Syprine (Trientine)
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Syprine (Trientine)

SYPRINE
(trientine hydrochloride) Capsule

DRUG 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 C6H18N4•2HCl with a molecular weight of 219.2. The structural formula is:

NH2(CH2)2NH(CH2)2NH(CH2)2NH2•2HCl

Trientine hydrochloride is a chelating compound for removal of excess copper from the body. SYPRINE1 (Trientine Hydrochloride) is available as 250 mg capsules for oral administration. Capsules SYPRINE (trientine) contain gelatin, iron oxides, stearic acid, and titanium dioxide as inactive ingredients.

What are the possible side effects of trientine (Syprine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • cough, trouble breathing;
  • pale skin, easy bruising or bleeding, weakness;
  • tired feeling, muscle or joint pain, swollen glands;
  • seizure (convulsions);
  • muscle weakness, dropping eyelids, double vision; or
  • problems with speech, balance, walking, lifting, chewing, or swallowing;

Less serious...

Read All Potential Side Effects and See Pictures of Syprine »

Last reviewed on RxList: 5/19/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

SYPRINE (trientine) is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with SYPRINE (trientine) 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. SYPRINE (trientine) and penicillamine cannot be considered interchangeable. SYPRINE (trientine) should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine, SYPRINE (trientine) is 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, SYPRINE (trientine) was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.

SYPRINE (trientine) is not indicated for treatment of biliary cirrhosis.

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 (trientine) 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 (trientine) 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 (trientine) 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 (trientine) , 250 mg, are light brown opaque capsules coded SYPRINE (trientine) on one side and MSD 661 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).

Distributed by: Aton Pharma, Lawrenceville, NJ 08648, USA. Manufactured by: Merck and Co., Inc., West Point, PA 19486 USA. Issued May 2007.

Last reviewed on RxList: 5/19/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Clinical experience with SYPRINE (trientine) has been limited. The following adverse reactions have been reported in a clinical study in patients with Wilson's disease who were on therapy with trientine hydrochloride: iron deficiency, systemic lupus erythematosus (see CLINICAL PHARMACOLOGY). In addition, the following adverse reactions have been reported in marketed use: dystonia, muscular spasm, myasthenia gravis.

SYPRINE (trientine) is not indicated for treatment of biliary cirrhosis, but in one study of 4 patients treated with trientine hydrochloride for primary biliary cirrhosis, the following adverse reactions were reported: heartburn; epigastric pain and tenderness; thickening, fissuring and flaking of the skin; hypochromic microcytic anemia; acute gastritis; aphthoid ulcers; abdominal pain; melena; anorexia; malaise; cramps; muscle pain; weakness; rhabdomyolysis. A causal relationship of these reactions to drug therapy could not be rejected or established.

Read the Syprine (trientine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

In general, mineral supplements should not be given since they may block the absorption of SYPRINE (trientine) . However, iron deficiency may develop, especially in children and menstruating or pregnant women, or as a result of the low copper diet recommended for Wilson's disease. If necessary, iron may be given in short courses, but since iron and SYPRINE (trientine) each inhibit absorption of the other, two hours should elapse between administration of SYPRINE (trientine) and iron.

It is important that SYPRINE (trientine) be taken 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. This permits maximum absorption and reduces the likelihood of inactivation of the drug by metal binding in the gastrointestinal tract.

Last reviewed on RxList: 5/19/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Patient experience with trientine hydrochloride is limited (see CLINICAL PHARMACOLOGY). Patients receiving SYPRINE (trientine) should remain under regular medical supervision throughout the period of drug administration. Patients (especially women) should be closely monitored for evidence of iron deficiency anemia.

PRECAUTIONS

General

There are no reports of hypersensitivity in patients who have been administered trientine hydrochloride for Wilson's disease. However, there have been reports of asthma, bronchitis and dermatitis occurring after prolonged environmental exposure in workers who use trientine hydrochloride as a hardener of epoxy resins. Patients should be observed closely for signs of possible hypersensitivity.

