Symptomatic management of intermittent claudication (improvement in walking distance and speed).
The American College of Chest Physicians (ACCP) suggests use in patients with disabling intermittent claudication who do not respond to conservative measures (risk factor modification, exercise) and who are not candidates for surgical or catheter-based interventions. Use not suggested in patients with less disabling intermittent claudication because of its high cost, modest effect on walking distance, and lack of benefit on health-related quality of life.
Not evaluated in patients with rapidly progressing claudication, leg pain at rest, ischemic leg ulcers, or gangrene.
Long-term effects of cilostazol on limb preservation, hospitalization, and cardiovascular mortality not fully elucidated.
Thrombotic Complications of Coronary Angioplasty
Has been used alone or in combination with other antiplatelet agents (e.g., aspirin, clopidogrel) to prevent thrombosis† and restenosis† following coronary angioplasty/stenting.
Dosage and Administration
Administration
Oral Administration
Administer orally at least one-half hour before or 2 hours after breakfast and dinner.
Dosage
Adults
Intermittent Claudication
Oral
100 mg twice daily.
Patients receiving concomitant therapy with CYP3A4 (e.g., diltiazem, erythromycin, itraconazole, ketoconazole) or CYP2C19 (e.g., omeprazole) inhibitors: Initially, 50 mg twice daily. (See Specific Drugs and Foods under Interactions.)
Thrombotic Complications of Coronary Angioplasty
Oral
100 mg twice daily alone or in combination with aspirin (e.g., 81 mg daily) has been used in a limited number of patients.†
Special Populations
Hepatic Impairment
No specific dosage recommendations at this time. (See Hepatic Impairment under Cautions.)
Renal Impairment
No specific dosage recommendations at this time. (See Renal Impairment under Cautions.)
Hemostatic disorders or active pathologic bleeding, such as bleeding peptic ulcer or intracranial bleeding.
Known hypersensitivity to cilostazol or any ingredient in the formulation.
Warnings/Precautions
General Precautions
Cardiovascular Effects
Consider possible adverse cardiovascular effects (e.g., increased heart rate) when used in patients with heart disease (e.g., CAD). Long-term effects not known in patients without CHF or in those with more severe underlying heart disease than studied in clinical trials (i.e., no recent MI or stroke, no arrhythmias, no unstable angina or other signs of rapidly progressing cardiovascular disease). Do not use in patients with CHF. (See Boxed Warning.)
Use with Clopidogrel
Limited information regarding safety and efficacy of concurrent use with clopidogrel. Unknown whether concurrent clopidogrel therapy has additive effect on bleeding time. Use caution and monitor bleeding times during concomitant therapy.
Specific Populations
Pregnancy
Category C.
Lactation
Distributed into milk in rats; discontinue nursing or drug because of potential risk in nursing infants.
Pediatric Use
Safety and efficacy not established in children <18 years of age.
Geriatric Use
No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.
Hepatic Impairment
Not studied in patients with moderate to severe hepatic impairment; use with caution.
Renal Impairment
Use with particular caution in patients with severe renal impairment (Clcr <25 mL/minute). Safety and efficacy not established in patients undergoing hemodialysis. (See Elimination Route under Pharmacokinetics.)
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