|
IMPORTANT SAFETY
INFORMATION
Cilostazol and several of its metabolites are inhibitors
of phosphodiesterase III. Several drugs with this
pharmacologic effect have caused decreased survival
compared to placebo in patients with class III-IV
congestive heart failure (CHF). PLETAL (cilostazol) is
contraindicated in patients with congestive heart
failure of any severity.
PLETAL is contraindicated in patients with haemostatic
disorders or active pathologic bleeding, such as
bleeding peptic ulcer and intracranial bleeding. PLETAL
inhibits platelet aggregation in a reversible manner.
PLETAL is contraindicated in patients with know or
suspected hypersensitivity to any of its components.
Occurrence of new-onset CHF (no prior history of CHF)
with cilostazol was similar to placebo.
–
In placebo-controlled clinical trials of
cilostazol, 10 of 1,374 (0.73%) patients treated with
cilostazol and 7 of 973 (0.72%) patients treated with
placebo developed new-onset CHF
Patients in 3- to 6-month, placebo-controlled trials of
PLETAL were relatively stable (no recent myocardial
infarction or stroke, no rest pain or other signs of
rapidly progressing disease). There are no data as to
long-term risk or risk in patients with more severe
underlying heart disease.
Patients on PLETAL 100 mg BID experienced a mean
increase from baseline in heart rate of 7.4 beats per
minute (bpm), from a mean baseline of 70.3 bpm, and the
incidence of tachycardia was 4% versus 1% for placebo.
Because PLETAL is metabolized by CYP3A4 and CYP2C19,
blood levels may increase during co-administration with
inhibitors of these isozymes, such as ketoconazole,
diltiazem, erythomycin, and omeprazole. PLETAL does not
appear to increase blood levels of drugs metabolized by
CYP3A4.
The
most frequently reported adverse in events in clinical
studies with Pletal versus placebo were headache (34% vs
14%), diarrhea (19 % vs 7%), abnormal stools (15% vs
4%), palpitation (10% vs 1%), and dizziness (10% vs
6%). Headaches are generally mild to moderate in
severity and may diminish over time.
1
Please see
FULL
PRESCRIBING INFORMATION,
including
Boxed
WARNING, for
PLETAL.
|
