Pronunciation:

sye-LOE-sta-zol

Brand Names:

• Pletal

Dosage Forms:

• Tablet

Warnings:

Cilostazol is contraindicated in congestive heart failure of any severity. Cilostazol and many of its metabolites inhibit phosphodiesterase III. Several drugs with this pharmacologic effect have resulted in decreased survival compared with placebo in patients with class III to IV congestive heart failure .

Classifications:

Therapeutic—

Platelet Aggregation Inhibitor

Pharmacologic—

Phosphodiesterase Inhibitor

Uses of This Medicine:

Cilostazol improves the flow of blood through the blood vessels. It is used to reduce leg pain caused by poor circulation (intermittent claudication). Cilostazol makes it possible to walk farther before having to rest because of leg pain.

This medicine works by keeping blood from clotting and by dilating or relaxing the blood vessels.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of cilostazol in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cilostazol in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Abrocitinib
• Defibrotide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Abciximab
• Abiraterone Acetate
• Aceclofenac
• Acemetacin
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amiodarone
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Aprepitant
• Argatroban
• Aspirin
• Atazanavir
• Betrixaban
• Bivalirudin
• Boceprevir
• Bromfenac
• Bufexamac
• Caplacizumab-yhdp
• Celecoxib
• Ceritinib
• Choline Salicylate
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clonixin
• Clopidogrel
• Cobicistat
• Conivaptan
• Crizotinib
• Curcumin
• Dabigatran Etexilate
• Danaparoid
• Delavirdine
• Desirudin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Diltiazem
• Dipyridamole
• Dipyrone
• Dronedarone
• Droxicam
• Duloxetine
• Edoxaban
• Eliglustat
• Eptifibatide
• Erythromycin
• Escitalopram
• Eslicarbazepine Acetate
• Esomeprazole
• Etodolac
• Etofenamate
• Etoricoxib
• Etravirine
• Fedratinib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fexinidazole
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Fosaprepitant
• Fosnetupitant
• Ginkgo
• Heparin
• Ibrutinib
• Ibuprofen
• Idelalisib
• Imatinib
• Indinavir
• Indomethacin
• Inotersen
• Itraconazole
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lansoprazole
• Lepirudin
• Letermovir
• Letrozole
• Levomilnacipran
• Lopinavir
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Melphalan
• Miconazole
• Mifepristone
• Milnacipran
• Moclobemide
• Morniflumate
• Nabumetone
• Naproxen
• Nefazodone
• Nelfinavir
• Nepafenac
• Netupitant
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Omaveloxolone
• Omeprazole
• Oxaprozin
• Oxcarbazepine
• Oxyphenbutazone
• Pantoprazole
• Parecoxib
• Paroxetine
• Phenindione
• Phenobarbital
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piperaquine
• Piracetam
• Piroxicam
• Posaconazole
• Prasugrel
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Rabeprazole
• Regorafenib
• Ritonavir
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Saquinavir
• Selumetinib
• Sertraline
• Sodium Salicylate
• Sparsentan
• Sulfinpyrazone
• Sulindac
• Telaprevir
• Telithromycin
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tipranavir
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Trazodone
• Turmeric
• Valdecoxib
• Venlafaxine
• Verapamil
• Vilazodone
• Vonoprazan
• Voriconazole
• Vortioxetine
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Simvastatin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Bitter Orange

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Active bleeding (including peptic ulcers, bleeding in the brain) or
• Blood clotting problems or
• Congestive heart failure—Should not be used in patients with these conditions.

• Heart rhythm problems (eg, tachycardia) or
• Ischemic heart disease, history of or
• Kidney disease or
• Leukopenia (low white blood cells) or
• Liver disease or
• Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

It is best to take this medicine at the same time each day.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of peripheral vascular disease (circulation problems):
    • Adults—100 milligrams (mg) two times a day, taken at least 30 minutes before or 2 hours after breakfast and dinner. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by a doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

It may take several weeks for this medicine to work. If you feel that this medicine is not working, do not stop taking it on your own. Instead, check with your doctor.

Cilostazol can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Contact your doctor right away if you have any changes to your heart rhythm. You might have a fast, pounding, or irregular heartbeat or pulse, fainting, or palpitations with this medicine.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Cilostazol may cause heart problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain.

Smoking tobacco products, such as cigarettes, may worsen your condition. It contains nicotine which may further narrow blood vessels and may also affect how this medicine works. Therefore, it is best to avoid smoking.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Fast or irregular heartbeat

fever

Less common

Abnormal bleeding

bloody or black tarry stools

bruises or red spots on the skin

fainting

nausea, heartburn, or indigestion (severe or continuing)

nosebleeds

stiff neck

stomach pain, cramping, or burning (severe)

swelling of the tongue

vomiting of blood or material that looks like coffee grounds

Incidence not known

Bleeding gums

bleeding tendency

blistering, peeling, loosening of the skin

blood in the urine or stools

blurred vision

chest pain

chills

clay-colored stools

confusion

cough or hoarseness

coughing up blood

dark urine

diarrhea

difficulty with breathing

drowsiness

fever with or without chills

general feeling of tiredness or weakness

headache, sudden and severe

inability to speak

itching of the eyes

itching of the skin

joint or muscle pain

light-colored stools

loss of appetite

loss of consciousness

lower back or side pain

nausea and vomiting

painful or difficult urination

pinpoint red spots on the skin

red skin lesions, often with a purple center

red, irritated eyes

seizures

skin rash

slurred speech

sores, ulcers, or white spots on the lips or in the mouth

stomach pain

swollen glands

temporary blindness

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

weakness in the arm or leg on one side of the body, sudden and severe

weakness of part of the body

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Dizziness or lightheadedness when getting up suddenly from a lying or sitting position

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

dizziness

gas

headache

increased cough

pain or stiffness in the muscles

pounding heartbeat

runny or stuffy nose

sore throat

swelling of the arms or legs

Less common

Bone pain

burning feeling in the throat or chest

difficulty with swallowing

hives

pain or stiffness in the joints

ringing or buzzing in the ears

swelling of the face, fingers, or lower legs

Incidence not known

Bruising

feeling of warmth

pain

redness of the face, neck, arms and occasionally, upper chest

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.