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

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.

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

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).

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.

Interactions

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

• MUSCULO-SKELETAL SYSTEM
• ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

SPECIFIC ANTIRHEUMATIC AGENTS

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

Reference

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

Changes

Therapeutic Drug Monitoring

Overdose