Dipyridamole capsules are indicated for:

▪ Secondary prevention of ischemic stroke and transient ischemic attacks, either as monotherapy or in combination with aspirin.
▪ Use as an adjunct to oral anticoagulant therapy for the prevention of thromboembolism in patients with prosthetic heart valves.

Dipyridamole is believed to inhibit the enzymes adenosine deaminase and phosphodiesterase, thereby preventing the breakdown of cAMP, a regulator of platelet activity. Increased cAMP levels suppress the release of arachidonic acid from membrane phospholipids and decrease thromboxane A2 production. Additionally, Dipyridamole promotes the release of prostacyclin, which activates adenylate cyclase and further elevates intraplatelet cAMP levels, ultimately leading to inhibition of platelet aggregation.

Adults including the elderly: The recommended dose is 200 mg capsule twice daily, usually one in the morning and one in the evening preferably with meals. The capsules should be swallowed whole without chewing.

Children: Dipyridamole 200 mg capsule is not recommended for children.

Dipyridamole enhances plasma levels and cardiovascular effects of adenosine; therefore, adenosine dose should be reduced when used concurrently with dipyridamole. Evidence suggests that combining acetylsalicylic acid and dipyridamole results in additive effects. When used together, the incidence of bleeding complications is not higher than with acetylsalicylic acid alone. Additional administration of dipyridamole with acetylsalicylic acid does not increase bleeding risk. When dipyridamole is administered with warfarin, no increase in the frequency or severity of bleeding has been observed compared to warfarin alone. Dipyridamole may potentiate the hypotensive effects of antihypertensive agents and may counteract the anticholinesterase activity of cholinesterase inhibitors, potentially worsening myasthenia gravis.

Hypersensitivity to any component of the formulation. Warnings and precautions: Due to its vasodilatory properties, dipyridamole should be used cautiously in patients with severe coronary artery disease, including unstable angina and recent myocardial infarction, as well as in those with left ventricular outflow obstruction or hemodynamic instability (e.g., decompensated heart failure). Patients receiving regular doses of dipyridamole for myocardial perfusion imaging should discontinue oral dipyridamole 24 hours before testing. In patients with myasthenia gravis, dosage adjustment may be required. Dipyridamole should be used with caution in patients with coagulation disorders.

Reported adverse effects include: Blood and lymphatic system disorders such as thrombocytopenia. Immune system disorders such as hypersensitivity reactions. Psychiatric and nervous system disorders including headache, dizziness, and cardiac-related disorders such as tachycardia. Vascular disorders such as hypotension and flushing. Gastrointestinal disorders include diarrhea, nausea, vomiting, and abdominal discomfort. Respiratory disorders include bronchospasm. Skin and subcutaneous tissue disorders include rash and urticaria. Musculoskeletal disorders include myalgia. General disorders include fatigue and malaise. Injuries and procedural complications include post-procedural hemorrhage and operative hemorrhage.

Although there is insufficient evidence of safety in human pregnancy, dipyridamole has been used for many years without apparent adverse effects. Animal studies have not demonstrated harm, but caution is advised during pregnancy, especially in the first trimester, unless the expected benefit outweighs the potential risk. Dipyridamole should only be used during lactation when considered essential by the physician.

Dipyridamole should be used cautiously in patients with rapidly worsening angina, subvalvular aortic stenosis, hemodynamic instability related to recent myocardial infarction, or those undergoing myocardial imaging with intravenous dipyridamole. It should also be used carefully in hypotension, unstable angina, and aortic stenosis. Safety and efficacy have not been established in children under 12 years of age.

Experience with dipyridamole overdose is limited. Symptoms may include warmth sensation, flushing, sweating, restlessness, weakness, dizziness, decreased blood pressure, and anginal symptoms.

Antiplatelet agent.

Store below 30°C, protected from light and moisture. Keep out of reach of children.