Pyridoxine

Generic name
Pyridoxine
Brand name
ATC Code
A11HA02
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Pyridoxine

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

T½: > 10 days

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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Neonatal epileptic seizures
  • Oral
    • Premature infants Gestational age < 36 weeks
      [2]
      • Maintenance dose: (start intravenously)Until the results of additional studies are known: 15 - 30 mg/kg/day in 1 dose. Max: 200 mg/day.
    • Gestational age ≥ 36 weeks and ≥ 2.5 kg
      [2]
      • With and without hypothermia: Maintenance dose (start intravenously): Until the results of additional research are known: 15 - 30 mg/kg/day in 1 dose. Max: 200 mg/day.
  • Intravenous
    • Premature infants Gestational age < 36 weeks
      [2] [6]
      • Initial dose: 100 mg/dose, once only.
      • Maintenance dose: Until the results of additional research are known: 15 - 30 mg/kg/day in 1 dose. Max: 200 mg/day.

      • The initial dose should preferably be given during EEG or aEEG recording.

    • Gestational age ≥ 36 weeks and ≥ 2.5 kg
      [2] [6]
      • Initial dose: With and without hypothermia: 100 mg/dose, once only.
      • Maintenance dose: Until the results of additional research are known: 15 - 30 mg/kg/day in 1 dose. Max: 200 mg/day.

      • The initial dose should preferably be given during EEG or aEEG recording.
Persistent neonatal convulsion / status epilepticus
  • Intravenous
    • 1 month up to 2 years
      [2] [3]
      • 100 mg/dose, once only.

      • Watch out for hypotonia, bradycardia, respiratory arrest and hypothermia after IV administration of pyridoxine. In cases of insufficient response, consider additional doses: give a 2nd/3rd dose (over 30 minutes) under EEG monitoring and observation
Pyridoxine-dependent epilepsy
  • Oral
    • 0 years up to 18 years
      [2] [3]
      • 5 - 30 mg/kg/day in 1 dose

      • Treatment by or after consultations with a paediatric specialist who has experience using pyridoxine for this indication.
        CAVE: When switching from pyridoxine to pyridoxal phosphate, pyridoxine should be discontinued.
Pyridoxine deficiency
  • Oral
    • 1 month up to 18 years
      [1]
      • 10 - 50 mg/day in 1 dose
Vitamin B6-sensitive homocystinuria
  • Oral
    • 0 years up to 18 years
      [5]
      • 100 - 500 mg/day in 3 doses. The dosage should be individually adjusted to the lowest effective dose. Give folic acid too with high doses..

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

  • Intravenous
    • 0 years up to 18 years
      [5]
      • 100 - 500 mg/day in 3 doses. The dosage should be individually adjusted to the lowest effective dose. Give folic acid too with high doses..

      • Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using pyridoxine for this indication.
Prophylaxis for isoniazid
  • Oral
    • < 1 year
      [4]
      • 10 mg/day in 1 dose

      • Adding pyridoxine to the isoniazid therapy for preventing neuropathy is only needed in children who are being breast-fed and in children/adolescents with an insufficient diet.

    • ≥ 1 year
      [4]
      • 20 mg/day in 1 dose

      • Adding pyridoxine to the isoniazid therapy for preventing neuropathy is only needed in children who are being breast-fed and in children/adolescents with an insufficient diet.
Primary hyperoxaluria, type I
  • Oral
    • 1 month up to 18 years
      [5]
      • Initial dose: 10 mg/day in 1 dose
      • Maintenance dose: Increase after 2 months to 500 mg/m²/day in 1 dose until the effect is achieved..
Reduction of mucous lining lesions after high doses of cytarabine
  • Oral
    • 1 month up to 18 years
      [1]
      • 300 mg/m²/day in 2 doses.
      • Duration of treatment:

        Days 1 to 5

  • Intravenous
    • 1 month up to 18 years
      [1]
      • 300 mg/m²/day in 2 doses.
      • Duration of treatment:

        Days 1 to 5

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

No information is present at this moment.

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

In primary hyperoxaluria type I: there is often only a partial response. Be aware of the possibility of neurotoxicity at doses above 1000 mg/day (peripheral neuropathy, encephalopathy). Pyridoxine may cause apnoea and prolonged cerebral depression after the first administration.

Application after high doses of cytarabine is open to discussion because there is insufficient evidence.

Interactions

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

OTHER PLAIN VITAMIN PREPARATIONS

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

Other plain vitamin preparations
A11HA04

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Smit LS et al, Richtlijnen voor behandeling van neonatale epileptische aanvallen, Nederlands Vlaamse Werkgroep Neonatale Neurologie van de sectie Neonatologie van de NVK en van de Nederlandse Vereniging voor Kinderneurologie, Nieuwe aangepaste versie juni 2012
  3. Waardenburg van DA, et al, Richtlijn status epilepticus kinderen ouder dan één maand., Nederlandse Vereniging voor Kindergeneeskunde, Augustus 2005
  4. Hartwig NC, et al., Vademecum pediatrische antimicrobiële therapie, 2005
  5. Blau, Hoffmann, Leonard and Clarke, Physicians guide to the treatment and follow-up of metabolic diseases, Springer, 2006
  6. Coughlin CR 2nd, et al., Consensus guidelines for the diagnosis and management of pyridoxine-dependent epilepsy due to α-aminoadipic semialdehyde dehydrogenase deficiency., J Inherit Metab Dis, 2021, Jan;44(1), 178-192

Changes

Therapeutic Drug Monitoring


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