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Cilostazol (Cilostazol)

Trade Name : Cilostazol

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 100 mg/1

CILOSTAZOL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Cilostazol (Cilostazol) which is also known as Cilostazol and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 100 mg/1 per ml. Read more

Cilostazol (Cilostazol) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions, Left Ventricular Outflow Obstruction () 05/2017
  • Cilostazol is contraindicated in patients with heart failure of any severity. 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 heart failure .
  • WARNING: CONTRAINDICATED IN HEART FAILURE PATIENTS
  • See full prescribing information for complete boxed warning.
  • Cilostazol is contraindicated in patients with heart failure of any severity. Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with the pharmacologic effect have caused decreased survival compared to placebo patients with class III-IV heart failure. ()
  • Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance.
  • Cilostazol tablets are a phosphodiesterase III inhibitor (PDE III inhibitor) indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance ()
  • No data
  • 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 ()
  • Reduce the dose to 50 mg twice daily when coadministered with CYP3A4 inhibitors such as ketoconazole, itraconazole, erythromycin, and diltiazem, or CYP2C19 inhibitors such as ticlopidine, fluconazole, and omeprazole ()
  • Cilostazol tablets USP are available as 50 mg pillow-shaped and 100 mg round, white to off-white, debossed tablets.
  • Tablets: 50 mg and 100 mg ()
  • Cilostazol tablets are contraindicated in patients with:
  • Heart failure of any severity ()
  • Hypersensitivity to cilostazol or any components of cilostazol tablets ()
  • No data
  • Risks of tachycardia, palpitation, tachyarrhythmia or hypotension. Risks of exacerbations of angina pectoris or myocardial infarction in patients with a history of ischemic heart disease ()
  • Left ventricular outflow tract obstruction has been reported in patients with sigmoid shaped interventricular septum ()
  • Risks of thrombocytopenia or leukopenia progressing to agranulocytosis-monitor platelets and white blood cell counts ()
  • Avoid use in patients with hemostatic disorders or active pathologic bleeding ()
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • - n- [see n- Array
  • -n- [see Warnings and Precautions (n- Array
  • - n- [see Warnings and Precautions (n- Array
  • -n- [see Warnings and Precautions (n- Arrayn- )]
  • -n- [see Warnings and Precautions (n- Array
  • Most common adverse reactions greater than or equal to 2% and at least twice that for placebo in patients on 100 mg twice daily are headache, diarrhea, abnormal stools, and palpitation ()
  • Inhibitors of CYP3A4
  • Coadministration of strong (e.g., ketoconazole) and moderate (e.g., erythromycin, diltiazem and grapefruit juice) CYP3A4
  • inhibitors can increase exposure to cilostazol. Reduce cilostazol dose to 50 mg twice daily when coadministered with
  • strong or moderate inhibitors of CYP3A4 n n
  • Inhibitors of CYP2C19
  • Coadministration with CYP2C19 inhibitors (e.g., omeprazole) increases systemic exposure of cilostazol active
  • metabolites. Reduce cilostazol dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of
  • CYP2C19 n n
  • Strong and moderate CYP3A4 and CYP2C19 inhibitors
  • No data
  • Information on acute overdosage with cilostazol 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 LDn
  • of cilostazol is greater than 5 g per kg in mice and rats and greater than 2 g per kg in dogs.
  • Cilostazol, USP is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). Cilostazol, USP is 6-[4-(1-cyclohexyl-1-tetrazol-5-yl)butoxy]-3,4-dihydro-2(1)-quinolinone, CAS-73963-72-1.
  • The structural formula is:
  • CHNO M.W. 369.46
  • Cilostazol, USP 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 USP for oral administration are available in 50 mg pillow-shaped and 100 mg round, white to off-white debossed tablets. Each tablet, in addition to the active ingredient, contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, and povidone.
  • Meets USP Dissolution Test 3.
  • No data
  • No data
  • The ability of cilostazol to improve walking distance in patients with stable intermittent claudication was studied in eight,
  • randomized, placebo-controlled, double-blind trials of 12 to 24 weeksu2019 duration involving 2,274 patients using dosages of
  • 50 mg twice daily (n = 303), 100 mg twice daily (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 50 or 100 mg twice daily 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.n
  • Figure 2
  • Across the eight clinical trials, the range of improvement in maximal walking distance in patients treated with cilostazol
  • 100 mg twice daily, expressed as the change from baseline, was 28% to 100%.
  • The corresponding changes in the placebo group were u201310% 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 twice daily or 50 mg twice daily 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 study hypothesis.
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information)
  • Advise the patient:
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. O 5/2017
  • Cilostazol (sil-OS-tah-zol) Tablets USP, for oral use
  • Read this Patient Information leaflet before you start taking cilostazol tablets and each time you get a refill. There may
  • be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
  • What is the most important information I should know about cilostazol tablets?
  • Cilostazol tablets can cause serious side effects:
  • What are cilostazol tablets?
  • Cilostazol tablets are a prescription medicine used to reduce the symptoms of intermittent claudication and can increase
  • your ability to walk further distances.
  • It is not known if cilostazol tablets are safe and effective for use in children.
  • How do cilostazol tablets work?
  • Improvement in symptoms may occur as soon as 2 weeks, but could take up to 12 weeks.
  • Who should not take cilostazol tablets?
  • Do not take cilostazol tablets if you:
  • Tell your doctor before taking this medicine if you have any of these conditions.
  • What should I tell my doctor before taking cilostazol tablets?
  • Before you take cilostazol tablets, tell your doctor if you:
  • Tell your doctor about all the medicines you take,
  • vitamins and herbal supplements.
  • Ask your doctor for a list of these medicines if you are not sure. You can ask your pharmacist for a list of
  • medicines that interact with cilostazol tablets. Know the medicines you take. Keep a list of them to show to your doctor
  • and pharmacist when you get a new medicine.
  • How should I take cilostazol tablets?
  • What are the possible side effects of cilostazol tablets?
  • Cilostazol tablets may cause serious side effects, including:
  • The most common side effects of cilostazol tablets include:
  • Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible
  • side effects of cilostazol tablets. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store cilostazol tablets?
  • Store cilostazol tablets at 68u00b0 to 77u00b0F (20u00b0 to 25u00b0C).
  • Keep cilostazol tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of cilostazol tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use cilostazol tablets for a condition for which they were not prescribed. Do not give cilostazol tablets to other people, even if they have the same symptoms that you have. They may harm them.
  • This Patient Information summarizes the most important information about cilostazol tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about cilostazol tablets that is written for health professionals.
  • For more information, call 1-888-838-2872.
  • What are the ingredients in cilostazol tablets USP?
  • Active ingredient:
  • Inactive ingredients:
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. G 5/2017
  • No data
  • No data

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