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SYPRINE (trientine) is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with SYPRINE (trientine) is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. SYPRINE (trientine) and penicillamine cannot be considered interchangeable. SYPRINE (trientine) should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine, SYPRINE (trientine) is not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, SYPRINE (trientine) was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.
SYPRINE (trientine) is not indicated for treatment of biliary cirrhosis.
DOSAGE AND ADMINISTRATION
Systemic evaluation of dose and/or interval between dose has not been done. However, on limited clinical experience, the recommended initial dose of SYPRINE (trientine) is 500-750 mg/day for pediatric patients and 750-1250 mg/day for adults given in divided doses two, three or four times daily. This may be increased to a maximum of 2000 mg/day for adults or 1500 mg/day for pediatric patients age 12 or under.
The daily dose of SYPRINE (trientine) should be increased only when the clinical response is not adequate or the concentration of free serum copper is persistently above 20 mcg/dL. Optimal long-term maintenance dosage should be determined at 6-12 month intervals (see PRECAUTIONS, Laboratory Tests).
It is important that SYPRINE (trientine) be given on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other drug, food, or milk. The capsules should be swallowed whole with water and should not be opened or chewed.
Capsules SYPRINE (trientine) , 250 mg, are light brown opaque capsules coded SYPRINE (trientine) on one side and MSD 661 on the other. They are supplied as follows:
NDC 25010-710-15 in bottles of 100.
Keep container tightly closed.
Store at 2-8°C (36-46°F).
Distributed by: Aton Pharma, Lawrenceville, NJ 08648, USA. Manufactured by: Merck and Co., Inc., West Point, PA 19486 USA. Issued May 2007.
Last reviewed on RxList: 5/19/2009
This monograph has been modified to include the generic and brand name in many instances.
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