TRIENTINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

MSN LABORATORIES PRIVATE LIMITED

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 ofa 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 i

Product summary:

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 69539-078-91 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 – 509 216, INDIA Distributed by: MSN Pharmaceuticals Inc. Piscataway, NJ 08854-3714 Issued on:   May 2019                                                                                                                                                                  

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIENTINE HYDROCHLORIDE - TRIENTINE HYDROCHLORIDE CAPSULE
MSN LABORATORIES PRIVATE LIMITED
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TRIENTINE HYDROCHLORIDE CAPSULES USP 250 MG
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 to