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:

Novadoz Pharmaceuticals LLC

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Trientine hydrochloride capsules USP 250 mg is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride capsules USP 250 mg 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 capsules USP 250 mg and penicillamine cannot be considered interchangeable. Trientine hydrochloride capsules USP 250 mg 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 USP 250 mg 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 capsules USP 250 mg was reported not to be effective

Dettagli prodotto:

Trientine hydrochloride capsules, USP 250 mg, are capsules with light brown opaque body imprinted with "250" and light brown opaque cap imprinted with "TRN" in black ink. They are supplied as follows: NDC 72205-008-91 in bottles of 100. STORAGE Dispense in a tight container and store in a refrigerator; 2 to 8°C (36 to 46°F). Keep container tightly closed. Manufactured by: MSN Laboratories Private Limited Telangana – 509 228, INDIA Distributed by: Novadoz Pharmaceuticals LLC Piscataway, NJ 08854-3714 Issued on:   June 2022

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

TRIENTINE HYDROCHLORIDE - TRIENTINE HYDROCHLORIDE CAPSULE
NOVADOZ PHARMACEUTICALS LLC
----------
TRIENTINE HYDROCHLORIDE CAPSULES USP 250 MG R ONLY
DESCRIPTION
Trientine hydrochloride is 1,2-Ethanediamine, N,N'-bis
(2-aminoethyl)-,dihydrochloride. It
is a white to pale yellow crystalline powder. It is freely soluble in
water, soluble in
methanol, slightly soluble in alcohol (96%), and insoluble in
chloroform and in ether.
The empirical formula is C H
N •2HCl with a molecular weight of 219.16. The structural
formula is: NH (CH ) NH(CH ) NH(CH ) NH •2HCI
Trientine hydrochloride is a chelating compound for removal of excess
copper from the
body. Trientine hydrochloride capsules USP 250 mg are available as 250
mg capsules for
oral administration.Trientine hydrochloride capsules USP 250 mg
contains 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 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 t