TRIENTINE HYDROCHLORIDE capsule

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Trientine Hydrochloride (UNII: HC3NX54582) (Trientine - UNII:SJ76Y07H5F)

Saatavilla:

Dr.Reddys Laboratories Inc

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Trientine hydrochloride capsules are 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 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 was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.   Trienti

Tuoteyhteenveto:

Trientine hydrochloride capsules USP, 250 mg, are yellow opaque, hard gelatin size “1” capsules imprinted with “RDY” on cap and “459” on body in black ink filled with white to pale yellow powder. They are supplied as follows:   Bottle of 100 capsules NDC 43598-459-01 STORAGE   Keep container tightly closed. Store at 20°C to 25°C (68°F to 77°F); [see USP Controlled Room Temperature].  Distributed by: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 USA   Made in India     Issued: 07/2019

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

TRIENTINE HYDROCHLORIDE- TRIENTINE HYDROCHLORIDE CAPSULE
DR.REDDYS LABORATORIES INC
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DESCRIPTION
Trientine hydrochloride is N,N'-bis (2-aminoethyl)-1,2-ethanediamine
dihydrochloride. It is a white to
pale yellow powder. It is soluble in methanol and freely soluble in
water.
The molecular 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, USP is available as 250 mg capsules for oral
administration. Trientine
hydrochloride capsules, USP contain colloidal silicon dioxide, ferric
oxide yellow, gelatin, magnesium
stearate, polyethylene glycol, and titanium dioxide as inactive
ingredients. Imprinting ink contains black
iron oxide, potassium hydroxide, propylene glycol and shellac.
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 164
months). Thirty-four of the 41
patients improved, 4 had no change in clinical global res