Posology : מינונים

4.2 Posology and method of administration
Treatment should only be initiated by specialist physicians with experience in the management of Wilson's disease.

Posology:

The starting dose would usually correspond to the lowest dose in the range and the dose should subsequently be adapted according to the patient's clinical response (see section 4.4).
Adults (including elderly): 1.0 -2.0 grams (4-8 capsules) daily in 2 to 4 divided doses.
The recommended doses are expressed as grams or mg of the trientine dihydrochloride salt.

Special populations

Elderly
No dose adjustment is required in elderly patients.
Renal impairment
There is limited information in patients with renal impairment. No specific dose adjustment is required in these patients (see section 4.4).

Hepatic impairment
There is no data available for the use of trientine in patients with impaired liver function. However, monitoring may be necessary to avoid either toxicity or inefficacy (see section 4.4).

Paediatric population
The starting dose in paediatrics is lower than for adults and depends on age and body weight.

Children≥ 5 years:
The weight-based dose is not established, but the initial dose generally used is 20 mg/kg/day rounded off to the nearest 250 mg capsule of trientine dihydrochloride given in two – three divided doses. The recommended initial dose of trientine dihydrochloride capsule is usually between 500-1250 mg (2-5 capsules). The maintenance dose is titrated according to clinical response and serum copper level.

Children aged < 5 years:
The safety and efficacy of trientine in children aged < 5 years have not been established. No data are available.

Method of administration
For oral use.

The capsules should be swallowed whole with water.
There is no information about chewing, opening and dispersing the capsule. It is important that trientine is given on an empty stomach, at least one hour before the meals or two hours after the meals and at least one hour apart from any other medicinal product, food, or milk (see section 4.5).