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Label Changes for:

Surmontil (Trimipramine Maleate) Capsules

December 2012

Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)- December 2012



Monoamine Oxidase Inhibitors (MAOIs)
  • The use of MAOIs intended to treat psychiatric disorders….
Hypersensitivity to Tricyclic Antidepressants
  • Cross-sensitivity between Surmontil and other dibenzazepines is a possibility.