HomeNDC LookupIngredientsCilostazol › 60505-2521-03
cilostazol 50 mg Tablet, 30-count — NDC 60505-2521-03 package photo

cilostazol 50 mg Tablet, 30-count

by Apotex Corp. · 30 TABLET in 1 BOTTLE (60505-2521-3)
NDC 60505-2521-03
🏷️ FDA NDC (as labeled) 60505-2521-3 billing pads the package segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.2316/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 60505-2521-3
Product NDC 60505-2521
11-digit billing NDC 60505252103
UNII N7Z035406B
UPC 0360505252213
Application # ANDA077030
SPL Set ID ceac1ae3-c343-28ca-c083-b748d21a15e6
Established class (EPC) Phosphodiesterase 3 Inhibitor
Mechanism of action Phosphodiesterase 3 Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-10-18
Route ORAL
Dosage form TABLET
Substance CILOSTAZOL
GCN Seq No 037979
GCN 08603
HICL code 017433
Ingredient (HICL) Cilostazol
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M9
Therapeutic class — intermediate (HIC2) Drugs Given To Alter Blood Coagulation
HIC3 code M9P
Therapeutic class — specific (HIC3) Platelet Aggregation Inhibitors
AHFS code 20:12.18.00
AHFS class Platelet-Aggregation Inhibitors
FDB label name CILOSTAZOL 50 MG TABLET
FDB brand name Cilostazol
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 60505-2521-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 60505-2521-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerApotex Corp.
Application holderAPOTEX INC
FDA applicationANDA077030 (ANDA)
Labeler code60505
First marketedOct 2011
Product typeHuman Prescription Drug
Portfolio306 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CILOSTAZOL 50 MG TABLET Ingredient Cilostazol
📗 Our plain-language guide HelloPharmacist
  • Cilostazol helps with a condition called intermittent claudication — that's the cramping or aching you feel in your legs when you walk, caused by arteries that are too narrow to de...
  • What exactly does cilostazol do, and why did my doctor prescribe it for leg pain?
  • Yes, timing around meals really does matter with this one. Take your tablet at least 30 minutes before eating, or wait 2 hours after a meal. A high-fat meal can push up to 90% more...
  • How do I take it, and does it matter whether I eat first?
📖 Read our full Cilostazol guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeRound
ImprintAPO;CIL;100
Size9 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2316 $6.95 / 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cilostazol 50 mg 00093-2065-06 Teva 60 tablets $0.122 AB Availability likely
cilostazol 50 mg 50268-0176-15 AvPAK 50 tablets $0.122 AB Availability likely
Cilostazol 50 mg 70436-0156-06 Slate 60 tablets $0.122 AB Availability likely
cilostazol 50 mgthis 60505-2521-03 Apotex 30 tablets AB FDA listed
Cilostazol 50 mg 62135-0983-60 Chartwell 60 tablets FDA listed
Cilostazol 50 mg 63629-8796-01 Bryant 60 tablets AB FDA listed
Cilostazol 50 mg 72189-0116-60 direct 60 tablets AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2011
On the market since
Oct 2011
📍
2026
Currently FDA-listed
15 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
60 tablets60505-2521-01 17,621 Rx · $242,544
1000 tablets60505-2521-08 No Medicaid data
Drug total (last 4 qtrs): 17,621 Rx · 1,031,691 units · $242,544 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Cilostazol — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cilostazol. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$4.46M
Claims incl. refills
186.5K
Beneficiaries
127.7K
Spend / beneficiary
$34.95
Spend / claim
$23.93
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
60505-2521-01 60 TABLET in 1 BOTTLE (60505-2521-1) $0.1219 / ea $7.31 2011-10-18 Active
60505-2521-03 You're viewing this 30 TABLET in 1 BOTTLE (60505-2521-3) 2011-10-18 Active
60505-2521-08 1000 TABLET in 1 BOTTLE (60505-2521-8) 2011-10-18 Active

You're viewing the smallest of 3 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 60 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 60505-2521-03?
NDC 60505-2521-03 is a 30-count package — 30 tablet in 1 bottle.
What is the difference between NDC 60505-2521-03 and NDC 60505-2521-01?
Both are cilostazol 50 mg Tablet — the drug itself is identical. NDC 60505-2521-03 is the 30-count package, while NDC 60505-2521-01 is the 60 tablets package.
What NDC number is used to bill for this package of cilostazol 50 mg Tablet?
Bill NDC 60505-2521-03 — the 11-digit billing format is 60505252103. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 60505-2521-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 60505-2521-03, written without dashes as 60505252103. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 60505-2521-03, the first segment (60505) is the labeler code FDA assigned to Apotex Corp.; the middle segment (2521) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Apotex Corp.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 tablets (60505-2521-01), 1000 tablets (60505-2521-08). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Apotex Corp. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 112 words

WARNING: CONTRAINDICATED IN HEART FAILURE PATIENTS Cilostazol tablets are contraindicated in patients with heart failure of any severity. 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 heart failure [see Contraindications ( 4 )] .

