Trientine hydrochloride 250 MG Oral Capsule
INDICATIONS AND USAGE Trientine hydrochloride capsules are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride capsules is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defmed. Trientine hydrochloride capsules and penicillamine cannot be considered interchangeable. Trientine hydrochloride capsules should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine, trientine hydrochloride capsules are 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, trientine hydrochloride capsules was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment. Trientine hydrochloride capsules are not indicated for treatment of biliary cirrhosis.
Zydus Pharmaceuticals (USA) Inc.
CAPSULE BROWN 1203
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HOW SUPPLIED
TRIENTINE HYDROCHLORIDE capsules USP, 250 mg are white to pale yellow-colored crystalline powder filled in size '1' capsule having an opaque light brown cap printed with '1203' in black ink and an opaque white body and are supplied as follows: NDC 70710-1203-1 in bottles of 100 capsules with child-resistant closure. STORAGE Keep container tightly closed. Store at 2° to 8°C (36°to 46°F). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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