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Cilostazol (Cilostazol)

Trade Name : Cilostazol

West-Ward Pharmaceuticals Corp.

TABLET

Strength 50 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 West-Ward Pharmaceuticals Corp.. It is available in strength of 50 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
  • Cilostazol tablets are 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.
  • WARNING: CONTRAINDICATED IN HEART FAILURE PATIENTS
  • See full prescribing information for complete boxed warning.
  • Cilostazol tablets are 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
  • Cilostazol Tablets USP are available as 50 mg and 100 mg round, white tablets. The 50 mg tablet is a flat faced beveled edge tablet, debossed with product identification u201c54 521u201d on one side and plain on the other side. The 100 mg tablet is a standard biconvex tablet, debossed with product identification u201c54 757u201d on one side and plain on the other side.
  • u2022
  • 3
  • Cilostazol is contraindicated in patients with:
  • Hypersensitivity to cilostazol or any components of cilostazol (e.g., anaphylaxis, angioedema).
  • No data
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • 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
  • Co-administration 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 co-administered with strong or moderate inhibitors of CYP3A4 [ and ].
  • Inhibitors of CYP2C19
  • Co-administration with CYP2C19 inhibitors (e.g., omeprazole) increases systemic exposure of cilostazol active metabolites. Reduce cilostazol dose to 50 mg twice daily when co-administered with strong or moderate inhibitors of CYP2C19 [ and ].
  • u2022
  • 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 LD of cilostazol is greater than 5 g/kg in mice and rats and greater than 2 g/kg in dogs.
  • Cilostazol is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). The empirical formula of cilostazol is CHNO, and its molecular weight is 369.46. Cilostazol is 6-[4-(1-cyclohexyl-1-tetrazol-5-yl)butoxy]-3,4-dihydro-2(1)-quinolinone, CAS-73963-72-1. The structural formula is:
  • Cilostazol USP occurs as white to off-white 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 are available for oral administration containing 50 mg or and 100 mg cilostazol USP. Each tablet, in addition to the active ingredient, contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.
  • Each tablet meets the requirements of Test 3 for Dissolution in the USP monograph for Cilostazol Tablets USP.
  • 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 weeks' 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.
  • Figure 2 depicts the percent mean improvement in maximal walking distance, at study end for each of the eight studies.
  • Figure 2: Percent Mean Improvement in Maximal Walking Distance at Study End for the Eight Randomized, Double-Blind, Placebo-Controlled Clinical Trials.
  • 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 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 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 of 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.u00a0u00a0
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information)
  • Advise the patient:
  • that the beneficial effects of cilostazol on the symptoms of intermittent claudication may not be immediate. Although the patient may experience benefit in 2 to 4 weeks after initiation of therapy, treatment for up to 12 weeks may be required before a beneficial effect is experienced. Discontinue cilostazol if symptoms do not improve after 3 months.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10003054/08
  • Revised July 2017
  • Cilostazol Tablets USP
  • (sye loeu2019 sta zol)
  • Rx Only
  • Read this Patient Information leaflet before you start taking Cilostazol Tablets USP 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?
  • Cilostazol can cause serious side effects:
  • What is cilostazol?
  • Cilostazol is 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 is safe and effective for use in children.
  • How does cilostazol work?
  • Improvement in symptoms may occur as soon as 2 weeks, but could take up to 12 weeks.
  • Who should not take cilostazol?
  • Do not take cilostazol 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?
  • Before you take cilostazol, tell your doctor if you:
  • Tell your doctor about all the medicines you take,
  • 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. 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?
  • What are the possible side effects of cilostazol?
  • Cilostazol may cause serious side effects, including:
  • The most common side effects of cilostazol 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. 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?
  • Store cilostazol at room temperature between 20u02daC to 25u02daC (68u02daF to 77u02daF). [Store at USP Controlled Room Temperature.]
  • Keep cilostazol and all medicines out of the reach of children.
  • General information about the safe and effective use of cilostazol.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use cilostazol for a condition for which it was not prescribed. Do not give cilostazol to other people, even if they have the same symptoms that you have. It may harm them.
  • This Patient Information summarizes the most important information about cilostazol. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about cilostazol that is written for health professionals.
  • For more information, call 1-800-962-8364.
  • What are the ingredients in cilostazol?
  • Active ingredient:
  • Inactive ingredients:
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10003054/08
  • Revised July 2017
  • Cilostazol Tablets USP, 50 mg
  • 0054-0028-21
  • Rx only
  • Cilostazol Tablets USP, 100 mg
  • 0054-0044-21
  • Rx only

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