Cilostazol Tablets

PRODUCT DETAILS

  • RLD: PLETAL®
  • Strength: Available in 50 mg and 100 mg tablets
  • Therapeutic Class: Phosphodiesterase III Inhibitor

StrengthNDC NumberSaleable UnitWholesaler Numbers
50 mg70436-156-06Bottle of 60Cardinal Health: 5709308
McKesson: 2305993
Amerisource: 10255199
100 mg70436-157-06Bottle of 60Cardinal Health: 5709316
McKesson: 2306009
Amerisource: 10255286

50 mg: White, round tablets, one side debossed “YH205”; the other side plain.

100 mg: White, round tablets, one side debossed “YH210”; the other side plain

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Important Safety Information For: CILOSTAZOL TABLETS USP

WARNING: CONTRAINDICATED IN HEART FAILURE PATIENTS

Cilostazol tablets are contraindicated in heart failure of any severity. 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 heart failure.

Cilostazol Tablets are contraindicated in patients with:

  • Heart failure of any severity: 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 heart failure.
  • Hypersensitivity to cilostazol or any components of cilostazol tablets (e.g., anaphylaxis, angioedema)

Cilostazol may induce tachycardia, palpitation, tachyarrhythmia, or hypotension. Patients with a history of ischemic heart disease may be at risk for exacerbations of angina pectoris or myocardial infarction.

Left ventricular outflow tract obstruction has been reported in patients with sigmoid shaped interventricular septum. Monitor patients for the development of a new systolic murmur or cardiac symptoms after starting cilostazol.

Cases of thrombocytopenia or leukopenia progressing to agranulocytosis when cilostazol was not immediately discontinued have been reported. Agranulocytosis is reversible on discontinuation of cilostazol.

Cilostazol inhibits platelet aggregation in a reversible manner. Cilostazol has not been studied in patients with hemostatic disorders or active pathologic bleeding. Avoid use of cilostazol in these patients.

The most common adverse reactions (greater than or equal to 2% and at least twice that for placebo) in patients on 100 mg twice daily are headache, diarrhea, abnormal stools, and palpitation.

Please see the package insert for Cilostazol Tablets for full prescribing information.

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