Classes
DEA Class; Rx
Common Brand Names; Pletal
- Antiplatelet Agents, Hematologic;
- PDE-3 Inhibitors;
- Phospholipase A2 Inhibitors
Description
Platelet aggregation inhibitor with vasodilating activity; for the reduction of the symptoms of intermittent claudication.
Indications
Indicated for the treatment of claudication associated with peripheral vascular disease (PVD); including the treatment of peripheral arterial disease in patients with diabetic neuropathy, and for the treatment of chronic arterial occlusion due to arteriosclerosis obliterans or thromboangiitis obliterans (Buerger’s disease).
Contraindications
Congestive heart failure of any severity
Hypersensitivity
Adverse Effects
- Headache (27-34%)
- Diarrhea (12-19%)
- Abnormal stools (12-15%)
- Infection (10-14%)
- Rhinitis (7-12%)
- Pharyngitis (7-10%)
- Dizziness (9-10%)
- Palpitations (5-10%)
- Peripheral edema (7-9%)
- Back pain (6-7%)
- Dyspepsia (6%)
- Abdominal pain (4-5%)
- Tachycardia (4%)
- Increased cough (3-4%)
- Myalgia (2-3%)
- Atrial fibrillation (<2%)
- CHF (<2%)
- MI (<2%)
- Hematemesis (<2%)
- Ecchymosis (<2%)
- Blood in eye (<2%)
- Epistaxis (<2%)
- Hemoptysis (<2%)
- Nausea
- Decreased platelet aggregation
- Agranulocytosis
- Aplastic anemia
- Leukopenia
- Thrombocytopenia
- Stevens-Johnson syndrome
Warnings
Use with caution in liver and renal disease
Leukopenia that progresses to agranulocytosis may occur (in which case, discontinue therapy); monitor white blood cell counts periodically
Discontinue therapy if thrombocytopenia occurs; monitor platelets periodically
Use with caution in patients taking platelet aggregation inhibitors
Avoid use in patients with hemostatic disorders or active pathologic bleeding (eg, bleeding peptic ulcer, intracranial bleeding) due to reversible platelet aggregation
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
Left ventricular outflow tract obstruction reported in patients with sigmoid shaped interventricular septum; monitor patients for development of new systolic murmur or cardiac symptoms after initiating therapy
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 and Lactation
Pregnancy category: C
Lactation: Excretion in milk unknown; not recommended
Maximum Dosage
200 mg/day PO.
200 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Cilostazol
tablet
- 50mg
- 100mg