Cilostate tablets

Cilostate

  • Active Ingredient: Cilostazol
  • 100 mg, 50 mg
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What is Cilostate?

The active ingredient of Cilostate brand is cilostazol. Cilostazol is a vasodilator that works by relaxing the muscles in your blood vessels to help them dilate (widen). Cilostazol dilates arteries that supply blood to your legs. Cilostazol also improves circulation by keeping platelets in the blood from sticking together and clotting. 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.

Used for

Cilostate is used to treat diseases such as: Intermittent Claudication.

Side Effect

Possible side effects of Cilostate include: bleeding tendency; stiff neck; bruises or red spots on the skin; painful or difficult urination; swollen glands.

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Clinical Studies

The ability of Cilostate 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 Cilostate 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 Cilostate 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.

Advertencia:

Medicamentos similares al Cilostate provocaron un mayor riesgo de muerte en pacientes con insuficiencia cardГ­aca congestiva (afecciГіn en la que el corazГіn no puede bombear una cantidad suficiente de sangre a las demГЎs partes del cuerpo). DГ­gale a su mГ©dico si tiene o ha tenido insuficiencia cardГ­aca congestiva. Probablemente su mГ©dico le diga que no tome Cilostate.

Consulte a su mГ©dico sobre los riesgos de tomar Cilostate.

A priming dose of ketoconazole 400 mg (a strong inhibitor of CYP3A4), was given one day prior to coadministration of single doses of ketoconazole 400 mg and Cilostate 100 mg. This regimen increased Cilostate Cmax by 94% and AUC by 117%. Other strong inhibitors of CYP3A4, such as itraconazole, voriconazole, clarithromycin, ritonavir, saquinavir, and nefazodone would be expected to have a similar effect .

Contraindications

Cilostate tablets are contraindicated in patients with:

  • Heart failure of any severity: Cilostate 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.
  • Hypersensitivity to Cilostate or any components of Cilostate tablets (e.g., anaphylaxis, angioedema)

Background

Cilostate (sye loe' sta zol) acts by semi-selective inhibition of phosphodiesterase III, which causes an increase in intracellular cyclic AMP resulting in arterial vasodilation and inhibition of platelet aggregation. Cilostate is used largely to treat symptoms of intermittent claudication due to peripheral vascular disease where it has been shown to increase pain-free walking distance and improve exercise tolerance. Cilostate has also been evaluated as an antiplatelet agent and is used off-label as a means of prevention of recurrent stroke. Cilostate was approved in the United States in 1999 and is widely used with more than one million prescriptions filled yearly. Current indications are limited to treatment of symptoms of intermittent claudication. Cilostate is available in tablets of 50 and100 mg in several generic forms and under the brand name Pletal. The recommended maintenance dose is 100 mg twice daily. Side effects can include headache, dizziness, tachycardia, palpitations, diarrhea and peripheral edema. Rare, but serious adverse events include thrombocytopenia and agranulocytosis.

Why is this medication prescribed?

Cilostate is used to reduce the symptoms of intermittent claudication (pain in the legs that worsens when walking and improves when resting that is caused by narrowing of the blood vessels that supply blood to the legs). Cilostate is in a class of medications called platelet-aggregation inhibitors (antiplatelet medications). It works by improving blood flow to the legs.

Cilostate did not inhibit 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 PLETAL on the pharmacodynamics of both drugs is unknown.

CONTRAINDICATIONS

PLETAL is contraindicated in patients with:

  • Heart failure of any severity: Cilostate 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.
  • Hypersensitivity to Cilostate or any components of PLETAL (e.g., anaphylaxis, angioedema)


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