Dipyridamole (injection): Difference between revisions
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|fdaLIADAdult====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. | |||
===Dosage=== | |||
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. | |||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Dipyridamole (injection) in adult patients. | |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Dipyridamole (injection) in adult patients. | ||
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Dipyridamole (injection) in adult patients. | |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Dipyridamole (injection) in adult patients. | ||
|fdaLIADPed=Safety and effectiveness in pediatric patients have not been established. | |||
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Dipyridamole (injection) in pediatric patients. | |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Dipyridamole (injection) in pediatric patients. | ||
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Dipyridamole (injection) in pediatric patients. | |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Dipyridamole (injection) in pediatric patients. | ||
|contraindications=Hypersensitivity to dipyridamole. | |||
|warnings=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. | |||
|clinicalTrials=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 WARNINGS). | |||
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: | |||
|drugInteractions=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 CLINICAL PHARMACOLOGY, Mechanism of Action). | |||
Myasthenia gravis patients receiving therapy with cholinesterase inhibitors may experience worsening of their disease in the presence of dipyridamole. | |||
|FDAPregCat=B | |||
|useInPregnancyFDA=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. | |||
|useInNursing=Dipyridamole is excreted in human milk. | |||
|nonClinToxic=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. | |||
|alcohol=Alcohol-Dipyridamole (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |alcohol=Alcohol-Dipyridamole (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | ||
}} | }} | ||
Revision as of 17:00, 4 May 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]
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Overview
Dipyridamole (injection) is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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.
Dosage
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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Dipyridamole (injection) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Dipyridamole (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness in pediatric patients have not been established.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Dipyridamole (injection) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Dipyridamole (injection) in pediatric patients.
Contraindications
Hypersensitivity to dipyridamole.
Warnings
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 Reactions
Clinical Trials Experience
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 WARNINGS).
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:
Postmarketing Experience
There is limited information regarding Dipyridamole (injection) Postmarketing Experience in the drug label.
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 CLINICAL PHARMACOLOGY, Mechanism of Action).
Myasthenia gravis patients receiving therapy with cholinesterase inhibitors may experience worsening of their disease in the presence of dipyridamole.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): 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.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dipyridamole (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Dipyridamole (injection) during labor and delivery.
Nursing Mothers
Dipyridamole is excreted in human milk.
Pediatric Use
There is no FDA guidance on the use of Dipyridamole (injection) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Dipyridamole (injection) in geriatric settings.
Gender
There is no FDA guidance on the use of Dipyridamole (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Dipyridamole (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Dipyridamole (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Dipyridamole (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Dipyridamole (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Dipyridamole (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Dipyridamole (injection) Administration in the drug label.
Monitoring
There is limited information regarding Dipyridamole (injection) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Dipyridamole (injection) and IV administrations.
Overdosage
There is limited information regarding Dipyridamole (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Dipyridamole (injection) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Dipyridamole (injection) Mechanism of Action in the drug label.
Structure
There is limited information regarding Dipyridamole (injection) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Dipyridamole (injection) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Dipyridamole (injection) Pharmacokinetics in the drug label.
Nonclinical Toxicology
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.
Clinical Studies
There is limited information regarding Dipyridamole (injection) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Dipyridamole (injection) How Supplied in the drug label.
Storage
There is limited information regarding Dipyridamole (injection) Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Dipyridamole (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Dipyridamole (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Dipyridamole (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Dipyridamole (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Dipyridamole (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Dipyridamole (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.