WARNING: CONTRAINDICATED IN HEART FAILURE PATIENTS See full prescribing information for complete boxed warning. Cilostazol tablets is contraindicated in patients with heart failure of any severity. Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III.

Several drugs with the pharmacologic effect have caused decreased survival compared to placebo patients with class III-IV heart failure. (4)

🎯 Indications and Usage 51 words

1 INDICATIONS AND USAGE Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. Cilostazol is a phosphodiesterase III inhibitor (PDE III inhibitor) indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance ( 1 )

⏱️ Dosage and Administration 176 words

2 DOSAGE AND ADMINISTRATION The recommended dosage of cilostazol is 100 mg twice daily taken at least half an hour before or two hours after breakfast and dinner ( 2.1 ) Reduce the dose to 50 mg twice daily when coadministered with CYP3A4 inhibitors such as ketoconazole, itraconazole, erythromycin, and diltiazem, or CYP2C19 inhibitors such as ticlopidine, fluconazole, and omeprazole ( 2.2 )

2.1Recommended dosage The recommended dosage of cilostazol is 100 mg twice daily taken at least half an hour before or two hours after breakfast and dinner. 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. If symptoms are unimproved after 3 months, discontinue cilostazol.

2.2Dose Reduction with CYP3A4 and CYP2C19 Inhibitors Reduce dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, erythromycin, and diltiazem) or inhibitors of CYP2C19 (e.g., ticlopidine, fluconazole, and omeprazole) [see Drug Interactions ( 7.1 )] .

💊 Dosage Forms and Strengths 63 words

3 DOSAGE FORMS AND STRENGTHS Cilostazol tablets, USP 50 mg are white, round, flat-faced, bevelled-edge tablets, engraved "APO" on one side and "CIL" over "50" on the other side. Cilostazol tablets, USP 100 mg tablets are white, round, flat-faced, bevelled-edge tablets, engraved "APO" on one side and "CIL" over "100" on the other side. Tablets: 50 mg and 100 mg ( 3 )

Contraindications 76 words

4 CONTRAINDICATIONS Cilostazol is contraindicated in patients with: Heart failure of any severity: 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 heart failure. Hypersensitivity to cilostazol or any components of cilostazol tablets (e.g., anaphylaxis, angioedema) Heart failure of any severity ( 4 ) Hypersensitivity to cilostazol or any components of cilostazol tablets ( 4 )

⚠️ Warnings and Cautions ~1 min read

5 WARNINGS AND PRECAUTIONS Risks of tachycardia, palpitation, tachyarrhythmia or hypotension. Risks of exacerbations of angina pectoris or myocardial infarction in patients with a history of ischemic heart disease ( 5.2 ) Left ventricular outflow tract obstruction has been reported in patients with sigmoid shaped interventricular septum ( 5.1 ) Risks of thrombocytopenia or leukopenia progressing to agranulocytosis-monitor platelets and white blood cell counts ( 5.3 ) Avoid use in patients with hemostatic disorders or active pathologic bleeding ( 5.4 )

5.1Tachycardia Cilostazol may induce tachycardia, palpitation, tachyarrhythmia or hypotension. The increase in heart rate associated with cilostazol is approximately 5 to 7 bpm. Patients with a history of ischemic heart disease may be at risk for exacerbations of angina pectoris or myocardial infarction.

5.2Left Ventricular Outflow Tract Obstruction Left ventricular outflow tract obstruction has been reported in patients with sigmoid shaped interventricular septum. Monitor patients for the development of a new systolic murmur or cardiac symptoms after starting cilostazol.

5.3Hematologic Adverse Reactions Cases of thrombocytopenia or leukopenia progressing to agranulocytosis when cilostazol was not immediately discontinued have been reported. Agranulocytosis is reversible on discontinuation of cilostazol. Monitor platelets and white blood cell counts periodically.

5.4Hemostatic Disorders or Active Pathologic Bleeding Cilostazol inhibits platelet aggregation in a reversible manner. Cilostazol has not been studied in patients with hemostatic disorders or active pathologic bleeding. Avoid use of cilostazol tablets in these patients.

