Prednisolone

Generic name
Prednisolone
Brand name
ATC Code
H02AB06
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Prednisolone

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.

General Dose Info

For once-daily administration, take the dose in the morning.

Dosages

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Juvenile Idiopathic Arthritis (J.I.A.); JIA associated chronic uveitis.
  • Oral
    • 1 month up to 18 years
      [7] [12] [23]
      • 0.25 - 1 mg/kg/day in 1 dose
      • Directions for administration:

        Administer in the morning (to limit the growth-inhibiting effect).
Corticosteroid therapy in immunological/haematological illnesses: Low dose
  • Oral
    • 1 month up to 18 years
      • 0.25 - 1 mg/kg/day in 3 doses.

      • Down titrate when used for more than 14 days, see indication phasing out schedule.

  • Intravenous
    • 1 month up to 18 years
      • Prednisolone sodium succinate: 0.25 - 1 mg/kg/day in 3 doses.

      • Down titrate when used for more than 14 days, see indication phasing out schedule. 
Corticosteroid therapy in immunological/haematological illnesses: High dose
  • Oral
    • 1 month up to 18 years
      • 2 mg/kg/day in 3 doses.

      • Down titratie when used longer than 14 days, see indication phasing-out schedule

  • Intravenous
    • 1 month up to 18 years
      • Prednisolone sodium succinate: 2 mg/kg/day in 3 doses.

      • Down titratie when used longer than 14 days, see indication phasing-out schedule
Allergic reactions
  • Intravenous
    • 1 month up to 18 years
      • Prednisolone sodium succinate: 1 mg/kg/dose, once only. Max single dose: 25 mg/dose.
  • Intramuscular
    • 1 month up to 18 years
      • Prednisolone sodium succinate: 1 mg/kg/dose, once only. Max single dose: 25 mg/dose.
  • Rectal
    • 1 month up to 18 years
      [15]
      • Prednisolone acetate: 100 mg/dose in 1 dose During maximum of 2 days; maximum cumulative dose 300 mg / 2 days.
Asthmatic status
  • Oral
    • 1 month up to 18 years
      [8] [10] [11] [31]
      • 1 - 2 mg/kg/day in 2 doses.
      • Duration of treatment:

        3-5 days

      • Directions for administration:

        Use of the solution is preferred
        If the first dose is vomited up, readminister it

        • Max < 2 year: 20 mg/day
        • Max 2-5 year: 30 mg/day
        • Max > 5 year: 40 mg/day

        Down titration not indicated.

  • Intravenous
    • 1 month up to 18 years
      [10] [11] [31]
      • Prednisolone sodium succinate: 1 - 2 mg/kg/day in 2 doses. Max: 40 mg/day.
      • Duration of treatment:

        3-5 days

      • Down titration not indicated.

  • Rectal
    • 1 month up to 18 years
      [15]
      • Prednisolone acetate 100 - 112 mg/dose in 1 dose Maximal treatment duration: 2 days. Maximal cumulative dose: 446 mg / 2 days.
Phasing-out schedule
  • Oral
    • 1 month up to 18 years

      • Prednisolone/prednisone PHASING-OUT SCHEDULE (when used for longer than 14 days)

        • As long as the underlying disease permits, reduce the dose by 5 mg/week to a dose of 2.5 mg/m²/day in a single dose in the morning.

         
Inflammatory bowel disease (IBD)
  • Oral
    • 1 month up to 18 years
      [3]
      • 1 mg/kg/day in 1 dose. Max: 40 mg/day.
      • Directions for administration:

        Administer in the morning.

      • Down titrate when used for more tahn 14 dagen, see indication phasing-out schedule
Allergic bronchopulmonary aspergillosis (ABPA) in CF
  • Oral
    • 1 month up to 18 years
      [5]
      • 0.5 - 2 mg/kg/day in 1 dose. Max: 60 mg/day.
      • Directions for administration:

        Administer in the morning.

