Cilostazol: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{AK}}
|authorTag=
|genericName=Cilostazol
 
|aOrAn=a
Gerald Chi
|drugClass=Phosphodiesterase 3 inhibitor
 
|indication=Intermittent claudication
<!--Overview-->
|hasBlackBoxWarning=Yes
 
|adverseReactions=headache, dizziness, palpitation, diarrhea, rhinitis and pharyngitis.
|genericName=
|blackBoxWarningTitle=<b><span style="color:#FF0000;"> Contraindication </span></b>
 
|blackBoxWarningBody=<i><span style="color:#FF0000;">Heart failure</span></i>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-IV [[congestive heart failure]]. Cilostazol tablets are contraindicated in patients with [[congestive heart failure]] of any severity.
 
|fdaLIADAdult======Intermittent claudication 1=====
 
|aOrAn=
 
a
 
|drugClass=
 
 
 
|indication=
 
 
 
|hasBlackBoxWarning=
 
Yes
 
|adverseReactions=
 
 
 
<!--Black Box Warning-->
 
|blackBoxWarningTitle=
Title
 
|blackBoxWarningBody=
<i><span style="color:#FF0000;">ConditionName: </span></i>
 
* Content
 
<!--Adult Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Adult)-->
 
|fdaLIADAdult=
 
=====Condition1=====


* Dosing Information
* Dosing Information


:* '''100 mg q12h PO''' taken at least half an hour before or two hours after breakfast and dinner.
:* Dosage
:* '''50 mg q12h PO''' should be considered during co-administration of such inhibitors of CYP3A4 as [[ketoconazole]], [[itraconazole]], [[erythromycin]] and [[diltiazem]] and during co-administration of such inhibitors of CYP2C19 as [[omeprazole]].


Patients may respond as early as 2 to 4 weeks after the initiation of therapy, but treatment for up to 12 weeks may be needed before a beneficial effect is experienced.
=====Condition2=====
|offLabelAdultGuideSupport======Secondary prevention of stroke and TIA=====


* Developed by: American College of Chest Physicians
* Dosing Information


* Class of Recommendation: (Class II) (Link)
:* Dosage


* Strength of Evidence: (Category C) (Link)
=====Condition3=====


* Dosing Information/Recommendation
* Dosing Information


:* '''100 mg PO bid'''<ref name="Lansberg-2012">{{Cite journal  | last1 = Lansberg | first1 = MG. | last2 = O'Donnell | first2 = MJ. | last3 = Khatri | first3 = P. | last4 = Lang | first4 = ES. | last5 = Nguyen-Huynh | first5 = MN. | last6 = Schwartz | first6 = NE. | last7 = Sonnenberg | first7 = FA. | last8 = Schulman | first8 = S. | last9 = Vandvik | first9 = PO. | title = Antithrombotic and thrombolytic therapy for ischemic stroke: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. | journal = Chest | volume = 141 | issue = 2 Suppl | pages = e601S-36S | month = Feb | year = 2012 | doi = 10.1378/chest.11-2302 | PMID = 22315273 }}</ref>
:* Dosage


=====Thrombosis prophylaxis in percutaneous coronary intervention =====
=====Condition4=====


* Developed by:  American College of Chest Physicians
* Dosing Information


* Class of Recommendation: (Class II) (Link)
:* Dosage


* Strength of Evidence: (Category C) (Link)
<!--Off-Label Use and Dosage (Adult)-->


* Dosing Information/Recommendation
<!--Guideline-Supported Use (Adult)-->


:* '''100 mg PO bid'''<ref name="Vandvik-2012">{{Cite journal  | last1 = Vandvik | first1 = PO. | last2 = Lincoff | first2 = AM. | last3 = Gore | first3 = JM. | last4 = Gutterman | first4 = DD. | last5 = Sonnenberg | first5 = FA. | last6 = Alonso-Coello | first6 = P. | last7 = Akl | first7 = EA. | last8 = Lansberg | first8 = MG. | last9 = Guyatt | first9 = GH. | title = Primary and secondary prevention of cardiovascular disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. | journal = Chest | volume = 141 | issue = 2 Suppl | pages = e637S-68S | month = Feb | year = 2012 | doi = 10.1378/chest.11-2306 | PMID = 22315274 }}</ref>
|offLabelAdultGuideSupport=
|offLabelAdultNoGuideSupport======Secondary prevention of femoral artery occlusion after peripheral intervention=====
 
