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.
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 PLETOZ (Cilostazol, Pletal)
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
