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)

Intermittent claudication

• Dosing Information

• 100 mg q12h PO taken at least half an hour before or two hours after breakfast and dinner.
• 50 mg q12h PO should be considered during co-administration of such inhibitors of CYP3A4 as ketoconazole, itraconazole, erythromycin and diltiazem and during co-administration 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.

Condition 2

• Dosing Information

• (Dosage)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

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

• Dosing Information/Recommendation

• (Dosage)

Condition 2

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

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

• Dosing Information/Recommendation

• (Dosage)

Non–Guideline-Supported Use

Condition 1

• Dosing Information

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

Condition 2

• Dosing Information

• (Dosage)

Condition 3

• Dosing Information

• (Dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1

• Dosing Information

• (Dosage)

Condition 2

• Dosing Information

• (Dosage)

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)

• Dosing Information/Recommendation

• (Dosage)

Condition 2

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

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

• Dosing Information/Recommendation

• (Dosage)

Non–Guideline-Supported Use

Condition 1

• Dosing Information

• (Dosage)

Condition 2

• Dosing Information

• (Dosage)

Condition 3

• Dosing Information

• (Dosage)

Contraindications

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

Warnings

Conidition 1

(Description)

Conidition 2

(Description)

Conidition 3

(Description)

Adverse Reactions

Clinical Trials Experience

Adverse events were assessed in eight placebo-controlled clinical trials involving 2274 patients exposed to either 50 or 100 mg b.i.d. cilostazol (n=1301) or placebo (n=973), with a median treatment duration of 127 days for patients on cilostazol and 134 days for patients on placebo.

The only adverse event resulting in discontinuation of therapy in ≥3% of patients treated with cilostazol 50 or 100 mg b.i.d. was headache, which occurred with an incidence of 1.3%, 3.5%, and 0.3% in patients treated with PLETAL 50 mg b.i.d., 100 mg b.i.d, or placebo, respectively. Other frequent causes of discontinuation included palpitation and diarrhea, both 1.1% for cilostazol (all doses) versus 0.1% for placebo.

Body as a Whole

• Common:

• Abdominal pain
• Back pain
• Headache
• Infection

• Less common:

Chills, face edema, fever, generalized edema, malaise, neck rigidity, pelvic pain, retroperitoneal haemorrhage.

Central Nervous System

• Common:

• Dizziness
• Vertigo

• Less common:

Anxiety, insomnia, neuralgia.

Cardiovascular

• Common:

• Palpitation
• Tachycardia

• Less common:

Atrial fibrillation, atrial flutter, cerebral infarct,cerebral ischemia, congestive heart failure, heart arrest,haemorrhage, hypotension, myocardial infarction, myocardial ischemia, nodal arrhythmia, postural hypotension, supraventricular tachycardia, syncope, varicose vein, vasodilation, ventricular extrasystoles, ventricular tachycardia.

Respiratory

• Common:

• Cough

• Pharyngitis

• Rhinitis

• Less common:

Asthma, epistaxis, hemoptysis, pneumonia, sinusitis.

Gastrointestinal

• Common:

• Abnormal stool
• Diarrhea
• Dyspepsia
• Flatulence
• Nausea

• Less common:

Anorexia, cholelithiasis,colitis, duodenal ulcer, duodenitis, esophageal haemorrhage, esophagitis, increased GGT, gastritis, gastroenteritis, gum haemorrhage, hematemesis, melena,peptic ulcer, periodontal abscess, rectal haemorrhage, stomach ulcer, tongue edema.

Hypersensitive Reactions

(list/description of adverse reactions)

Metabolic & Nutritional

• Common:

• Peripheral edema

• Less common:

Increased creatinine, gout, hyperlipemia, hyperuricemia.

Musculoskeletal

• Common:

• Myalgia

• Less common:

Arthralgia, bone pain, bursitis.

Miscellaneous

Less common adverse reactions:

• Endocrine: Diabetes mellitus.

• Hemic and Lymphatic: Anemia, ecchymosis,iron deficiency anemia, polycythemia, purpura.

• Skin and Appendages: Dry skin, furunculosis, skin hypertrophy, urticaria.

• Special Senses: Amblyopia, blindness, conjunctivitis, diplopia, ear pain, eye haemorrhage, retinal haemorrhage, tinnitus.

• Urogenital: Albuminuria, cystitis, urinary frequency, vaginal haemorrhage, vaginitis.

Postmarketing Experience

The following events have been reported spontaneously from worldwide post-marketing experience since the launch of PLETAL in the US.

