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Dipyridamole
Overview
What is Dipyridamole?
Dipyridamole is a coronary vasodilator described as 2,6 bis-(diethanolamino)-4,8-dipiperidino-pyrimido-(5,4-d)
pyrimidine. It has the molecular formula CHNO 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.
What does Dipyridamole look like?
What are the available doses of Dipyridamole?
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What should I talk to my health care provider before I take Dipyridamole?
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How should I use Dipyridamole?
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.
The dose of intravenous dipyridamole 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
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.
What interacts with Dipyridamole?
Hypersensitivity to dipyridamole.
What are the warnings of Dipyridamole?
The most serious
risks associated with ketorolac tromethamine are:
Serious adverse reactions associated with the administration
of intravenous dipyridamole have included cardiac death, fatal and non-fatal
myocardial infarction, ventricular fibrillation, symptomatic ventricular tachycardia,
stroke, transient cerebral ischemia, seizures, anaphylactoid reaction and
bronchospasm. There have been reported cases of asystole, sinus node arrest,
sinus node depression and conduction block. Patients with abnormalities of
cardiac impulse formation/conduction or severe coronary artery disease may
be at increased risk for these events.
In a study of
3911 patients given intravenous dipyridamole as an adjunct to thallium myocardial
perfusion imaging, two types of serious adverse events were reported: 1) four
cases of myocardial infarction (0.1%), two fatal (0.05%); and two non-fatal
(0.05%); and 2) six cases of severe bronchospasm (0.2%). Although the incidence
of these serious adverse events was small (0.3%, 10 of 3911), the potential
clinical information to be gained through use of intravenous dipyridamole
thallium imaging (see INDICATIONS AND USAGE noting the rate of false positive
and false negative results) must be weighed against the risk to the patient.
Patients with a history of unstable angina may be at a greater risk for severe
myocardial ischemia. Patients with a history of asthma may be at a greater
risk for bronchospasm during dipyridamole use.
When
thallium myocardial perfusion imaging is performed with intravenous dipyridamole,
parenteral aminophylline should be readily available for relieving adverse
events such as bronchospasm or chest pain. Vital signs should be monitored
during, and for 10 to 15 minutes following, the intravenous infusion of dipyridamole
and an electrocardiographic tracing should be obtained using at least one
chest lead. Should severe chest pain or bronchospasm occur, parenteral aminophylline
may be administered by slow intravenous injection (50 to 100 mg over 30 to
60 seconds) in doses ranging from 50 to 250 mg. In the case of severe
hypotension, the patient should be placed in a supine position with the head
tilted down if necessary, before administration of parenteral aminophylline.
If 250 mg of aminophylline does not relieve chest pain symptoms within a few
minutes, sublingual nitroglycerin may be administered. If chest pain continues
despite use of aminophylline and nitroglycerin, the possibility of myocardial
infarction should be considered. If the clinical condition of a patient with
an adverse event permits a one minute delay in the administration of parenteral
aminophylline, thallium-201 may be injected and allowed to circulate for one
minute before the injection of aminophylline. This will allow initial thallium
perfusion imaging to be performed before reversal of the pharmacologic effects
of dipyridamole on the coronary circulation.
What are the precautions of Dipyridamole?
See WARNINGS
Drug Interactions:
Oral maintenance theophylline and other xanthine derivatives
such as caffeine may abolish the coronary vasodilatation induced by intravenous
dipyridamole administration. This could lead to a false negative thallium
imaging result (see ).
Myasthenia gravis patients receiving
therapy with cholinesterase inhibitors may experience worsening of their disease
in the presence of dipyridamole.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
In studies in which dipyridamole was administered in the
feed at doses of up to 75 mg/kg/day (9.4 times* the maximum recommended daily
human oral dose) in mice (up to 128 weeks in males and up to 142 weeks in
females) and rats (up to 111 weeks in males and females), there was no evidence
of drug related carcinogenesis. Mutagenicity tests of dipyridamole with bacterial
and mammalian cell systems were negative. There was no evidence of impaired
fertility when dipyridamole was administered to male and female rats at oral
doses up to 500 mg/kg/day (63 times* the maximum recommended daily human oral
dose). A significant reduction in number of corpora lutea with consequent
reduction in implantations and live fetuses was, however, observed at 1250
mg/kg/day.
*Calculation based on assumed body weight
of 50 kg.
Pregnancy Category B:
Reproduction studies performed in mice and rats at daily
oral doses of up to 125 mg/kg (15.6 times* the maximum recommended daily human
oral dose) and in rabbits at daily oral doses of up to 20 mg/kg (2.5 times*
the maximum recommended daily human oral dose) have revealed no evidence of
impaired embryonic development 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 responses, this drug should be
used during pregnancy only if clearly needed.
