TRIENTINE HYDROCHLORIDE capsule

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Rising Pharmaceuticals, Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Trientine hydrochloride is 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 should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine, trientine hydrochloride 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, trientine hydrochloride was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment. Trientine hydrochloride is not indicated f

Резиме производа:

Trientine Hydrochloride Capsules, USP 250 mg, are Size “1” hard gelatin capsule with brown opaque cap/brown opaque body, imprinted “C27” on cap with black ink and “250mg” on body with black ink filled with white to pale yellow powder. They are supplied as follows: NDC 64980-450-01 Bottles of 100 Capsules. Storage Keep container tightly closed. Store at 2°C to 8°C (36°F to 46°F).  Manufactured by: Suven Life Sciences Limited Plot No. 262-271, IDA, Pashamylaram, Sangareddy District, Telangana, India 502307 Distributed by: Rising Pharmaceuticals, Inc. Saddle brook, NJ 07663 M.L No.: 24/MD/AP/2009/F/R Rev.  02/2020

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

TRIENTINE HYDROCHLORIDE- TRIENTINE HYDROCHLORIDE CAPSULE
RISING PHARMACEUTICALS, INC.
----------
TRIENTINE HYDROCHLORIDE CAPSULES, USP
RX ONLY
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 219.2. The structural
formula is: NH (CH ) NH(CH ) NH(CH ) NH •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.
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-