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

Interactions
PK
Renal impairment
References

Penicillamine

Generic name
Penicillamine
Brand name
ATC Code
M01CC01

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

No information is present at this moment.

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Dosages

Wilson’s disease
  • Oral
    • 1 month up to 18 years
      • 20 mg/kg/day in 2 - 3 doses.

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

    • ≥ 18 years
      • Initial dose: 1.000 - 1.500 mg/day in 2 - 3 doses.
      • Maintenance dose: 750 - 1.000 mg/day in 2 - 3 doses.

      • D-penicillamine is tolerated better when the dose is slowly increased: start at 250-500 mg/day, increase in steps of 250 mg every 4-7 days up to a maximum of 1000-1500 mg/day.


        Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience with using D-penicillamine for this indication.
Cystinuria
  • Oral
    • 2 years up to 12 years
      • 20 - 30 mg/kg/day in 3 doses. Max: 1.200 mg/day.

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

    • 12 years up to 18 years
      • 20 - 30 mg/kg/day in 3 doses. Max: 1.500 mg/day.

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

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Adjustment not necessary
GFR 30-50 ml/min/1.73 m2
Do not administer
GFR 10-30 ml/min/1.73 m2
Do not administer
GFR < 10 ml/min/1.73 m2
Do not administer

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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

Hypersensitivity, rashes, glomerulotubulopathy, proteinuria, abnormal blood counts (leukopenia, thrombocytopenia, aplastic anaemia), lupus-like clinical picture. Severe side effects in about 20% of patients (Wilson’s disease).

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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

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

Be aware of the possibility of hypersensitivity, glomerulotubulopathy or abnormal blood counts. Add pyridoxine 25 mg/day as prophylaxis vitamin B6 status.

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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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Reference

  1. Blau, Hoffmann, Leonard and Clarke, Physicians guide to the treatment and follow-up of metabolic diseases., Springer, 2006

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Changes

Changes