DIPYRIDAMOLE tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Lannett Company, Inc.

INN (Међународно име):

DIPYRIDAMOLE

Састав:

DIPYRIDAMOLE 25 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Dipyridamole Tablets, USP 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.

Резиме производа:

Dipyridamole Tablets USP, 25 mg are orange, round, film-coated tablets debossed "LCI" on one side and "1461" on the other side and are available in bottles of: 100 tablets            NDC 0527-1461-01 500 tablets            NDC 0527-1461-05 1000 tablets          NDC 0527-1461-10 Dipyridamole Tablets USP, 50 mg are orange, round, film-coated tablets debossed "LCI" on one side and "1462" on the other side and are available in bottles of: 100 tablets            NDC 0527-1462-01 500 tablets            NDC 0527-1462-05 1000 tablets          NDC 0527-1462-10 Dipyridamole Tablets USP, 75 mg are orange, round, film-coated tablets debossed "LCI" on one side and "1463" on the other side and are available in bottles of: 100 tablets            NDC 0527-1463-01 500 tablets            NDC 0527-1463-05 1000 tablets          NDC 0527-1463-10 Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. KEEP OUT OF REACH OF CHILDREN. Dispense in tight, light-resistant containers as defined in the USP. Manufactured By: Lannett Company, Inc. Philadelphia, PA 19136 Rev. 01/08

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

DIPYRIDAMOLE- DIPYRIDAMOLE TABLET, FILM COATED
LANNETT COMPANY, INC.
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DIPYRIDAMOLE TABLETS, USP
25 MG, 50 MG, AND 75 MG
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
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.
Dipyridamole Tablets USP, 25 mg, 50 mg and 75 mg for oral
administration contain 25 mg, 50 mg, and
75 mg of dipyridamole, USP, respectively.
Inactive ingredients for Dipyridamole Tablets USP, 25 mg, 50 mg, and
75 mg: microcrystalline
cellulose, povidone, crospovidone, lactose monohydrate, colloidal
silicon dioxide, magnesium
stearate, FD&C Red # 40 aluminum lake, FD&C Yellow #6 aluminum lake,
lecithin, polyethylene
glycol, polyvinyl alcohol, 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