Warfarin Cilostazol did not inhibit the pharmacologic effects PT, aPTT, bleeding time, or platelet aggregation of R-and S-warfarin after a single mg dose of warfarin. Absolute bioavailability is not known.
Cilostazol is extensively metabolized by hepatic cytochrome P enzymes, mainly 3A4, and, to a lesser extent, 2C19, with metabolites largely excreted in urine. Pharmacokinetics are approximately dose proportional. Cilostazol and its active metabolites have apparent elimination half-lives of about hours.
Cilostazol and its active metabolites accumulate about 2-fold with chronic administration and reach steady state blood levels within a few days. The pharmacokinetics of cilostazol and its two major active metabolites were similar in healthy subjects and patients with intermittent claudication due to peripheral arterial disease PAD.
Figure 1 shows the mean plasma concentration-time profile at steady state after multiple dosing of PLETAL mg twice daily. The binding for 3,4-dehydro-cilostazol is Mild hepatic impairment did not affect protein binding. The displacement of cilostazol from plasma proteins by erythromycin , quinidine, warfarin, and omeprazole was not clinically significant.
Metabolism Cilostazol is eliminated predominantly by metabolism and subsequent urinary excretion of metabolites. The enzyme responsible for metabolism of 3,4-dehydro-cilostazol, the most active of the metabolites, is unknown.
There was no evidence of induction of hepatic microenzymes. Do not take cilostazol if you have congestive heart failure. Cilostazol can make this condition worse. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Cilostazol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Headache, diarrhea, runny nose, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. How should I take Pletal cilostazol?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Cilostazol is usually taken twice a day on an empty stomach, at least 30 minutes before or 2 hours after breakfast or dinner. Take the medicine at the same time each day. It may take up to 12 weeks before your symptoms improve.
Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment. Store at room temperature away from moisture and heat. What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose.
Based on these data, the recommended dose of cilostazol is 50 mg bid in the presence of omeprazole. Caution is advised when cilostazol is co-administered with CYP3A4 substrates with a narrow therapeutic index e. Caution is advised in case of co-administration with statins metabolised by CYP3A4, for example simvastatin, atorvastatin and lovastatin.
John's wort on cilostazol pharmacokinetics has not been evaluated. The antiplatelet effect may theoretically be altered and should be carefully monitored when cilostazol is co-administered with CYP3A4 and CYP2C19 inducers.
Other potential interactions Caution is needed when co-administering cilostazol with any other agent which has the potential to reduce blood pressure due to the possibility that there may be an additive hypotensive effect with a reflex tachycardia. Studies in animals have shown reproductive toxicity see Section 5. The potential risk for humans is unknown. Pletal must not be used during pregnancy see section 4. Lactation The transfer of cilostazol to breast milk has been reported in animal studies.
The excretion of cilostazol in human milk is unknown. Due to the potential harmful effect in the newborn child breast fed by a treated mother, the use of Pletal is not recommended during breast feeding.
Fertility Cilostazol reversibly impaired fertility of female mice but not in other animal species see section 5. The clinical significance is unknown. These reactions were usually of mild to moderate intensity and were sometimes alleviated by reducing the dose. Adverse reactions reported in clinical trials and in the post-marketing period are included in the table below. The frequencies correspond with:
Cilostazol may also be used for purposes not listed in this medication guide, lek pletal 100mg. Cilostazol may also be used for other purposes not listed in this medication guide, lek pletal 100mg. Patients should be warned to report any episode of bleeding or easy bruising whilst on therapy. Other potential interactions Caution is needed when co-administering cilostazol with any other agent which has the potential to reduce blood pressure due to the possibility that there may be an additive hypotensive effect with a reflex tachycardia, lek pletal 100mg. Hepatic Impairment The pharmacokinetics pletal cilostazol and its metabolites were similar in subjects with mild hepatic disease as compared to healthy subjects. Follow your doctor's instructions. Renal arteries were not responsive to the effects of cilostazol. Patients receiving treatment with cilostazol should continue with their life-style modifications smoking cessation and exerciseand pharmacological interventions such as lipid lowering and antiplatelet treatment to reduce the risk of cardiovascular events. The excretion of cilostazol 100mg human milk is unknown. Since cilostazol lek extensively metabolised by hepatic enzymes, it is contraindicated in patients with moderate or severe hepatic impairment. The physician should reassess the patient after 3 months of treatment with a view pletal discontinuing cilostazol lek an inadequate effect is observed or symptoms have not been improved, lek pletal 100mg. Taking cilostazol lek food has been shown to increase the maximum plasma concentrations Cmax of cilostazol, lek pletal 100mg, which may be associated with an increased frequency of 100mg reactions. Patients who may be at increased risk for serious cardiac adverse events as a result pletal increased heart rate, e. A full blood count should be performed if infection is suspected or there is any other clinical evidence of blood dyscrasia. Do not take cilostazol 100mg you have congestive heart failure.
Due to the potential harmful pletal in 100mg newborn child breast fed by a treated mother, the use of Pletal is not recommended lek breast feeding. There was no apparent increase in frequency of hemorrhagic adverse effects in patients taking cilostazol and aspirin compared to patients taking placebo 100mg equivalent doses of aspirin. Cilostazol and its active metabolites have apparent elimination half-lives of about hours. The binding for 3,4-dehydro-cilostazol is Cilostazol also improves circulation by keeping platelets in the blood from sticking together and clotting. PLETAL reversibly inhibits platelet aggregation induced by a variety of stimuli, including thrombinlek pletal 100mg, ADP, collagenlek acid, epinephrineand shear stress. Side effects in more detail What other drugs will affect Pletal cilostazol? Oral Anticoagulants like warfarin In a single-dose clinical study, no inhibition of the metabolism of warfarin or an effect on the coagulation parameters PT, lek pletal 100mg, aPTT, bleeding time was observed. If any of these effects persist pletal worsen, tell your doctor or pharmacist promptly. Metabolism Cilostazol is eliminated predominantly by metabolism and subsequent urinary excretion of metabolites.
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