<ref name="Iida-2013">{{Cite journal  | last1 = Iida | first1 = O. | last2 = Yokoi | first2 = H. | last3 = Soga | first3 = Y. | last4 = Inoue | first4 = N. | last5 = Suzuki | first5 = K. | last6 = Yokoi | first6 = Y. | last7 = Kawasaki | first7 = D. | last8 = Zen | first8 = K. | last9 = Urasawa | first9 = K. | title = Cilostazol reduces angiographic restenosis after endovascular therapy for femoropopliteal lesions in the Sufficient Treatment of Peripheral Intervention by Cilostazol study. | journal = Circulation | volume = 127 | issue = 23 | pages = 2307-15 | month = Jun | year = 2013 | doi = 10.1161/CIRCULATIONAHA.112.000711 | PMID = 23652861 }}</ref>
=====Condition1=====
|fdaLIADPed=<b>Condition 1</b>
 
* Developed by:  
 
* Class of Recommendation:  
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
|fdaLIADPed=
 
=====Condition1=====


* Dosing Information
* Dosing Information


:: (Dosage)
:* Dosage
|offLabelPedGuideSupport=<b>Condition 1</b>
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->


* Developed by: (Organization)
<!--Guideline-Supported Use (Pediatric)-->


* Class of Recommendation: (Class) (Link)
|offLabelPedGuideSupport=


* Strength of Evidence: (Category A/B/C) (Link)
=====Condition1=====


* Dosing Information/Recommendation
* Developed by:


:* (Dosage)
* Class of Recommendation:  
|offLabelPedNoGuideSupport=<b>Condition 1</b>
 
* Strength of Evidence:


* Dosing Information
* Dosing Information


:* There is limited information about <i>Off-Label Non–Guideline-Supported Use</i> of Cilostazol in pediatric patients.
:* Dosage
|contraindications=* [[congestive heart failure]].
* Haemostatic disorders or active pathologic bleeding.
* [[peptic ulcer]].
* [[Intracranial bleeding]].
* Hypersensitivity to any of its components.
|warnings======Hematologic Adverse Reactions=====
Rare cases have been reported of [[thrombocytopenia ]]or [[leukopenia ]]progressing to [[agranulocytosis ]]when cilostazol was not immediately discontinued. The agranulocytosis, however, was reversible on discontinuation of cilostazol.


=====Use with Clopidogrel=====
=====Condition2=====
There is limited information with respect to the efficacy or safety of the concurrent use of cilostazol and [[clopidogrel]], a platelet-aggregation inhibiting drug indicated for use in patients with peripheral arterial disease. Although it cannot be determined whether there was an additive effect on bleeding times during concomitant administration with cilostazol and [[clopidogrel]], caution is advised for checking bleeding times during co-administration.
|clinicalTrials=Adverse events were assessed in eight placebo-controlled clinical trials involving 2274 patients exposed to either 50 or 100 mg b.i.d. cilostazol (n=1301) or placebo (n=973), with a median treatment duration of 127 days for patients on cilostazol and 134 days for patients on placebo.


The only adverse event resulting in discontinuation of therapy in ≥3% of patients treated with cilostazol 50 or 100 mg b.i.d. was headache, which occurred with an incidence of 1.3%, 3.5%, and 0.3% in patients treated with PLETAL 50 mg b.i.d., 100 mg b.i.d, or placebo, respectively. Other frequent causes of discontinuation included [[palpitation ]]and [[diarrhea]], both 1.1% for cilostazol (all doses) versus 0.1% for placebo.
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


======Body as a Whole======
<!--Non–Guideline-Supported Use (Pediatric)-->
*Common:
:*Abdominal pain
:*Back pain
:*Headache
:*Infection


*Less common:
|offLabelPedNoGuideSupport=
[[Chills]], face [[edema]], [[fever]], [[generalized edema]], [[malaise]], [[neck rigidity]], [[pelvic pain]], [[retroperitoneal haemorrhage]].
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
 
|contraindications=
 
* Condition1
 
<!--Warnings-->
 
|warnings=
 
* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
 
|clinicalTrials=
 
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.


======Central Nervous System======
======Central Nervous System======


*Common:
:*Dizziness
:*Vertigo


*Less common:
[[Anxiety]], [[insomnia]], [[neuralgia]].


