Jane S. Ricciuti, RPh, MS


December 27, 2002

In This Article


(sertraline hydrochloride)

Manufacturer: Pfizer, Inc.

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 11/19/02)

Clinical Summary: Zoloft (sertraline hydrochloride) labeling was changed to add important drug interaction information derived from the "Phase 1 Open Study Designed to Determine the Potential Interaction of Sertraline With Cisapride or Pimozide in Healthy Male and Female Subjects."

Sentences indicating the significance of this interaction were added to the "Contraindications" and "Precautions" sections of the product labeling.

Contraindications: Concomitant use in patients taking pimozide is contraindicated (see Precautions).

Precautions -- Drug Interactions -- CNS Active Drugs: In a controlled study of a single dose (2 mg) of pimozide, 200 mg sertraline (qd) coadministration to steady state was associated with a mean increase in pimozide AUC and Cmax of about 40%, but was not associated with any changes in EKG. Since the highest recommended pimozide dose (10 mg) has not been evaluated in combination with sertraline, the effect on QT interval and PK parameters at doses higher than 2 mg are not known at this time. While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide and due to the interaction noted at a low dose of pimozide, concomitant administration of Zoloft and pimozide should be contraindicated (see Contraindications).


Zoloft (sertraline hydrochloride) labeling

Medscape DrugInfo

Zoloft (sertraline hydrochloride)


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