      • Down titrate when used for more than 14 days, see indivation phasing-out schedule
Juvenile dermatomyositis
  • Oral
    • 1 month up to 18 years
      [6]
      • 1 - 2 mg/kg/day in 1 - 3 doses.
Idiopathic peripheral facial paralysis, HB grade IV or higher
  • Oral
    • < 15 years
      [9]
      • 1 mg/kg/day in 1 dose
      • Duration of treatment:

         7 days

      • Start treatment within 72 hours of the condition arising.
Idiopathic nephrotic syndrome: 1e disease period
  • Oral
    • 1 month up to 18 years
      [4] [32]
      • Initial dose: 60 mg/m²/day in 1 - 3 doses. Max: 60 mg/day. For 4 or 6 weeks.
      • Maintenance dose: 40 mg/m²/dose once every 2 days. Max: 50 mg/day. For 4 or 6 weeks.

      • Total treatment duration 2 x 4 weeks OR 2 x 6 weeks
Idiopathic nephrotic syndrome: Recurrent
  • Oral
    • 1 month up to 18 years
      [4] [32]
      • Initial dose: 60 mg/m²/day in 1 dose. Max: 60 mg/day. until the urine has been free of protein for 3 days.
      • Maintenance dose: 40 mg/m²/dose once every 2 days. For a minimum of 4 weeks.
Stress dosing: Moderate stress: slightly raised temperature between 38.0-39.0°C, mild flu infection, vaccination, anaesthesia (dentist).
  • Intravenous
    • 0 years up to 18 years
      • Prednisolone sodium succinate: 7.5 mg/m²/day in 3 doses.
  • Oral
    • 0 years up to 18 years
      • 7.5 mg/m²/day in 3 doses.
Stress dosing: Severe stress: Temperature > 39°C, vomiting, diarrhoea, severely ill, accident, operation, narcosis (for perioperative policy, see the prednisolone monograph)
  • Intravenous
    • 0 years up to 18 years
      • Prednisolone sodium succinate: 12.5 mg/m²/day in 3 doses.
  • Oral
    • 0 years up to 18 years
      • 12.5 mg/m²/day in 3 doses.
Stress dosing: PERIOPERATIVE SUBSTITUTION SCHEDULE
  • Intravenous
    • 0 years up to 18 years

      • The following dosage recommendations are only guidelines. The dose should always be coordinated with the treating paediatric endocrinologist.

        • For older children, an extra dose of hydrocortisone may be needed the evening before surgery
        • The surgery should preferably be planned early in the morning. If it is only being done during the day, the morning dose of hydrocortisone must be given as a 3-fold dose. In the case of surgery later in the day, a glucose/NaCl infusion is recommended due to the risk of hypoglycaemia from the moment of fasting.
        • The glucocorticoid dosage after the first day post-op should be determined as guided
          by the clinical condition of the patient, and if necessary by the (expected) post-operative complications.
        • Intravenous: Prednisolone sodium succinate
           
        Severity of the surgery Time 0-1 year (0.3-0.5 m²) 1-3 years (0.5-0.7 m²) 3-12 years (0.7-1.2 m²) > 12 years (1.2-1.5 m²) Adults
        MINOR

        e.g. inspection under narcosis, place tympanostomy tubes        		 When inducing anaesthesia 2.5 mg intravenous prednisolone 5 mg intravenous prednisolone 7.5 mg intravenous prednisolone 10 mg intravenous prednisolone 20 mg intravenous prednisolone
        MINOR Rest of the surgery day 2-fold or 3-fold oral dose of hydrocortisone 2-fold or 3-fold oral dose of hydrocortisone 2-fold or 3-fold oral dose of hydrocortisone 2-fold or 3-fold oral dose of hydrocortisone 2-fold or 3-fold oral dose of hydrocortisone
        MINOR first post-op day Normal substitution dose of hydrocortisone Normal substitution dose of hydrocortisone Normal substitution dose of hydrocortisone Normal substitution dose of hydrocortisone Normal substitution dose of hydrocortisone
        MEDIUM

        e.g. inguinal hernia, tonsillectomy, adenotomy        		 When inducing anaesthesia 2.5 mg intravenous prednisolone 5 mg intravenous prednisolone 7.5 mg intravenous prednisolone 10 mg intravenous prednisolone 20 mg intravenous prednisolone
        MEDIUM Rest of the surgery day (spread over the remaining 24 hours) 2x 1.5 mg intravenous prednisolone 2x 2.5 mg intravenous prednisolone 2x5 mg intravenous prednisolone 2x5 mg intravenous prednisolone 2x 10 mg intravenous prednisolone
        MEDIUM first day post-op (spread over 24 hours) 3x 1.5 mg intravenously or 3-fold dose of hydrocortisone orally 3x 2.5 mg intravenously or 3-fold dose of hydrocortisone orally 3x 5 mg intravenously or 3-fold dose of hydrocortisone orally 3x 5 mg intravenously or 3-fold dose of hydrocortisone orally 3x 10 mg intravenously or 3-fold dose of hydrocortisone orally
        MAJOR

