Pletal

[cilostazol]

Warnings & Precautions
PRECAUTIONS

PLETAL is contraindicated in patients with congestive heart failure. In patients without congestive heart failure, the long-term effects of PDE III inhibitors (including PLETAL) are unknown. Patients in the 3-6 month placebo-controlled trials of PLETAL were relatively stable (no recent myocardial infarction or strokes, no rest pain or other signs of rapidly progressing disease) and only 19 patients died (0.7% in the placebo group and 0.8% in the group on PLETAL). The calculated relative risk of death of 1.2 has a wide 95% confidence limit (0.5-3.1). There are no data as to longer-term risk or risk in patients with more severe underlying heart disease.

Hematologic adverse reactions:

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Rare cases have been reported of thrombocytopenia or leukopenia progressing to agranulocytosis when cilostazol was not immediately discontinued. The agranulocytosis, however, was reversible on discontinuation of cilostazol.

Use with Clopidogrel.

There is limited information with respect to the efficacy or safety of the concurrent use of cilostazol and clopidogrel, a platelet-aggregation inhibiting drug indicated for use in patients with peripheral arterial disease. Coadministration significantly increased AUC of dehydro-cilostazol metabolite by 24%. Although it cannot be determined whether there was an additive effect on bleeding times during concomitant administration with cilostazol and clopidgrel, caution should be advised for checking bleeding times during coadministration.