InnoGen Pharmaceuticals
Full Prescribing Info
Each tablet contains 50 mg or 100 mg of Cilostazol.
Pharmacology: Pharmacokinetics: Cilostazol is absorbed after oral doses and absorption is increased if taken with a high fat meal. Cilostazol is extensively metabolised in the liver by cytochrome P450 isoenzymes, mainly CYP3A4 and to a lesser extent CYP2C19, to both active and inactive metabolites; these are predominantly excreted in the urine (74%) with the remainder in the faeces (20%). The active metabolites have apparent elimination half-lives of 11 to 13 hours. Cilostazol is 95 to 98% protein bound.
It is used in the management of peripheral vascular disease; often used for atherosclerotic or occlusive arterial disease but in its widest sense covers both arterial and venous disorders and may be due to atherosclerosis, vasospasm, or thromboembolism.
Dosage/Direction for Use
The usual dose is 100 mg twice daily, at least 30 minutes before meal or 2 hours after meal; doses should be reduced in patients taking enzyme inhibitors. Response to treatment may occur in 2 to 4 weeks, but up to 12 weeks may be required. Or as prescribed by the physician.
Cilostazol is contraindicated in patients with congestive heart failure of any severity. It is also contraindicated in patients with a known predisposition to bleeding, a history of ventricular arrhythmias, QT interval prolongation, severe renal impairment, or moderate to severe hepatic impairment.
Cilostazol Tablet is contraindicated in patients with known or suspected hypersensitivity to any of its components.
Special Precautions
Cilostazol should be avoided or used in reduced doses in patients taking inhibitors of the cytochrome P450 isoenzymes CYP3A4 or CYP2C19.
Adverse Reactions
Adverse effects of Cilostazol include headache, dizziness, palpitations, and diarrhoea; oedema, nausea and vomiting, other cardiac arrhythmias, chest pain, rhinitis, ecchymosis, and skin rashes have also been reported. Cardiovascular toxicity has been reported in animal studies of Cilostazol, and prolonged oral use of other phosphodiesterase inhibitors for the treatment of heart failure has been associated with increased mortality.
Drug Interactions
Cilostazol is extensively metabolised to active and inactive metabolites by cytochrome P450 isoenzymes, mainly CYP3A4 and to a lesser extent CYP2C19. Therefore use with other drugs that inhibit or are metabolised by these hepatic enzymes may result in changes in plasma concentrations of either drug and, possibly, adverse effects. Cilostazol should therefore be used with caution in patients taking drugs metabolised by these enzymes; in patients taking enzyme inhibitors it should be avoided or a reduced dose of 50 mg twice daily should be considered.
Store at temperatures not exceeding 30°C.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AC23 - cilostazol ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Tab 50 mg x 30's. 100 mg x 30's.
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