🤒 Adverse Reactions ~3 min read

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Patients with Heart Failure [see Boxed Warning] Tachycardia [see Warnings and Precautions ( 5.1 )] Left Ventricular Outflow Tract Obstruction [see Warnings and Precautions ( 5.2 )] Hematologic Adverse Reactions [see Warnings and Precautions ( 5.3 )] Hemostatic Disorders or Active Pathologic Bleeding [see Warnings and Precautions ( 5.4 )] Most common adverse reactions greater than or equal to 2% and at least twice that for placebo in patients on 100 mg twice daily are headache, diarrhea, abnormal stools, and palpitation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions were assessed in eight placebo-controlled clinical trials involving patients exposed to either 50 or 100 mg twice daily cilostazol tablets (n=1301) or placebo (n=973), with a median treatment duration of 127 days for patients on cilostazol tablets and 134 days for patients on placebo.

The most frequent adverse reaction resulting in discontinuation of therapy in more than 3% of patients treated with cilostazol tablets was headache [50 mg twice daily (1.3%), 100 mg twice daily (3.5%) and placebo (0.3%)]. Other frequent causes of discontinuation included palpitation and diarrhea, both 1.1% for cilostazol tablets (all doses) versus 0.1% for placebo. The most common adverse reactions, occurring in at least 2% of patients treated with cilostazol tablets 50 or 100 mg twice daily, are shown in Table 1.

Table 1: Most Common Adverse Reactions in Patients on cilostazol tablets 50 or 100 mg Twice Daily (Incidence at least 2% and Occurring More Frequently (≥ 2%) in the 100 mg Twice Daily Group than on Placebo) Adverse Reactions Placebo (N=973) Cilostazol tablets 50 mg twice daily (N=303) Cilostazol tablets 100 mg twice daily (N=998) Headache 14% 27% 34% Diarrhea 7% 12% 19% Abnormal stools 4% 12% 15% Palpitation 1% 5% 10% Dizziness 6% 9% 10% Pharyngitis 7% 7% 10% Infection 8% 14% 10% Peripheral edema 4% 9% 7% Rhinitis 5% 12% 7% Dyspepsia 4% 6% 6% Abdominal pain 3% 4% 5% Tachycardia 1% 4% 4% Less frequent clinical significant adverse reactions (less than 2%) that were experienced by patients treated with cilostazol 50 mg twice daily or 100 mg twice daily in the eight controlled clinical trials and that occurred at a frequency in the 100 mg twice daily group greater than in the placebo group are listed below.

Body as a whole: fever, generalized edema, malaise Cardiovascular: atrial fibrillation, heart failure, myocardial infarction, nodal arrhythmia, supraventricular tachycardia, ventricular extrasystoles, ventricular tachycardia Digestive: anorexia, melena Hematologic and Lymphatic: anemia Metabolic and Nutritional: increased creatinine, hyperuricemia Nervous: insomnia Respiratory: epistaxis Skin and Appendages: urticaria Special Senses: conjunctivitis, retinal hemorrhage, tinnitus Urogenital: urinary frequency

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of cilostazol tablets. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: Aplastic anemia, granulocytopenia, pancytopenia, bleeding tendency Cardiac disorders: Torsade de pointes and QTc prolongation in patients with cardiac disorders (e.g. complete atrioventricular block, heart failure; and bradyarrythmia), angina pectoris.

Gastrointestinal disorders: Gastrointestinal he…

🔄 Drug Interactions 128 words

7 DRUG INTERACTIONS Strong and moderate CYP3A4 and CYP2C19 inhibitors: Increase exposure to cilostazol. Reduce cilostazol tablets dose ( 2.2 , 7.1 )

7.1Inhibitors of CYP3A4 or CYP2C19 Inhibitors of CYP3A4 Coadministration of strong (e.g., ketoconazole) and moderate (e.g., erythromycin, diltiazem and grapefruit juice) CYP3A4 inhibitors can increase exposure to cilostazol. Reduce cilostazol dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP3A4 [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )]. Inhibitors of CYP2C19 Coadministration with CYP2C19 inhibitors (e.g., omeprazole) increases systemic exposure of cilostazol active metabolites.

Reduce cilostazol dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP2C19 [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].

👥 Use in Specific Populations ~2 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Teratogenic Effects Pregnancy Category C. Cilostazol has been shown to be teratogenic in rats at doses that are greater than 5-times the human MRHD on a body surface area basis. There are no adequate and well-controlled studies in pregnant women.

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, 14 th 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).

8.3Nursing Mothers Transfer of cilostazol into milk has been reported in rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from cilostazol, discontinue nursing or discontinue cilostazol.