======Cardiovascular======
======Cardiovascular======


*Common:
:*Palpitation
:*Tachycardia


*Less common:
[[Atrial fibrillation]], [[atrial flutter]], cerebral [[infarct]],[[ cerebral ischemia]], [[congestive heart failure]], [[Cardiac arrest|heart arrest]],[[ haemorrhage]], [[hypotension]], [[myocardial infarction]], [[myocardial ischemia]], nodal arrhythmia, [[postural hypotension]], [[supraventricular tachycardia]], [[syncope]], [[varicose vein]], [[vasodilation]], [[ventricular extrasystoles]], [[ventricular tachycardia]].


======Respiratory======
======Respiratory======


*Common:
:*[[Cough]]


:*[[Pharyngitis]]


:*[[Rhinitis]]
======Gastrointestinal======
 
 
 
======Hypersensitivity======
 
 
 
======Miscellaneous======
 
 
 
<!--Postmarketing Experience-->
 
|postmarketing=
 
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
======Central Nervous System======
 
 
 
======Cardiovascular======
 
 
 
======Respiratory======
 


*Less common:
[[Asthma]], [[epistaxis]], [[hemoptysis]], [[pneumonia]], [[sinusitis]].


======Gastrointestinal======
======Gastrointestinal======


*Common:
:*Abnormal stool
:*Diarrhea
:*Dyspepsia
:*Flatulence
:*Nausea


*Less common:
[[Anorexia]], [[cholelithiasis]],[[ colitis]], [[duodenal ulcer]], [[duodenitis]], esophageal haemorrhage, [[esophagitis]], increased [[GGT]], [[gastritis]], [[gastroenteritis]], gum haemorrhage, [[hematemesis]], [[melena]],[[ peptic ulcer]], periodontal abscess, rectal haemorrhage, [[stomach ulcer]], tongue edema.


======Hypersensitive Reactions======
======Hypersensitivity======
 
 
 
======Miscellaneous======
 


: (list/description of adverse reactions)


======Metabolic & Nutritional======
<!--Drug Interactions-->
*Common:
:*Peripheral edema


*Less common:
|drugInteractions=
Increased [[creatinine]], [[gout]], [[hyperlipemia]], [[hyperuricemia]].


======Musculoskeletal======
* Drug
:* Description


*Common:
<!--Use in Specific Populations-->
:*Myalgia


*Less common:
|useInPregnancyFDA=
[[Arthralgia]], bone pain, [[bursitis]].
* '''Pregnancy Category'''


======Miscellaneous======
|useInPregnancyAUS=
Less common adverse reactions:
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


*'''Endocrine:''' [[Diabetes mellitus]].
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.


*'''Hemic and Lymphatic:''' [[Anemia]], [[ecchymosis]],[[ iron deficiency anemia]], [[polycythemia]], [[purpura]].
|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.


*'''Skin and Appendages:''' Dry skin, [[furunculosis]], skin hypertrophy, [[urticaria]].
|useInNursing=
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.


*'''Special Senses:''' [[Amblyopia]], [[blindness]], [[conjunctivitis]], [[diplopia]], ear pain, eye haemorrhage, [[retinal haemorrhage]], [[tinnitus]].
|useInPed=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.


*'''Urogenital:''' [[Albuminuria]], [[cystitis]], [[urinary frequency]], vaginal haemorrhage, vaginitis.
|useInGeri=
|postmarketing=The following events have been reported spontaneously from worldwide post-marketing experience since the launch of PLETAL in the US.
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.


======Blood and lymphatic system disorders:======
|useInGender=
[[Agranulocytosis]],[[ aplastic anemia]], [[granulocytopenia]], [[pancytopenia]], [[thrombocytopenia]], [[leukopenia]],
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
[[bleeding tendency]]


======Cardiac disorders:======
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.


[[Torsades de pointes]], [[QT prolongation|QTc prolongation]] (torsades de pointes and QTc prolongation occurred in patients with cardiac disorders, e.g. [[complete atrioventricular block]], c[[ardiac failure ]]and [[bradyarrythmia]], when treated with cilostazol. Cilostazol was used "off label" due to its positive [[chronotropic]] action)
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.


======Gastrointestinal disorders:======
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.


*Gastrointestinal haemorrhage
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.


