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

Interactions
PK
Renal impairment
References

Hydroxocobalamin

Generic name
Hydroxocobalamin
Brand name
ATC Code
B03BA03

Pharmacokinetics in children

No information

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

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Available formulations

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Dosages

Megaloblastic anaemia
  • Intramuscular
    • 1 month up to 18 years
      [3]
      • 1 mg/dose once a week.
      • Duration of treatment:

        For 5 weeks, then maintenance of 1 mg per 2 months

      • Only in cases of demonstrated deficiency.

  • Subcutaneous
    • 1 month up to 18 years
      [3]
      • 1 mg/dose once a week.
      • Duration of treatment:

        For 5 weeks, then maintenance of 1 mg per 2 months.

      • Inject deep subcutaneously.
        Only for demonstrated deficiency.
Cystathione beta-synthase deficiency
  • Oral
    • 2 years up to 18 years
      [2]
      • 1 mg/day in 1 dose

      • The optimum dosing frequency has not been determined.
        Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using hydroxocobalamin for this indication.

  • Intramuscular
    • 2 years up to 18 years
      [2]
      • 1 mg/dose 1x per month.

      • The optimum dosing frequency has not been determined.
        Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using hydroxocobalamin for this indication.
Functional defects of methionine synthase and functional defects of methylmalonyl mutase plus methionine synthase
  • Intramuscular
    • 0 months up to 7 months
      [2]
      • 1 mg/day in 1 dose

      • Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using hydroxocobalamin for this indication.

    • 7 months up to 18 years
      [2]
      • 1 mg/dose Twice a week.

      • Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using hydroxocobalamin for this indication.

  • Oral
    • 7 months up to 18 years
      [2]
      • 1 mg/day in 1 dose

      • Not for cblF
        Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using hydroxocobalamin for this indication.

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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

No information is present at this moment.

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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

Premature children or neonates (for the benzyl alcohol preparation).

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

Sodium benzoate for tackling secondary hyperammonaemia is contraindicated in organic acid disorders. Patients with organic acid disorders have a tendency to develop hypokalaemia. Potassium levels must only be corrected if there is diuresis.

Formulations containing benzyl alcohol as a preservative should not be used in premature children and neonates because of the greater risk of toxic and anaphylactoid responses; caution is needed in children aged less than three years.

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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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Folic acid and derivatives
B03BB01

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Blau, Hoffmann, Leonard and Clarke, Physicians guide to the treatment and follow-up of metabolic diseases., Springer, 2006
  3. Franssen MJAM et al, Werkboek Kinderhematologie, VU Uitgeverij, 2001, 2e druk

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Changes

Changes