Drug Catalog - Product Detail
CILOSTAZOL TABS 100MG 60CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 51991-0168-06 | BRECKENRIDGE | 60EA | 100MG | NA |
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Description
DESCRIPTION CILOSTAZOL is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). The molecular formula of cilostazol is C 20 H 27 N 5 O 2 , and its molecular weight is 369.46. Cilostazol is 6-[4-(1-cyclohexyl-1 H -tetrazol-5-yl) butoxy]- 3,4-dihydro-2(1 H )-quinolinone. The structural formula is: CILOSTAZOL Cilostazol occurs as white to off-white crystals or as a 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 for oral administration are available in 50 mg and 100 mg round, white debossed tablets. Each tablet, in addition to the active ingredient, contains the following inactive ingredients: carboxymethylcellulose calcium, pregelantized starch, hypromellose, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Chemical Structure
How Supplied
HOW SUPPLIED CILOSTAZOL is supplied as 50 mg and 100 mg tablets. The 50 mg tablets are white, round, debossed with B167 on one side and 50 on the other, and are provided in bottles of 60 tablets (NDC #51991-167-06) and 1000 tablets (NDC #51991-167-10). The 100 mg tablets are white, round, debossed with B168 on one side and 100 on the other, and provided in bottles of 60 tablets (NDC #51991-168-06) and 1000 tablets (NDC #51991-168-10). Rx ONLY. STORAGE Store CILOSTAZOL tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].
Indications & Usage
INDICATIONS AND USAGE CILOSTAZOL is indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance.
Dosage and Administration
DOSAGE AND ADMINISTRATION The recommended dosage of CILOSTAZOL is 100 mg b.i.d. taken at least half an hour before or two hours after breakfast and dinner. A dose of 50 mg b.i.d. should be considered during coadministration of such inhibitors of CYP3A4 as ketoconazole, itraconazole, erythromycin and diltiazem, and during coadministration of such inhibitors of CYP2C19 as omeprazole. Patients may respond as early as 2 to 4 weeks after the initiation of therapy, but treatment for up to 12 weeks may be needed before a beneficial effect is experienced. Discontinuation of Therapy The available data suggest that the dosage of CILOSTAZOL can be reduced or discontinued without rebound (i.e., platelet hyperaggregability).