======General disorders and administration site conditions:======
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.


*Pain
<!--Administration and Monitoring-->
*[[chest pain]]
*[[hot flushes]]


======Hepatobiliary disorders:======
|administration=


*Hepatic dysfunction/abnormal liver function tests
* Oral
*[[jaundice]]


======Injury, poisoning and procedural complications:======
* Intravenous


*Extradural [[haematoma ]]
|monitoring=
*Subdural haematoma


=====Investigations:=====
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


*[[Blood glucose]] increased, blood [[uric acid]] increased, [[platelet count]] decreased, [[white blood cell count]] decreased, increase in [[BUN]] (blood urea increased), blood pressure increase
=====Condition1=====


======Nervous system disorders:======
* Description


*[[Intracranial haemorrhage]]
<!--IV Compatibility-->
*[[cerebral haemorrhage]]
*[[cerebrovascular accident]]


======Respiratory, thoracic and mediastinal disorders:======
|IVCompat=


*Pulmonary haemorrhage
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
*[[ interstitial pneumonia]]


'''Skin and subcutaneous tissue disorders:'''
<!--Overdosage-->


*Haemorrhage subcutaneous, [[pruritus]], skin eruptions including [[Stevens-Johnson syndrome]], skin drug eruption ([[dermatitis medicamentosa]])
|overdose=


======Vascular disorders:======
===Acute Overdose===


*Subacute [[thrombosis ]](these cases of subacute thrombosis occurred in patients treated with aspirin and "off label" use of cilostazol for prevention of thrombotic complication after coronary stenting)
====Signs and Symptoms====
|drugInteractions======Aspirin=====


*Short-term (<4 days) co-administration of aspirin with cilostazol increased the inhibition of ADP-induced ex vivo platelet aggregation by 22% to 37% when compared to either aspirin or cilostazol alone. Short-term (<4 days) co-administration of aspirin with cilostazol increased the inhibition of arachidonic acid-induced ex vivo platelet aggregation by 20% compared to cilostazol alone and by 48% compared to aspirin alone. However, short-term co-administration of aspirin with cilostazol had no clinically significant impact on PT, aPTT or bleeding time compared to aspirin alone.
* Description


*Effects of long-term co-administration in the general population are unknown. In eight randomized, placebo-controlled, double-blind clinical trials, aspirin was co-administered with cilostazol to 201 patients. The most frequent doses and mean durations of aspirin therapy were 75 mg to 81 mg daily for 137 days (107 patients) and 325 mg daily for 54 days (85 patients). There was no apparent increase in incidence of hemorrhagic adverse effects in patients taking cilostazol and aspirin compared to patients taking placebo and equivalent doses of aspirin.
====Management====


=====Warfarin=====
* Description


The cytochrome P-450 isoenzymes involved in the metabolism of R-warfarin are CYP3A4, CYP1A2 and CYP2C19 and in the metabolism of S-warfarin, CYP2C9. Cilostazol did not inhibit either the metabolism or the pharmacologic effects (PT, aPTT, bleeding time or platelet aggregation) of R- and S-warfarin after a single 25-mg dose of warfarin. The effect of concomitant multiple dosing of warfarin and cilostazol on the pharmacokinetics and pharmacodynamics of both drugs is unknown.
===Chronic Overdose===


=====Clopidogrel=====
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


Multiple doses of clopidogrel do not significantly increase steady state plasma concentrations of cilostazol.
<!--Pharmacology-->


=====Inhibitors of CYP3A4=====
<!--Drugbox2-->


======Strong Inhibitors of CYP3A4======
|drugBox=


A priming dose of [[ketoconazole ]]400 mg (a strong inhibitor of CYP3A4), was given one day prior to co-administration of single doses of [[ketoconazole ]]400 mg and cilostazol 100 mg. This regimen increased cilostazol Cmax by 94% and AUC by 117%. Other strong inhibitors of CYP3A4, such as [[itraconazole]], [[fluconazole]], [[miconazole]], [[fluvoxamine]], [[fluoxetine]], [[nefazodone ]]and [[sertraline]], would be expected to have a similar effect


