Stazol tablets

Stazol

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

The active ingredient of Stazol 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

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

Side Effect

Possible side effects of Stazol include: unusual tiredness or weakness; chills; sore throat; loss of consciousness; difficulty with swallowing; bleeding tendency; inability to speak; weakness in the arm or leg on one side of the body, sudden and severe.

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Pharmacodynamics

Stazol's effects on platelet aggregation were evaluated in both healthy subjects and in patients with stable symptoms of cerebral thrombosis, cerebral embolism, transient ischemic attack, or cerebral arteriosclerosis over a range of doses from 50 mg every day to 100 mg three times a day. Stazol significantly inhibited platelet aggregation in a dose-dependent manner. The effects were observed as early as 3 hours post-dose and lasted up to 12 hours following a single dose. Following chronic administration and withdrawal of Stazol, the effects on platelet aggregation began to subside 48 hours after withdrawal and returned to baseline by 96 hours with no rebound effect. A Stazol dosage of 100 mg twice daily consistently inhibited platelet aggregation induced with arachidonic acid, collagen and adenosine diphosphate (ADP). Bleeding time was not affected by Stazol administration.

Effects on circulating plasma lipids have been examined in patients taking PLETAL. After 12 weeks, as compared to placebo, PLETAL 100 mg twice daily produced a reduction in triglycerides of 29.3 mg/dL (15%) and an increase in HDL-cholesterol of 4.0 mg/dL (≅10%).

5.4 Hemostatic Disorders or Active Pathologic Bleeding

Stazol inhibits platelet aggregation in a reversible manner. Stazol has not been studied in patients with hemostatic disorders or active pathologic bleeding. Avoid use of Stazol in these patients.

Stazol did not inhibit the metabolism of R-and S-warfarin after a single 25-mg dose of warfarin.

How to use Stazol

Read the Patient Information Leaflet if available from your pharmacist before you start taking Stazol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth without food as directed by your doctor, usually twice daily, at least 30 minutes before or 2 hours after breakfast and dinner. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Use this medication regularly to get the most benefit from it. Remember to use it at the same times each day.

Your symptoms may improve in 2-4 weeks, but it may take up to 12 weeks before you get the full benefit of this drug.

Tell your doctor if your condition persists or worsens.

Common Side Effects of Stazol

Tell your doctor if any of the following side effects are severe or don't go away:

  • Diarrhea
  • Nausea
  • Stomach pain or gas
  • Heartburn or indigestion
  • Headache
  • Dizziness or lightheadedness
  • Increased frequency of coughing
  • Muscle pain

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What Are Side Effects Associated with Using Stazol?

Side effects of Stazol include:

Other side effects of Stazol include:

Postmarketing side effects of Stazol reported include:

  • Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia, granulocytopenia, thrombocytopenia, leukopenia, bleeding tendency
  • Cardiovascular: Torsades de pointes, QTc prolongation
  • GI: Gastrointestinal bleeding
  • General: Pain, chest pain, hot flashes/flushes, extradural or subduralhematoma, high blood sugar (hyperglycemia), hyperuricemia, increased BUN, elevated BP, decreased platelet or white blood cell (WBC) count
  • Hepatic: Liverdysfunction, abnormal liver function tests, yellowing skin and eyes (jaundice)
  • Neurologic: Intracranial or cerebralhemorrhage, cerebrovascular accident (CVA)
  • Respiratory: Pulmonary hemorrhage, interstitialpneumonia
  • Skin: Subcutaneous hemorrhage, itching, skin eruptions such as Stevens-Johnson syndrome, skin drug eruption (dermatitis medicamentosa)
  • Vascular: Subacutethrombosis

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

What should I discuss with my healthcare provider before taking Stazol (Pletal)?

Do not take Stazol if you have congestive heart failure. Stazol can make this condition worse.

To make sure Stazol is safe for you, tell your doctor if you have:

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Stazol passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

12.2 Pharmacodynamics

Stazol's effects on platelet aggregation were evaluated in both healthy subjects and in patients with stable symptoms of cerebral thrombosis, cerebral embolism, transient ischemic attack, or cerebral arteriosclerosis over a range of doses from 50 mg every day to 100 mg three times a day. Stazol significantly inhibited platelet aggregation in a dose-dependent manner. The effects were observed as early as 3 hours post-dose and lasted up to 12 hours following a single dose. Following chronic administration and withdrawal of Stazol, the effects on platelet aggregation began to subside 48 hours after withdrawal and returned to baseline by 96 hours with no rebound effect. A Stazol dosage of 100 mg twice daily consistently inhibited platelet aggregation induced with arachidonic acid, collagen and adenosine diphosphate (ADP). Bleeding time was not affected by Stazol administration.

Effects on circulating plasma lipids have been examined in patients taking Stazol. After 12 weeks, as compared to placebo, Stazol 100 mg twice daily produced a reduction in triglycerides of 29.3 mg/dL (15%) and an increase in HDL- cholesterol of 4.0 mg/dL (≅10%).

