Generic Name: Dipyridamole
Class: Vasodilating Agents, Miscellaneous
VA Class: BL117
CAS Number: 58-32-2
Introduction
A non-nitrate coronary vasodilator and platelet aggregation inhibitor.100 170 171 172
Uses for Persantine
Thromboembolism Associated with Prosthetic Heart Valves
Used as an adjunct to coumarin anticoagulants for the prevention of postoperative thromboembolic complications of heart valve replacement.100 101 102 103 104 105 106 107 108 156 Data are insufficient to recommend the use of dipyridamole over the combination of low-dose aspirin and warfarin in such patients.156
Should not be used alone, without an oral anticoagulant, in patients with mechanical prosthetic heart valves.101 102 105 108 109 140 141 142
Transient Ischemic Attacks and Completed Thrombotic Stroke
Used in extended-release form in fixed combination with aspirin for secondary prevention of stroke in patients who have had TIAs or completed thrombotic stroke.145 146 147 148 149 154 164
The American College of Chest Physicians (ACCP), American Stroke Association (ASA), and AHA consider the fixed combination of aspirin and extended-release dipyridamole an acceptable option for initial antiplatelet therapy for secondary prevention of noncardioembolic ischemic stroke and TIAs.147 149 150 154 164 180 In such patients, ACCP, ASA, and AHA recommend the combination of aspirin and extended-release dipyridamole over therapy with aspirin alone and suggest therapy with clopidogrel alone over aspirin alone.154 164 180
Adjunct to Thallium Myocardial Perfusion Imaging
Used IV as an adjunct to thallous (thallium) chloride Tl 201 myocardial perfusion imaging in patients unable to exercise adequately.157 158 159 165
ACC and AHA recommend myocardial stress perfusion imaging with dipyridamole or adenosine or dobutamine echocardiography before or early after hospital discharge in patients with ST-segment-elevation MI who are not undergoing cardiac catheterization and who are unable to exercise.157
Persantine Dosage and Administration
Administration
Administer orally or IV.100 158
Oral Administration
Administer conventional tablets 4 times daily.100
Administer extended-release dipyridamole and aspirin fixed-combination capsules twice daily in the morning and evening without regard to food.145 Swallow capsules whole without chewing.145
Extended-release dipyridamole in fixed combination with aspirin is not interchangeable with the individual components of aspirin and conventional dipyridamole tablets (e.g., Persantine).145
IV Administration
Dilution
Dilute injection in ≥1:2 ratio with 0.45% sodium chloride injection, 0.9% sodium chloride injection, or 5% dextrose injection to a final volume of approximately 20–50 mL.158
Rate of Administration
Adjunct to thallium myocardial perfusion imaging: 0.142 mg/kg per minute for 4 minutes.158
Administration Risks
Infusion of undiluted injection may cause local irritation.158
Dosage
Adults
Thromboembolism Associated with Prosthetic Heart Valves
Prophylaxis
Oral
Conventional tablets: 75–100 mg 4 times daily; use in conjunction with coumarin anticoagulant therapy.100 101 102 104 105 106 107 108
Transient Ischemic Attacks and Completed Thrombotic Stroke
Secondary Prevention
Oral
Fixed combination with aspirin: 200 mg of extended-release dipyridamole and 25 mg of aspirin (1 capsule) twice daily in the morning and evening.145 154
If headaches become intolerable during initial treatment, reduce dosage to 200 mg of dipyridamole and 25 mg of aspirin (1 capsule) once daily at bedtime; administer low-dose aspirin in the morning.145 Resume the usual regimen (200 mg of extended-release dipyridamole and 25 mg of aspirin twice daily) as soon as possible (usually within 1 week) because no outcome data available with the reduced-dose regimen and headaches diminish during continued treatment.145
Dose of aspirin in fixed-combination product may not be adequate to prevent recurrent MI or angina pectoris in patients with stroke or TIA.145
If an antiplatelet effect is not desired in patients undergoing elective surgery, discontinue therapy with dipyridamole in fixed combination with aspirin 7–10 days prior to elective surgery.175
Adjunct to Thallium Myocardial Perfusion Imaging
IV
Single IV dose of 0.57 mg/kg, infused at a rate of 0.142 mg/kg per minute for 4 minutes.158 165 Maximum tolerated IV dose not determined; clinical experience suggests that a total dose >60 mg is not needed for any patient.158
Inject thallium-201 IV ≤5 minutes following completion of the dipyridamole infusion.158
Prescribing Limits
Adults
Adjunct to Thallium Myocardial Perfusion Imaging
IV
