Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)
Oxford Pharmaceuticals, LLC
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 yellow, round, biconvex, coated tablets debossed tablets of 25 mg, 50 mg and 75 mg coded “181”, ”182” and ”183”, respectively on one side and “O” on the other. They are available in bottles of 100 tablets as indicated below: 25 mg Tablets (NDC 69584-181-10) 50 mg Tablets (NDC 69584-182-10) 75 mg Tablets (NDC 69584-183-10) Store at 20°– 25°C (68°– 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Address medical inquiries to: 1-844‑508‑1455, 8:00 AM to 4.30 PM ET, Monday – Friday Manufactured by: OXFORD PHARMACEUTICALS Birmingham, AL 35211 8200025 Rev 00 01/21
Abbreviated New Drug Application
DIPYRIDAMOLE- DIPYRIDAMOLE TABLET, FILM COATED OXFORD PHARMACEUTICALS, LLC ---------- 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 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_: Carnauba wax, D&C yellow no. 10, FD&C yellow no. 6, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone, propylene glycol, propylparaben, silicon dioxide, sodium citrate, sodium starch glycolate, stearic acid, talc, titanium dioxide, and xanthan gum. 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 di Đọc toàn bộ tài liệu