Laboratory Tests

The most reliable index for monitoring treatment is the determination of free copper in the serum, which equals the difference between quantitatively determined total copper and ceruloplasmin-copper. Adequately treated patients will usually have less than 10 mcg free copper/dL of serum.

Therapy may be monitored with a 24-hour urinary copper analysis periodically (i.e., every 6-12 months). Urine must be collected in copper-free glassware. Since a low copper diet should keep copper absorption down to less than one milligram a day, the patient probably will be in the desired state of negative copper balance if 0.5 to 1.0 milligram of copper is present in a 24-hour collection of urine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Data on carcinogenesis, mutagenesis, and impairment of fertility are not available.

Pregnancy

Pregnancy Category C

Trientine hydrochloride was teratogenic in rats at doses similar to the human dose. The frequencies of both resorptions and fetal abnormalities, including hemorrhage and edema, increased while fetal copper levels decreased when trientine hydrochloride was given in the maternal diets of rats. There are no adequate and well-controlled studies in pregnant women. SYPRINE (trientine) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SYPRINE (trientine) is administered to a nursing mother.

Pediatric Use

Controlled studies of the safety and effectiveness of SYPRINE (trientine) in pediatric patients have not been conducted. It has been used clinically in pediatric patients as young as 6 years with no reported adverse experiences.

Geriatric Use

Clinical studies of SYPRINE (trientine) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience is insufficient to determine differences in responses between the elderly and younger patients. In general, dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Last reviewed on RxList: 5/19/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

There is a report of an adult woman who ingested 30 grams of trientine hydrochloride without apparent ill effects. No other data on overdosage are available.

CONTRAINDICATIONS

Hypersensitivity to this product.

Last reviewed on RxList: 5/19/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Introduction

Wilson's disease (hepatolenticular degeneration) is an autosomal inherited metabolic defect resulting in an inability to maintain a nearzero 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 one showed deterioration in clinical condition. One of the patients who improved while on therapy with trientine hydrochloride experienced a recurrence of the symptoms of systemic lupus erythematosus which had appeared originally during therapy with penicillamine. Therapy with trientine hydrochloride was discontinued. No other adverse reactions, except iron deficiency, were noted among any of these 41 patients.

One investigator treated 13 patients with trientine hydrochloride following their development of intolerance to d-penicillamine. Retrospectively, he compared these patients to an additional group of 12 patients with Wilson's disease who were both tolerant of and controlled with d-penicillamine therapy, but who failed to continue any copper chelation therapy. The mean age at onset of disease of the latter group was 12 years as compared to 21 years for the former group. The trientine hydrochloride group received dpenicillamine for an average of 4 years as compared to an average of 10 years for the non-treated group.

Various laboratory parameters showed changes in favor of the patients treated with trientine hydrochloride. Free and total serum copper, SGOT, and serum bilirubin all showed mean increases over baseline in the untreated group which were significantly larger than with the patients treated with trientine hydrochloride. In the 13 patients treated with trientine hydrochloride, previous symptoms and signs relating to d-penicillamine intolerance disappeared in 8 patients, improved in 4 patients, and remained unchanged in one patient. The neurological status in the trientine hydrochloride group was unchanged or improved over baseline, whereas in the untreated group, 6 patients remained unchanged and 6 worsened. Kayser-Fleischer rings improved significantly during trientine hydrochloride treatment.

The clinical outcome of the two groups also differed markedly. Of the 13 patients on therapy with trientine hydrochloride (mean duration of therapy 4.1 years; range 1 to 13 years), all were alive at the data cutoff date, and in the non-treated group (mean years with no therapy 2.7 years; range 3 months to 9 years), 9 of the 12 died of hepatic disease.

Chelating Properties

Preclinical Studies

Studies in animals have shown that trientine hydrochloride has cupriuretic activities in both normal and copper-loaded rats. In general, the effects of trientine hydrochloride on urinary copper excretion are similar to those of equimolar doses of penicillamine, although in one study they were significantly smaller.

