Cilostazol

Cilostazol®
Black Box Warning
Adult Indications and Dosage
Pediatric Indications and Dosage
Contraindications
Warnings
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration and Monitoring
IV Compatibility
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient information
Precautions with Alcohol
Brand Names
Look-Alike Drug Names
Drug Shortage Status
Price

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Synonyms / Brand Names: Cilostazol®, Pletal®

Disclaimer

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Black Box Warning

FDA Package Insert for Cilostazol contains no information regarding Black Box Warning.

CONTRAINDICATION See full prescribing information for complete boxed warning. Condition Name: 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-IVcongestive heart failure. Cilostazol tablets are contraindicated in patients with congestive heart failure of any severity.

Overview

Cilostazol is a_Phosphodiesterase 3 Inhibitor drug that is FDA approved for the treatment of intermittent claudication. There is a Black Box Warning for this drug as shown here. Common adverse reactions include headache, dizziness, palpitation, diarrhea, rhinitis and pharyngitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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Condition 2

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Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1

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Condition 2

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Non–Guideline-Supported Use

Condition 1

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• There is limited information about Off-Label Non–Guideline-Supported Use of Cilostazol in adult patients.

Condition 2

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Condition 3

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Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1

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Condition 2

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Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

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Condition 2

• Developed by: (Organisation)

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Non–Guideline-Supported Use

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Contraindications

• congestive heart failure.
• Haemostatic disorders or active pathologic bleeding.
• [[peptic ulcer].
• Intracranial bleeding.
• Hypersensitivity to any of its components.

Warnings

Conidition 1

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Conidition 2

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Conidition 3

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Adverse Reactions

Clinical Trials Experience

Condition 1

Central Nervous System

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Cardiovascular

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Respiratory

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Gastrointestinal

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Hypersensitive Reactions

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Miscellaneous

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Condition 2

Central Nervous System

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Cardiovascular

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Respiratory

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Gastrointestinal

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Hypersensitive Reactions

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Miscellaneous

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Postmarketing Experience

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Drug Interactions

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Drug 2

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Drug 3

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Drug 4

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Drug 5

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Use in Specific Populations

Pregnancy

• Pregnancy Category (FDA): C

• Pregnancy Category (AUS): Cilostazol is not included in Australian Drug Evaluation Committee (ADEC) Pregnancy Categories.

In a rat developmental toxicity study, oral administration of 1000 mg cilostazol/kg/day was associated with decreased fetal weights and increased incidences of cardiovascular, renal and skeletal anomalies (ventricular septal, aortic arch and subclavian artery abnormalities, renal pelvic dilation, 14th rib and retarded ossification). At this dose, systemic exposure to unbound cilostazol in nonpregnant rats was about 5 times the exposure in humans given the MRHD. Increased incidences of ventricular septal defect and retarded ossification were also noted at 150 mg/kg/day (5 times the MRHD on a systemic exposure basis). In a rabbit developmental toxicity study, an increased incidence of retardation of ossification of the sternum was seen at doses as low as 150 mg/kg/day. In nonpregnant rabbits given 150 mg/kg/day, exposure to unbound cilostazol was considerably lower than that seen in humans given the MRHD and exposure to 3,4-dehydro-cilostazol was barely detectable. When cilostazol was administered to rats during late pregnancy and lactation, an increased incidence of stillborn and decreased birth weights of offspring was seen at doses of 150 mg/kg/day (5 times the MRHD on a systemic exposure basis). There are no adequate and well-controlled studies in pregnant women.

Labor and Delivery

(Description)

Nursing Mothers

Transfer of cilostazol into milk has been reported in experimental animals (rats). Because of the potential risk to nursing infants, a decision should be made to discontinue nursing or to discontinue cilostazol tablets.

Pediatric Use

The safety and effectiveness of cilostazol in pediatric patients have not been established.

Geriatric Use

Of the total number of subjects (n=2,274) in clinical studies of cilostazol, 56 percent were 65-years-old and over, while 16 percent were 75-years-old and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Pharmacokinetic studies have not disclosed any age-related effects on the absorption, distribution, metabolism and elimination of cilostazol and its metabolites.

Gender

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Race

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Renal Impairment

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Hepatic Impairment

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Carcinogenesis, Mutagenesis, Impairment of Fertility

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Immunocompromised Patients

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Miscellaneous

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Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

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Not Tested

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Variable

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Incompatible

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Y-Site

Compatible

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Variable

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Incompatible

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Admixture

Compatible

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Variable

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Incompatible

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Syringe

Compatible

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Not Tested

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Variable

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Incompatible

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TPN/TNA

Compatible

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Not Tested

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Variable

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Incompatible

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Overdosage

Acute Overdose

Signs and Symptoms

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Management

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Chronic Overdose

Signs and Symptoms

(Description)

Management

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Pharmacology

Cilostazol
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Mechanism of Action