======Moderate Inhibitors of CYP3A4======


*[[Erythromycin ]]and Other [[Macrolide ]]Antibiotics: [[Erythromycin ]]is a moderately strong inhibitor of CYP3A4. Co-administration of erythromycin 500 mg q 8h with a single dose of cilostazol 100 mg increased cilostazol Cmax by 47% and AUC by 73%. Inhibition of cilostazol metabolism by erythromycin increased the AUC of 4´-trans-hydroxy-cilostazol by 141%. Other macrolide antibiotics (e.g., [[clarithromycin]]), but not all (e.g., [[azithromycin]]), would be expected to have a similar effect.
<!--Mechanism of Action-->


*Diltiazem: [[Diltiazem]] 180 mg decreased the clearance of cilostazol by ~30%. Cilostazol Cmax increased ~30% and AUC increased ~40%.
|mechAction=


*Grapefruit Juice: [[Grapefruit juice]] increased the Cmax of cilostazol by ~50% , but had no effect on AUC.
*  
=====Inhibitors of CYP2C19=====


[[Omeprazole]]: Co-administration of omeprazole did not significantly affect the metabolism of cilostazol, but the systemic exposure to 3,4-dehydro-cilostazol was increased by 69%, probably the result of omeprazole’s potent inhibition of CYP2C19
<!--Structure-->


=====Quinidine =====
|structure=


Concomitant administration of [[quinidine ]]with a single dose of cilostazol 100 mg did not alter cilostazol pharmacokinetics.
*


=====Lovastatin=====
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


The concomitant administration of [[lovastatin ]]with cilostazol decreases cilostazol Css, max and AUCT by 15%. There is also a decrease, although nonsignificant, in cilostazol metabolite concentrations. Co-administration of cilostazol with lovastatin increases lovastatin and β–hydroxy lovastatin AUC approximately 70%. This is most likely clinically insignificant.
<!--Pharmacodynamics-->
|FDAPregCat=C
|useInPregnancyFDA=In a rat developmental toxicity study, oral administration of 1000 mg cilostazol/kg/day was associated with decreased fetal weights and increased incidences of cardiovascular, renal and skeletal anomalies (ventricular septal, aortic arch and subclavian artery abnormalities, renal pelvic dilation, 14th rib and retarded ossification). At this dose, systemic exposure to unbound cilostazol in nonpregnant rats was about 5 times the exposure in humans given the MRHD. Increased incidences of ventricular septal defect and retarded ossification were also noted at 150 mg/kg/day (5 times the MRHD on a systemic exposure basis). In a rabbit developmental toxicity study, an increased incidence of retardation of ossification of the sternum was seen at doses as low as 150 mg/kg/day. In nonpregnant rabbits given 150 mg/kg/day, exposure to unbound cilostazol was considerably lower than that seen in humans given the MRHD and exposure to 3,4-dehydro-cilostazol was barely detectable.
When cilostazol was administered to rats during late pregnancy and lactation, an increased incidence of stillborn and decreased birth weights of offspring was seen at doses of 150 mg/kg/day (5 times the MRHD on a systemic exposure basis).
There are no adequate and well-controlled studies in pregnant women.
|useInNursing=Transfer of cilostazol into milk has been reported in experimental animals (rats). Because of the potential risk to nursing infants, a decision should be made to discontinue nursing or to discontinue cilostazol tablets.
|useInPed=The safety and effectiveness of cilostazol in pediatric patients have not been established.
|useInGeri=Of the total number of subjects (n=2,274) in clinical studies of cilostazol, 56 percent were 65-years-old and over, while 16 percent were 75-years-old and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Pharmacokinetic studies have not disclosed any age-related effects on the absorption, distribution, metabolism and elimination of cilostazol and its metabolites.
|useInGender=The total and unbound oral clearances, adjusted for body weight, of cilostazol and its metabolites were not significantly different with respect to age and/or gender across a 50- to 80-year old age range.
|useInRenalImpair=Patients on dialysis have not been studied, but, it is unlikely that cilostazol can be removed efficiently by dialysis because of its high protein binding (95% to 98%).
Special caution is advised when cilostazol is used in patients with severe renal impairment: estimated creatinine clearance <25 mL/min.
|useInHepaticImpair=Patients with moderate or severe hepatic impairment have not been studied in clinical trials.
Special caution is advised when cilostazol is used in such patients.
|othersTitle=Smokers
|useInOthers=Population pharmacokinetic analysis suggests that smoking decreased cilostazol exposure by about 20%.
|administration=Oral
====Discontinuation of Therapy====
The available data suggest that the dosage of cilostazol tablets can be reduced or discontinued without rebound (i.e., platelet hyperaggregability)
|overdose=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.
|drugBox={{Drugbox2
| verifiedrevid = 460037234
| IUPAC_name = 6-[4-(1-cyclohexyl-1''H''-tetrazol-5-yl)butoxy]-<br>3,4-dihydro-2(1''H'')-quinolinone
| image = Cilostazol.JPG
| width = 300


