Description
Trientine Hydrochloride 250 Mg 100 Caps.
1. Clinical information
1.1 Therapeutic indications
Trientine Hydrochloride is indicated for the treatment of Wilson’s disease in adults, adolescents and children who are intolerant of D-penicillamine therapy for 5 years.
1.2 Posology and method of administration
Treatment should only be initiated by specialist physicians experienced in treating Wilson ‘s disease.
Drug amounts information
The initial dose usually corresponds to the lowest dose in the range, and the dose should then be adapted to the patient’s clinical response.
The recommended dose is between 450 mg and 975 mg (3 to 6 ½ film-coated tablets) per day in 2 to 4 divided doses.
Special populations
Old
Dose adjustment is not required in elderly patients.
Pediatric population
The initial dose in pediatrics is lower than in adults and depends on age and body weight.
Child ≥ 5 years
The dose is usually (between 1 mg and 225 per day and 600 half-divided dose 4-2 film-coated tablets 4).
Children under 5 years old
The safety and efficacy of trientin in children under 5 years of age have not been established.
The pharmaceutical form is not suitable for application to children under 5 years old.
Recommended doses of Trientine Hydrochloride are expressed as mg trientine base (i.e. not in mg of the trientin tetrahydrochloride salt).
Method of Application
Trientine Hydrochloride is for oral use. Film-coated tablets should be swallowed with water. The drawn film-coated tablet may be divided into two equal halves, if necessary, to provide a more precise dose or to facilitate administration.
It is important that Trientine Hydrochloride is given on an empty stomach, at least one hour before meals or two hours after meals and at least one hour after any other medicinal product, food or milk.











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