Rx Item-Syprine 250Mg Cap 100 By Valeant Pharma

Clinical Information
Gen. Code and Des.
2554 trientine HCl ORAL CAPSULE 250 MG
GCN and Des.
720 trientine HCl ORAL CAPSULE 250 MG
Strength
250MG
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
64000000 HEAVY METAL ANTAGONISTS
Active Ingredients
1093 trientine HCl 38260014
Inactive Ingredients
2549 gelatin 9000708



SYPRINE- trientine hydrochloride capsule
Aton Pharma, Inc.

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 C6 H18 N4 �2HCl with a molecular weight of 219.2. The structural formula is:

NH2 (CH2 )2 NH(CH2 )2 NH(CH2 )2 NH2 �2HCl

Trientine hydrochloride is a chelating compound for removal of excess copper from the body. SYPRINE 1 (Trientine Hydrochloride) is available as 250 mg capsules for oral administration. Capsules SYPRINE 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.
DOSAGE AND ADMINISTRATION

Systemic evaluation of dose and/or interval between dose has not been done. However, on limited clinical experience, the recommended initial dose of SYPRINE is 500-750 mg/day for pediatric patients and 750-1250 mg/day for adults given in divided doses two, three or four times daily. This may be increased to a maximum of 2000 mg/day for adults or 1500 mg/day for pediatric patients age 12 or under.

The daily dose of SYPRINE should be increased only when the clinical response is not adequate or the concentration of free serum copper is persistently above 20 mcg/dL. Optimal long-term maintenance dosage should be determined at 6-12 month intervals (see PRECAUTIONS, Laboratory Tests).

It is important that SYPRINE be given on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other drug, food, or milk. The capsules should be swallowed whole with water and should not be opened or chewed.

HOW SUPPLIED

Capsules SYPRINE, 250 mg, are light brown opaque capsules coded SYPRINE on one side and ATON 710 on the other. They are supplied as follows:

NDC 25010-710-15 in bottles of 100.

Storage
Keep container tightly closed.

Store at 2-8�C (36-46�F).

RX ITEM-Syprine 250Mg Cap 100 By Valeant
NDC 00187-2120-10 UPC/GTIN No.3-01872-12010-1 Mfg.Part No.212010 SYPRINE, ATON 710 capsule , brown , oblong oblong OpaqueBlack ink TRIENTINE HCL

Syprine 250Mg Cap 100 By Valeant Pharma
BRAND: SYPRINE NDC: 00187-2120-10,187212010 UPC: 3-01872-12010-1,301872120101 Valeant Pharma

TRIENTINE HCL ORAL CAPSUL
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