It works by stopping blood cells called platelets from sticking together and prevents them from forming harmful clots. Highlights of prescribing information acute ischemic stroke. Cilostazol approved for use in intermittent claudication fda drug. Cilostazol 100 mg tablets patient information leaflet. Congestive heart failure thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients see warnings and precautions 5. Thienopyridines, including plavix, increase the risk of bleeding. Pletal is contraindicated in patients with heart failure of any severity.
Highlights of prescribing information these highlights do not include all the information needed to use durezol safely and effectively. If a dose of cymbalta is missed, take the missed dose as soon as it is remembered. Cilostazol and its metabolites are further metabolized in the liver. Highlights of prescribing information emend capsules and. Drugs az pill identifier supplements symptom checker diseases dictionary media.
Cilostazol also improves circulation by keeping platelets in the blood from sticking together and clotting. Cilostazol stops a protein called phosphodiesterase iii from working. Cilostazol may induce tachycardia, palpitation, tachyarrhythmia or hypotension. These medications may cause some risk when taken together. Cilostazol is 95 98% protein bound, predominantly to albumin. Cilostazol affects both vascular beds and cardiovascular function. Consider dose adjustment and monitor esomeprazole may interfere with the absorption of drugs for which gastric ph affects bioavailability eg, erlotinib, dasatinib, nilotinib, ketoconazole, itraconazole, mycophenolate mofetil, and iron salts. Pletal cilostazol dose, indications, adverse effects. This information does not take the place of talking to your doctor about your medical condition or your treatment.
Nexium may impact systemic exposure of cyp2c19 substrates eg, citalopram, cilostazol, digoxin, diazepam. Cilostazol product information european medicines agency. Patients with a history of ischemic heart disease may be at risk for exacerbations of angina pectoris or myocardial infarction. Due to cilostazols platelet aggregation inhibitory effect it is possible that an increased bleeding risk occurs in combination with surgery including. Pletal cilostazol tablets for oral administration are available in 50 mg. Read this patient information leaflet before you start taking pletal and. See full prescribing information for complete boxed warning. Highlights of prescribing information 3 prs 16 weeks 16 weeks. Pletal is contraindicated in patients with chf of any severity. For information about generic name, click here synonyms brand names. Cilostazol is used to treat the symptoms of intermittent. Cilostazol is a quinolinonederivative drug substance it is used in the alleviation of the symptom of. The recommended dosage of cilostazol tablets is 100 mg twice daily taken at least half an hour before or two hours after breakfast and dinner. After initiation of avandia, and after dose increases, observe patients carefully for signs and symptoms of heart failure.
Highlights of prescribing information antiplatelet. The empirical formula of cilostazol is c 20 h 27 n 5 o 2, and its molecular weight is 369. Contraindicated in heart failure patients see full prescribing information for complete boxed warning. Medscape indicationspecific dosing for pletal cilostazol, frequencybased. Patient information pletal playtal severe allergic. Medium, apparatus 2, standard solution, test solution, and. However, the auc for pletal and its metabolites increase approximately proportionately with dose. Cilostazol should be used with caution in individuals who have lesions with a propensity to bleed, such as patients with peptic ulcer disease.
Assessment report for cilostazol containing medicinal. Pletal cilostazol is a quinolinone derivative that inhibits cellular phosphodiesterase more specific for phosphodiesterase iii. Do not chew or crush, and do not open the delayedrelease capsule and sprinkle its contents on food or mix with liquids because these actions might affect the enteric coating. Several drugs with this pharmacologic effect have caused decreased survival compared with placebo in patients with class iiiiv chf. Avoid concomitant use of plavix with omeprazole or esomeprazole because both significantly reduce the antiplatelet activity of plavix see drug interactions 7.
Cilostazol is 641cyclohexyl1htetrazol5ylbutoxy3,4dihydro21hquinolinone, cas73963721 the structural formula is. Pletal cilostazol 50 mg and 100 mg tablets product information page 4 of 12 a metaanalysis based on weighted mean differences across the nine studies indicated that there was a significant absolute overall postbaseline improvement of 42 m in maximal walking distance acd for pletal 100 mg b. Pletal cilostazol tablets for oral administration are available in 50 mg triangular and 100 mg round, white debossed tablets. Cilostazol, sold under the brand name pletal among others, is a medication used to help the symptoms of intermittent claudication in peripheral vascular disease. Plavix has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for one year or more.
Highlights of prescribing information these highlights do not. Cilostazol is contraindicated in patients with congestive heart failure of any severity. If this product is used for 10 days or longer, iop see full prescribing information for durezol. Highlights of prescribing information antiplatelet drugs and. Several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class iiiiv heart failure see. Cilostazol is a quinolinone derivative used for treatment of intermittent claudication and peripheral vascular disease. What is the most important information i should know about pletal. Wikidoc drug project is a constellation of drug information for healthcare providers and patients vigorously vetted on the basis of fda package insert, medlineplus, practice guidelines, scientific statements, and scholarly medical literature. The mean percent binding for 3,4dehydrocilostazol is 97. Download product insert pdfdownload safety data sheet sds pdf.
Pletal cilostazol dosing, indications, interactions, adverse effects. Read all of this leaflet carefully before you start taking this. Cilostazol and several of its metabolites are inhibitors of phosphodiesterase iii. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for pletal cilostazol. Mavyret is a prescription medicine used to treat adults and children 12 years of age and older or weighing at least 99 pounds 45 kilograms with chronic lasting a long time hepatitis c virus hep c.
