Trientine Hydrochloride 250 mg Capsule, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Copper Chelator class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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UNII 8PJ61P6TS3
Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
12 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $2.303 | $230.25 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $4.48 | $448.46 / 100 capsules |
| Medicare drug plans payPart D · Q2 2026 | $16.77 | $1,677.00 / 100 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Trientine Hydrochloride 250 mg 16571-0810-01 | Rising | 100 capsules | $2.303 | — | Availability likely | — |
| Trientine Hydrochloride 250 mg 31722-0683-01 | Camber | 100 capsules | $2.303 | AB | Availability likely | — |
| Trientine Hydrochloride 250 mg 43598-0459-01 | Dr.Reddys | 100 capsules | $2.303 | AB | Availability likely | — |
| Trientine Hydrochloride 250 mgthis 49884-0060-01 | Par | 100 capsules | $2.303 | — | Availability likely | — |
| Trientine hydrochloride 250 mg 72205-0008-91 | Novadoz | 100 capsules | $2.303 | AB | Availability likely | — |
| Syprine 250 mg 00187-2120-10 | Bausch | 100 capsules | — | AB | FDA listed | — |
| Trientine Hydrochloride 250 mg 68475-0200-01 | Navinta | 100 capsules | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 49884-0060-01 You're viewing this | 100 CAPSULE in 1 BOTTLE (49884-060-01) | 2019-09-27 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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 was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment. Trientine hydrochloride capsules are not indicated for treatment of biliary cirrhosis.
⏱️ Dosage and Administration ▾
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 trientine hydrochloride capsules is 500 to 750 mg/day for pediatric patients and 750 to 1,250 mg/day for adults given in divided doses two, three or four times daily. This may be increased to a maximum of 2,000 mg/day for adults or 1,500 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 PRECAUTIONS , Laboratory Tests ). 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.
⛔ Contraindications ▾
CONTRAINDICATIONS Hypersensitivity to this product.
⚠️ Warnings ▾
WARNINGS Patient experience with trientine hydrochloride is limited (see CLINICAL PHARMACOLOGY ). Patients receiving trientine hydrochloride 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.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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 CLINICAL PHARMACOLOGY ). 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 REACTIONS, contact Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
Drug Interactions 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 and iron.
It is important that trientine hydrochloride 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.
🆘 Overdosage ▾
OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
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 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 d-penicillamine 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…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Trientine Hydrochloride Capsules, USP are light brown opaque size ‘1’ capsule imprinted "PAR" on cap and “060” on the body containing white to off white powder. They are supplied as follows: NDC 49884-060-01 in bottles of 100 Storage Keep container tightly closed. Store at 2° to 8°C (36° to 46°F).
Manufactured for: Endo USA Malvern, PA 19355 U.S.A. Made in India Neutral Code: TN/DRUGS/TN00002121 © 2024 Endo, Inc. or one of its affiliates. OS060-01-74-02 Revised: 11/2024
📋 Description ▾
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 6 H 18 N 4 •2HCl with a molecular weight of 219.2. The structural formula is: NH 2 (CH 2 ) 2 NH(CH 2 ) 2 NH(CH 2 ) 2 NH 2 •2HCl Trientine hydrochloride is a chelating compound for removal of excess copper from the body. Trientine hydrochloride is available as 250 mg capsules for oral administration.
Trientine hydrochloride capsules USP, 250 mg contain stearic acid. In addition, the empty hard gelatin capsule shells contain gelatin, iron oxide black, iron oxide red, iron oxide yellow and titanium dioxide. The capsule shells are imprinted with TEK black ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.