Brand Name

    US Brand Name

    Pletal


    Description

    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.

    This product is available in the following dosage forms:

    • Tablet

    Before Using

    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.

    Pediatric

    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.

    Geriatric

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

    Breastfeeding

    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.

    Drug Interactions

    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
    • Abiraterone Acetate, Micronized
    • Aceclofenac
    • Acemetacin
    • Acenocoumarol
    • Alipogene Tiparvovec
    • Alteplase, Recombinant
    • Amiodarone
    • Amtolmetin Guacil
    • Anagrelide
    • Apixaban
    • Aprepitant
    • Argatroban
    • Aspirin
    • Atazanavir
    • Avacopan
    • Bedaquiline
    • Benzhydrocodone
    • Betrixaban
    • Bivalirudin
    • Boceprevir
    • Bromfenac
    • Budesonide
    • Bufexamac
    • Caplacizumab-yhdp
    • Carbamazepine
    • Celecoxib
    • Ceritinib
    • Choline Salicylate
    • Ciprofloxacin
    • Citalopram
    • Clarithromycin
    • Clonixin
    • Clopidogrel
    • Cobicistat
    • Codeine
    • Conivaptan
    • Crizotinib

    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

    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

    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

    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.






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