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:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

DIPYRIDAMOLE

Composition:

DIPYRIDAMOLE 25 mg

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 light yellow, round, biconvex, film-coated tablets debossed with 'ZE 43' on one side and plain on the other side are supplied as follows: NDC 68382-187-01 in bottle of 100 tablets NDC 68382-187-05 in bottle of 500 tablets NDC 68382-187-10 in bottle of 1000 tablets NDC 68382-187-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Dipyridamole Tablets USP, 50 mg are light yellow, round, biconvex, beveled-edge, film-coated tablets debossed with 'ZE 49' on one side and plain on the other side are supplied as follows: NDC 68382-188-01 in bottle of 100 tablets NDC 68382-188-05 in bottle of 500 tablets NDC 68382-188-10 in bottle of 1000 tablets NDC 68382-188-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Dipyridamole Tablets USP, 75 mg are light yellow, round, biconvex, beveled-edge, film-coated tablets debossed with 'ZE 50' on one side and plain on the other side are supplied as follows: NDC 68382-189-01 in bottle of 100 tablets NDC 68382-189-05 in bottle of 500 tablets NDC 68382-189-10 in bottle of 1000 tablets NDC 68382-189-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIPYRIDAMOLE- DIPYRIDAMOLE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
----------
DIPYRIDAMOLE TABLETS, USP
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.
It has the following
structural formula:
C
H
N O
Mol. Wt. 504.63
Dipyridamole, USP is intensely yellow crystalline powder or needles.
It is very soluble in
methanol, in alcohol, and in chloroform; slightly soluble in water;
very slightly soluble in
acetone and in ethyl acetate.
Each dipyridamole tablet intended for oral administration contains 25
mg or 50 mg or 75
mg of dipyridamole. In addition, each tablet contains the following
inactive ingredients:
corn starch, hypromellose, iron oxide yellow, lactose monohydrate,
magnesium
stearate, polyethylene glycol, povidone 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
24
40
8
4
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 dipyridamole tab