TRIENTINE HYDROCHLORIDE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

TRIENTINE HYDROCHLORIDE (UNII: HC3NX54582) (TRIENTINE - UNII:SJ76Y07H5F)

Commercializzato da:

Zydus Pharmaceuticals USA Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 o

Dettagli prodotto:

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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

TRIENTINE HYDROCHLORIDE - TRIENTINE HYDROCHLORIDE CAPSULE
ZYDUS PHARMACEUTICALS USA INC.
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TRIENTINE HYDROCHLORIDE CAPSULES, USP
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 C H
N •2HCl with a molecular weight of 219.16. The
structural formula is:
Trientine hydrochloride is a chelating compound for removal of excess
copper from the
body. Trientine hydrochloride capsules, USP intended for oral
administration contains
250 mg of trientine hydrochloride, USP and contains following inactive
ingredients:
gelatin, iron oxide red, iron oxide yellow, stearic acid, and titanium
dioxide.
The capsule is imprinted with black pharmaceutical ink and contains
following inactive
ingredients: black iron oxide, potassium hydroxide, propylene glycol,
purified water and
shellac.
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.
6
18
4
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 mg to
2,400 mg per day. The average dosage required to achieve an optimal
clinical response
varied between 1,000 mg and 2,000 mg per day. Th