국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)
NCS HealthCare of KY, Inc dba Vangard Labs
DIPYRIDAMOLE
DIPYRIDAMOLE 50 mg
ORAL
PRESCRIPTION DRUG
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.
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].
Abbreviated New Drug Application
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 전체 문서 읽기