*Calculation
based on assumed body weight of 50 kg.
Nursing Mothers:
Dipyridamole is excreted in human milk.
Pediatric Use:
Safety and effectiveness in pediatric patients have not been
established.
What are the side effects of Dipyridamole?
Adverse reaction information concerning intravenous dipyridamole
is derived from a study of 3911 patients in which intravenous dipyridamole
was used as an adjunct to thallium myocardial perfusion imaging and from spontaneous
reports of adverse reactions and the published literature.
Serious
adverse events (cardiac death, fatal and non-fatal myocardial infarction,
ventricular fibrillation, asystole, sinus node arrest, symptomatic ventricular
tachycardia, stroke, transient cerebral ischemia, seizures, anaphylactoid
reaction and bronchospasm) are described above (see ).
In the study of 3911 patients, the most
frequent adverse reactions were: chest pain/angina pectoris (19.7%), electrocardiographic
changes (most commonly ST-T changes) (15.9%), headache (12.2%), and dizziness
(11.8%).
Adverse reactions occurring in greater than
1% of the patients in the study are shown in the following table:
Less common adverse reactions occurring in 1% or less
of the patients within the study included:
Cardiovascular System:
Central
and Peripheral Nervous System:
Gastrointestinal System:
Respiratory System:
Other:
| Incidence (%) of Drug-Related | |||
| Adverse Events | |||
| Chest pain/angina pectoris | 19.7 | ||
| Headache | 12.2 | ||
| Dizziness | 11.8 | ||
| Electrocardiographic Abnormalities/ST-T changes | 7.5 | ||
| Electrocardiographic Abnormalities/Extrasystoles | 5.2 | ||
| Hypotension | 4.6 | ||
| Nausea | 4.6 | ||
| Flushing | 3.4 | ||
| Electrocardiographic Abnormalities/Tachycardia | 3.2 | ||
| Dyspnea | 2.6 | ||
| Pain Unspecified | 2.6 | ||
| Blood Pressure Lability | 1.6 | ||
| Hypertension | 1.5 | ||
| Paresthesia | 1.3 | ||
| Fatigue | 1.2 |
What should I look out for while using Dipyridamole?
Hypersensitivity to dipyridamole.
Serious adverse reactions associated with the administration
of intravenous dipyridamole have included cardiac death, fatal and non-fatal
myocardial infarction, ventricular fibrillation, symptomatic ventricular tachycardia,
stroke, transient cerebral ischemia, seizures, anaphylactoid reaction and
bronchospasm. There have been reported cases of asystole, sinus node arrest,
sinus node depression and conduction block. Patients with abnormalities of
cardiac impulse formation/conduction or severe coronary artery disease may
be at increased risk for these events.
In a study of
3911 patients given intravenous dipyridamole as an adjunct to thallium myocardial
perfusion imaging, two types of serious adverse events were reported: 1) four
cases of myocardial infarction (0.1%), two fatal (0.05%); and two non-fatal
(0.05%); and 2) six cases of severe bronchospasm (0.2%). Although the incidence
of these serious adverse events was small (0.3%, 10 of 3911), the potential
clinical information to be gained through use of intravenous dipyridamole
thallium imaging (see INDICATIONS AND USAGE noting the rate of false positive
and false negative results) must be weighed against the risk to the patient.
Patients with a history of unstable angina may be at a greater risk for severe
myocardial ischemia. Patients with a history of asthma may be at a greater
risk for bronchospasm during dipyridamole use.
When
thallium myocardial perfusion imaging is performed with intravenous dipyridamole,
parenteral aminophylline should be readily available for relieving adverse
events such as bronchospasm or chest pain. Vital signs should be monitored
during, and for 10 to 15 minutes following, the intravenous infusion of dipyridamole
and an electrocardiographic tracing should be obtained using at least one
chest lead. Should severe chest pain or bronchospasm occur, parenteral aminophylline
may be administered by slow intravenous injection (50 to 100 mg over 30 to
60 seconds) in doses ranging from 50 to 250 mg. In the case of severe
hypotension, the patient should be placed in a supine position with the head
tilted down if necessary, before administration of parenteral aminophylline.
If 250 mg of aminophylline does not relieve chest pain symptoms within a few
minutes, sublingual nitroglycerin may be administered. If chest pain continues
despite use of aminophylline and nitroglycerin, the possibility of myocardial
infarction should be considered. If the clinical condition of a patient with
an adverse event permits a one minute delay in the administration of parenteral
aminophylline, thallium-201 may be injected and allowed to circulate for one
minute before the injection of aminophylline. This will allow initial thallium
perfusion imaging to be performed before reversal of the pharmacologic effects
of dipyridamole on the coronary circulation.
