DIPYRIDAMOLE tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Oxford Pharmaceuticals, LLC

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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.

Produkto santrauka:

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

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DIPYRIDAMOLE- DIPYRIDAMOLE TABLET, FILM COATED
OXFORD PHARMACEUTICALS, LLC
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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