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CILOSTAZOL 100 MG TAB 5000

  • Manufacturer Name : TEVA USA
  • MFG # : 00093206450
  • NDC : 00093206450
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category N
Drug Type Code 1
FDA Approval Date 11/24/2004
FDA Therap Equiv AB
HCPCS -
Market Entry Date 10/24/2012
Medical Coverage -
Termination Date -
Unit TAB
Units Per Pkg 1
Active Ingredients 7339 cilostazol 73963721
AHFS Class 20121800 PLATELET-AGGREGATION INHIBITORS; 24121200 PHOSPHODIESTERASE TYPE 5 INHIBITORS
DEA Class NC
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 37978 cilostazol ORAL TABLET 100 MG
Inactive Ingredients 2537 povidone 9003398
OMP Family -
Product Category RX Pharmaceuticals
Strength 100MG
Common Brand Name COMMON BRAND NAME(S): Pletal
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: "blood thinners" (such as heparin, warfarin), certain other antiplatelet drugs (such as dipyridamole), tipranavir. This medication is sometimes used together with other drugs that may increase your risk of bleeding. Examples are certain antiplatelet drugs (such as aspirin, clopidogrel). Follow your doctor's instructions carefully and continue your medications as directed. Tell your doctor if you notice unusual bleeding. Consult your doctor or pharmacist for more details. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen/naproxen) which can increase the risk of bleeding/antiplatelet effect when used with cilostazol. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.
Allocation Period -
Case Quantity 6
Drug Form Pack Size 5000
Form TABLET
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 5000
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking cilostazol and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth without food as directed by your doctor, usually twice daily, at least 30 minutes before or 2 hours after breakfast and dinner. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Use this medication regularly to get the most benefit from it. Remember to use it at the same times each day. Your symptoms may improve in 2-4 weeks, but it may take up to 12 weeks before you get the full benefit of this drug. Tell your doctor if your condition lasts or gets worse.
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Talk with your doctor about an exercise program to improve walking and decrease pain. Lab and/or medical tests (such as complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe headache, very fast/irregular heartbeat, severe dizziness.
Phonetic Pronunciation (sye-LOE-sta-zol)
Precautions PRECAUTIONS: See also Warning section. Before taking cilostazol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: serious/active bleeding (such as bleeding ulcers, bleeding in the eye/brain), blood disorders (such as hemophilia, low platelet counts), heart disease (such as heart attack, chest pain, fast/irregular heartbeat), stroke, kidney disease. This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink. Cilostazol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using cilostazol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using cilostazol safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially swelling of the hands/feet (fluid retention) or QT prolongation (see above). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Headache, diarrhea, runny nose, and dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: swelling hands/feet, easy bruising/bleeding, black/bloody stools, vomit that looks like coffee grounds, signs of infection (such as sore throat that doesn't go away, fever). Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, fainting, fast/pounding/irregular heartbeat, severe dizziness, vision changes, weakness on one side of the body, trouble speaking, confusion. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: Cilostazol is used to improve the symptoms of a certain blood flow problem in the legs (intermittent claudication). Cilostazol can decrease the muscle pain/cramps that occur during exercise/walking. Claudication pain is caused by too little oxygen getting to the muscles. Cilostazol can increase blood flow and the amount of oxygen that gets to the muscles. Cilostazol is an antiplatelet drug and a vasodilator. It works by stopping blood cells called platelets from sticking together and prevents them from forming harmful clots. It also widens blood vessels in the legs. Cilostazol helps the blood to move more easily and keeps blood flowing smoothly in your body.

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CILOSTAZOL 100 MG TAB 5000 is manufactured by TEVA USA.
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