<!--Clinical data-->
|PD=
| tradename = Pletal
| Drugs.com = {{drugs.com|monograph|cilostazol}}
| MedlinePlus = a601038
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_US = C
| pregnancy_category = 
| legal_AU = <!-- Unscheduled / S2 / S3 / S4  / S8 -->
| legal_UK = <!-- GSL        / P      / POM / CD -->
| legal_US = <!-- OTC                  / Rx-only  -->
| legal_status = 
| routes_of_administration = Oral


<!--Pharmacokinetic data-->
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
| bioavailability = 
| protein_bound = 95–98%
| metabolism = [[Liver|Hepatic]] ([[CYP3A4]]- and [[CYP2C19]]-mediated)
| elimination_half-life = 11–13 hours
| excretion = Renal


<!--Identifiers-->
<!--Pharmacokinetics-->
| CASNo_Ref = {{cascite|correct|CAS}}
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 73963-72-1
| ATC_prefix = B01
| ATC_suffix = AC23
| PubChem = 2754
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB01166
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = 2652
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = N7Z035406B
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D01896
| ChEBI_Ref = {{ebicite|correct|EBI}}
| ChEBI = 31401
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL = 799


<!--Chemical data-->
|PK=
| C=20 | H=27 | N=5 | O=2
| molecular_weight = 369.46 g/mol
| smiles = O=C4Nc3c(cc(OCCCCc1nnnn1C2CCCCC2)cc3)CC4
| InChI = 1/C20H27N5O2/c26-20-12-9-15-14-17(10-11-18(15)21-20)27-13-5-4-8-19-22-23-24-25(19)16-6-2-1-3-7-16/h10-11,14,16H,1-9,12-13H2,(H,21,26)
| InChIKey = RRGUKTPIGVIEKM-UHFFFAOYAE
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI = 1S/C20H27N5O2/c26-20-12-9-15-14-17(10-11-18(15)21-20)27-13-5-4-8-19-22-23-24-25(19)16-6-2-1-3-7-16/h10-11,14,16H,1-9,12-13H2,(H,21,26)
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey = RRGUKTPIGVIEKM-UHFFFAOYSA-N
}}
|mechAction=The mechanism of the effects of cilostazol on the symptoms of intermittent claudication is not fully understood. Cilostazol and several of its metabolites are cyclic AMP (cAMP) [[phosphodiesterase ]]III inhibitors (PDE III inhibitors), inhibiting phosphodiesterase activity and suppressing cAMP degradation with a resultant increase in [[cAMP ]]in platelets and blood vessels, leading to inhibition of platelet aggregation and vasodilation, respectively.


Cilostazol reversibly inhibits platelet aggregation induced by a variety of stimuli, including [[thrombin]], [[ADP]], [[collagen]], [[arachidonic acid]], [[epinephrine]], and [[shear stress]]. Effects on circulating plasma lipids have been examined in patients taking cilostazol. After 12 weeks, as compared to placebo, cilostazol 100 mg b.i.d. produced a reduction in [[triglycerides ]]of 29.3 mg/dL (15%) and an increase in HDL-[[cholesterol ]]of 4.0 mg/dL (~10%).
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


====Cardiovascular Effects====
<!--Nonclinical Toxicology-->
Cilostazol affects both vascular beds and cardiovascular function. It produces non-homogeneous dilation of vascular beds, with greater dilation in femoral beds than in vertebral, [[carotid]] or [[superior mesenteric arteries]]. [[Renal arteries]] were not responsive to the effects of cilostazol.