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Structure

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Pharmacodynamics

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Pharmacokinetics

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Nonclinical Toxicology

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Clinical Studies

Condition 1

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Condition 2

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How Supplied

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• National Drug Code (NDC):
• Storage:
• Manufactured by:
• Distributed by:

Images

Drug Images

File:PILLIMAGE.jpg Drug Name: Ingredient(s): Imprint: Color(s): Shape: Size (mm): Score: Drug Label Author:

Package and Label Display Panel

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Patient Information

Patient Information from FDA

(sil-OS-tah-zol)

Please read this leaflet before you start taking cilostazol tablets and each time you renew it in case anything has changed. This leaflet does not replace careful discussions with your doctor. You and your doctor should discuss cilostazol when you start taking it and at regular check-ups. You should follow your doctor’s advice about when to have check-ups. What is cilostazol for? Cilostazol may improve the symptoms of patients with a medical condition called intermittent claudication. What is intermittent claudication? Intermittent claudication is pain in the legs that occurs with walking and disappears with rest. It occurs because narrowing or blockage of the arteries decreases blood flow to the legs. The decreased blood flow does not supply enough oxygen to the leg muscles during walking, resulting in these painful leg cramps.

What treatments are available for intermittent claudication?

The three main treatments available for intermittent claudication are:

• Exercise. Your doctor may advise an exercise program.
• Medication. Your doctor may prescribe a medication such as cilostazol. (See Who should not take cilostazol tablets?)
• Surgery. Your doctor may recommend a surgical procedure to bypass the blocked segment of the artery. Another procedure is called a percutaneous transluminal angioplasty. In this procedure, a catheter (a flexible tube) is inserted into the artery to reduce the blockage and improve blood flow.

How does cilostazol work?

• The exact way that many drugs work is not well understood. Although how cilostazol works is not completely clear, its main effects are to dilate (widen) the arteries supplying blood to the legs and to decrease the ability of platelets in the blood to stick together. Platelets are particles that circulate in the blood and play a role in clotting.
• Cilostazol may reduce the leg pain that patients with intermittent claudication experience, allowing them to walk farther before their leg pain occurs.
• Improvement in symptoms may occur as soon as 2 weeks, but could take up to 12 weeks. If you have not noticed any benefit from cilostazol tablets after 12 weeks you and your doctor may wish to discuss other forms of treatment.
• Sometimes blood vessel disease of the legs causes pain at rest or breakdown of skin in the leg. Cilostazol has not been shown to work in patients with these problems.

Who should not take cilostazol tablets?

• Patients who have congestive heart failure (CHF) must not take cilostazol tablets. The most common symptoms of CHF are shortness of breath and swelling of the legs. However, other conditions may also cause these symptoms. It is important that you discuss with your doctor whether you have CHF.
• Over 1,300 patients took cilostazol in studies that lasted for 3 to 6 months. The mortality rate in these patients was similar to placebo (less than 1%). These studies were too small to be sure there is not some increased risk of dying with longer use or in patients sicker than those in the studies.

How should cilostazol tablets be taken?

• Follow your doctor’s advice about how to take cilostazol tablets.
• You should take cilostazol tablets twice a day, at least one half-hour before or two hours after breakfast and dinner. Take cilostazol tablets at about the same times each day.
• Do not share cilostazol tablets with anyone else. It was prescribed only for you.
• Keep cilostazol tablets and all drugs out of the reach of children.

Can cilostazol tablets be taken with other drugs?

Certain drugs and foods can increase the amount of cilostazol in the blood. Because of this, your doctor may adjust your dose of cilostazol or even stop it if you are taking or are going to take one of the following medications. Drugs Interacting with Cilostazol Generic Name (Brand Names)Type of Drug erythromycin (such as E.E.S.®, Erythrocin®) Antibiotic ketoconazole (Nizoral®), itraconazole (Sporanox®) Antifungal diltiazem (Cardizem®) Antihypertensive omeprazole (Prilosec®) Gastric acid reducer This list does not include every drug that may interact with cilostazol tablets. Therefore, you should tell your doctor about all medications that you are taking, including vitamins, herbal supplements and over-the-counter drugs you can buy without a prescription. You should also check with your doctor before taking a new medication after you have begun cilostazol tablets.

What are the possible side effects of cilostazol tablets?

Cilostazol tablets may cause side effects including headache, diarrhea, abnormal stools, increased heart rate and palpitations. You should discuss possible side effects with your doctor before taking cilostazol tablets and any time you think you are having a side effect. This provides only a summary of information about cilostazol tablets. If you have any questions about cilostazol tablets, talk to your doctor. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Patient Information from NLM

For patient information about Cilostazol from NLM, click here.

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

Brand Names®

Look-Alike Drug Names

• (Paired Confused Name 1a) — (Paired Confused Name 1b)
• (Paired Confused Name 2a) — (Paired Confused Name 2b)
• (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Price

References