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Important Safety Information

Important Safety Information

  • Serzone (nefazodone HCl) is indicated for the treatment of depression
  • The efficacy of nefazodone HCl in the treatment of depression was established in outpatients and depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder
  • The efficacy of nefazodone HCl in reducing relapse in patients with major depression has been demonstrated in a randomized placebo-controlled trial

Common Adverse Effects and Contraindications/Warnings

  • Coadministration with Seldane� (terfenadine), Hismanal� (astemizole), Propulsid� (cisapride), Tegretol (carbamazepine), or Orap� (pimozide) is contraindicated
  • Coadministration with monoamine oxidase inhibitors (MAOIs) is not recommended
  • Coadministration with triazolam should be avoided in most patients, including the elderly
  • A dosage reduction of alprazolam (50%) recommended when used with nefazodone
  • The most common adverse events (reported at 5% and significantly different from placebo in placebo-controlled trials) were dry mouth (25% vs 13%), somnolence (25% vs 14%), nausea (22% vs 12%), dizziness (17% vs 5%), constipation (14% vs 8%), asthenia (11% vs 5%), lightheadedness (10% vs 3%), blurred vision (9% vs 3%), confusion (7% vs. 2%), and abnormal vision (7% vs 1%)


*Seldane® is a registered trademark of Hoescht Marion Roussel, Hismanal® is a registered trademark of Janssen Pharmaceuticals, Inc. Propulsid® is a registered trademark of Janssen Pharmaceuticals Inc. Orap® is a registered trademark of Gate Pharmaceuticals.
�Caution should be exercised when Serzone and digoxin are coadministered because of the narrow therapeutic index of digoxin. Plasma level monitoring for digoxin is recommended.

Please see accompanying product label for less frequently reported adverse events.











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