Dosing & Uses
Dosage Forms & Strengths
Peripheral Vascular Disease
100 mg PO q12hr 30 minutes before or 2 hours after meals
- CYP2C19 or CYP3A4 inhibitors: Reduce dosage to 50 mg PO q12hr
Thrombotic Complications of Coronary Angioplasty (Off-label)
100 mg q12hr 30 minutes before or 2 hours after meals
- May be administered alone or in combination with aspirin 81 mg/day
CrCl< 25 mL/min: Use caution
Moderate to severe: Use caution
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Abnormal stools (12-15%)
Peripheral edema (7-9%)
Back pain (6-7%)
Abdominal pain (4-5%)
Increased cough (3-4%)
Atrial fibrillation (<2%)
Blood in eye (<2%)
Frequency Not Defined
Decreased platelet aggregation
Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia, granulocytopenia, thrombocytopenia, leukopenia, bleeding tendency
Cardiovascular: Torsades de pointes, QTc prolongation
GI: GI hemorrhage
General: Pain, chest pain, hot flushes, extradural or subdural hematoma, hyperglycemia, hyperuricemia, increased BUN, elevated BP, decreased platelet or white blood cell (WBC) count
Hepatic: Hepatic dysfunction, abnormal liver function tests, jaundice
Neurologic: Intracranial or cerebral hemorrhage, cerebrovascular accident (CVA)
Respiratory: Pulmonary hemorrhage, interstitial pneumonia
Skin: Subcutaneous hemorrhage, pruritus, skin eruptions such as Stevens-Johnson syndrome, skin drug eruption (dermatitis medicamentosa)
Vascular: Subacute thrombosis
Black Box Warnings
Cilostazol and metabolites are inhibitors of phosphodiesterase III; such activity has been shown to decrease survival of patients with class III-IV CHF; contraindicated in patients with CHF of any severity
Congestive heart failure of any severity
Hemostatic disorders or active pathologic bleeding (eg, bleeding peptic ulcer, intracranial bleeding) due to reversible platelet aggregation
Use with caution in liver and renal disease
Leukopenia that progresses to agranulocytosis may occur (in which case, discontinue therapy)
Discontinue therapy if thrombocytopenia occurs
Use with caution in patients taking platelet aggregation inhibitors
Do not administer for at least 4-6 half-lives before elective surgical procedures
Avoid grapefruit juice
Response may be seen as early as 2-4 weeks after initiation, but treatment may be needed for up to 12 weeks
Dosage can be reduced or discontinued without rebound effects (eg, platelet hyperaggregability)
Cilostazol may induce tachycardia, palpitation, tachyarrhythmia and/or hypotension; patients with history of ischemic heart disease may be at risk for exacerbations of angina pectoris or myocardial infarction
Plasma concentrations and overall pharmacological activity are increased when cilostazol is administered with strong or moderate CYP3A4 inhibitors (eg, ketoconazole, itraconazole, erythromycin, diltiazem) and strong CYP2C19 inhibitors (eg, ticlopidine, fluconazole, omeprazole); dose reduction to 50 mg twice daily should be considered
Pregnancy & Lactation
Pregnancy category: C
Lactation: Excretion in milk unknown; not recommended
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Inhibits phosphodiesterase III, causing cyclic adenosine monophosphate (cAMP) to increase, which in turn inhibits platelet aggregation; causes homogeneous vasodilation, especially in femoral vascular beds
Onset: 2-12 weeks
Protein bound: 95-98% (especially albumin)
Metabolized by CYP3A4 (major), CYP2C19
Metabolites: 4'-trans-hydroxy-cilostazol, 3,4-dehydro-cilostazol
Half-life: 11-13 hr
Excretion: Urine (74%), feces (20%)
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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