        e.g. genitoplasty, laparotomy, craniotomy        		 When inducing anaesthesia 5 mg intravenous prednisolone 7.5 mg intravenous prednisolone 10 mg intravenous prednisolone 12.5 mg intravenous prednisolone 25 mg intravenous prednisolone
        MAJOR Rest of the surgery day (spread over the remaining 24 hours) 2x 2.5 mg intravenous prednisolone 2x 3.5 mg intravenous prednisolone 2x5 mg intravenous prednisolone 2x 7.5 mg intravenous prednisolone 2x 12.5 mg intravenous prednisolone
        MAJOR first day post-op (spread over 24 hours) 3x 2.5 mg intravenous prednisolone 3x 3.5 mg intravenous prednisolone 3x5 mg intravenous prednisolone 3x 7.5 mg intravenous prednisolone 3x 12.5 mg intravenous prednisolone
Laryngitis subglottica (pseudo-croup)
  • Rectal
    • 1 month up to 18 years
      [15] [16]
      • Prednisolone acetate 100 - 112 mg/dose in 1 dose Maximal treatment duration: 2 days. Maximal cumulative dose: 446 mg / 2 days.
Severe constitutional eczema
  • Oral
    • 6 months up to 18 years
      [24] [25] [27]
      • 0.5 - 1 mg/kg/day in 1 dose
        • Max 40 mg / day when used to bridge the period of an immunomodulating agent, such as azathioprine, mycophenolate mofetil or cyclosporine, to show effect.
        • Max 60 mg / day when used as a short-term intensive treatment.
        .

      • If longterm use is indicated after careful consideration, dosing every other day can be considered. Down titrate when used longer for 14 days, see indication phasing-out schedule.

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

Hyperglycemia, arrhythmias, hypertension, depression.

With long-term use of supraphysiological doses: growth inhibition and osteoporosis, in addition to gastrointestinal ulcers, decreased defense against infections, behavioral changes such as dysphoric behavior, hyperactivity and insomnia, obesity weight gain, Cushing-like symptoms and suppression of the hypothalamic-pituitary adrenal gland (Aljebab et al 2017).

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

There is a preference for using prednisolone rather than prednisone because of the (rare) occurrence of a conversion defect (11-beta-hydroxysteroid dehydrogenase reductase activity).

Monitoring in constitutional eczema:

  • Discuss the increased risk of skin infections and the symptoms of hyperglycaemia.
  • Check for any weight gain and cushing-like symptoms (Aljebab, 2017).
  • Check the height every 3 months to determine any growth inhibition.
  • Check blood pressure if used for more than 4 weeks. If this is increased in 2 consecutive controls, reduce prednisolone (slowly) (see tapering schedule).
  • Pay attention to vaccination advice during prednisolone use.
  • An ACTH test can be considered if disabling symptoms of adrenal suppression are still present after discontinuation. It may have been tapered too quickly and a low dose of prednisolone with a more gradual taper may be necessary. In this case, consult with a pediatric endocrinologist.
  • Bone density measurement can be considered for a fracture during or shortly after prednisolone treatment (Aljebab et al 2017).
  • With long-term use (> 4 weeks), supplement with calcium and vitamin D (Sánchez-Armendáriz et al. 2018, Dogru 2018).

In obese children, doses at the higher end of the dose range may be required for a good response, close monitoring is recommended (Ross et al. 2015).

