Trientine Hydrochloride

Prescription

Nomes comerciais: Trientine Hydrochloride

Forma Farmacêutica

Capsule

Via de Administração

ORAL

Fabricante

Endo USA, Inc.

About This Medication

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.

Princípios Ativos

Ingrediente	Concentração
Trientine Hydrochloride	-

Indicações e Uso

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.

Posologia e Administração

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.

Side Effects Overview

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.

Advertências e Precauções

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.

Contraindicações

CONTRAINDICATIONS Hypersensitivity to this product.

Farmacocinética

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 ).

Frequently Asked Questions

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 …

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 …

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.

CONTRAINDICATIONS Hypersensitivity to this product.

Trientine Hydrochloride is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Trientine Hydrochloride drug label (National Library of Medicine)
• openFDA — Trientine Hydrochloride label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 313472 (NLM Normalized Drug Names)
• NDC Directory — Trientine Hydrochloride (FDA National Drug Code)

Aviso Médico

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Fontes de dados: DailyMed (NLM), openFDA, MFDS