TRIENTINE HYDROCHLORIDE- trientine hydrochloride capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Camber Pharmaceuticals, Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 are 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 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 was reported not to be effective in improving any clinical or biochemical parameter after 12

Περίληψη προϊόντος:

Trientine hydrochloride capsules USP, 250 mg, are purple opaque cap/purple opaque body size ‘1’ hard gelatin capsules imprinted with ‘H’ on cap and ‘T4’ on the body with black ink, filled with white to pale yellow powder. They are supplied as follows: Bottles of 100               NDC 31722-683-01   STORAGE Keep container tightly closed. Store at 2° to 8°C (36° to 46°F). Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854 Manufactured by: HETERO TM HETERO LABS LIMITED      22-110, I.D.A., Jeedimetla,  Hyderabad - 500 055, India.                    Issued: 07/2022

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

TRIENTINE HYDROCHLORIDE - TRIENTINE HYDROCHLORIDE CAPSULE
CAMBER PHARMACEUTICALS, INC.
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TRIENTINE HYDROCHLORIDE CAPSULES, USP
DESCRIPTION
Trientine hydrochloride USP is
1,2-Ethanediamine,N,N'-bis(2-aminoethyl)-
,dihydrochloride. It is a white to pale yellow crystalline powder. It
is slightly soluble in
methanol.
The empirical formula is C
H
Cl
N
with a molecular weight of 219.15. The structural
formula is:
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 inactive
ingredients stearic
acid, the capsule shell contains D & C Red 28, FD & C Blue 1, gelatin,
and titanium
dioxide. The capsules are imprinted with black ink containing black
iron oxide, potassium
hydroxide, propylene glycol, shellac, strong ammonia solution.
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_
6
20
2
4
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,