PERSANTINE- dipyridamole tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)

Available from:

Boehringer Ingelheim Pharmaceuticals, Inc.

INN (International Name):

DIPYRIDAMOLE

Composition:

DIPYRIDAMOLE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PERSANTINE tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement. Hypersensitivity to dipyridamole and any of the other components.

Product summary:

PERSANTINE tablets are available as round, orange, sugar-coated tablets of 25 mg, 50 mg and 75 mg coded BI/17, BI/18 and BI/19, respectively. They are available in bottles of 100 tablets as indicated below: 25 mg Tablets        (NDC 0597-0017-01) 50 mg Tablets        (NDC 0597-0018-01) 75 mg Tablets        (NDC 0597-0019-01) Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

PERSANTINE- DIPYRIDAMOLE TABLET, COATED
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
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PERS ANTINE®
(DIPYRIDAMOLE USP)
25 MG, 50 MG, AND 75 MG TABLETS
DESCRIPTION
PERSANTINE® (dipyridamole USP) is a platelet inhibitor chemically
described as 2,2',2",2"'-[(4,8-
Dipiperidinopyrimido[5,4-_d_]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol.
It has the following structural
formula:
Dipyridamole is an odorless yellow crystalline powder, having a bitter
taste. It is soluble in dilute
acids, methanol and chloroform, and practically insoluble in water.
PERSANTINE tablets for oral administration contain:
ACTIVE INGREDIENT_TABLETS 25 mg, 50 mg, and 75 mg_: dipyridamole USP
25 mg , 50 mg and 75 mg,
respectively.
INACTIVE INGREDIENTS_TABLETS 25 mg, 50 mg, and 75 mg_: acacia,
carnauba wax, corn starch, edible
white ink, lactose monohydrate, magnesium stearate, D&C yellow #10
aluminum lake, D&C red #30,
helendon aluminum pink lake, sodium benzoate, methylparaben,
propylparaben, polyethylene glycol,
povidone, sucrose, talc, titanium dioxide, and white wax.
CLINICAL PHARMACOLOGY
It is believed that platelet reactivity and interaction with
prosthetic cardiac valve surfaces, resulting in
abnormally shortened platelet survival time, is a significant factor
in thromboembolic complications
occurring in connection with prosthetic heart valve replacement.
PERSANTINE tablets have been found to lengthen abnormally shortened
platelet survival time in a
dose-dependent manner.
In three randomized controlled clinical trials involving 854 patients
who had undergone surgical
placement of a prosthetic heart valve, PERSANTINE tablets, in
combination with warfarin, decreased
the incidence of postoperative thromboembolic events by 62 to 91%
compared to warfarin treatment
alone. The incidence of thromboembolic events in patients receiving
the combination of PERSANTINE
tablets and warfarin ranged from 1.2 to 1.8%. In three additional
studies involving 392 patients taking
PERSANTINE tablets and coumarin-like anticoagulants, the incidence of
throm