Blood and lymphatic system disorders:

Agranulocytosis,aplastic anemia, granulocytopenia, pancytopenia, thrombocytopenia, leukopenia, bleeding tendency

Cardiac disorders:

Torsades de pointes, QTc prolongation (torsades de pointes and QTc prolongation occurred in patients with cardiac disorders, e.g. complete atrioventricular block, cardiac failure and bradyarrythmia, when treated with cilostazol. Cilostazol was used "off label" due to its positive chronotropic action)

Gastrointestinal disorders:

• Gastrointestinal haemorrhage

General disorders and administration site conditions:

• Pain
• chest pain
• hot flushes

Hepatobiliary disorders:

• Hepatic dysfunction/abnormal liver function tests
• jaundice

Injury, poisoning and procedural complications:

• Extradural haematoma
• Subdural haematoma

Investigations:

• Blood glucose increased, blood uric acid increased, platelet count decreased, white blood cell count decreased, increase in BUN (blood urea increased), blood pressure increase

Nervous system disorders:

• Intracranial haemorrhage
• cerebral haemorrhage
• cerebrovascular accident

Respiratory, thoracic and mediastinal disorders:

• Pulmonary haemorrhage
• interstitial pneumonia

Skin and subcutaneous tissue disorders:

• Haemorrhage subcutaneous, pruritus, skin eruptions including Stevens-Johnson syndrome, skin drug eruption (dermatitis medicamentosa)

Vascular disorders:

• Subacute thrombosis (these cases of subacute thrombosis occurred in patients treated with aspirin and "off label" use of cilostazol for prevention of thrombotic complication after coronary stenting)

Drug Interactions

• Drug 1
• Drug 2
• Drug 3
• Drug 4
• Drug 5

Drug 1

(Description)

Drug 2

(Description)

Drug 3

(Description)

Drug 4

(Description)

Drug 5

(Description)

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

The total and unbound oral clearances, adjusted for body weight, of cilostazol and its metabolites were not significantly different with respect to age and/or gender across a 50- to 80-year old age range

Race

(Description)

Renal Impairment

Patients on dialysis have not been studied, but, it is unlikely that cilostazol can be removed efficiently by dialysis because of its high protein binding (95% to 98%). Special caution is advised when cilostazol is used in patients with severe renal impairment: estimated creatinine clearance <25 mL/min.

Hepatic Impairment

Patients with moderate or severe hepatic impairment have not been studied in clinical trials. Special caution is advised when cilostazol is used in such patients.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Dietary administration of cilostazol to male and female rats and mice for up to 104 weeks, at doses up to 500 mg/kg/day in rats and 1000 mg/kg/day in mice, revealed no evidence of carcinogenic potential. The maximum doses administered in both rat and mouse studies were, on a systemic exposure basis, less than the human exposure at the MRHD of the drug. Cilostazol tested negative in bacterial gene mutation, bacterial DNA repair, mammalian cell gene mutation and mouse in vivo bone marrow chromosomal aberration assays. It was, however, associated with a significant increase in chromosomal aberrations in the in vitro Chinese Hamster Ovary Cell assay.

Cilostazol did not affect fertility or mating performance of male and female rats at doses as high as 1000 mg/kg/day. At this dose, systemic exposures (AUCs) to unbound cilostazol were less than 1.5 times in males and about 5 times in females, the exposure in humans at the MRHD.

Immunocompromised Patients

(Description)

Miscellaneous

Smokers

Population pharmacokinetic analysis suggests that smoking decreased cilostazol exposure by about 20%.

Administration and Monitoring

Administration

Oral

Monitoring

Discontinuation of Therapy

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

IV Compatibility

FDA package insert doesn't contain any information regarding IV Compatibility

Overdosage

Acute Overdose

Signs and Symptoms

Information on acute overdosage with cilostazol tablets in humans is limited. The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: severe headache, diarrhea, hypotension, tachycardia and possibly cardiac arrhythmias. The patient should be carefully observed and given supportive treatment. Since cilostazol is highly protein-bound, it is unlikely that it can be efficiently removed by hemodialysis or peritoneal dialysis. The oral LD50 of cilostazol is >5.0 g/kg in mice and rats and >2.0 g/kg in dogs.

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Mechanism of Action

The mechanism of the effects of cilostazol on the symptoms of intermittent claudication is not fully understood. Cilostazol and several of its metabolites are cyclic AMP (cAMP) phosphodiesterase III inhibitors (PDE III inhibitors), inhibiting phosphodiesterase activity and suppressing cAMP degradation with a resultant increase in cAMP in platelets and blood vessels, leading to inhibition of platelet aggregation and vasodilation, respectively.