In dogs or cynomolgous monkeys, cilostazol increased heart rate, myocardial contractile force, and coronary blood flow as well as ventricular automaticity, as would be expected for a PDE III inhibitor. Left ventricular contractility was increased at doses required to inhibit platelet aggregation. A-V conduction was accelerated. In humans, heart rate increased in a dose-proportional manner by a mean of 5.1 and 7.4 beats per minute in patients treated with 50 and 100 mg b.i.d., respectively. In 264 patients evaluated with [[Holter monitors]], numerically more cilostazol-treated patients had increases in ventricular premature beats and non-sustained [[ventricular tachycardia]] events than did placebo-treated patients; the increases were not dose-related.
|nonClinToxic=
|structure=*Cilostazol is a [[quinolinone ]]derivative that inhibits cellular [[phosphodiesterase ]](more specific for phosphodiesterase III). The empirical formula of cilostazol is C20H27N5O2, and its molecular weight is 369.46. Cilostazol is 6-[4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy]-3,4-dihydro-2(1H)-quinolinone, CAS-73963-72-1.
*Cilostazol occurs as white to off-white crystals or as a crystalline powder that is slightly soluble in [[methanol ]]and [[ethanol]], and is practically insoluble in water, 0.1 N HCl, and 0.1 N NaOH.
*Cilostazol tablets for oral administration are available in 50 mg and 100 mg round, white debossed tablets. Each tablet, in addition to the active ingredient, contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, methylcellulose, carboxymethylcellulose calcium and magnesium stearate.
|PK=Cilostazol is absorbed after oral administration. A high fat meal increases absorption, with an approximately 90% increase in Cmax and a 25% increase in AUC. Absolute bioavailability is not known. Cilostazol is extensively metabolized by hepatic cytochrome P-450 enzymes, mainly 3A4, and, to a lesser extent, 2C19, with metabolites largely excreted in urine. Two metabolites are active, with one metabolite appearing to account for at least 50% of the pharmacologic (PDE III inhibition) activity after administration of cilostazol. Pharmacokinetics are approximately dose proportional. Cilostazol and its active metabolites have apparent elimination half-lives of about 11-13 hours. Cilostazol and its active metabolites accumulate about 2-fold with chronic administration and reach steady state blood levels within a few days. The pharmacokinetics of cilostazol and its two major active metabolites were similar in healthy normal subjects and patients with intermittent claudication due to peripheral arterial disease (PAD).


The mean ±SEM plasma concentration-time profile at steady state after multiple dosing of cilostazol 100 mg b.i.d. is shown below
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
{|
|[[File:Cilostazolpharmaco.JPG|600px|thumb]]
|}


====Distribution====
<!--Clinical Studies-->
'''Plasma Protein and Erythrocyte Binding'''


Cilostazol is 95-98% protein bound, predominantly to albumin. The mean percent binding for 3,4 dehydro cilostazol is 97.4% and for 4´-trans-hydroxy-cilostazol is 66%. Mild hepatic impairment did not affect protein binding. The free fraction of cilostazol was 27% higher in subjects with renal impairment than in normal volunteers. The displacement of cilostazol from plasma proteins by erythromycin, quinidine, warfarin, and omeprazole was not clinically significant.
|clinicalStudies=


====Metabolism and Excretion====
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
Cilostazol is eliminated predominately by metabolism and subsequent urinary excretion of metabolites. Based on in vitro studies, the primary isoenzymes involved in cilostazol's metabolism are [[CYP3A4 ]]and, to a lesser extent, [[CYP2C19]]. The enzyme responsible for metabolism of 3,4 dehydro cilostazol, the most active of the metabolites, is unknown.


Following oral administration of 100 mg radiolabeled cilostazol, 56% of the total analytes in plasma was cilostazol, 15% was 3,4-dehydro-cilostazol (4-7 times as active as cilostazol), and 4% was 4´-trans-hydroxy-cilostazol (one fifth as active as cilostazol). The primary route of elimination was via the urine (74%), with the remainder excreted in feces (20%). No measurable amount of unchanged cilostazol was excreted in the urine, and less than 2% of the dose was excreted as 3,4-dehydro-cilostazol. About 30% of the dose was excreted in urine as 4´-trans-hydroxy-cilostazol. The remainder was excreted as other metabolites, none of which exceeded 5%. There was no evidence of induction of hepatic microenzymes.
=====Condition1=====
|nonClinToxic=====Carcinogenesis, Mutagenesis, Impairment of Fertility====


