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ZOLOFT (sertraline hydrochloride) Contraindications

Contraindications

ZOLOFT (sertraline hydrochloride) is contraindicated in patients with known hypersensitivity to the drug.

Monoamine Oxidase Inhibitors:

Cases of serious, sometimes fatal, reactions have been reported in patients receiving ZOLOFT (sertraline hydrochloride) in combination with a monoamine oxidase inhibitor (MAOI), including the selective MAOI, selegiline and the reversible MAOI (reversible inhibitor of monoamine oxidase - RIMA), moclobemide and linezolid,an antibiotic which is a reversible non-selective MAOI and methylthioninium chloride (methylene blue), which is a MAOI. Some cases presented with features resembling the serotonin syndrome. Similar cases have been reported with other antidepressants during combined treatment with an MAOI and in patients who have recently discontinued an antidepressant and have been started on an MAOI. Symptoms of a drug interaction between an SSRI and an MAOI include: hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability, and extreme agitation progressing to delirium and coma. Therefore, ZOLOFT should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. Similarly, at least 14 days should elapse after discontinuing ZOLOFT treatment before starting an MAOI.

Pimozide:

The concomitant use of ZOLOFT and pimozide is contraindicated as ZOLOFT has been shown to increase plasma pimozide levels. Elevation of pimozide blood concentration may result in QT interval prolongation and severe arrhythmias including Torsade de Pointes - see PRECAUTIONS and PART III: CONSUMER INFORMATION.

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