DIPYRIDAMOLE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ANI Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dipyridamole 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:

Dipyridamole Tablets USP are available containing 25 mg, 50 mg or 75 mg of dipyridamole USP. 25 mg tablets: White to off white, round, film-coated tablets debossed with ‘AN’ on one side and ‘35’ on the other side. They are available in bottles of 100 tablets (NDC 62559-235-01). 50 mg tablets: White to off white, round, film-coated tablets debossed with ‘AN’ on one side and ‘36’ on the other side. They are available in bottles of 100 tablets (NDC 62559-236-01). 75 mg tablets: White to off white, round, film-coated tablets debossed with ‘ANI’ on one side and ‘237’ on the other side. They are available in bottles of 100 tablets (NDC 62559-237-01). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 10493 Rev 09/21

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIPYRIDAMOLE- DIPYRIDAMOLE TABLET, FILM COATED
ANI PHARMACEUTICALS, INC.
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DIPYRIDAMOLE TABLETS USP
DESCRIPTION
Dipyridamole Tablets USP are 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.
Dipyridamole Tablets USP 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:_ corn starch,
lactose
monohydrate, magnesium stearate, polyethylene glycol, polyvinyl
alcohol, povidone,
sodium bicarbonate, sodium lauryl sulfate, talc, and titanium dioxide.
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.
Dipyridamole 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, dipyridamole 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 dipyridamole tablets and
warfarin ranged from 1.2
to 1.8%. In three additional studies involving 392 patients taking
dipyridamole tablets and
coumarin-like anticoagulants, the incidence of thromboembolic events
ranged from 2.3
to 6.9%.
In these trials, the coumarin anticoagulant was begun between 24 hours
and 4 days
postoperatively, and the dipyrid