VAXOL Cilostazol 50mg Tablet 100's
RXDRUG-DRP-4555-05
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Cilostazol is used for the symptomatic treatment of intermittent claudication in patients without rest pain and no peripheral tissue necrosis.
Dosage/Direction for Use
For intermittent claudication: 100 mg twice daily at least 30 minutes before or 2 hours after meals. Cilostazol should be taken on an empty stomach. Response to treatment may occur in 2 to 4 weeks, but up to 12 weeks may be required.
Overdosage
Signs and symptoms include severe headache, hypotension and diarrhea, tachycardia and possible cardiac arrhythmias. Carefully monitor the patient and provide supportive treatment. Hemodialysis or peritoneal dialysis is an unlikely treatment for overdose since the drug is highly protein bound.
Administration
Should be taken on an empty stomach: Take at least 30 min before or 2 hr after meals.
Contraindications
Known hypersensitivity to cilostazol or any component of the product.
Congestive heart failure of any severity.
Hemostatic disorders or active pathologic bleeding, such as bleeding peptic ulcer or intracranial bleeding.
History of ventricular arrhythmias.
QT interval prolongation.
Severe renal impairment or moderate to severe hepatic impairment.
Congestive heart failure of any severity.
Hemostatic disorders or active pathologic bleeding, such as bleeding peptic ulcer or intracranial bleeding.
History of ventricular arrhythmias.
QT interval prolongation.
Severe renal impairment or moderate to severe hepatic impairment.
Warnings
Cilostazol (Vaxol) 50 mg: This product contains FD & C Yellow #5 (Tartrazine) which may cause allergic reactions including bronchial asthma in certain susceptible person.
Special Precautions
Caution in patients with severe renal impairment (Creatinine clearance less than 25 mL/minute) and with moderate to severe hepatic impairment. May cause cardiovascular risks and lesions including endocardial hemorrhage, hemosiderin deposition and fibrosis in the left ventricle, hemorrhage and necrosis of the smooth muscle in the wall of the coronary artery, intimal thickening of the coronary artery and coronary arteritis and periarteritis.
There are no adequate and well-controlled studies on its use in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Cilostazol is distributed into milk in rats, discontinue nursing or drug therapy.
Safety and efficacy in children have not been established.
There are no adequate and well-controlled studies on its use in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Cilostazol is distributed into milk in rats, discontinue nursing or drug therapy.
Safety and efficacy in children have not been established.
Use In Pregnancy & Lactation
There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Cilostazol may have a potential risk to nursing infants, decide whether to discontinue nursing, or to discontinue the drug.
Cilostazol may have a potential risk to nursing infants, decide whether to discontinue nursing, or to discontinue the drug.
Adverse Reactions
Adverse effects include headache which results upon discontinuation of therapy; Other frequent effects include palpitations, tachycardia; dizziness, abnormal stool, diarrhea, dyspepsia, flatulence, nausea; infection and peripheral edema, asthenia; gastritis, myocardial infarction, congestive heart failure, postural hypotension, insomnia, anxiety, abnormal dream, dyspnoea, pneumonia, cough, hypersensitivity reactions, diabetes mellitus, anaemia, haemorrhage, thrombocythaemia, myalgia, renal impairment.
Drug Interactions
Cilostazol may enhance the effects of anticoagulant and antiplatelet agents. Antifungal drugs (e.g. imidazole) may decrease the metabolism of cilostazol via the CYP isoenzymes. CYP2C19 inhibitors (e.g. delavirdine, fluvoxamine, gemfibrozil, isoniazid, omeprazole, and ticlopidine) and CYP3A4 inhibitors (e.g. azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, telithromycin, and verapamil) could increase the levels and effects of cilostazol. A reduction of dose to 50 mg twice daily is recommended. CYP3A4 inducers (aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins) may decrease the levels or effects of cilostazol. A reduction to 50 mg twice daily is also recommended. Dasatinib may enhance the antithrombotic effects of cilostazol. Macrolide antibiotics (e.g. clarithromycin, erythromycin, telithromycin) may decrease the metabolism, via CYP isoenzymes, of cilostazol. Nonsteroidal anti-inflammatory drugs and salicylates may enhance the adverse or toxic effects of antiplatelet agents thereby an increased risk of bleeding may occur. Omega-3-acid ethyl esters may enhance the effect of antiplatelet agents. Omeprazole and treprostinil may enhance the adverse or toxic effects of cilostazol. Avoid concurrent ingestion of grapefruit juice due to the potential to inhibit CYP3A4.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Cilostazol is a quinolinone-derivative selective phosphodiesterase (PDE) inhibitor. Although its mechanism of action has not been fully elucidated, the drug appears to inhibit activation of cellular PDE type III (PDE III) resulting in suppressed degradation, and thus increased concentrations, of cyclic AMP (cAMP) in platelets and blood vessels. Cilostazol reversibly inhibits platelet aggregation induced by a wide range of stimuli, including thrombin, adenosine diphosphate (ADP), collagen, arachidonic acid, epinephrine and stress related clinical events.
Pharmacokinetics: Cilostazol is absorbed after oral doses; absorption is increased when administered with a high fat meal. It undergoes extensive hepatic metabolism via cytochrome P450 isoenzymes, mainly CYP3A4 and to a lesser extent CYP2C19, to both active and inactive metabolites which are predominantly excreted in the urine (74%) with the remainder in the feces (20%). Its active metabolites have apparent elimination half-lives of 11 to 13 hours. Cilostazol is 95 to 98% bound to protein.
Pharmacokinetics: Cilostazol is absorbed after oral doses; absorption is increased when administered with a high fat meal. It undergoes extensive hepatic metabolism via cytochrome P450 isoenzymes, mainly CYP3A4 and to a lesser extent CYP2C19, to both active and inactive metabolites which are predominantly excreted in the urine (74%) with the remainder in the feces (20%). Its active metabolites have apparent elimination half-lives of 11 to 13 hours. Cilostazol is 95 to 98% bound to protein.
MedsGo Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
Features
Brand
Vaxol
Full Details
Dosage Strength
50 mg
Drug Ingredients
- Cilostazol
Drug Packaging
Tablet 100's
Generic Name
Cilostazol
Dosage Form
Tablet
Registration Number
DRP-4555-05
Drug Classification
Prescription Drug (RX)
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