Drug Catalog - Product Detail
DIPYRIDAMOLE FOR INJECTION INJECT. 5MG/ML 5X10ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00641-2569-44 | HIKMA | 10 | 5MG/ML | SOLUTION |
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Description
Dipyridamole is a coronary vasodilator described as 2,6 bis-(diethanolamino)-4,8 dipiperidino-pyrimido-(5,4-d) pyrimidine. The structural formula is: C24H40N8O4 MW 504.63 Dipyridamole Injection, USP is a sterile, odorless, pale yellow liquid which can be diluted in sodium chloride injection or dextrose injection for intravenous administration. Each mL contains 5 mg dipyridamole, USP, 50 mg polyethylene glycol 600 and 2 mg tartaric acid in Water for Injection, USP. pH 2.2-3.2; hydrochloric acid added for pH adjustment. Formula1.jpg
How Supplied
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. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised December 2019 462-341-03
Indications & Usage
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
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.