Dipyridamole

FDA label, Hikma Pharmaceuticals USA Inc., intravenous, effective 2026-05-20. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Platelet Aggregation Inhibitor

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

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Basis

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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. Infusion of undiluted dipyridamole may cause local irritation. Thallium-201 should be injected within 5 minutes following the 4-minute infusion of dipyridamole.

Do not mix Dipyridamole Injection with other drugs in the same syringe or infusion container. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Shaking the vial should redissolve any crystals that may have formed during storage.

Drug interactions

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Label text (1 paragraph)

Drug Interactions Oral maintenance theophylline and other xanthine derivatives such as caffeine may abolish the coronary vasodilatation induced by intravenous Dipyridamole Injection administration. This could lead to a false negative thallium imaging result (see CLINICAL PHARMACOLOGY – Mechanism of Action ). Myasthenia gravis patients receiving therapy with cholinesterase inhibitors may experience worsening of their disease in the presence of dipyridamole.

Contraindications

Hypersensitivity to dipyridamole or any of the other components of the drug.

Pregnancy and lactation

Pregnancy

Pregnancy Teratogenic Effects 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 1½, 2 and 25 times the maximum recommended daily human oral dose, respectively, on a mg/m2 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 injection should be used during pregnancy only if clearly needed.

Lactation

Nursing Mothers As dipyridamole is excreted in human milk, caution should be exercised when dipyridamole injection is administered to a nursing woman.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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