dipyridamole- Dipyridamole injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Dipyridamole (UNII: 64ALC7F90C) (Dipyridamole - UNII:64ALC7F90C)

Available from:

HOSPIRA, INC.

INN (International Name):

Dipyridamole

Pharmaceutical form:

INJECTION, SOLUTION

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 was almost identical. Hypersensitivity to dipyridamole.

Product summary:

Dipyridamole Injection, is available in 2 mL and 10 mL ampules: 10 mg/2 mL (5 mg per mL) Box of 10 (List 2043). 50 mg/10 mL (5 mg per mL) Box of 10 (List 2043). Store between 15°C (59°F) − 25°C (77°F). Protect from direct light. Retain in carton until time of use. Avoid freezing. ©Hospira 2004 EN-0451 Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Summary of Product characteristics

DIPYRIDAMOLE- DIPYRIDAMOLE INJECTION, SOLUTION
HOSPIRA, INC.
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DIPYRIDAMOLE
INJECTION
FOR INTRAVENOUS INJECTION
R ONLY
DESCRIPTION
Dipyridamole is a coronary vasodilator described as 2,6
bis-(diethanolamino)-4,8-dipiperidino-
pyrimido-(5,4-d) pyrimidine. It has the molecular formula C
H N O and the following structural
formula:
M. W. 504.64
Dipyridamole injection is an odorless, pale yellow liquid which can be
diluted in sodium chloride
injection or dextrose injection for intravenous administration.
Each mL of sterile solution for intravenous administration contains 5
mg dipyridamole, with 2 mg
tartaric acid, and 50 mg polyethylene glycol 600. pH is adjusted to
2.2 to 3.2 with hydrochloric acid.
CLINICAL PHARMACOLOGY
In a study of 10 patients with angiographically normal or minimally
stenosed (less than 25% luminal
diameter narrowing) coronary vessels, dipyridamole 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 intra venous administration of dipyridamole 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 to 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
mediator of coronary vasodilation. The vasodilatory effects of
dipyridamole are abolished by
administration of the adenosine receptor antagonist theophylline.
X
24
40
8
4
How dipyridamole-induced vasodilation leads to abnormalities in
thallium distribution and