Short-term (less than or equal to 4 days) coadministration of aspirin with Stazol increased the inhibition of ADP- induced ex vivo platelet aggregation by 22% to 37% when compared to either aspirin or Stazol alone. Short-term (less than or equal to 4 days) coadministration of aspirin with Stazol increased the inhibition of arachidonic acid-induced ex vivo platelet aggregation by 20% compared to Stazol alone and by 48% compared to aspirin alone. However, short-term coadministration of aspirin with Stazol had no clinically significant impact on PT, aPTT, or bleeding time compared to aspirin alone. Effects of long-term coadministration in the general population are unknown.

In eight randomized, placebo-controlled, double-blind clinical trials, aspirin was coadministered with Stazol to 201 patients. The most frequent doses and mean durations of aspirin therapy were 75 to 81 mg daily for 137 days (107 patients) and 325 mg daily for 54 days (85 patients). There was no apparent increase in frequency of hemorrhagic adverse effects in patients taking Stazol and aspirin compared to patients taking placebo and equivalent doses of aspirin.

Stazol 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 Stazol on the pharmacodynamics of both drugs is unknown.

What Other Drugs Interact with Stazol?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Stazol has no known severe interactions with other drugs.

Stazol has serious interactions with at least 38 different drugs.

Stazol has moderate interactions with at least 111 different drugs.

Mild interactions of Stazol include:

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

ВїCГіmo se debe usar este medicamento?

La presentaciГіn del Stazol es en tabletas para administrarse por vГ­a oral. Por lo general, se toma dos veces al dГ­a, al menos, 30 minutos antes del desayuno y de la cena o 2 horas despuГ©s de estas comidas. Tome el Stazol aproximadamente a la misma hora todos los dГ­as. Siga atentamente las instrucciones del medicamento recetado y pГ­dales a su mГ©dico o a su farmacГ©utico que le expliquen cualquier cosa que no entienda. Tome el Stazol segГєn lo indicado. No aumente ni disminuya la dosis, ni la tome con mГЎs frecuencia que la indicada por su mГ©dico.

El Stazol controla los sГ­ntomas de la claudicaciГіn intermitente, pero no la cura. Si bien es posible que note mejoras en el tГ©rmino de 2 a 4 semanas, es posible que transcurran hasta 12 semanas antes de que note el beneficio total (aumento de la distancia que puede caminar) del Stazol. ContinГєe tomando Stazol aunque se sienta bien. No deje de tomar Stazol sin consultar a su mГ©dico.

Nursing Mothers

Transfer of Stazol into milk has been reported in rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from PLETAL, discontinue nursing or discontinue PLETAL.

Contraindications

  • Congestive heart failure of any severity
  • Hypersensitivity
  • Hemostatic disorders or active pathologic bleeding (e.g., bleeding peptic ulcer, intracranial bleeding) due to reversible platelet aggregation

Effects of Drug Abuse

  • No information available

  • See "What Are Side Effects Associated with Using Stazol?"

  • See "What Are Side Effects Associated with Using Stazol?"

  • Use with caution in liver and renal disease
  • Leukopenia that progresses to agranulocytosis may occur (in which case, discontinue therapy)
  • Discontinue therapy if thrombocytopenia occurs
  • Use with caution in patients taking platelet aggregation inhibitors
  • Do not administer for at least 4-6 half-lives before elective surgical procedures
  • Avoid grapefruit juice
  • Response may be seen as early as 2-4 weeks after initiation, but treatment may be needed for up to 12 weeks
  • Dosage can be reduced or discontinued without rebound effects (e.g., platelet hyperaggregability)
  • Stazol may induce fast heart rate (tachycardia), palpitation, tachyarrhythmia and/or low blood pressure (hypotension); patients with history of ischemic heart disease may be at risk for exacerbations of angina pectoris or myocardial infarction
  • Plasma concentrations and overall pharmacological activity are increased when Stazol is administered with strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, diltiazem) and strong CYP2C19 inhibitors (e.g., ticlopidine, fluconazole, omeprazole); dose reduction to 50 mg twice daily should be considered

  • Use Stazol with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done
  • Stazol excretion in milk is unknown; it is not recommended for use if breastfeeding

What is Stazol?

Stazol is a vasodilator that works by relaxing the muscles in your blood vessels to help them dilate (widen). Stazol dilates arteries that supply blood to your legs. Stazol also improves circulation by keeping platelets in the blood from sticking together and clotting.

Stazol is used to treat the symptoms of intermittent claudication. This condition causes reduced blood flow to the legs, leading to pain while walking. Stazol improves your ability to walk longer distances without pain.

Stazol may also be used for purposes not listed in this medication guide.

What are the side effects of Stazol?

The most common adverse effects of Stazol are:

Other important side effects which have also been reported with Stazol include a reduction in numbers of white blood cells and platelets. Severe skin reactions also have been reported.

Stazol inhibits the enzyme phosphodiesterase III. Other drugs that inhibit this enzyme have caused death in individuals with heart failure. Therefore, individuals with heart failure should not use Stazol.

Where can I get more information?

Your pharmacist can provide more information about Stazol.


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