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cilostazol 50 mg tablet

In stock Manufacturer TEVA USA 00093206506
$0.30 / Tablet

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Uses

Intermittent Claudication

Cilostazol is used for the symptomatic treatment of intermittent claudication. The American College of Chest Physicians (ACCP) suggests addition of cilostazol to aspirin or clopidogrel therapy in patients with refractory intermittent claudication who do not respond to conservative measures (e.g., smoking cessation, exercise). Use of cilostazol has not been studied in patients with rapidly progressing claudication or in those with leg pain at rest, ischemic leg ulcers, or gangrene. Long-term effects of the drug on limb preservation and hospitalization have not been fully elucidated.

In patients with stable intermittent claudication, cilostazol therapy has been shown to provide improvement in walking distance and speed as determined by standardized exercise treadmill tests and functional status questionnaires. Results of several randomized, double-blind, placebo-controlled studies of 12-24 weeks' duration indicate that cilostazol is more effective than placebo in increasing initial (until onset of claudication pain) and absolute (intolerable pain) claudication distances. Mean and median maximal walking distances reportedly increased by 28-100 and 17- respectively, among patients who received cilostazol (100 mg twice daily) compared with mean and median changes of -10-41% and -2-29%, respectively, among those who received placebo. Limited data suggest that cilostazol (100 mg twice daily) also may be more effective than pentoxifylline (400 mg 3 times daily) in improving walking distance in patients with intermittent claudication.

Thrombotic Complications of Coronary Angioplasty

Because of its antiplatelet activity, cilostazol has been used alone or in combination with other antiplatelet agents (e.g., aspirin, clopidogrel) to prevent thrombosis and restenosis following coronary angioplasty/stent implantation. In a randomized, double-blind, placebo-controlled study, patients undergoing coronary artery stent implantation with bare-metal stents who received cilostazol (100 mg twice daily for 6 months) in addition to therapy with aspirin and clopidogrel (75 mg daily for 30 days) had a larger minimal coronary artery lumen diameter (primary end point) and a 36% reduction in the risk of restenosis (defined as narrowing of the stented coronary artery lumen by at least 50% as documented by quantitative coronary angiography). However, more recent studies, including a systematic review of 10 randomized controlled trials comparing triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol) with dual antiplatelet therapy (aspirin and clopidogrel), have failed to demonstrate or exclude a beneficial effect of cilostazol on clinical outcomes (e.g., reinfarction, major bleeding, mortality) when added to clopidogrel and aspirin therapy. Therefore, experts generally do not recommend the use of cilostazol for the prevention of postprocedural complications in patients undergoing coronary artery stent placement, with the possible exception of those with an allergy or intolerance to aspirin or clopidogrel; in such cases, ACCP states that cilostazol may be used as a substitute for either aspirin or clopidogrel as part of the dual antiplatelet regimen.

Ischemic Stroke

Cilostazol has been used for the secondary prevention of stroke in patients with a history of noncardioembolic stroke or transient ischemic attacks (TIAs). ACCP, the American Stroke Association (ASA), and the American Heart Association (AHA) recommend antiplatelet therapy for secondary prevention of ischemic atherothrombotic (noncardioembolic) stroke or TIAs in patients with prior TIAs or stroke. ACCP considers cilostazol an acceptable antiplatelet option for such patients; other options include aspirin monotherapy, clopidogrel, or the combination of aspirin and extended-release dipyridamole. When selecting an appropriate antiplatelet regimen for the secondary prevention of noncardioembolic stroke, factors such as the patient's individual risk for recurrent stroke, tolerance, and cost of the different agents should be considered.

Dosage and Administration

General

Although symptomatic relief of claudication may occur in some patients within 2-4 weeks following initiation of cilostazol therapy, the manufacturer states that up to 12 weeks may be required to obtain optimum therapeutic effect.

Administration

Cilostazol is administered orally twice daily, at least one-half hour before or 2 hours after breakfast and dinner.

Dosage

Intermittent Claudication

The usual dosage of cilostazol for the symptomatic management of intermittent claudication in adults is 100 mg twice daily. Dosage of cilostazol should be initiated at 50 mg twice daily in patients receiving concomitant therapy with drugs that inhibit cytochrome P-450 (CYP) 3A4 (e.g., clarithromycin, diltiazem, erythromycin, itraconazole, ketoconazole) or CYP2C19 (e.g., omeprazole).(See Drug Interactions: Drugs or Foods Affecting Hepatic Microsomal Enzymes.)

Thrombotic Complications of Coronary Angioplasty

Cilostazol 100 mg twice daily has been used as a substitute for either aspirin or clopidogrel as part of a dual antiplatelet regimen in patients with coronary artery stents who have an allergy or intolerance to either aspirin or clopidogrel.

Special Populations

A reduced dosage of cilostazol should be considered when given concomitantly with drugs that inhibit or are substrates for CYP3A4 or CYP2C19.(See Drug Interactions: Drugs or Foods Affecting Hepatic Microsomal Enzymes.)

