Methylprednisolone

Generic name
Methylprednisolone
Brand name
ATC Code
H02AB04
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Methylprednisolone

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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Pulse therapy after rejection of donor organs or therapy-resistant SLE
  • Intravenous
    • 1 month up to 18 years
      [1] [6]
      • 10 - 15 mg/kg/day in 1 dose. Max: 30mg/kg/day, but not exceeding 1 g/day.
      • Duration of treatment:

        In organ transplants: for 3 days; in SLE, sJIA for 1-3 days.

      • Administer in 30-60 minutes with blood pressure and heart rate monitoring.
Alloreactive lung problems
  • Intravenous
    • 1 month up to 18 years
      [1]
      • Pulse: 10 mg/kg/day in 1 dose Max single dose: 1 g/dose.
      • Duration of treatment:

        Pulse for 3 days.

      • Administer in 30-60 minutes with blood pressure and heart rate monitoring. At least once, more often if necessary; maximum 6 pulses at a frequency of once a month.

        The pulse is followed by 2 mg/kg/day prednisolone maintenance therapy, then phasing out weekly by 0.5 mg/kg/day to 0.5 mg/kg/day.
Spinal cord injury
  • Intravenous
    • 1 month up to 18 years
      [1] [5]
      • Initial dose: 30 mg/kg/dose, once only. as a bolus in 15 minutes followed by a 45-minute break..
      • Maintenance dose: 5.4 mg/kg/hour, continuous infusion. For 23 hours..

      • Impending spinal cord lesion. Treatment should be started within 8 hours.
Haemolytic autoimmune anaemia
  • Intravenous
    • 1 month up to 18 years
      [1]
      • 4 - 8 mg/kg/day in 4 doses.
      • Duration of treatment:

        1-3 days

      • Dosage is based on clinical effect.
Juvenile dermatomyositis
  • Intravenous
    • 1 month up to 18 years
      [2]
      • High-dose therapy: 15 - 30 mg/kg/day in 1 dose
      • Duration of treatment:

        3 successive days
Inflammatory diseases, endocrinologic diseases, neoplastic diseases
  • Oral
    • 2 years up to 18 years
      [8]
      • Initial dose: 0.8 - 1.5 mg/kg/day in 1 dose. Max: 80 mg/day.
      • Maintenance dose: 1 - 4 mg/day in 1 dose. Max: 8 mg/day.

      • In long-term maintenance treatment, do not stop abruptly, but taper off slowly with 2 mg increments per 2-3 days; in the last week administer 2 mg every other day.

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, hypertrophic cardiomyopathy in preterm neonates, pseudotumor cerebri, pancreatitis when high doses are administered. Changes in mood, abnormal behavior, insomnia and irritability are very common in children. 
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, subcapsular cataract, nuclear cataract.

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

Contra-indications in children

For the Act-O-Vial: children aged < 3 years because of the presence of benzyl alcohol.

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 glucocorticoids; 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.

Allergic reactions have been reported after use of Solumedrol 40 mg/ml Act-O-Vial in patients with cow's milk protein allergy. Therefore, this solution should not be used by children with cow's milk protein allergy [Savvatianos 2011]

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
H02AB06
H02AB07
H02AB08

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. CBO, Richtlijn Dermatomyositis, polymyositis en sporadische \'inclusion body\' myositis, www.cbo.nl, 2004, 99-111
  3. CBG, DHPC Solu-Medrol, 28-8-2017
  4. Sanofi-Aventis, SmPC Urbason solubile 16 mg Tr.st.amp. (11404), 10/2018
  5. Pfizer, SmPC Solu-Medrol 500 mg Tr.st.amp. (16217), 04/2019
  6. Dermapharm, SmPC Metasol 16 mg Plv. z. Herst. e. Inj.- /Inf.lsg. (1-37772), 09/2019
  7. Savvatianos s. et al, Cow’s milk allergy as a cause of anaphylaxis to systemic corticosteroids, Allergy 66, 2011, 66, 979–986
  8. mibe GmbH Arzneimittel, SmPC Methylprednisolon JENAPHARM® 4 mg, 8 mg, 16 mg, 32 mg Tabletten (32484.00.00), 09/2022

Changes

Therapeutic Drug Monitoring


Overdose