DIPYRIDAMOLE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)

Available from:

Hikma Pharmaceuticals USA Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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 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. Hypersensitivity to dipyridamole.

Product summary:

Dipyridamole Injection, USP is available in:     10 mL (50 mg/ 10 mL) SINGLE DOSE vial packaged in 5s (NDC 0641-2569-44) 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIPYRIDAMOLE- DIPYRIDAMOLE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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DIPYRIDAMOLE INJECTION, USP
RX ONLY
DESCRIPTION
Dipyridamole is a coronary vasodilator described as 2,6
bis-(diethanolamino)-4,8
dipiperidino-pyrimido-(5,4-d) pyrimidine. The structural formula is:
C
H
N O 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.
CLINICAL PHARMACOLOGY
In a study of 10 patients with angiographically normal or minimally
stenosed (less than
25% luminal diameter narrowing) coronary vessels, Dipyridamole
Injection in a dose of
0.56 mg/kg infused over 4 minutes resulted in an average fivefold
increase in coronary
blood flow velocity compared to resting coronary flow velocity (range
3.8 to 7 times
resting velocity). The mean time to peak flow velocity was 6.5 minutes
from the start of
the 4-minute infusion (range 2.5 to 8.7 minutes). Cardiovascular
responses to the
intravenous administration of Dipyridamole Injection when given to
patients in the supine
position include a mild but significant increase in heart rate of
approximately 20% and
mild but significant decreases in both systolic and diastolic blood
pressure of
approximately 2-8%, with vital signs returning to baseline values in
approximately 30
minutes.
MECHANISM OF ACTION
Dipyridamole is a coronary vasodilator in man. The mechanism of
vasodilation has not
been fully elucidated, but may result from inhibition of uptake of
adenosine, an important
24
40
8
4
mediator of coronary vasodilation. The vasodilatory effects of
dipyridamole are abolished
by administration of the adenosine receptor antagonist theophylline.
How dipyridamole-induced vasodilation leads to abnormalities in
thallium distribution and
ventricular function is also uncertain but presumably