Dipyridamole

Indications

Indications and Usage Dipyridamole Injection is indicated as an alternative to exercise in thallium myocardial perfusion imaging for the evaluation of coronary artery disease in patients who cannot exercise adequately. In a study of about 1100 patients who underwent coronary arteriography and Dipyridamole Injection assisted thallium imaging, the results of both tests were interpreted blindly and the sensitivity and specificity of the dipyridamole thallium study in predicting the angiographic outcome were calculated. The sensitivity of the dipyridamole test (true positive dipyridamole divided by the total number of patients with positive angiography) was about 85%. The specificity (true negative divided by the number of patients with negative angiograms) was about 50%. In a subset of patients who had exercise thallium imaging as well as dipyridamole thallium imaging, sensitivity and specificity of the two tests were almost identical.

Dosage and administration (summary)

Dosage and Administration The dose of intravenous Dipyridamole Injection as an adjunct to thallium myocardial perfusion imaging should be adjusted according to the weight of the patient. The recommended dose is 0.142 mg/kg/min (0.57 mg/kg total) infused over 4 minutes. Although the maximum tolerated dose has not been determined, clinical experience suggests that a total dose beyond 60 mg is not needed for any patient. Prior to intravenous administration, Dipyridamole Injection should be diluted in at least a 1:2 ratio with sodium chloride injection 0.45%, sodium chloride injection 0.9% or dextrose injection 5% for a total volume of approximately 20 to 50 mL.

Contraindications

Contraindications Hypersensitivity to dipyridamole.

Warnings and precautions

Warnings Serious adverse reactions associated with the administration of intravenous Dipyridamole Injection have included cardiac death, fatal and non-fatal myocardial infarction, ventricular fibrillation, symptomatic ventricular tachycardia, stroke, transient cerebral ischemia, seizures, anaphylactoid reaction and bronchospasm. There have been reported cases of asystole, sinus node arrest, sinus node depression and conduction block. Patients with abnormalities of cardiac impulse formation/conduction or severe coronary artery disease may be at increased risk for these events.

Storage and supply

How Supplied Dipyridamole Injection, USP is available in: 10 mL (50 mg/10 mL) SINGLE DOSE vial packaged in 5s (NDC 0641-2569-44) Storage PROTECT FROM LIGHT: Keep covered in carton until time of use. Store between 15° to 25°C (59° to 77°F). Avoid freezing. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc.

Source: Dipyridamole (Dipyridamole) — US FDA prescribing information, 2025-10-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.