TRIENTINE HYDROCHLORIDE capsule

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Kadmon Pharmaceuticals, LLC

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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

Ապրանքի ամփոփագիր:

Trientine Hydrochloride Capsules, USP, 250 mg are opaque white capsules coded KD034 250 mg on the body of the capsule printed in green ink and Kadmon ® on the cap of the capsule printed in blue ink. They are supplied as follows: NDC 66435-700-10 in bottles of 100. NDC 66435-700-12 blister pack (contains 12 Clovique (trientine hydrochloride), capsules 250mg). NDC 66435-700-20 carton (contains 10 Clovique blister packs) Bottle: Keep container tightly closed. Store at 2-8°C (36°F and 46°F). Carton/Blister Pack: Clovique carton should be kept refrigerated at 2-8°C (36°F and 46°F). For patient convenience, individual blister pack (or tray) may be stored for a maximum single period of 30 days at or below room temperature (25°C (77°F)) with protection from sources of heat and humidity. Capsules stored at room temperature should be discarded after 30 days. Manufactured by: Xcelience Tampa, FL 33607, USA Manufactured For: Kadmon Pharmaceuticals, LLC Warrendale, PA 15086, USA C151.00042 Rev. 12/2018

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

TRIENTINE HYDROCHLORIDE- TRIENTINE HYDROCHLORIDE CAPSULE
KADMON PHARMACEUTICALS, LLC
----------
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 Capsules, USP are available as 250 mg
capsules for oral
administration. Each capsule contains 250 mg trientine hydrochloride,
USP and the
inactive ingredient stearic acid. The capsule shell consists of
gelatin and titanium dioxide.
The capsule shell ink contains shellac, titanium dioxide, FD&C yellow
#5 aluminum lake,
FD&C blue #1 aluminum lake, FD&C blue#2/indigo carmine aluminum lake,
and FD&C
blue #1/brilliant blue FCF aluminum lake.
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 cl