DIPYRIDAMOLE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Kansainvälinen yleisnimi):

DIPYRIDAMOLE

Koostumus:

DIPYRIDAMOLE 50 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

Dipyridamole Tablets, USP are available as: 25 mg: White, round, film-coated, unscored tablets. Debossed with stylized b on one side and 252 on the other side. 50 mg: White, round, film-coated, unscored tablets. Debossed with stylized b on one side and 285 on the other side. Available in blistercards of: 30 Tablets NDC 0615-1573-39 75 mg: White, round, film-coated, unscored tablets. Debossed with BARR on one side and 286 on the other side. Dispense with a child-resistant closure in a tight, light-resistant container. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

DIPYRIDAMOLE- DIPYRIDAMOLE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
DIPYRIDAMOLE TABLETS, USP
Revised NOVEMBER 2005
11001008
RX ONLY
DES CRIPTION:
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 M.W. 504.63
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: 25 mg, 50 mg, and 75 mg; dipyridamole USP 25 mg, 50
mg and 75 mg, respectively.
INACTIVE INGREDIENTS: Colloidal silicon dioxide, hypromellose, lactose
anhydrous, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80,
propylene glycol, stearic acid, sodium
starch glycolate, 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
24
40
8
4
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