Dietary administration of cilostazol to male and female rats and mice for up to 104 weeks, at doses up to 500 mg/kg/day in rats and 1000 mg/kg/day in mice, revealed no evidence of carcinogenic potential. The maximum doses administered in both rat and mouse studies were, on a systemic exposure basis, less than the human exposure at the MRHD of the drug. Cilostazol tested negative in bacterial gene mutation, bacterial DNA repair, mammalian cell gene mutation and mouse in vivo bone marrow chromosomal aberration assays. It was, however, associated with a significant increase in chromosomal aberrations in the in vitro Chinese Hamster Ovary Cell assay.
* Description


Cilostazol did not affect fertility or mating performance of male and female rats at doses as high as 1000 mg/kg/day. At this dose, systemic exposures (AUCs) to unbound cilostazol were less than 1.5 times in males and about 5 times in females, the
<!--How Supplied-->
|clinicalStudies=*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


[[image:Cilo2.png|800px|thumb|none|left]]
|howSupplied=


*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.
|howSupplied='''50 mg:''' White, round, debossed with “E” over “123” on one side and plain on the other.
'''100 mg:''' White, round, debossed with “E” over “223” on one side and plain on the other.
|storage=Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature].
|packLabel={|
| [[image:Cilostazollabel.jpg|400px|thumb]]
|}


{|
<!--Patient Counseling Information-->
| [[image:Cilostazollabel1.png|400px|thumb]]
|}
|fdaPatientInfo=(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.
|fdaPatientInfo=
'''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?'''
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


The three main treatments available for intermittent claudication are:
<!--Precautions with Alcohol-->
*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?'''
|alcohol=


*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.
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
*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?'''
<!--Brand Names-->


*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.
|brandNames=
*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?'''
* ®<ref>{{Cite web | title =  | url =  }}</ref>


*Follow your doctor’s advice about how to take cilostazol tablets.
<!--Look-Alike Drug Names-->
*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?'''
|lookAlike=


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.
* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
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?'''
<!--Drug Shortage Status-->


Cilostazol tablets may cause side effects including headache, diarrhea, abnormal stools, increased heart rate and palpitations.
|drugShortage=
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.'''
|alcohol=Alcohol-Cilostazol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|price=[http://www.goodrx.com/{{urlencode:{{#if:{{{1|}}}|{{{1}}}|{{PAGENAME}}}}}}/price Price]
|nlmPatientInfo=For patient information about Cilostazol from NLM, click [[Cilostazol (patient information)|here]].
|NDC=0185-0123-60 bottles of 60 and 0185-0123-05 bottles of 500
|manBy=Sandoz Inc.Princeton, NJ 08540
|distBy=Bryant Ranch Prepack
|isPill=Yes
|dosageValue=50
|dosageUnit=mg
|pillImprint=E 123
|pillSize=9
|pillShape=Round
|pillColor=White
|pillScoring=1
|pillImage=Cilostazol50mg.jpg
|drugShortage=[http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm Drug Shortage Status]
}}
}}
{{LabelImage
 
|fileName=Clostazol label 01.jpg
<!--Pill Image-->
 
{{PillImage
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
|drugName=
|NDC=
|drugAuthor=
|ingredients=
|pillImprint=
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<!--Label Display Image-->
{{LabelImage
{{LabelImage
|fileName=Clostazol label 02.jpg
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
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{{LabelImage
{{LabelImage
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|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}
{{LabelImage
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<!--Category-->
[[Category:Cardiovascular Drugs]]
[[Category:Drug]]

Revision as of 02:35, 7 July 2014

Cilostazol
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

Disclaimer

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Cilostazol is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Cilostazol in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cilostazol in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Cilostazol in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Cilostazol in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cilostazol in pediatric patients.

Contraindications

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Cilostazol in the drug label.

Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Cilostazol in the drug label.

Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cilostazol in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cilostazol during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cilostazol with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Cilostazol with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Cilostazol with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Cilostazol with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cilostazol with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Cilostazol in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Cilostazol in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cilostazol in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cilostazol in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Cilostazol in the drug label.

Condition1
  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Cilostazol in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Cilostazol in the drug label.

Pharmacology

There is limited information regarding Cilostazol Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Cilostazol in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Cilostazol in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Cilostazol in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Cilostazol in the drug label.

Condition1
  • Description

How Supplied

Storage

There is limited information regarding Cilostazol Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Cilostazol |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Cilostazol |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Cilostazol in the drug label.

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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