DIPYRIDAMOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals of New York LLC

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, 25 mg are white to pale yellow, round, standard convex film-coated tablets debossed with “C81” on one side and plain on the other side. They are available as follows: Bottles of 100:                        NDC 0115-1070-01 Bottles of 1,000:                     NDC 0115-1070-03 Dipyridamole Tablets USP, 50 mg are white to pale yellow, round, standard convex film-coated tablets debossed with “C82” on one side and plain on the other side. They are available as follows: Bottles of 100:                        NDC 0115-1071-01 Bottles of 1,000:                     NDC 0115-1071-03 Dipyridamole Tablets USP, 75 mg are white to pale yellow, round, standard convex film-coated tablets debossed with “C83” on one side and plain on the other side. They are available as follows: Bottles of 100:                        NDC 0115-1072-01 Bottles of 1,000:                     NDC 0115-1072-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep this and all medication out of the reach of children. Dispense in tightly-closed, light-resistant container as defined in the USP, with child-resistant closure, as required. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIPYRIDAMOLE- DIPYRIDAMOLE TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
DIPYRIDAMOLE TABLETS, USP
(25 MG, 50 MG AND 75 MG)
RX ONLY
DESCRIPTION
Dipyridamole is a platelet inhibitor chemically described as
2,2',2",2'''-[(4,8-
Dipiperidinopyrimido[5,4-_d_]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol.
The molecular
weight is 504.63 and the molecular formula is C
H
N O . The structural formula is
represented below:
Dipyridamole, USP is intensely yellow crystalline powder or needles.
It is practically
insoluble in water, sparingly soluble in ethyl alcohol, very slightly
soluble in acetone and
ethyl acetate.
Each tablet, for oral administration, contains 25 mg, 50 mg or 75 mg
dipyridamole, USP.
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
hypromellose, lactose monohydrate, magnesium stearate, polyethylene
glycol, povidone,
pregelatinized starch, sodium starch glycolate, Type A, 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
24
40
8
4
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 cou