Cilosta® : Each tablet contains Cilostazol INN 100 mg.
Cilosta® is a preparation of Cilostazol which is a quinolinone derivative. The
mechanism of action is to specifically inhibit cellular phosphodiesterase III (PDE III)
and suppress cAMP degradation with a resultant increase in cAMP in platelets and
blood vessels, leading to inhibition of platelet aggregation and vasodilation.
Cilosta® is indicated for the reduction of symptoms of intermittent claudication, as
indicated by an increased walking distance.
Dosage and Administration
The recommended dosage of Cilosta® is 100 mg bid, taken at least half an hour
before or two hours after breakfast and dinner. A dose of 50 mg bid should be
considered during coadministration of Fluconazole, Ketoconazole, Itraconazole,
Erythromycin, Clarithromycin, Fluvoxamine, Fluoxetine, Nefazodone, Sertraline
Cilostazol is contraindicated in patients with congestive heart failure of any severity.
Cilostazol is also contraindicated in patients with known or suspected
hypersensitivity to any of its components.
Cilostazol should be used with caution in patients with any degree of heart failure.
There is no information with respect to the efficacy or safety of the concurrent use
of Cilostazol and Clopidogrel.
Pharmacokinetic studies have demonstrated that Omeprazole and Erythromycin
significantly increased the systemic exposure of Cilostazol and/or its major
metabolites. Population pharmacokinetic studies showed higher concentrations of
Cilostazol among patients concurrently treated with Diltiazem.
The most common side effects are headache, diarrhoea, vomiting, leg cramps,
rash etc. The less frequent side effects are anorexia and edema.
Use in Special Population
Pregnancy : There are no adequate and well controlled studies in pregnant women.
Lactation : Transfer of Cilostazol into milk has been reported in experimental
animals. Because of the potential risk to nursing infants, a decision should be
made to discontinue nursing or to discontinue Cilostazol. Paediatric use: The safety
and effectiveness of Cilostazol in paediatric patients have not been established.
Store in a cool & dry place, protected from light and moisture.
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