DIPYRIDAMOLE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Dipyridamole Tablets, USP are available as round, white, film-coated tablets of 25 mg, 50 mg, and 75 mg coded 81/SL, 82/SL, and 83/SL, respectively. They are available in bottles of 30 tablets as indicated below: 25 mg Tablets (NDC 71205-894-30) 50 mg Tablets (NDC 71205-895-30) 75 mg Tablets (NDC 71205-896-30) They are available in bottles of 60 tablets as indicated below: 25 mg Tablets (NDC 71205-894-60) 50 mg Tablets (NDC 71205-895-60) 75 mg Tablets (NDC 71205-896-60) They are available in bottles of 90 tablets as indicated below: 25 mg Tablets (NDC 71205-894-90) 50 mg Tablets (NDC 71205-895-90) 75 mg Tablets (NDC 71205-896-90) They are available in bottles of 100 tablets as indicated below: 25 mg Tablets (NDC 71205-894-00) 50 mg Tablets (NDC 71205-895-00) 75 mg Tablets (NDC 71205-896-00) They are available in bottles of 500 tablets as indicated below: 25 mg Tablets (NDC 71205-894-55) 50 mg Tablets (NDC 71205-895-55) 75 mg Tablets (NDC 71205-896-55) They are available in bottles of 1000 tablets as indicated below: 25 mg Tablets (NDC 71205-894-11) 50 mg Tablets (NDC 71205-895-11) 75 mg Tablets (NDC 71205-896-11) 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. For medical inquiries, please visit the website www.risingpharma.com or call 1-866-562-4597. Distributed by: Rising Pharmaceuticals, Inc.,   Saddle Brook, NJ 07663 USA Manufactured by: Murty Pharmaceuticals, Inc.,  Lexington, KY 40509 USA Repackaged and Relabeled by: Proficient Rx LP  Thousand Oaks, CA 91320 Revised: December 2019  P112-03

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIPYRIDAMOLE- DIPYRIDAMOLE TABLET, FILM COATED
PROFICIENT RX LP
----------
DIPYRIDAMOLE TABLETS
DIPYRIDAMOLE TABLETS, USP
25 MG, 50 MG, AND 75 MG TABLETS
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 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,
hydroxypropyl
methylcellulose, lactose monohydrate, magnesium stearate, polyethylene
glycol,
povidone, 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
pos