Special Warning : אזהרת שימוש

8.   WARNINGS
Patient experience with trientine hydrochloride is limited (see 6. CLINICAL PHARMACOLOGY). Patients receiving trientine hydrochloride should remain under regular medical supervision throughout the period of drug administration. Patients (especially women) should be closely monitored for evidence of iron deficiency anemia. For the first month of treatment, the patient should have his temperature taken nightly, and he should be asked to report any symptom such as fever or skin eruption.
Because of the potential for contact dermatitis, any site of exposure to the capsule contents should be washed with water promptly.

9.   PRECAUTIONS
General
There are no reports of hypersensitivity in patients who have been administered trientine hydrochloride for Wilson’s disease. However, there have been reports of asthma, bronchitis and dermatitis occurring after prolonged environmental exposure in workers who use trientine hydrochloride as a hardener of epoxy resins. Patients should be observed closely for signs of possible hypersensitivity.
Laboratory Tests
The most reliable index for monitoring treatment is the determination of free copper in the serum, which equals the difference between quantitatively determined total copper and ceruloplasmin-copper. Adequately treated patients will usually have less than 10 mcg free copper/dL of serum.
Therapy may be monitored with a 24-hour urinary copper analysis periodically (i.e., every 6- 12 months). Urine must be collected in copper-free glassware. Since a low copper diet should keep copper absorption down to less than one milligram a day, the patient probably will be in the desired state of negative copper balance if 0.5 to 1.0 mg of copper is present in a 24-hour collection of urine.

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