Cautions

Contraindications

Congestive heart failure of any severity (decreased survival observed in patients with New York Heart Association [NYHA] class III or IV congestive heart failure who received other drugs that inhibit PDE type 3). 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

Major Toxicities

Cardiovascular Effects

Increased heart rate, PVCs, and nonsustained ventricular tachycardia have been reported in patients receiving cilostazol.

General Precautions

Cardiovascular Effects

Cilostazol has been used in patients with heart disease other than congestive heart failure (e.g., coronary artery disease); however, the adverse cardiovascular effects (e.g., increased heart rate) associated with the drug should be considered when it is used in such patients. Based on limited long-term data from a placebo-controlled trial in patients with intermittent claudication without heart failure, the effects of cilostazol on mortality were not different from those observed with placebo. The manufacturer states that the long-term effects of cilostazol in patients with more severe underlying heart disease than that in patients who received cilostazol in clinical trials (i.e., no recent myocardial infarction or stroke, no arrhythmias, no unstable angina or other signs of rapidly progressing cardiovascular disease) currently are not known. Therefore, cilostazol is contraindicated in patients with congestive heart failure of any severity.(See Cautions: Contraindications.)

Hematologic Effects

Rare cases of thrombocytopenia or leukopenia progressing to agranulocytosis have been reported when cilostazol was not immediately discontinued; agranulocytosis was reversible with discontinuance of cilostazol.

Use with Clopidogrel

Information is limited regarding the safety and efficacy of concurrent use of cilostazol and clopidogrel. Currently it is unknown whether concurrent therapy with cilostazol and clopidogrel has additive effects on bleeding time. Caution should be used and bleeding times monitored during such concurrent therapy.

Specific Populations

Pregnancy

Category C.

Lactation

Cilostazol is 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 younger than 18 years of age.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.

Renal Impairment

Increased plasma metabolite concentrations and altered protein binding of parent drug and metabolites (with modest effects on pharmacologic activity) in patients with severe renal impairment. Particular caution should be used in patients with severe renal impairment (creatinine clearance less than 25 mL/minute). Safety and efficacy not established in patients undergoing hemodialysis. Because of high protein binding (95-98%), it is unlikely that cilostazol would be removed by hemodialysis.

Hepatic Impairment

Safety and efficacy not established in patients with moderate to severe hepatic impairment; use with caution in such patients.

Common Adverse Effects

Headache, diarrhea, abnormal (e.g., loose) stools, dizziness, infection, palpitation, pharyngitis, back pain, nausea, peripheral edema, rhinitis, dyspepsia, abdominal pain, increased cough, tachycardia, flatulence, myalgia, and vertigo.

Adverse effects most frequently resulting in discontinuance of cilostazol were headache, palpitation, and diarrhea.

Drug Interactions

Aspirin

Pharmacologic interaction (i.e., additive effects on activated partial thromboplastin time [aPTT], prothrombin time [PT], or bleeding time) during short-term (e.g., not exceeding 5 days) therapy with low doses (e.g., 325 mg daily) unlikely. Although aspirin and cilostazol have been used concomitantly in clinical trials for up to 6 months without evidence of an increased risk of hemorrhage, the manufacturers caution that the long-term effects of analgesic doses of aspirin on coagulation parameters in the general population currently are unknown.

Warfarin

Pharmacokinetic and pharmacologic interaction (i.e., effects on coagulation parameters) following single-dose administration of warfarin unlikely. The effect of concomitant multiple dosing of cilostazol and warfarin on the pharmacokinetics and pharmacodynamics of both drugs currently is unknown.

Clopidogrel

Potentially additive antiplatelet effects with clopidogrel and cilostazol. Caution is advised and bleeding times should be monitored during such concomitant therapy. Pharmacokinetic interaction unlikely.

Drugs or Foods Affecting Hepatic Microsomal Enzymes

Drugs That Inhibit or are Substrates for CYP3A4

Pharmacokinetic interaction (increased plasma cilostazol concentrations); use with caution and consider reduced dosage.(See Dosage and Administration: Special Populations.) Potential pharmacokinetic interaction (increased plasma cilostazol concentrations, decreased clearance) with other inhibitors of CYP3A4 isoenzyme, including, but not limited to, certain azole antifungals (e.g., fluconazole, itraconazole, ketoconazole, miconazole),certain macrolide antibiotics (e.g., erythromycin or clarithromycin but not azithromycin), certain selective serotonin-reuptake inhibitors (e.g., fluoxetine, fluvoxamine, nefazodone, sertraline), certain antiretroviral agents (e.g., indinavir), metronidazole, diltiazem, and danazol.

Grapefruit Juice

No substantial pharmacokinetic interaction (increased plasma cilostazol concentration but no effect on AUC); the manufacturer states that no particular caution concerning concomitant use is necessary.

Lovastatin

Potential pharmacokinetic interaction (increased plasma lovastatin concentrations and decreased plasma cilostazol concentration) with lovastatin, a substrate for CYP3A4, although unlikely to be clinically important.

Drugs That Inhibit CYP2C19

Pharmacokinetic interaction (increased plasma concentrations of active metabolite 3,4-dehydro-cilostazol) with CYP2C19 inhibitors, including omeprazole; use with caution and consider reduced dosage.(See Dosage and Administration: Special Populations.)

Quinidine

Pharmacokinetic interaction unlikely.

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