Human Studies

Renal clearance studies were carried out with penicillamine and trientine hydrochloride on separate occasions in selected patients treated with penicillamine for at least one year. Six-hour excretion rates of copper were determined off treatment and after a single dose of 500 mg of penicillamine or 1.2 g of trientine hydrochloride. The mean urinary excretion rates of copper were as follows:

No. of Patients Single Dose Treatment Basal Excretion Rate
(μg Cu + + /6hr)
Test-dose Excretion Rate
(μg Cu + + /6hr)
6 Trientine, 1.2 g 19 234
4 Penicillamine, 500 mg 17 320

In patients not previously treated with chelating agents, a similar comparison was made:

No. of Patients Single Dose Treatment Basal Excretion Rate
(μg Cu + + /6hr)
Test-dose Excretion Rate
(μg Cu + + /6hr)
8 Trientine, 1.2 g 71 1326
7 Penicillamine, 500 mg 68 1074

These results demonstrate that SYPRINE (trientine) is effective as a cupriuretic agent in patients with Wilson's disease although on a molar basis it appears to be less potent or less effective than penicillamine. Evidence from a radio-labelled copper study indicates that the different cupriuretic effect between these two drugs could be due to a difference in selectivity of the drugs for different copper pools within the body.

Pharmacokinetics

Data on the pharmacokinetics of trientine hydrochloride are not available. Dosage adjustment recommendations are based upon clinical use of the drug (see DOSAGE AND ADMINISTRATION).

Last reviewed on RxList: 5/19/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients should be directed to take SYPRINE (trientine) 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. Because of the potential for contact dermatitis, any site of exposure to the capsule contents should be washed with water promptly. For the first month of treatment, the patient should have his temperature taken nightly, and he should be asked to report any symptom such as fever or skin eruption.

Last reviewed on RxList: 5/19/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients should be directed to take SYPRINE (trientine) 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. Because of the potential for contact dermatitis, any site of exposure to the capsule contents should be washed with water promptly. For the first month of treatment, the patient should have his temperature taken nightly, and he should be asked to report any symptom such as fever or skin eruption.

Last reviewed on RxList: 5/19/2009
This monograph has been modified to include the generic and brand name in many instances.

SYPRINE
(trientine hydrochloride) Capsule

DRUG 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 C6H18N4•2HCl with a molecular weight of 219.2. The structural formula is:

NH2(CH2)2NH(CH2)2NH(CH2)2NH2•2HCl

Trientine hydrochloride is a chelating compound for removal of excess copper from the body. SYPRINE1 (Trientine Hydrochloride) is available as 250 mg capsules for oral administration. Capsules SYPRINE (trientine) contain gelatin, iron oxides, stearic acid, and titanium dioxide as inactive ingredients.

Last reviewed on RxList: 5/19/2009
This monograph has been modified to include the generic and brand name in many instances.

SYPRINE
(trientine hydrochloride) Capsule

DRUG 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 C6H18N4•2HCl with a molecular weight of 219.2. The structural formula is:

NH2(CH2)2NH(CH2)2NH(CH2)2NH2•2HCl

Trientine hydrochloride is a chelating compound for removal of excess copper from the body. SYPRINE1 (Trientine Hydrochloride) is available as 250 mg capsules for oral administration. Capsules SYPRINE (trientine) contain gelatin, iron oxides, stearic acid, and titanium dioxide as inactive ingredients.

Last reviewed on RxList: 5/19/2009
This monograph has been modified to include the generic and brand name in many instances.

SYPRINE
(trientine hydrochloride) Capsule

DRUG 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 C6H18N4•2HCl with a molecular weight of 219.2. The structural formula is:

NH2(CH2)2NH(CH2)2NH(CH2)2NH2•2HCl

Trientine hydrochloride is a chelating compound for removal of excess copper from the body. SYPRINE1 (Trientine Hydrochloride) is available as 250 mg capsules for oral administration. Capsules SYPRINE (trientine) contain gelatin, iron oxides, stearic acid, and titanium dioxide as inactive ingredients.

