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

Interactions
PK
Renal impairment
References

Tetracosactide

Generic name
Tetracosactide
Brand name
ATC Code
H01AA02

Pharmacokinetics in children

No information

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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

West’s syndrome
  • Intravenous
    • 1 month up to 1 year
      • Initial dose: 0.25 mg/day in 1 dose for 3 days.
      • Maintenance dose: 0.25 mg/dose every 2-8 days.

      • Adjust the dosage depending on the effect.

    • 1 year up to 6 years
      • Initial dose: 0.25 - 0.5 mg/day in 1 dose for 3 days.
      • Maintenance dose: 0.25 - 0.5 mg/dose every 2-8 days.

      • Adjust the dosage depending on the effect.

    • 6 years up to 18 years
      • Initial dose: 0.25 - 1 mg/day in 1 dose For 3 days.
      • Maintenance dose: 0.25 - 1 mg/dose every 2-8 days.

      • Adjust the dosage depending on the effect.

  • Intramuscular
    • Depotpreparat (modifisert frisetting av virkestoff)
      • 1 month up to 2 years
        • Initial dose: 0.25 mg/day in 1 dose
        • Maintenance dose: 0.25 mg/dose every 2-8 days.

        • Dose adjustment based on effect

      • 2 years up to 5 years
        • Initial dose: 0.25 - 0.5 mg/day in 1 dose
        • Maintenance dose: 0.25 - 0.5 mg/dose every 2-8 days.

        • Adjust the dosage depending on the effect.

      • 5 years up to 18 years
        • Initial dose: 0.25 - 1 mg/day in 1 dose
        • Maintenance dose: 0.25 - 1 mg/dose every 2-8 days.

        • Adjust the dosage depending on the effect.

    • Normal preparation (immediate release)
      • 1 month up to 18 years
        • 0.8 mg/day in 2 doses. During 4 weeks..

        • Taper down as follows:
          - 5 days 0,4 mg and 0,2 mg IM per day
          - 5 days 0,2 mg and 0,2 mg IM per day
          - 5 days 0,2 mg per day IM and stop afterwards

          Determine morning cortisol plasmalevel one week after termination

      • 1 month up to 18 years
        [2]
        • 0.8 mg/day in 2 doses. During 4 weeks..

        • Taper down as follows:
          - 5 days 0,4 mg and 0,2 mg IM per day
          - 5 days 0,2 mg and 0,2 mg IM per day
          - 5 days 0,2 mg per day IM and stop afterwards

          Determine morning cortisol plasmalevel one week after termination
Diagnostic agent: ACTH test
  • Intravenous
    • Normal preparation (immediate release)
      • 1 month up to 18 years
        • 250 microg./dose, bolus in 15 sec.

        • Alternative: Low-dose ACTH test: 1 microg/dose, one-time.

          The effect of tetracosactide is short.

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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

growth inhibition in children,
reversible myocardial hypertrophy in infants and young children [SmPC Synacthen]

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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

Due to the benzyl alcohol content, Tetracosactide Depot is contraindicated in premature and newborn infants (0 to 30 days).

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

When prolonged treatment is given to children, the growth should be checked carefully because of the possibility of growth inhibition. Regular echocardiographic examination is needed in infants and young children because long-term use at higher than recommended doses can cause reversible myocardial hypertrophy.

Severe icterus has been observed with concomitant use of tetracosactide and valproate in children. These two drugs must not be used together. [SmPC Synacthen]

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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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Somatropin and somatropin agonists
H01AC09
H01AC03
H01AC07
H01AC08
H01AC01

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Noordam C et al, Werkboek Kinderendocrinologie, digitale publicatie op www.nvk.nl (alleen leden), 2010
  3. Alfasigma S.p.A., SmPC Synacthen (RVG 05082) 03-11-2020, www.geneesmiddeleninformatiebank.nl
  4. Abdu TAM et al, Comparison of the low dose short synacthen test (1 mcg), the conventional dose short synacthen test (250 mcg) and the insulin tolerance test for assessment of the hypothalamo-pituitary-adrenal axis in patients with pituary disease., J. Clin. Endocrinol Metab, 1999, 84, 883-84
  5. Beishuizen et al, De lage dosis ACTH stimulatie test: waarom veel als minder genoeg is?, Ned Tijdschr Klin Chem, 2000, 25, 361-364
  6. Alfasigma S.p.A., SmPC Synacthen Depot (6445684.00.00), 02/2021

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Changes

Changes