Información de la droga para Cilostazol Tablets, 50 mg and 100 mg (Sandoz Inc.): Patient Information about cilostazol

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  • (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.

    Sandoz Inc.

    Princeton, NJ 08540

    Rev. 08/08

    MF0223REV08/08

    OS812

  • Drug Information Provided by National Library of Medicine (NLM).
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