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Dipyridamole Injection

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Dipyridamole Injection

INDICATIONS

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 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 was almost identical.

DOSAGE AND ADMINISTRATION

The dose of 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/minute (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 0.45% sodium chloride injection, 0.9% sodium chloride injection, or 5% dextrose injection for a total volume of approximately 20 to 50 mL. Infusion of undiluted dipyridamole injection 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, when-ever solution and container permit.

HOW SUPPLIED

Dipyridamole Injection USP for intravenous injection is available as follows:

Each 2 mL vial contains 10 mg of dipyridamole,

NDC 55390-555-10; box of 10 vials.

Each 10 mL vial contains 50 mg of dipyridamole,

NDC 55390-555-90; box of 10 vials.

Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature.

Avoid freezing.

Protect from light. Retain in carton until time of use. Discard unused portion.

Manufactured by: Ben Venue Laboratories, Inc. Bedford, Ohio 44146. Manufactured for: Bedford Laboratories™ Bedford, Ohio 44146. December 2007.

Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.

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