Last reviewed on RxList: 5/19/2009
This monograph has been modified to include the generic and brand name in many instances.

Syprine Patient Information Including Side Effects

Brand Names: Syprine

Generic Name: trientine (Pronunciation: TRYE en teen)

What is trientine (Syprine)?

Trientine is a chelating (KEE-late-ing) agent. A chelating agent is capable of removing a heavy metal, such as lead, mercury, or copper, from the blood.

Trientine is used to treat Wilson's disease in people who cannot take penicillamine (Cuprimine, Depen).

Wilson's disease is a genetic metabolic defect that causes excess copper to build up in the body.

Trientine may also be used for purposes not listed in this medication guide.

What are the possible side effects of trientine (Syprine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • cough, trouble breathing;
  • pale skin, easy bruising or bleeding, weakness;
  • tired feeling, muscle or joint pain, swollen glands;
  • seizure (convulsions);
  • muscle weakness, dropping eyelids, double vision; or
  • problems with speech, balance, walking, lifting, chewing, or swallowing;

Less serious side effects include:

  • skin rash;
  • muscle spasm or contractions;
  • heartburn;
  • stomach pain;
  • loss of appetite; or
  • skin flaking, cracking, or thickening;

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Syprine (trientine) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about trientine (Syprine)?

Before using trientine, tell your doctor if you are allergic to any drugs, or if you have rheumatoid arthritis, a kidney or bladder condition called cystinuria, or a liver condition called biliary cirrhosis.

Take the trientine capsule with water. Do not take trientine with milk.

Take trientine on an empty stomach, at least 1 hour before or 2 hours after eating a meal or snack or taking any other medicines.

Do not chew or open a trientine capsule. Swallow the pill whole.

Do not use a capsule that has been accidentally broken. The medicine from a broken capsule can be dangerous if it gets on your skin. If skin contact occurs, rinse the area thoroughly with plain water. Watch for signs of skin irritation and call your doctor if you develop a rash.

You may need to take your temperature every night for at least the first month of treatment with trientine. Call your doctor if you have a fever.

Side Effects Centers

Syprine Patient Information including How Should I Take

What should I discuss with my health care provider before taking trientine (Syprine)?

You should not use this medication if you are allergic to trientine.

Before using trientine, tell your doctor if you are allergic to any drugs, or if you have:

  • rheumatoid arthritis;
  • a kidney or bladder condition called cystinuria; or
  • a liver condition called biliary cirrhosis.

If you have any of these conditions, you may need dose adjustments or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether trientine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take trientine (Syprine)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take the trientine capsule with water. Do not take trientine with milk.

Take trientine on an empty stomach, at least 1 hour before or 2 hours after eating a meal or snack or taking any other medicines.

Trientine is usually taken 2 to 4 times each day. Follow your doctor's instructions.

Do not chew or open a trientine capsule. Swallow the pill whole.

Do not use a capsule that has been accidentally broken. The medicine from a broken capsule can be dangerous if it gets on your skin. If skin contact occurs, rinse the area thoroughly with plain water. Watch for signs of skin irritation and call your doctor if you develop a rash.

You may need to take your temperature every night for at least the first month of treatment with trientine. Call your doctor if you have a fever.

To be sure this medication is helping your condition, your blood will need to be tested often. Your iron levels will also be checked to make sure they don't get too low. Do not miss any scheduled appointments.

Store this medication in the refrigerator and do not allow it to freeze.

Side Effects Centers

Syprine Patient Information including If I Miss a Dose

What happens if I miss a dose (Syprine)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Syprine)?

A trientine overdose is not expected to produce life-threatening symptoms.

What should I avoid while taking trientine (Syprine)?

Avoid eating, drinking milk, or taking other medications within 1 hour before or after taking trientine.

Do not take any vitamins or mineral supplements unless your doctor tells you to. You may occasionally need to take an iron supplement, but follow your doctor's instructions.

What other drugs will affect trientine (Syprine)?

There may be other drugs that can interact with trientine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about trientine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.03. Revision date: 12/15/2010.

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