8.4Pediatric Use Safety and effectiveness of cilostazol in pediatric patients have not been established.

8.5Geriatric 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 excluded. Pharmacokinetic studies have not disclosed any age-related effects on the absorption, distribution, metabolism, and elimination of cilostazol and its metabolites.

8.6Hepatic Impairment No dose adjustment is required in patients with mild hepatic impairment. Patients with moderate or severe hepatic impairment have not been studied in clinical trials and dosing recommendations cannot be provided [see Clinical Pharmacology ( 12.3 )].

8.7Renal Impairment No dose adjustment is required in patients with 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%) [see Clinical Pharmacology ( 12.3 )].

🆘 Overdosage 94 words

10 OVERDOSAGE Information on acute overdosage with cilostazol 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 LD 50 of cilostazol is greater than 5 g per kg in mice and rats and greater than 2 g per kg in dogs.

🧬 Clinical Pharmacology ~3 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Cilostazol and several of its metabolites inhibit phosphodiesterase III activity and suppress 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. Cardiovascular effects: Cilostazol affects both vascular beds and cardiovascular function.

It produces heterogeneous 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 cynomolgus 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 twice daily, respectively.

12.2Pharmacodynamics Cilostazol’s effects on platelet aggregation were evaluated in both healthy subjects and in patients with stable symptoms of cerebral thrombosis, cerebral embolism, transient ischemic attack, or cerebral arteriosclerosis over a range of doses from 50 mg every day to 100 mg three times a day. Cilostazol significantly inhibited platelet aggregation in a dose-dependent manner. The effects were observed as early as 3 hours post-dose and lasted up to 12 hours following a single dose.

Following chronic administration and withdrawal of cilostazol, the effects on platelet aggregation began to subside 48 hours after withdrawal and returned to baseline by 96 hours with no rebound effect. A cilostazol dosage of 100 mg twice daily consistently inhibited platelet aggregation induced with arachidonic acid, collagen and adenosine diphosphate (ADP). Bleeding time was not affected by cilostazol administration.

Effects on circulating plasma lipids have been examined in patients taking cilostazol. After 12 weeks, as compared to placebo, cilostazol 100 mg twice daily produced a reduction in triglycerides of 29.3 mg/dL (15%) and an increase in HDL-cholesterol of 4.0 mg/dL (≅ 10%). Drug Interactions Aspirin Short-term (less than or equal to 4 days) coadministration of aspirin with cilostazol increased the inhibition of ADP- induced ex vivo platelet aggregation by 22% to 37% when compared to either aspirin or cilostazol alone.

Short-term (less than or equal to 4 days) coadministration of aspirin with cilostazol increased the inhibition of arachidonic acid-induced ex vivo platelet aggregation by 20% compared to cilostazol alone and by 48% compared to aspirin alone. However, short- term coadministration of aspirin with cilostazol had no clinically significant impact on PT, aPTT, or bleeding time compared to aspirin alone. Effects of long-term coadministration in the general population are unknown.

In eight randomized, placebo-controlled, double-blind clinical trials, aspirin was coadministered with cilostazol to 201 patients. The most frequent doses and mean durations of aspirin therapy were 75 to 81 mg daily for 137 days (107 patients) and 325 mg daily for 54 days (85 patients). There was no apparent increase in frequency of hemorrhagic adverse effects in patients taking cilostazol and aspirin compared to patients taking placebo and equivalent doses of aspirin.

Warfarin Cilostazol did not inhibit the pharmacologic effects (PT, aPTT, bleeding time, or platelet aggregation) of R- and S- warfarin after a single 25-mg dose of warfarin. The effect of concomitant multiple dosing of warfarin and cilostazol on the pharmacodynamics of both drugs is unknown.

12.3 Pharmacokinetics Cil…

📦 How Supplied / Storage and Handling 133 words

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How supplied Cilostazol tablets, USP are supplied as 50 mg and 100 mg tablets. Cilostazol tablets, USP 50 mg are white, round, flat-faced, bevelled-edge tablets, engraved "APO" on one side and "CIL" over "50" on the other side. They are supplied as follows: Bottles of 30 NDC 60505-2521-3 Bottles of 60 NDC 60505-2521-1 Bottles of 1,000 NDC 60505-2521-8 Cilostazol tablets, USP 100 mg tablets are white, round, flat-faced, bevelled-edge tablets, engraved "APO" on one side and "CIL" over "100" on the other side.

