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Dipyridamole 50 Mg Tabs 100 By Rising Pharma.

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Dipyridamole 50 Mg Tabs 100 By Rising Pharma.

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Dipyridamole 50 Mg Tabs 100 By Rising Pharma. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD3946621/RXB10005718/RXa134312/RXA311565
Size : 100
Selling UoM : EA
NDC: 64980-0134-01
UPC Barcode : 364980013406
Supplier: 0050000253 RISING PHARM INC
Supplier Material : 013401
Generic Code : 041699 DIPYRIDAMOLE ORAL TABLET 50 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic R

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Product Description.:

SL, 82
tablet , film-coated , white , round round

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.

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.

INDICATIONS

Persantine (dipyridamole USP) tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.
DOSAGE AND ADMINISTRATION

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement. The recommended dose is 75-100 mg four times daily as an adjunct to the usual warfarin therapy. Please note that aspirin is not to be administered concomitantly with coumarin anticoagulants.

SIDE EFFECTS

Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of Persantine (dipyridamole USP) tablets initial side effects usually disappear.

PRECAUTIONS
General

Coronary Artery Disease: Dipyridamole has a vasodilatory effect and should be used with caution in patients with severe coronary artery disease (e.g., unstable angina or recently sustained myocardial infarction). Chest pain may be aggravated in patients with underlying coronary artery disease who are receiving dipyridamole.

Hepatic Insufficiency: Elevations of hepatic enzymes and hepatic failure have been reported in association with dipyridamole administration.

Hypotension: Dipyridamole should be used with caution in patients with hypotension since it can produce peripheral vasodilation.
Laboratory Tests

Dipyridamole has been associated with elevated hepatic enzymes.
Carcinogenesis, Mutagenesis, Impairment of Fertility

In studies in which dipyridamole was administered in the feed to mice (up to 111 weeks in males and females) and rats (up to 128 weeks in males and up to 142 weeks in females), there was no evidence of drug-related carcinogenesis. The highest dose administered in these studies (75 mg/kg/day) was, on a mg/m2 basis, about equivalent to the maximum recommended daily human oral dose (MRHD) in mice and about twice the MRHD in rats. Mutagenicity tests of dipyridamole with bacterial and mammalian cell systems were negative. There was no evidence of impaired fertility when dipyridamole was administered to male and female rats at oral doses up to 500 mg/kg/day (about 12 times the MRHD on a mg/m2 basis). A significant reduction in number of corpora lutea with consequent reduction in implantations and live fetuses was, however, observed at 1250 mg/kg (more than 30 times the MRHD on a mg/m2 basis).
Pregnancy

Teratogenic Effects: PREGNANCY CATEGORY B

Reproduction studies have been performed in mice, rabbits and rats at oral dipyridamole doses of up to 125 mg/kg, 40 mg/kg and 1000 mg/kg, respectively (about 1 ?, 2 and 25 times the maximum recommended daily human oral dose, respectively, on a mg/m2 basis) and have revealed no evidence of harm to the fetus due to dipyridamole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Persantine should be used during pregnancy only if clearly needed.
Nursing Mothers

As dipyridamole is excreted in human milk, caution should be exercised when Persantine tablets are administered to a nursing woman.
Pediatric Use

Safety and effectiveness in the pediatric population below the age of 12 years have not been established.