Trientine Hydrochloride

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Overview

What is Trientine Hydrochloride?

Trientine hydrochloride, USP is -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 CHN•2HCl with a molecular weight of 219.2. The structural formula is:

NH(CH)NH(CH)NH(CH)2NH•2HCl

Trientine hydrochloride, USP 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 black iron oxide, gelatin, potassium hydroxide, propylene glycol, shellac, stearic acid and titanium dioxide as inactive ingredients.

The USP Dissolution Test is pending.

What does Trientine Hydrochloride look like?

What are the available doses of Trientine Hydrochloride?

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What should I talk to my health care provider before I take Trientine Hydrochloride?

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How should I use Trientine Hydrochloride?

Trientine hydrochloride is 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 should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.

Unlike penicillamine, trientine hydrochloride 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, trientine hydrochloride was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.

Trientine hydrochloride is not indicated for treatment of biliary cirrhosis.

Systemic evaluation of dose and/or interval between dose has not been done. However, on limited clinical experience, the recommended initial dose of trientine hydrochloride 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 trientine hydrochloride 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 to 12 month intervals (see ).

It is important that trientine hydrochloride capsules 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.

What interacts with Trientine Hydrochloride?

Hypersensitivity to this product.

What are the warnings of Trientine Hydrochloride?

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What are the precautions of Trientine Hydrochloride?

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What are the side effects of Trientine Hydrochloride?

Clinical experience with trientine hydrochloride 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 ). In addition, the following adverse reactions have been reported in marketed use: dystonia, muscular spasm, myasthenia gravis.

Trientine hydrochloride 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.

To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

What should I look out for while using Trientine Hydrochloride?

Hypersensitivity to this product.

Patient experience with trientine hydrochloride is limited (see ). Patients receiving trientine hydrochloride capsules 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.

What might happen if I take too much Trientine Hydrochloride?

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.

How should I store and handle Trientine Hydrochloride?

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Keep tightly closed.Broken 1,000 mg tablets must be stored in the bottle and must be used within three months.Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Keep tightly closed.Broken 1,000 mg tablets must be stored in the bottle and must be used within three months.Trientine hydrochloride capsules, USP 250 mg, are white to off-white opaque hard gelatin capsules radially printed “” on the cap with black ink and body is plain. They are supplied as follows: NDC StorageKeep container tightly closed. Store at 2° to 8°C (36° to 46°F).Manufactured by:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: May 20172002532-02Trientine hydrochloride capsules, USP 250 mg, are white to off-white opaque hard gelatin capsules radially printed “” on the cap with black ink and body is plain. They are supplied as follows: NDC StorageKeep container tightly closed. Store at 2° to 8°C (36° to 46°F).Manufactured by:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: May 20172002532-02Trientine hydrochloride capsules, USP 250 mg, are white to off-white opaque hard gelatin capsules radially printed “” on the cap with black ink and body is plain. They are supplied as follows: NDC StorageKeep container tightly closed. Store at 2° to 8°C (36° to 46°F).Manufactured by:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: May 20172002532-02Trientine hydrochloride capsules, USP 250 mg, are white to off-white opaque hard gelatin capsules radially printed “” on the cap with black ink and body is plain. They are supplied as follows: NDC StorageKeep container tightly closed. Store at 2° to 8°C (36° to 46°F).Manufactured by:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: May 20172002532-02Trientine hydrochloride capsules, USP 250 mg, are white to off-white opaque hard gelatin capsules radially printed “” on the cap with black ink and body is plain. They are supplied as follows: NDC StorageKeep container tightly closed. Store at 2° to 8°C (36° to 46°F).Manufactured by:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: May 20172002532-02Trientine hydrochloride capsules, USP 250 mg, are white to off-white opaque hard gelatin capsules radially printed “” on the cap with black ink and body is plain. They are supplied as follows: NDC StorageKeep container tightly closed. Store at 2° to 8°C (36° to 46°F).Manufactured by:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: May 20172002532-02Trientine hydrochloride capsules, USP 250 mg, are white to off-white opaque hard gelatin capsules radially printed “” on the cap with black ink and body is plain. They are supplied as follows: NDC StorageKeep container tightly closed. Store at 2° to 8°C (36° to 46°F).Manufactured by:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: May 20172002532-02Trientine hydrochloride capsules, USP 250 mg, are white to off-white opaque hard gelatin capsules radially printed “” on the cap with black ink and body is plain. They are supplied as follows: NDC StorageKeep container tightly closed. Store at 2° to 8°C (36° to 46°F).Manufactured by:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: May 20172002532-02

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Clinical Information

Chemical Structure

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Clinical Pharmacology

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.

Non-Clinical Toxicology

Hypersensitivity to this product.

Patient experience with trientine hydrochloride is limited (see ). Patients receiving trientine hydrochloride capsules 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.

In general, mineral supplements should not be given since they may block the absorption of trientine hydrochloride. 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 trientine hydrochloride each inhibit absorption of the other, two hours should elapse between administration of trientine hydrochloride capsules and iron.

It is important that trientine hydrochloride capsules 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.

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.

Clinical experience with trientine hydrochloride 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 ). In addition, the following adverse reactions have been reported in marketed use: dystonia, muscular spasm, myasthenia gravis.

Trientine hydrochloride 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.

To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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