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:

Oceanside Pharmaceutials

INN (International Name):

trientine hydrochloride

Composition:

trientine hydrochloride 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 were reported not to be effective in improving any clinical or biochemical parameter after 12 weeks

Product summary:

Trientine Hydrochloride Capsules, 250 mg, are hard gelatin capsules with light brown opaque cap and body, imprinted with “SYPRINE” on cap and “ATON/710” on the body. They are supplied as follows: NDC 68682-212-10 in bottles of 100. Keep container tightly closed. Store at 2° to 8°C (36° to 46°F). Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Steinbach, MB R5G 1Z7, Canada ©2020 Bausch Health Companies Inc. or its affiliates Rev. 09/2020 9561202 20002992

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

TRIENTINE HYDROCHLORIDE- TRIENTINE HYDROCHLORIDE CAPSULE
OCEANSIDE PHARMACEUTIALS
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TRIENTINE HYDROCHLORIDE CAPSULES
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 are available as 250 mg capsules for
oral administration. Trientine
Hydrochloride Capsules contain gelatin, iron oxides, 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 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 2-164
months). Thirty-four of the 41 patients
improved, 4 had no change in clinical global response, 2 were lost to
follow-up and