They are supplied as follows: Bottles of 30 NDC 60505-2522-3 Bottles of 60 NDC 60505-2522-1 Bottles of 1,000 NDC 60505-2522-8

16.2Storage and handling Store cilostazol tablets at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

📋 Description 127 words

11 DESCRIPTION Cilostazol is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). The empirical formula of cilostazol is C 20 H 27 N 5 O 2 , and its molecular weight is 369.47. Cilostazol is 6-[4-(1-cyclohexyl-1 H -tetrazol-5-yl) butoxy]-3,4-dihydro-2(1 H )-quinolinone, CAS-73963-72-1.

The structural formula is: 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

0.1N NaOH. Cilostazol tablets, USP for oral administration are available in 50 mg and 100 mg round, white tablets. Each tablet, in addition to the active ingredient, contains the following inactive ingredients: corn starch, croscarmellose sodium, magnesium stearate, and silicon dioxide. Meets USP Dissolution Test 2

💬 Information for Patients 135 words

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Advise the patient: to take cilostazol tablets at least one-half hour before or two hours after food. to discuss with their doctor before taking any CYP3A4 or CYP2C19 inhibitors (e.g., omeprazole). that the beneficial effects of cilostazol tablets on the symptoms of intermittent claudication may not be immediate. Although the patient may experience benefit in 2 to 4 weeks after initiation of therapy, treatment for up to 12 weeks may be required before a beneficial effect is experienced.

Discontinue cilostazol tablets if symptoms do not improve after 3 months. APOTEX INC. CILOSTAZOL TABLETS, USP 50 mg and 100 mg.

Manufactured by Manufactured for Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 Revised: May 2017 Rev.

09

💬 Patient Medication Information ~3 min read

PATIENT INFORMATION Cilostazol Tablets, USP (sye loe' sta zol) for oral use 50 mg and 100 mg Read this Patient Information leaflet before you start taking cilostazol tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about cilostazol tablets? Cilostazol tablets can cause serious side effects: Cilostazol tablets stops a protein called phosphodiesterase III from working. Other similar drugs which affect this protein may cause death if you already have heart problems, called class 3 to 4 (III-IV) heart failure.

Do not take cilostazol tablets if you have heart failure of any kind. What are cilostazol tablets? Cilostazol tablets is a prescription medicine used to reduce the symptoms of intermittent claudication and can increase your ability to walk further distances.

It is not known if cilostazol tablets is safe and effective for use in children. How does cilostazol tablets work? Improvement in symptoms may occur as soon as 2 weeks, but could take up to 12 weeks.

Who should not take cilostazol tablets? Do not take cilostazol tablets if you: have heart problems (heart failure) are allergic to cilostazol or any of the ingredients in cilostazol tablets. See the end of this leaflet for a complete list of ingredients in cilostazol tablets.

Tell your doctor before taking this medicine if you have any of these conditions. What should I tell my doctor before taking cilostazol tablets? Before you take cilostazol tablets, tell your doctor if you: drink grapefruit juice.

Taking cilostazol tablets and drinking grapefruit juice can increase the amount of cilostazol tablets causing side effects. have any other medical conditions. are pregnant or planning to become pregnant. It is not known if cilostazol tablets will harm your unborn baby. are breastfeeding or planning to breastfeed. It is not known if cilostazol tablets passes into your breast milk.

You and your doctor should decide if you will take cilostazol tablets or breastfeed. You should not do both. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Ask your doctor for a list of these medicines if you are not sure. You can ask your pharmacist for a list of medicines that interact with cilostazol tablets. Know the medicines you take.

Keep a list of them to show to your doctor and pharmacist when you get a new medicine. How should I take cilostazol tablets? Take cilostazol tablets exactly as your doctor tells you to take it.

Your doctor will tell you how much cilostazol tablets to take and when to take it. Your doctor may change your dose if needed. Take cilostazol tablets 30 minutes before you eat or 2 hours after you eat.

What are the possible side effects of cilostazol tablets? Cilostazol tablets may cause serious side effects, including: heart problems. Taking cilostazol tablets may cause you to have heart problems, including a fast heart beat, palpitations, irregular heartbeat, and low blood pressure.

See "What is the most important information I should know about cilostazol tablets?" severe allergic reactions (anaphylaxis, angioedema). Call your doctor or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction: hives swelling of your face, lips, mouth, or tongue trouble breathing or wheezing dizziness changes in your blood cell counts (thrombocytopenia or leukopenia). Your doctor should do blood tests to check your blood cell counts while you take cilostazol tablets.

The most common side effects of cilostazol tablets include: headache abnormal stools diarrhea Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of cilostazol tablets. For more information, ask your doctor or…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.