Aspirin And Extended - Release Dipyridamole - Aspirin And Extended - Release Dipyridamole capsule prescribing information
Aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.
In the event of intolerable headaches during initial treatment, switch to one capsule at bedtime and low-dose aspirin in the morning. Because there are no outcome data with this regimen and headaches become less of a problem as treatment continues, patients should return to the usual regimen as soon as possible, usually within one week.
25 mg/200 mg capsules with a red opaque cap and a yellow opaque body, filled with light yellow to yellow extended-release dipyridamole pellets and a white to off-white, round, film-coated, biconvex, unscored, plain aspirin tablet. The capsule is imprinted axially with “AN” in yellow ink on the cap and “596” in red ink on the body.
Aspirin and extended-release dipyridamole has not been studied in patients with hepatic or renal impairment. Avoid using aspirin containing products, such as aspirin and extended-release dipyridamole in patients with severe hepatic or severe renal (glomerular filtration rate < 10 mL/min) dysfunction
[see
5.2 Renal Failure
Avoid aspirin in patients with severe renal failure (glomerular filtration rate less than 10 mL/minute)
[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]
.
5.3 Hepatic Insufficiency
Elevations of hepatic enzymes and hepatic failure have been reported in association with dipyridamole administration
[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]
.
and
Clinical Pharmacology (12.3)]
.
Do not use aspirin, USP in children or teenagers with viral infections because of the risk of Reye syndrome.
Aspirin and extended-release dipyridamole capsules are not interchangeable with the individual components of aspirin and dipyridamole tablets.
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