Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)
ANI Pharmaceuticals, Inc.
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 containing 25 mg, 50 mg or 75 mg of dipyridamole USP. 25 mg tablets: White to off white, round, film-coated tablets debossed with ‘AN’ on one side and ‘35’ on the other side. They are available in bottles of 100 tablets (NDC 62559-235-01). 50 mg tablets: White to off white, round, film-coated tablets debossed with ‘AN’ on one side and ‘36’ on the other side. They are available in bottles of 100 tablets (NDC 62559-236-01). 75 mg tablets: White to off white, round, film-coated tablets debossed with ‘ANI’ on one side and ‘237’ on the other side. They are available in bottles of 100 tablets (NDC 62559-237-01). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 10493 Rev 09/21
Abbreviated New Drug Application
DIPYRIDAMOLE- DIPYRIDAMOLE TABLET, FILM COATED ANI PHARMACEUTICALS, INC. ---------- DIPYRIDAMOLE TABLETS USP DESCRIPTION Dipyridamole Tablets USP are 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 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:_ corn starch, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, sodium lauryl sulfate, 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 to 6.9%. In these trials, the coumarin anticoagulant was begun between 24 hours and 4 days postoperatively, and the dipyrid Izlasiet visu dokumentu