Cilostazol detailed information

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Cilostazol detailed information®
Black Box Warning
Adult Indications and Dosage
Pediatric Indications and Dosage
Contraindications
Warnings
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration and Monitoring
IV Compatibility
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient information
Precautions with Alcohol
Brand Names
Look-Alike Drug Names
Drug Shortage Status
Price

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

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Black Box Warning

FDA Package Insert for Cilostazol detailed information contains no information regarding Black Box Warning.

CONTRAINDICATION

See full prescribing information for complete boxed warning.

Condition Name: 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-IVcongestive heart failure. Cilostazol tablets are contraindicated in patients with congestive heart failure of any severity.

Overview

Cilostazol detailed information is a_Phosphodiesterase 3 Inhibitor drug that is FDA approved for the treatment of intermittent claudication. There is a Black Box Warning for this drug as shown here. Common adverse reactions include _______.

Adult Indications and Dosage

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Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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  • There is limited information about Off-Label Non–Guideline-Supported Use of Cilostazol detailed information in adult patients.
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Pediatric Indications and Dosage

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Guideline-Supported Use

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Adverse Reactions

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Use in Specific Populations

Pregnancy

  • Pregnancy Category (AUS): Cilostazol detailed information is not included in Australian Drug Evaluation Committee (ADEC) Pregnancy Categories.

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Administration and Monitoring

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Monitoring

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IV Compatibility

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Admixture

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Syringe

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TPN/TNA

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Overdosage

Acute Overdose

Signs and Symptoms

Information on acute overdosage with cilostazol tablets 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 LD50 of cilostazol is >5.0 g/kg in mice and rats and >2.0 g/kg in dogs.

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Pharmacology

Cilostazol detailed information
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Clinical Studies

  • The ability of cilostazol to improve walking distance in patients with stable intermittent claudication was studied in eight large, randomized, placebo-controlled, double-blind trials of 12 to 24 weeks’ duration using dosages of 50 mg b.i.d. (n=303), 100 mg b.i.d. (n=998) and placebo (n=973). Efficacy was determined primarily by the change in maximal walking distance from baseline (compared to change on placebo) on one of several standardized exercise treadmill tests.
  • Compared to patients treated with placebo, patients treated with cilostazol tablets 50 mg or 100 mg b.i.d. experienced statistically significant improvements in walking distances both for the distance before the onset of claudication pain and the distance before exercise-limiting symptoms supervened (maximal walking distance). The effect of cilostazol on walking distance was seen as early as the first on-therapy observation point of two or four weeks.
  • The following figure depicts the percent mean improvement in maximal walking distance, at study end for each of the eight studies.

Percent Mean Improvement in Maximal Walking Distance at Study End for the Eight Randomized, Double-Blind, Placebo-Controlled Clinical Trials

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  • Across the eight clinical trials, the range of improvement in maximal walking distance in patients treated with cilostazol 100 mg b.i.d., expressed as the percent mean change from baseline, was 28% to 100%.
  • The corresponding changes in the placebo group were –10% to 41%.
  • The Walking Impairment Questionnaire, which was administered in six of the eight clinical trials, assesses the impact of a therapeutic intervention on walking ability. In a pooled analysis of the six trials, patients treated with either cilostazol 100 mg b.i.d. or 50 mg b.i.d. reported improvements in their walking speed and walking distance as compared to placebo. Improvements in walking performance were seen in the various subpopulations evaluated, including those defined by gender, smoking status, diabetes mellitus, duration of peripheral artery disease, age and concomitant use of beta blockers or calcium channel blockers. Cilostazol has not been studied in patients with rapidly progressing claudication or in patients with leg pain at rest, ischemic leg ulcers or gangrene. Its long-term effects on limb preservation and hospitalization have not been evaluated.
  • A randomized, double-blind, placebo-controlled Phase IV study was conducted to assess the long-term effects of cilostazol, with respect to mortality and safety, in 1,439 patients with intermittent claudication and no heart failure. The trial stopped early due to enrollment difficulties and a lower than expected overall death rate. With respect to mortality, the observed 36-month Kaplan-Meier event rate for deaths on study drug with a median time on study drug of 18 months was 5.6% (95% CI of 2.8% to 8.4%) on cilostazol and 6.8% (95% CI of 1.9% to 11.5%) on placebo. These data appear to be sufficient to exclude a 75% increase in the risk of mortality on cilostazol, which was the a priori study hypothesis.

How Supplied

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Patient Information

Patient Information from FDA

(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.

Patient Information from NLM

For patient information about Cilostazol from NLM, click here.

Precautions with Alcohol

Alcohol-Cilostazol detailed information interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Brand Names®

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Drug Shortage Status

Price

References


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