What might happen if I take too much Dipyridamole?
No cases of overdosage in humans have been reported. It is
unlikely that overdosage will occur because of the nature of use (i.e., single
intravenous administration in controlled settings). See WARNINGS.
How should I store and handle Dipyridamole?
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, INC., LAKE FOREST, IL 60045 USADipyridamole 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, INC., LAKE FOREST, IL 60045 USADipyridamole 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, INC., LAKE FOREST, IL 60045 USADipyridamole 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, INC., LAKE FOREST, IL 60045 USADipyridamole 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, INC., LAKE FOREST, IL 60045 USADipyridamole 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, INC., LAKE FOREST, IL 60045 USADipyridamole 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, INC., LAKE FOREST, IL 60045 USA
Clinical Information
Chemical Structure
No Image foundClinical 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:
How dipyridamole-induced
vasodilation leads to abnormalities in thallium distribution and ventricular
function is also uncertain but presumably represents a “steal”
phenomenon in which relatively intact vessels dilate, and sustain enhanced
flow, leaving reduced pressure and flow across areas of hemodynamically important
coronary vascular constriction.
Pharmacokinetics
and Metabolism:
Non-Clinical Toxicology
Hypersensitivity to dipyridamole.Serious adverse reactions associated with the administration of intravenous dipyridamole have included cardiac death, fatal and non-fatal myocardial infarction, ventricular fibrillation, symptomatic ventricular tachycardia, stroke, transient cerebral ischemia, seizures, anaphylactoid reaction and bronchospasm. There have been reported cases of asystole, sinus node arrest, sinus node depression and conduction block. Patients with abnormalities of cardiac impulse formation/conduction or severe coronary artery disease may be at increased risk for these events.
In a study of 3911 patients given intravenous dipyridamole as an adjunct to thallium myocardial perfusion imaging, two types of serious adverse events were reported: 1) four cases of myocardial infarction (0.1%), two fatal (0.05%); and two non-fatal (0.05%); and 2) six cases of severe bronchospasm (0.2%). Although the incidence of these serious adverse events was small (0.3%, 10 of 3911), the potential clinical information to be gained through use of intravenous dipyridamole thallium imaging (see INDICATIONS AND USAGE noting the rate of false positive and false negative results) must be weighed against the risk to the patient. Patients with a history of unstable angina may be at a greater risk for severe myocardial ischemia. Patients with a history of asthma may be at a greater risk for bronchospasm during dipyridamole use.
When thallium myocardial perfusion imaging is performed with intravenous dipyridamole, parenteral aminophylline should be readily available for relieving adverse events such as bronchospasm or chest pain. Vital signs should be monitored during, and for 10 to 15 minutes following, the intravenous infusion of dipyridamole and an electrocardiographic tracing should be obtained using at least one chest lead. Should severe chest pain or bronchospasm occur, parenteral aminophylline may be administered by slow intravenous injection (50 to 100 mg over 30 to 60 seconds) in doses ranging from 50 to 250 mg. In the case of severe hypotension, the patient should be placed in a supine position with the head tilted down if necessary, before administration of parenteral aminophylline. If 250 mg of aminophylline does not relieve chest pain symptoms within a few minutes, sublingual nitroglycerin may be administered. If chest pain continues despite use of aminophylline and nitroglycerin, the possibility of myocardial infarction should be considered. If the clinical condition of a patient with an adverse event permits a one minute delay in the administration of parenteral aminophylline, thallium-201 may be injected and allowed to circulate for one minute before the injection of aminophylline. This will allow initial thallium perfusion imaging to be performed before reversal of the pharmacologic effects of dipyridamole on the coronary circulation.
Adverse reaction information concerning intravenous dipyridamole is derived from a study of 3911 patients in which intravenous dipyridamole was used as an adjunct to thallium myocardial perfusion imaging and from spontaneous reports of adverse reactions and the published literature.
Serious adverse events (cardiac death, fatal and non-fatal myocardial infarction, ventricular fibrillation, asystole, sinus node arrest, symptomatic ventricular tachycardia, stroke, transient cerebral ischemia, seizures, anaphylactoid reaction and bronchospasm) are described above (see ).
In the study of 3911 patients, the most frequent adverse reactions were: chest pain/angina pectoris (19.7%), electrocardiographic changes (most commonly ST-T changes) (15.9%), headache (12.2%), and dizziness (11.8%).
Adverse reactions occurring in greater than 1% of the patients in the study are shown in the following table:
Less common adverse reactions occurring in 1% or less of the patients within the study included:
Cardiovascular System:
Central and Peripheral Nervous System:
Gastrointestinal System:
Respiratory System:
Other:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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