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Pletal has not been studied in patients with hemostatic disorders or active pathologic bleeding.
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There are no adequate data in the use of cilostazol in pregnant womenStudies in animals have shown reproductive toxicitysee Section 5.3The potential risk for humans is unknownPletal must not be used during pregnancysee section 4.3
Based on its mechanism of actioncilostazol may induce tachycardiapalpitationtachyarrhythmia and/or hypotensionThe increase in heart rate associated with cilostazol is approximately 5 to 7 bpmin patients at risk this consequently may induce angina pectoris.
Figure 2 depicts the percent mean improvement in maximal walking distanceat study end for each of the eight studies.
The effect of CYP3A4 and CYP2C19 inducerssuch as carbamazepinephenytoinrifampicin and StJohn’s worton cilostazol pharmacokinetics has not been evaluatedThe antiplatelet effect may theoretically be altered and should be carefully monitored when cilostazol is co-administered with CYP3A4 and CYP2C19 inducers.
The suitability of treatment with cilostazol should be carefully considered alongside other treatment options such as revascularisation.
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