Pletal

[cilostazol]

Drug Description
*CONTRAINDICATION

Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with
class III-IV congestive heart failure. PLETAL is contraindicated in patients with congestive heart failure of any severity.

DESCRIPTION

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PLETAL® (PLAY-tal) (cilostazol) (sil-OS-tah-zol) Tablets

PLETAL (cilostazol) is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). The empirical formula of cilostazol is C20H27N5O2, 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, CAS-73963-72-1.

Cilostazol occurs as white to off-white crystals or as a crystalline powder that is slightly soluble inmethanol and ethanol, and is practically insoluble in water, 0.1 N HCl, and 0.1 N NaOH.PLETAL (cilostazol) tablets for oral administration are available in 50 mg triangular and 100 mg round,white debossed tablets.

Each tablet, in addition to the active ingredient, contains the following inactive ingredients: carboxymethylcellulose calcium, corn starch, hydroxypropyl methylcellulose 2910, magnesium stearate, and microcrystalline cellulose.

HOW SUPPLIED

PLETAL is supplied as 50 mg and 100 mg tablets. The 50 mg tablets are white, triangular, debossed with PLETAL 50, and provided in bottles of 60 tablets (NDC #59148-003-16), and hospital unit dose packs of 100 tablets (NDC #59148-003-35).

The 100 mg tablets are white, round, debossed with PLETAL 100, and provided in bottles of 60 tablets (NDC #59148-002-16), and hospital unit dose packs of 100 tablets (NDC #59148-002-35).

Rx ONLY.

STORAGE
Store PLETAL tablets at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].
Manufactured for OTSUKA AMERICA PHARMACEUTICAL, INC.
Rockville, MD 20850
Manufactured by OTSUKA PHARMACEUTICAL CO., LTD.
Tokushima 771-0192, Japan
1101/05-04
U.S. Patent No. 4,277,479