrocortisone (4 mg corresponds to 120 mg). After longer use, phase out dexamethasone to 4 mg/day, then switch to hydrocortisone (or 30 mg prednisone) and phase out according to the regimen for hydrocortisone or prednisone.
Laryngitis subglottica (pseudo-croup)
  • Oral
    • 3 months up to 18 years
      [2]
      • 0.15 - 0.6 mg/kg/dose, once only. Max: 16 mg/dose.

      • Consider a second dose after 24-48 hours if necessary after insufficient response
Cerebral oedema
  • Intravenous
    • 1 month up to 18 years and < 35 kg
      [1] [20]

      • Start: 20 mg/dose; 
        Following doses:
        Day 1-3: 32 mg/day in 8 divided doses
        Day 4: 16 mg/day in 4 divided doses
        Day 5: 8 mg/day in 4 divided doses
        Day 6 and onwards: decrease dose every day with 1 mg/day 

         
Dexamethasone suppression test, short
  • Oral
    • 1 month up to 18 years
      [1]
      • 0.58 mg/m²/dose, once only.

      • Administer a single dose at 23:00, round the dosage upwards to 0.25 mg. Measure the plasma concentration at 08:00.
Dexamethasone suppression test, long
  • Oral
    • 1 month up to 18 years
      [1]
      • 2 mg/day in 4 doses.

      • Alternative: 2 mg/1.73m² for 2 days, in consultation with an endocrinologist
Chronic Lung Disease (CLD)
  • Intravenous
    • Premature infants, Gestational age < 28 weeks
      [5] [8] [9] [14] [15] [17] [18]

      • Days 1 to 3: 0.2 mg/kg/day in 2 doses.
        After that, depending on the response, choose the short or long pattern:

        SHORT PATTERN:
        Days 4 and 5: 0.1 mg/kg/day in 2 doses.  
        Days 6 and 7: 0.05 mg/kg/day in 2 doses.  

        LONG PATTERN:
        Days 4, 5 and 6: 0.15 mg/kg/day in 2 doses.  
        Days 7-10: 0.1 mg/kg/day in 2 doses.  
        Days 11-14: 0.05 mg/kg/day in 2 doses. 

        Depending on the clinical picture, another regimen can be chosen.
Extubation in expected reactive tube oedema
  • Intravenous
    • Term neonate
      [1]
      • Initial dose: 30 Minuten vor der Extubation: 0.5 mg/kg/dose, once only.
      • Maintenance dose: 0.25 mg/kg/dose 8 h und 16 h nach der Extubation.
Treatment of moderate to severe symptoms of COVID-19
  • Intravenous
    • 1 month up to 18 years
      [22] [23]
      • 0.15 mg/kg/day in 1 dose. Max: 6 mg/day.
      • Duration of treatment:

        Max 10 days

      • Only in patients who receive respiratory support (oxygen or invasive mechanical ventilation)

    • Term neonate
      [22] [23]
      • 0.075 mg/kg/day in 1 dose. Max: 3 mg/day.
      • Duration of treatment:

        Max 10 days

      • Only in patients who receive respiratory support (oxygen or invasive mechanical ventilation)

    • Premature neonates Gestational age < 37 weeks
      [22] [23]
      • 0.075 mg/kg/day in 1 dose. Max: 3 mg/day.
      • Duration of treatment:

        Max10 days

      • Only in patients who receive respiratory support (oxygen or invasive mechanical ventilation)

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.

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

Hyperglycaemia, arrhythmias.
In prolonged use of supra-physiological doses: growth inhibition and osteoporosis, in addition to gastrointestinal ulcers, reduced resistance to infections, obesity and suppression of the hypothalamic-pituitary-adrenal axis. Intracranial pressure increases with papilloedema (pseudotumor cerebri), especially in children during or shortly after quick withdrawal.
Retinopathy in premature infants.
Hypertrophic cardiomyopathy in preterm infants. In early treatment (within 96 hours after birth) with dexamethasone at a starting dose of 0.25 mg/kg body weight 2×/day in premature infants with chronic lung disease, long-term adverse effects on neurological development have been found.

 

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

Injection fluid containing benzyl alcohol: premature infants and neonates.

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

Monitor the growth and development of infants and children closely during prolonged use of corticosteroids; to prevent growth inhibition, aim for an alternating dose. The progression of chickenpox and measles can be more severe and even fatal in non-immune patients who are using corticosteroids; exposed patients should be given medical treatment immediately.

Please note: the CF injection liquid contains benzyl alcohol (the 4 mg/ml vial contains 10.5 mg/ml benzyl alcohol) and it is not suitable for administration to neonates (premature in particular).

