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U.S. Department of Health and Human Services

Safety

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Surmontil (Trimipramine Maleate) Capsules

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

Summary View

 

CONTRAINDICATIONS

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.
 

WARNINGS

  • If concomitant use of Surmontil with other serotonergic drugs, including Triptans, Tricyclic antidepressants, Fentanyl, Lithium, Tramadol, Buspirone, Tryptophan, and St. John’s Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increased.
 

PRECAUTIONS

Drug Interactions
  • Monoamine Oxidase Inhibitors (MAOIs) (See CONTRAINDICATIONS, WARNINGS, and DOSAGE AND ADMINISTRATION.)
  • Serotonergic Drugs (See CONTRAINDICATIONS, WARNINGS, and DOSAGE AND ADMINISTRATION.)