Cilostazol is contraindicated in patients with hemostatic disorders or active pathologic bleeding, such as gi bleeding, retinal bleeding, retroperitoneal bleeding, or intracranial bleeding. Cilostazol 100 mg tablets patient information leaflet pil. Cilostazolcontaining medicinal product see annex i 100 mg tablets. Highlights of prescribing information use of cymbalta. Cilostazol occurs as white to offwhite crystals or as a crystalline powder that is slightly soluble in methanol and ethanol, and is practically insoluble in water, 0. Cilostazol and metabolites are inhibitors of phosphodiesterase iii. Cilostazol 100 mg tablets patient information leaflet pil by consilient health ltd. With clinical experience and offering operational flexibility, lexiscan regadenoson injection has been an important part of the nuclear cardiology community for over a decade and counting.
If no improvement is seen after 3 months, stopping the medication is reasonable. List of approved drug products containing cilostazol in the fda orange book on. Jan 27, 2020 cilostazol tablets can cause serious side effects. The increase in heart rate associated with cilostazol is approximately 5 to 7 bpm. Cilomilast inn, codenamed sb207,499, proposed trade name ariflo is a drug which was developed for the treatment of respiratory disorders such as asthma and chronic obstructive pulmonary disease copd.
Cilostazol 100 mg tablets patient information leaflet pil by mylan. The clinically important adverse reactions observed in trials comparing plavix plus aspirin to placebo plus aspirin and trials comparing plavix alone to. No measurable amount of cilostazol is excreted unchanged and less than. Zemplar capsules are used to prevent and treat secondary hyperparathyroidism increased parathyroid hormone levels in adults and children 10 years of age and older with stage 3 or stage 4 chronic kidney disease and in stage 5 patients on dialysis. Cilostazol tablets for oral administration are available as 50 mg or 100 mg round, white debossed tablets. Cilostazol tablets test 2if the product complies with this test, the labeling indicates that it meets usp dissolution test 2.
Avandia is not recommended in patients with symptomatic heart failure. Anoro ellipta umeclidinium and vilanterol inhalation. Other similar drugs which affect this protein may cause death if you already have heart problems, called class 3 to 4 iiiiv heart failure. Cilostazol cilostazol 50 mg and 100 mg tablets product information page 4 of 12 a metaanalysis based on weighted mean differences across the nine studies indicated that there was a significant absolute overall postbaseline improvement of 42 m in maximal walking distance acd for pletal 100 mg b. Cilostazol dilates arteries that supply blood to your legs. Mavyret glecaprevirpibrentasvir for hepatitis c official. Cilostazol and its metabolites accumulate about 2fold with chronic administration and reach steady state blood levels within a few days. Cilostazol art 31 ar for publishing european medicines agency. It is orally active and acts as a selective phosphodiesterase4 inhibitor phosphodiesterase pde inhibitors, such as theophylline, have been used to treat copd for centuries. Learn about side effects, drug interactions, dosages, warnings, and more. Cilostazol reference guide for safe and effective use from the. Updated january 2015 page 1 package insert template for atorvastatin tablet brand or product name product name tablet 10mg product name tablet 20mg product name tablet 40mg product name tablet 80mg name and strength of active substances.
Cilostazol is a vasodilator that works by relaxing the muscles in your blood vessels to help them dilate widen. Nexium esomeprazole magnesium packets gerd and related. Pletal is supplied as 50 and 100mg tablets in bottles of 60 and unit dose cartons of 100. Cilostazol fda orange book approved drug product list. See full prescribing information for recommended dosages of concomitant dexamethasone and 5ht3 antagonist for hec and mec. Cilostazol is a quinolinone derivative used for treatment of intermittent claudication and peripheral vascular disease cilostazol is available under the following different brand names. Administer cymbalta orally with or without meals and swallow whole. Mild hepatic impairment did not affect protein binding. Cilostazol is an antiplatelet drug and a vasodilator. The free fraction of cilostazol was 27% higher in subjects with renal impairment than in normal volunteers. Initiation of avandia in patients with established nyha class iii or iv heart failure is contraindicated. Cilostazol fda prescribing information, side effects and. Jul 18, 2019 cilostazol is a vasodilator that works by relaxing the muscles in your blood vessels to help them dilate widen. Do not take cilostazol tablets if you have heart failure of any kind.
Cilostazol fda prescribing information, side effects and uses. A premature discontinuation of pradaxa increases the risk of thrombotic events, and b spinalepidural hematoma see full prescribing information for complete boxed warning procedures when possible, then restart promptly 2. Open the package containing the transfer device by peeling the paper label off the package. Pletal cilostazol stops a protein called phosphodiesterase iii from working. Cilostazol information, side effects, warnings and recalls. Jan 01, 2020 cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. Pletal playtal cilostazol silostahzol tablets contraindication cilostazol and several of its metabolites are inhibitors of phosphodiesterase iii. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for pletal cilostazol skip to.
Jul 03, 2015 several drugs with this pharmacologic effect have caused decreased survival compared with placebo in patients with class iiiiv chf. Strong cilostazol package insert connolly 2011 dronedarone package insert revised dec2011 goldstein 1991 jessup 2009 korber 2009 loke 2011 pioglitazone package insert rosiglitazone package insert syncope acetylcholinesterase inhibitors acheis peripheral alpha blockers doxazosin alpha prazosin terazosin tertiary tcas chlorpromazine. Cilostazol reversibly inhibits platelet aggregation induced by a variety of stimuli, including thrombin, adp, collagen, arachidonic acid, epinephrine, and shear stress. Pletal cilostazol dosing, indications, interactions. Remove the protective cap from one end of the transfer device and keeping the vial of swfi upright, insert the piercing pin vertically into the center of the stopper of the vial of swfi.