TRIENTINE HYDROCHLORIDE capsule

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Lannett Company Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Trientine Hydrochloride Capsule is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with Trientine Hydrochloride Capsule 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 Capsule and penicillamine cannot be considered interchangeable. Trientine hydrochloride Capsule should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine, Trientine Hydrochloride Capsule 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 Capsule was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treat

Vörulýsing:

Trientine Hydrochloride Capsules, USP 250 mg, are hard gelatin capsules with opaque orange cap imprinted with NAV and opaque white body imprinted with 101 in black ink. They are supplied as follows: NDC 0527-4068-37 in bottles of 100.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

TRIENTINE HYDROCHLORIDE - TRIENTINE HYDROCHLORIDE CAPSULE
LANNETT COMPANY INC.
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TRIENTINE HYDROCHLORIDE CAPSULES USP
RX ONLY
DESCRIPTION
Trientine hydrochloride 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 empirical 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 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 stearic
acid, gelatin,
titanium dioxide and FD&C yellow 6 as inactive ingredients. Imprinting
ink contains
shellac, propylene glycol, black iron oxide and potassium hydroxide.
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 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. The mean duration of trientine
hydrochloride
therapy was 48.7 months (range 2-164 months).
Thirty-four of