PERSANTINE

A phosphodiesterase inhibitor that blocks uptake and metabolism of adenosine by erythrocytes and vascular endothelial cells.

Dipyridamole also potentiates the antiaggregating action of prostacyclin. (From AMA Drug Evaluations Annual, 1994, p752).

For as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement and also used in prevention of angina.

Dipyridamole, a non-nitrate coronary vasodilator that also inhibits platelet aggregation, is combined with other anticoagulant drugs, such as warfarin, to prevent thrombosis in patients with valvular or vascular disorders.

Dipyridamole is also used in myocardial perfusion imaging, as an antiplatelet agent, and in combination with aspirin for stroke prophylaxis.

cAMP and cAMP-inhibited cGMP 3',5'-cyclic phosphodiesterase 10A Inhibitor cGMP-specific 3',5'-cyclic phosphodiesterase Inhibitor 3',5'-cyclic-AMP phosphodiesterase 4A Inhibitor + 1 more target.

Dipyridamole is metabolized in the liver to the glucuronic acid conjugate and excreted with the bile.

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Hypotension, if it occurs, is likely to be of short duration, but a vasopressor drug may be used if necessary.

The oral

LD in rats is greater than 6,000 mg/kg while in the dogs, the oral LD is approximately 400 mg/kg.

Hypersensitivity to dipyridamole and any of the other components.

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement The recommended dose is to 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.

USP, 25 mg are light yellow, round, biconvex, film-coated tablets debossed with 'ZE 43' on one side and plain on the other side are supplied as follows: NDC 68382-187-01 in bottle of 100 tablets NDC 68382-187-05 in bottle of 500 tablets NDC 68382-187-10 in bottle of 1000 tablets NDC 68382-187-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Dipyridamole Tablets USP, 50 mg are light yellow, round, biconvex, beveled-edge, film-coated tablets debossed with 'ZE 49' on one side and plain on the other side are supplied as follows: NDC 68382-188-01 in bottle of 100 tablets NDC 68382-188-05 in bottle of 500 tablets NDC 68382-188-10 in bottle of 1000 tablets NDC 68382-188-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Dipyridamole Tablets USP, 75 mg are light yellow, round, biconvex, beveled-edge, film-coated tablets debossed with 'ZE 50' on one side and plain on the other side are supplied as follows: NDC 68382-189-01 in bottle of 100 tablets NDC 68382-189-05 in bottle of 500 tablets NDC 68382-189-10 in bottle of 1000 tablets NDC 68382-189-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets.

Store at 20°C to 25°C (68°F to 77°F) .

Keep out of reach of children.

Dispense in a tight, light-resistant container.

Package insert available at or call 1-877-993-8779.

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 1/2, 2 and 25 times the maximum recommended daily human oral dose, respectively, on a mg/m 2 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, dipyridamole tablets should be used during pregnancy only if clearly needed.

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

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