Cilostazol

Cilostazol
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

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Black Box Warning

CONTRAINDICATION See full prescribing information for complete Boxed Warning. * 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 congestive heart failure. CILOSTAZOL is contraindicated in patients with congestive heart failure of any severity.

Overview

Cilostazol is a phosphodiesterase 3 (PDE3) inhibitor and platelet aggregation inhibitor that is FDA approved for the {{{indicationType}}} of intermittent claudication, as indicated by an increased walking distance. There is a Black Box Warning for this drug as shown here. Common adverse reactions include palpitations, peripheral edema, tachyarrhythmia, abdominal pain, diarrhea, indigestion, decreased platelet aggregation, backache, myalgia, dizziness, headache, cough, pharyngitis, and rhinitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Intermittent Claudication

• Dosing Information

• 100 mg PO bid, taken at least half an hour before or two hours after breakfast and dinner.
• A dose of 50 mg PO bid should be considered during coadministration of such inhibitors of CYP3A4 as ketoconazole, itraconazole, erythromycin and diltiazem, and during coadministration of such inhibitors of CYP2C19 as omeprazole.
• Patients may respond as early as 2 to 4 weeks after the initiation of therapy, but treatment for up to 12 weeks may be needed before a beneficial effect is experienced.
• Discontinuation of Therapy

• The available data suggest that the dosage of CILOSTAZOL can be reduced or discontinued without rebound (i.e., platelet hyperaggregability).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Secondary Prophylaxis of Noncardioembolic Ischemic Stroke or TIA

• Developed by: American College of Chest Physicians (ACCP)

• Dosing Information

• In patients with a history of noncardioembolic ischemic stroke or TIA, ACCP recommends long-term treatment with aspirin (75-100 mg once daily), clopidogrel (75 mg once daily), aspirin/extended-release dipyridamole (25 mg/200 mg bid), or cilostazol (100 mg bid) over no anti-platelet therapy (Grade 1A), oral anticoagulants (Grade 1B), the combination of clopidogrel plus aspirin (Grade 1B), or triflusal (Grade 2B).

• Of the recommended antiplatelet regimens, ACCP suggests clopidogrel or aspirin/extended-release dipyridamole over aspirin (Grade 2B) or cilostazol (Grade 2C).

Elective PCI (Bare-metal or Drug-eluting Stent)

• Developed by: American College of Chest Physicians (ACCP)

• Dosing Information

• Use of low-dose aspirin 75 to 100 mg daily and clopidogrel 75 mg daily alone is recommended, rather than cilostazol in addition to these drugs (Grade 1B).
• Aspirin 75 to 100 mg daily and clopidogrel 75 mg daily as part of dual antiplatelet therapy is suggested, rather than the use of either drug with cilostazol (Grade 1B).
• Cilostazol 100 mg twice daily as substitute for either low-dose aspirin 75 to 100 mg daily or clopidogrel 75 mg daily as part of a dual antiplatelet regimen is suggested in patients with an allergy or intolerance of either drug class (Grade 2C).

Non–Guideline-Supported Use

Primary Prophylaxis of Cerebrovascular Accident

• Dosing Information

• 100–200 mg PO qd

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Cilostazol in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Cilostazol in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cilostazol in pediatric patients.

Contraindications

• Condition1

Warnings

CONTRAINDICATION See full prescribing information for complete Boxed Warning. * 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 congestive heart failure. CILOSTAZOL is contraindicated in patients with congestive heart failure of any severity.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Cilostazol in the drug label.

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Cilostazol in the drug label.

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cilostazol in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cilostazol during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cilostazol with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Cilostazol with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Cilostazol with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Cilostazol with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cilostazol with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Cilostazol in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Cilostazol in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cilostazol in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cilostazol in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Cilostazol in the drug label.

Condition1

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Cilostazol in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Cilostazol in the drug label.

Pharmacology

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Cilostazol in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Cilostazol in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Cilostazol in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Cilostazol in the drug label.

Condition1

• Description

How Supplied

Storage

There is limited information regarding Cilostazol Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Cilostazol in the drug label.

Precautions with Alcohol

• Alcohol-Cilostazol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Pletal®

Look-Alike Drug Names

• N/A

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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