ASPIRIN AND DIPYRIDAMOLE

There are no significant interactions between aspirin and dipyridamole. The kinetics of the components are unchanged by their co-administration as aspirin and extended-release dipyridamole capsules.

AbsorptionDipyridamole Peak plasma levels of dipyridamole are achieved 2 hours (range 1 to 6 hours) after administration of a daily dose of 400 mg aspirin and extended-release dipyridamole capsules (given as 200 mg BID). The peak plasma concentration at steady-state is 1.98 mcg/mL (1.01 to 3.99 mcg/...

ESPS2 (European Stroke Prevention Study-2) was a double-blind, placebo-controlled, 24-month study in which 6602 patients over the age of 18 years had an ischemic stroke (76%) or transient ischemic attack (TIA, 24%) within three months prior to entry. Patients were enrolled in 13 European countries between February 1989 and May 1995 and were randomized to one of four treatment groups: Aspirin/extended-release dipyridamole 25 mg/200 mg; extended-release dipyridamole (ER-DP) 200 mg alone; aspirin (ASA) 25 mg alone; or placebo. The mean age in this population was 66.7 years with 58% of them being ...

The following adverse reactions are discussed elsewhere in the labeling:

• Hypersensitivity [see Contraindications ( 4.1 )]
• Allergy [see Contraindications ( 4.2 )]
• Risk of Bleeding [see Warnings and Precautions ( 5.1 )]
• The most frequently reported adverse reactions (>10% and greater than placebo) were headache, dyspepsia, abdominal pain, nausea, and diarrhea ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact NorthStar RxLLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwa...

• Hypersensitivity to any product ingredients ( 4.1 )
• Patients with known allergy to NSAIDs ( 4.2 )
• Patients with the syndrome of asthma, rhinitis, and nasal polyps ( 4.2 ) 4.1 Hypersensitivity Aspirin and extended-release dipyridamole capsules are contraindicated in patients with known hypersensitivity to any of the product components. 4.2 Allergy Aspirin is contraindicated in patients with k...

• Aspirin and extended-release dipyridamole capsules increases the risk of bleeding ( 5.1 )
• Avoid use in patients with severe hepatic or renal insufficiency ( 5.2 , 5.3 )
• Interrupt aspirin and extended-release dipyridamole capsules 48 hours before using intravenous dipyridamole or other adenosinergic agents for stress testing ( 5.6 , 7.1 ) 5.1 Risk of Bleeding Aspirin and extended-release dipyridamole capsules increases the risk of bleeding. Risk factors for bleeding include the use of other...

7 DRUG INTERACTIONS

• Co-administration with anticoagulants, antiplatelets, or NSAIDs can increase risk of bleeding ( 7.1 )
• Decreased renal function can occur with co-administration with NSAIDs ( 7.1 ) 7.1 Drug Interaction Study Information Obtained From Literature Adenosinergic agents (e.g. adenosine, regadenoson) Dipyridamole has been reported to increase the plasma levels and cardiovascular e...