TRIENTINE HYDROCHLORIDE capsule

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Par Pharmaceutical, Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

Trientine Hydrochloride Capsules, USP are light brown opaque size ‘1’ capsule imprinted "PAR" on cap and “060” on the body containing white to off white powder. They are supplied as follows: NDC  49884-060-01 in bottles of 100 Storage Keep container tightly closed. Store at 2° to 8°C (36° to 46°F). Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Formulations Private Limited, 9/215, Pudupakkam, Kelambakkam - 603 103. Made in India Mfg. Lic. No.: TN00002121 OS060-01-74-01 Issued: 06/2017

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

TRIENTINE HYDROCHLORIDE- TRIENTINE HYDROCHLORIDE CAPSULE
PAR PHARMACEUTICAL, INC.
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TRIENTINE HYDROCHLORIDE CAPSULES USP, 250 MG
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 is available as 250 mg capsules for oral
administration. Trientine
hydrochloride capsules USP, 250 mg contain stearic acid. In addition,
the empty hard gelatin capsule
shells contain gelatin, iron oxide black, iron oxide red, iron oxide
yellow and titanium dioxide. The
capsule shells are imprinted with tek black ink containing butyl
alcohol, dehydrated alcohol, isopropyl
alcohol, potassium hydroxide, propylene glycol, shellac and 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
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
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