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TRIENTINE HYDROCHLORIDE


DIR Classification


Classification:Less-DIR concern
Severity Score:1

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • ADVERSE REACTIONS
  • Clinical experience with Syprine 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 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.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
0
42912
Other ADRs
50
14117229

Odds Ratio = N/A

Drug Property Information



ATC Code(s): N/A
Active Ingredient:trientine hydrochloride
Active Ingredient UNII:HC3NX54582
Drugbank ID:DB06824
PubChem Compound:5565
CAS Number:112-24-3
Dosage Form(s):capsule
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure:
SMILE Code:
C(CNCCNCCN)N

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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