국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)
Boehringer Ingelheim Pharmaceuticals, Inc.
DIPYRIDAMOLE
DIPYRIDAMOLE 25 mg
ORAL
PRESCRIPTION DRUG
PERSANTINE 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.
PERSANTINE tablets are available as round, orange, sugar-coated tablets of 25 mg, 50 mg and 75 mg coded BI/17, BI/18 and BI/19, respectively. They are available in bottles of 100 tablets as indicated below: 25 mg Tablets (NDC 0597-0017-01) 50 mg Tablets (NDC 0597-0018-01) 75 mg Tablets (NDC 0597-0019-01) Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
New Drug Application
PERSANTINE- DIPYRIDAMOLE TABLET, COATED BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. ---------- PERS ANTINE® (DIPYRIDAMOLE USP) 25 MG, 50 MG, AND 75 MG TABLETS DESCRIPTION PERSANTINE® (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. PERSANTINE tablets for oral administration contain: ACTIVE INGREDIENT_TABLETS 25 mg, 50 mg, and 75 mg_: dipyridamole USP 25 mg , 50 mg and 75 mg, respectively. INACTIVE INGREDIENTS_TABLETS 25 mg, 50 mg, and 75 mg_: acacia, carnauba wax, corn starch, edible white ink, lactose monohydrate, magnesium stearate, D&C yellow #10 aluminum lake, D&C red #30, helendon aluminum pink lake, sodium benzoate, methylparaben, propylparaben, polyethylene glycol, povidone, sucrose, talc, titanium dioxide, and white wax. 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. PERSANTINE 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, PERSANTINE 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 PERSANTINE tablets and warfarin ranged from 1.2 to 1.8%. In three additional studies involving 392 patients taking PERSANTINE tablets and coumarin-like anticoagulants, the incidence of throm 전체 문서 읽기