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
H02AB02
H02AB09
H02AB04
H02AB07
H02AB08

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Brand, PLP et al, Werkboek Kinderlongziekten, VU Uitgeverij, 2001
  3. Turner D, et al. , Management of pediatric ulcerative colitis: joint ECCO and ESPGHAN Evidence-Based Consensus Guidelines, JPGN , 2012, 55(3), 340-61
  4. Heijden, van der AJ, Werkboek Kindernefrologie, NVK, 2002
  5. CBO, Richtlijn Diagnostiek en behandeling Cystic Fibrosis, www.cbo.nl, 2007
  6. CBO, Richtlijn Dermatomyositis, polymyositis en sporadische \'inclusion body\' myositis, www.cbo.nl, 2004, 99-111
  7. CBO, Richtlijn Diagnostiek en behandeling van Reumatoide Artritis, www.cbo.nl, 2009, 77
  8. Hoog, de M et al, Concept Richtlijn Status Astmaticus, 2005
  9. CBO, Richtlijn Idiopathische Perifere aangezichts verlamming, www.cbo.nl, 2009, 53
  10. Kruijff de, CC et al, 5 acute problemen in de Kindergeneeskunde: Acuut Astma, www.nvk.nl, 11 april 2012
  11. NVK, Dutch "Guideline Astma in Children", 2021
  12. Nederlands OOgheelkundig gezelschap, Richtlijn Uveitis, 2015
  13. Uptodate: UpToDate®, Pediatric Drug information: Prednisolon systemisch Topic 16043 Version 237.0, accessed 05/19
  14. gelbe-liste.de, www.gelbe-liste.de, accessed 05/19
  15. INFECTOPHARM Arzneimittel und Consilium GmbH, SmPC, Infectocortikrupp® 100 mg Zäpfchen (8500.00.00), 06/17
  16. bene-Arzneimittel GmbH, SmPC, Klismacort® 100 mg Rektalkapseln Weichgelatinekapseln (7078.00.00), 10/17
  17. GALENpharma GmbH, SmPC, Prednisolon 2/5/10/20/50 mg GALEN® Tabletten (6079504.01.00), 12/17
  18. Merck Serono GmbH, SmPC, Solu-Decortin® H 10/25/50/100/250/500/1000 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder Infusionslösung (9238.00.00), 09/17
  19. mibe GmbH Arzneimittel, SmPC, Prednisolut® 10/25/50/100/250/500/1000 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung (40401.01.00), 05/18
  20. Winthrop Arzneimittel GmbH, SmPC, Predni H Injekt 10/25/50 mg/ml Injektionssuspension (Kristallsuspension) (6165959.00.00/6165936.00.00/6165907.00.00), 08/17
  21. Pharmapol Arzneimittelvertrieb-GmbH, SmPC, Okrido® 6 mg/ml Lösung zum Einnehmen (88676.00.00), 08/17
  22. Merck Serono GmbH, SmPC, Decortin® H 1/5/10/20/50 mg Tabletten (6108973.00.00), 09/17
  23. NVK, Juveniele idiopathische artritis, medicamenteuze behandeling van kinderen met, www.nvk.nl, 11-04-2018
  24. Solomons, B., Infantile eczema treated with oral cortisone; a clinical report., Br Med J, 1954, 1 (4872), 1190-1
  25. Glaser, J. , Treatment with ACTH and cortisone of atopic dermatitis (eczema) in infants and children, J Allergy, 1952, 23(3), 222-8
  26. Aljebab, F., et al, Systematic Review of the Toxicity of Long-Course Oral Corticosteroids in Children., PLoS One, 2017, 12(1), e0170259
  27. Nederlandse Vereniging voor Dermatologie en Venerelogie, Richtlijn Constitutioneel eczeem, https://nvdv.nl/professionals/richtlijnen-en-onderzoek/richtlijnen/richtlijn-constitutioneel-eczeem, 2019
  28. Dogru, M., Is vitamin D level associated with the natural course of atopic dermatitis?, Allergol Immunopathol, 2018, 46 (6), 546-551
  29. Ross, E. L., et al , Development of recommendations for dosing of commonly prescribed medications in critically ill obese children, Am J Health Syst Pharm, 2015, 72(7), 542-56
  30. Sánchez-Armendáriz, K., et al, Oral vitamin D3 5000 IU/day as an adjuvant in the treatment of atopic dermatitis: a randomized control trial, Int J Dermatol, 2018, 57(12), 1516-20
  31. Global Initiative for Asthma (GINA), 2021 GINA Report, Global Strategy for Asthma Management and Prevention, 2021
  32. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group., Clinical Practice Guideline for the Management of Glomerular Diseases, Kidney Int., 2021, 100(4S), S1-S276

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