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Trientine Capsules
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  • FDA PI

Trientine Capsules

Generic name: trientine hydrochloride
Dosage form: capsule
Drug class:Chelating agents

Medically reviewed by Drugs.com. Last updated on Oct 1, 2021.

Trientine Capsules Description

Trientine hydrochloride, USP is N,N'-bis (2-aminoethyl)-1,2-ethanediamine dihydrochloride. It is a white to pale yellow crystalline hygroscopic powder. It is freely soluble in water, soluble in methanol, slightly soluble in ethanol, and insoluble in chloroform and ether.

The molecular formula is C6H18N4•2HCl with a molecular weight of 219.2. The structural formula is: NH2(CH2)2NH(CH2)2NH(CH2)2NH2•2HCl

Trientine hydrochloride, USP is a chelating compound for removal of excess copper from the body.

Trientine hydrochloride, USP is available as 250 mg capsules for oral administration. Trientine hydrochloride capsules, USP contain gelatin, iron oxide black, iron oxide red, iron oxide yellow, potassium hydroxide, propylene glycol, shellac, stearic acid and titanium dioxide as inactive ingredients.

Trientine Capsules - Clinical Pharmacology

Introduction

Wilson's disease (hepatolenticular degeneration) is an autosomal inherited metabolic defect resulting in an inability to maintain a near-zero balance of copper. Excess copper accumulates possibly because the liver lacks the mechanism to excrete free copper into the bile. Hepatocytes store excess copper but when their capacity is exceeded copper is released into the blood and is taken up into extrahepatic sites. This condition is treated with a low copper diet and the use of chelating agents that bind copper to facilitate its excretion from the body.

Clinical Summary
Forty-one patients (18 male and 23 female) between the ages of 6 and 54 with a diagnosis of Wilson's disease and who were intolerant of d-penicillamine were treated in two separate studies with trientine hydrochloride. The dosage varied from 450 to 2400 mg per day. The average dosage required to achieve an optimal clinical response varied between 1000 mg and 2000 mg per day. The mean duration of trientine hydrochloride therapy was 48.7 months (range 2 to 164 months). Thirty-four of the 41 patients improved, 4 had no change ..