Cilostazol reversibly inhibits platelet aggregation induced by a variety of stimuli, including thrombin, ADP, collagen, arachidonic acid, epinephrine, and shear stress. Effects on circulating plasma lipids have been examined in patients taking cilostazol. After 12 weeks, as compared to placebo, cilostazol 100 mg b.i.d. produced a reduction in triglycerides of 29.3 mg/dL (15%) and an increase in HDL-cholesterol of 4.0 mg/dL (~10%).

Cardiovascular Effects

Cilostazol affects both vascular beds and cardiovascular function. It produces non-homogeneous dilation of vascular beds, with greater dilation in femoral beds than in vertebral, carotid or superior mesenteric arteries. Renal arteries were not responsive to the effects of cilostazol.

In dogs or cynomolgous monkeys, cilostazol increased heart rate, myocardial contractile force, and coronary blood flow as well as ventricular automaticity, as would be expected for a PDE III inhibitor. Left ventricular contractility was increased at doses required to inhibit platelet aggregation. A-V conduction was accelerated. In humans, heart rate increased in a dose-proportional manner by a mean of 5.1 and 7.4 beats per minute in patients treated with 50 and 100 mg b.i.d., respectively. In 264 patients evaluated with Holter monitors, numerically more cilostazol-treated patients had increases in ventricular premature beats and non-sustained ventricular tachycardia events than did placebo-treated patients; the increases were not dose-related.

Structure

• Cilostazol is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). The empirical formula of cilostazol is C20H27N5O2, and its molecular weight is 369.46. Cilostazol is 6-[4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy]-3,4-dihydro-2(1H)-quinolinone, CAS-73963-72-1.
• Cilostazol occurs as white to off-white crystals or as a crystalline powder that is slightly soluble in methanol and ethanol, and is practically insoluble in water, 0.1 N HCl, and 0.1 N NaOH.
• Cilostazol tablets for oral administration are available in 50 mg and 100 mg round, white debossed tablets. Each tablet, in addition to the active ingredient, contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, methylcellulose, carboxymethylcellulose calcium and magnesium stearate.

Pharmacodynamics

(Description)

Pharmacokinetics

Cilostazol is absorbed after oral administration. A high fat meal increases absorption, with an approximately 90% increase in Cmax and a 25% increase in AUC. Absolute bioavailability is not known. Cilostazol is extensively metabolized by hepatic cytochrome P-450 enzymes, mainly 3A4, and, to a lesser extent, 2C19, with metabolites largely excreted in urine. Two metabolites are active, with one metabolite appearing to account for at least 50% of the pharmacologic (PDE III inhibition) activity after administration of cilostazol. Pharmacokinetics are approximately dose proportional. Cilostazol and its active metabolites have apparent elimination half-lives of about 11-13 hours. Cilostazol and its active metabolites accumulate about 2-fold with chronic administration and reach steady state blood levels within a few days. The pharmacokinetics of cilostazol and its two major active metabolites were similar in healthy normal subjects and patients with intermittent claudication due to peripheral arterial disease (PAD).

The mean ±SEM plasma concentration-time profile at steady state after multiple dosing of cilostazol 100 mg b.i.d. is shown below

Distribution

Plasma Protein and Erythrocyte Binding

Cilostazol is 95-98% protein bound, predominantly to albumin. The mean percent binding for 3,4‑dehydro‑cilostazol is 97.4% and for 4´-trans-hydroxy-cilostazol is 66%. Mild hepatic impairment did not affect protein binding. The free fraction of cilostazol was 27% higher in subjects with renal impairment than in normal volunteers. The displacement of cilostazol from plasma proteins by erythromycin, quinidine, warfarin, and omeprazole was not clinically significant.

Metabolism and Excretion

Cilostazol is eliminated predominately by metabolism and subsequent urinary excretion of metabolites. Based on in vitro studies, the primary isoenzymes involved in cilostazol's metabolism are CYP3A4 and, to a lesser extent, CYP2C19. The enzyme responsible for metabolism of 3,4‑dehydro‑cilostazol, the most active of the metabolites, is unknown.

Following oral administration of 100 mg radiolabeled cilostazol, 56% of the total analytes in plasma was cilostazol, 15% was 3,4-dehydro-cilostazol (4-7 times as active as cilostazol), and 4% was 4´-trans-hydroxy-cilostazol (one fifth as active as cilostazol). The primary route of elimination was via the urine (74%), with the remainder excreted in feces (20%). No measurable amount of unchanged cilostazol was excreted in the urine, and less than 2% of the dose was excreted as 3,4-dehydro-cilostazol. About 30% of the dose was excreted in urine as 4´-trans-hydroxy-cilostazol. The remainder was excreted as other metabolites, none of which exceeded 5%. There was no evidence of induction of hepatic microenzymes.