Mild stress: not feeling good, languid, temperature < 38.0°C, short physical effort only
Moderate stress: slightly raised temperature between 38.0-39.0°C, mild flu infection, vaccination, anaesthesia (dentist). Psychological stress (test, exam) or serious physical effort can in exceptional cases also be a reason for temporarily increasing the substitution dose to a 2-fold or 3-fold dose. The temperature is not always a good parameter for assessing stress
Severe stress: Temperature > 39°C, vomiting, diarrhoea, severely ill, accident, operation, narcosis (for perioperative policy, see the prednisone monograph)

The available data points to long term side effects on the neurological development of premature infants with a chronic pulmonary disease when dexamethasone is used in an early treatment (<96 hours) of 0.25 mg/kg twice daily.

Hypertrophic cardiomyopathy has been reported after administration to premature infants. Therefore, perform appropriate diagnostic assessment and monitoring of cardiac function and structure.

 


 

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Mineralocorticoids
H02AA02
Glucocorticoids
H02AB09
H02AB04
H02AB06
H02AB07
H02AB08

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Bjornson CL, et al, Croup., Lancet, 2008, Jan 26;371(9609), 329-39
  3. Kamps WA et al, Werkboek ondersteundende behandeling kinderoncologie, VU Uitgeverij, 2005
  4. SKION, Werkboek supportive Care, www.skion.nl, Updateb 29-11-2016
  5. Werkgroep Neonatale Farmacologie NVK sectie Neonatologie, Expert opinie, 28 maart 2018
  6. Baranwal, A. et al, Dexamethasone pretreatment for 24 h versus 6 h for prevention of postextubation airway obstruction in children: a randomized double-blind trial." , Intensive Care Med , 2014, 40 (9), 1285-94
  7. Couser, RJ et al, Effectiveness of dexamethasone in preventing extubation failure in preterm infants at increased risk for airway edema, J Pediatr, 1992, 121(4), 591-6
  8. Cuna, A. et al, A comparison of 7-day versus 10-day course of low-dose dexamethasone for chronically ventilated preterm infants, J Perinatol , 2017, 37 (3):, 301-5
  9. Doyle, L. W. et al, Low-dose dexamethasone facilitates extubation among chronically ventilator-dependent infants: a multicenter, international, randomized, controlled trial., Pediatrics, 2006, 117 (1), 75-83
  10. Khemani, R.G. et al, Corticosteroids for the prevention and treatment of post-extubation stridor in neonates, children and adults, Cochrane Database Syst, 2009, Rev (3), Cd001000
  11. Lugo, R. A. et al, Pharmacokinetics of dexamethasone in premature neonates." , Eur J Clin Pharmacol , 1996, 49(6), 477-83
  12. Lukkassen, I. M. et al, Dexamethasone reduces reintubation rate due to postextubation stridor in a high-risk paediatric population, Acta Paediatr, 2006, 95 (1), 74-6
  13. Nederlandse Vereniging voor Kindergeneeskunde, Werkboek Kindernefrologie, www.nvk.nl, 2010
  14. Onland, W. et al, Systemic corticosteroid regimens for prevention of bronchopulmonary dysplasia in preterm infants., Cochrane Database Syst , 2017, Rev 1, Cd010941
  15. Poets, C. F. et al, Prevention of bronchopulmonary dysplasia in extremely low gestational age neonates: current evidence, Arch Dis Child Fetal Neonatal Ed, 2018, 103 (3), F285-f291
  16. Veldhoen, E. S. et al, Post-extubation stridor in Respiratory Syncytial Virus bronchiolitis: Is there a role for prophylactic dexamethasone?" , PLoS One, 2017, 12 (2), e0172096
  17. Walther, F.J. et al, Adrenal suppression and extubation rate after moderately early low-dose dexamethasone therapy in very preterm infants." , Early Hum Dev , 2003, 74(1), 37-45
  18. Yates, H. L. et al, Minidex: very low dose dexamethasone (0.05 mg/kg/day) in chronic lung disease., Arch Dis Child Fetal Neonatal, 2011, Ed 96 (3), F190-4
  19. Anene, O, Dexamethasone for the prevention of postextubation airway obstruction: a prospective, randomized, double-blind, placebo-controlled trial, Crit Care Med , 1996, 24(10), 1666-9
  20. Centrafarm B.V, SmPC Dexamethason injectievloeistof 20 mg/ml (RVG 55091) 10-09-2019, www.geneesmiddeleninformatiebank.nl
  21. INFECTOPHARM Arzneimittel und Consilium GmbH, SmPC InfectoDexaKrupp 2 mg/5 ml Saft , 08/2017
  22. Children's Hospital of the KIngs Daughters (CHKD), Treatment Guideline for COVID-19 in children, https://www.chkd.org/uploadedFiles/Documents/COVID-19/CHKD%20COVID%2019%20treatment%20guideline.pdf,, 08-07-2020, version 2.5
  23. SWAB in samenwerking met het CIB, NVZA, NVMM, NVII, NVIC, NVK en NVALT, Medicamenteuze behandelopties bij patiënten met COVID-19 (infecties met SARS-CoV-2), July, 10. 2020
  24. AcuCort AB, SmPC Zeqmelit (21-14388/21-14389 /21-14390) 27.12.2023, https://www.legemiddelsok.no/

Changes

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