国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
trientine hydrochloride (UNII: HC3NX54582) (trientine - UNII:SJ76Y07H5F)
Oceanside Pharmaceutials
trientine hydrochloride
trientine hydrochloride 250 mg
ORAL
PRESCRIPTION DRUG
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
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
New Drug Application Authorized Generic
TRIENTINE HYDROCHLORIDE- TRIENTINE HYDROCHLORIDE CAPSULE OCEANSIDE PHARMACEUTIALS ---------- 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 完全なドキュメントを読む