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 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. Trientine hydrochloride 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 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.

Dr.Reddys Laboratories Inc

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] off label use` `[4] pain` `[5] nausea` `[6] headache` `[7] dyspnoea` `[8] pyrexia` `[9] arthralgia` `[10] toxicity to various agents`

4 years ago

CAPSULE YELLOW RDY 459

HOW SUPPLIED

TRIENTINE HYDROCHLORIDE capsules USP, 250 mg, are yellow opaque, hard gelatin size “1” capsules imprinted with “RDY” on cap and “459” on body in black ink filled with white to pale yellow powder. They are supplied as follows: Bottle of 100 capsules NDC 43598-459-01 STORAGE Keep container tightly closed. Store at 20°C to 25°C (68°F to 77°F); [see USP Controlled Room Temperature]. Distributed by: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 USA Made in India Issued: 07/2019

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Trientine hydrochloride 250 MG Oral Capsule

FDA Reported Adverse Reactions [1] drug ineffective [2] fatigue [3] off label use [4] pain [5] nausea [6] headache [7] dyspnoea [8] pyrexia [9] arthralgia [10] toxicity to various agents

CAPSULE YELLOW RDY 459

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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] off label use` `[4] pain` `[5] nausea` `[6] headache` `[7] dyspnoea` `[8] pyrexia` `[9] arthralgia` `[10] toxicity to various agents`