Nonclinical Toxicology

Clinical Studies

• The ability of cilostazol to improve walking distance in patients with stable intermittent claudication was studied in eight large, randomized, placebo-controlled, double-blind trials of 12 to 24 weeks’ duration using dosages of 50 mg b.i.d. (n=303), 100 mg b.i.d. (n=998) and placebo (n=973). Efficacy was determined primarily by the change in maximal walking distance from baseline (compared to change on placebo) on one of several standardized exercise treadmill tests.
• Compared to patients treated with placebo, patients treated with cilostazol tablets 50 mg or 100 mg b.i.d. experienced statistically significant improvements in walking distances both for the distance before the onset of claudication pain and the distance before exercise-limiting symptoms supervened (maximal walking distance). The effect of cilostazol on walking distance was seen as early as the first on-therapy observation point of two or four weeks.
• The following figure depicts the percent mean improvement in maximal walking distance, at study end for each of the eight studies.

Percent Mean Improvement in Maximal Walking Distance at Study End for the Eight Randomized, Double-Blind, Placebo-Controlled Clinical Trials

• Across the eight clinical trials, the range of improvement in maximal walking distance in patients treated with cilostazol 100 mg b.i.d., expressed as the percent mean change from baseline, was 28% to 100%.
• The corresponding changes in the placebo group were –10% to 41%.
• The Walking Impairment Questionnaire, which was administered in six of the eight clinical trials, assesses the impact of a therapeutic intervention on walking ability. In a pooled analysis of the six trials, patients treated with either cilostazol 100 mg b.i.d. or 50 mg b.i.d. reported improvements in their walking speed and walking distance as compared to placebo. Improvements in walking performance were seen in the various subpopulations evaluated, including those defined by gender, smoking status, diabetes mellitus, duration of peripheral artery disease, age and concomitant use of beta blockers or calcium channel blockers. Cilostazol has not been studied in patients with rapidly progressing claudication or in patients with leg pain at rest, ischemic leg ulcers or gangrene. Its long-term effects on limb preservation and hospitalization have not been evaluated.
• A randomized, double-blind, placebo-controlled Phase IV study was conducted to assess the long-term effects of cilostazol, with respect to mortality and safety, in 1,439 patients with intermittent claudication and no heart failure. The trial stopped early due to enrollment difficulties and a lower than expected overall death rate. With respect to mortality, the observed 36-month Kaplan-Meier event rate for deaths on study drug with a median time on study drug of 18 months was 5.6% (95% CI of 2.8% to 8.4%) on cilostazol and 6.8% (95% CI of 1.9% to 11.5%) on placebo. These data appear to be sufficient to exclude a 75% increase in the risk of mortality on cilostazol, which was the a priori study hypothesis.

How Supplied

50 mg: White, round, debossed with “E” over “123” on one side and plain on the other and supplied as:

• National Drug Code (NDC): 0185-0123-60 bottles of 60 and 0185-0123-05 bottles of 500
• Storage: Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature].
• Manufactured by: Sandoz Inc.Princeton, NJ 08540
• Distributed by:Bryant Ranch Prepack

100 mg: White, round, debossed with “E” over “223” on one side and plain on the other and supplied as:

• National Drug Code (NDC): 0185-0223-60 bottles of 60 and 0185-0223-05 bottles of 500
• Storage: Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature].
• Manufactured by: Sandoz Inc.Princeton, NJ 08540
• Distributed by:Bryant Ranch Prepack

Images

Drug Images

Drug Name: Cilostazol 50 MG Oral Tablet Ingredient(s): carboxymethylcellulose calcium / magnesium stearate / cellulose, microcrystalline Imprint: E;123 Color(s): White Shape: Round Size (mm): 9 mm Score: 1 Drug Label Author: Bryant Ranch Prepack

Drug Name: Cilostazol 100 MG Oral Tablet Ingredient(s): carboxymethylcellulose calcium / magnesium stearate / cellulose, microcrystalline Imprint: E;223 Color(s): White Shape: Round Size (mm): 9 mm Score: 1 Drug Label Author: Bryant Ranch Prepack

Package and Label Display Panel

Sandoz Inc. Princeton, NJ 08540 OS8128 Rev. 02/13 MF0223REV02/13 Cilostazol 100mg Tablet

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

Cilostazol®, Platel®.

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