Trientine Hydrochloride
Generic Name: trientine hydrochloride
Brand Names:
Trientine Hydrochloride
DESCRIPTION Trientine hydrochloride, USP 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 molecular formula is C 6 H 18 N 4 •2HCl with a molecular weight of 219.2.
Overview
DESCRIPTION Trientine hydrochloride, USP 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 molecular formula is C 6 H 18 N 4 •2HCl with a molecular weight of 219.2.
Uses
INDICATIONS AND USAGE 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.
Side Effects
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.
Interactions
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 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.
Warnings
WARNINGS Patient experience with trientine hydrochloride is limited (see CLINICAL PHARMACOLOGY ). 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. CONTRAINDICATIONS Hypersensitivity to this product.
Pregnancy
Pregnancy 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. Trientine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Storage
HOW SUPPLIED Trientine Hydrochloride Capsule, USP 250 mg, are Size “1” hard gelatin capsule with brown opaque cap/brown opaque body, imprinted “C27” on cap with black ink and “250mg” on body with black ink filled with white to pale yellow powder. They are supplied as follows: NDC 16571-810-01 Bottles of 100 Capsules.
Frequently Asked Questions
What is Trientine Hydrochloride used for?▼
INDICATIONS AND USAGE 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.
What are the side effects of Trientine Hydrochloride?▼
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.
Can I take Trientine Hydrochloride during pregnancy?▼
Pregnancy 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. Trientine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
What are the important warnings for Trientine Hydrochloride?▼
WARNINGS Patient experience with trientine hydrochloride is limited (see CLINICAL PHARMACOLOGY ). 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. CONTRAINDICATIONS Hypersensitivity to this product.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.