Clinical experience suggests that a total dipyridamole dose >60 mg is not needed for any patient.158
Cautions for Persantine
Contraindications
Known hypersensitivity to dipyridamole or any ingredient in the formulation.100 145 158
Warnings/Precautions
Warnings
Cardiovascular and Cerebrovascular Effects
Serious adverse effects, including acute myocardial ischemia or MI, cardiac death, VF, symptomatic VT, stroke, transient cerebral ischemia, and seizures, reported with IV infusion.158 Asystole, sinus node arrest, sinus node depression, and conduction block reported also reported with IV infusion.158 Patients with abnormalities of cardiac impulse formation or conduction or severe CAD (e.g., unstable angina) may be at increased risk for these events.158
Weigh the important clinical information to be gained by myocardial perfusion thallium imaging with IV dipyridamole against the risk to the patient. 158 Consider the rate of false positive and false negative results of dipyridamole-assisted thallium imaging compared with coronary arteriography when choosing to use such imaging.158
Monitor vital signs during and for 10–15 minutes after IV infusion; obtain an ECG using ≥1 chest lead.158
Appropriate resuscitative measures should be readily available for relieving adverse effects such as severe chest pain.158 If severe chest pain occurs, administer IV aminophylline in doses of 50–250 mg by slow IV injection (e.g., 50–100 mg over 30–60 seconds).158 (See Specific Drugs under Interactions.) Place patients with severe hypotension in a supine position with the head tilted down, if necessary, before administration of IV aminophylline.158 If the highest recommended dosage of aminophylline (250 mg) does not relieve chest pain within a few minutes, may administer sublingual nitroglycerin.158 If chest pain continues despite such combination therapy, consider the possibility of MI.158
If the clinical condition of the patient with an adverse event permits a 1-minute delay, may perform thallium imaging before reversal of the pharmacologic effects occurs.158 165
Sensitivity Reactions
Anaphylactoid reactions and bronchospasm reported with IV dipyridamole.158 Patients with a history of asthma may be at greater risk for bronchospasm.158
Appropriate resuscitative measures should be readily available for relieving adverse effects such as severe bronchospasm.158 165 If severe bronchospasm occurs, administer aminophylline in doses of 50–250 mg by slow IV injection (e.g., 50–100 mg over 30–60 seconds).158 (See Cardiovascular and Cerebrovascular Effects under Cautions.)
General Precautions
Use of Fixed Combinations
When used in fixed combination with aspirin, consider the cautions, precautions, and contraindications associated with aspirin.145
Cardiovascular Effects
Use with caution in patients with hypotension or severe CAD (e.g., unstable angina, recently sustained MI) since peripheral vasodilation may occur.100 145 Dipyridamole may precipitate chest pain in patients with CAD.100 145
Amount of aspirin in the commercially available fixed-combination product may not be adequate to prevent recurrent MI or angina pectoris in patients with stroke or TIA.145
Hepatic Effects
Liver dysfunction (e.g., elevations of hepatic enzymes, hepatic failure) reported.100 145
Specific Populations
Pregnancy
Category B: Conventional tablets and injection.100 158
Category D: Fixed combination with aspirin.145
Lactation
Distributed into milk.100 145 158 Use caution.100 145
Pediatric Use
Conventional tablets: Safety and efficacy not established in pediatric patients <12 years of age.100
Fixed combination with aspirin: Safety and efficacy not established;145 should not be used in pediatric patients because of aspirin component.145
Injection: Safety and efficacy not established.158
Common Adverse Effects
Conventional tablets: Headache,100 dizziness,100 GI intolerance (e.g., abdominal distress),100 vomiting,100 diarrhea,100 flushing,100 rash,100 pruritus.100
Injection: Chest pain/angina pectoris,158 ECG changes (most commonly ST-T changes),158 headache,158 dizziness.158
Interactions for Persantine
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Adenosine | Potentiation of adenosine vasoactive effects100 168 169 Increased plasma adenosine concentrations100 168 169 | Dosage adjustment of adenosine may be necessary100 168 169 |
Anticholinesterase agents | Antagonizes anticholinesterase effects100 158 | Potential to aggravate myasthenia gravis100 158 |
Heparin | Possible increased risk of bleeding complications166 167 | Use with caution and monitor closely166 167 |
Methylxanthines (e.g., aminophylline, caffeine [e.g., coffee], theophylline | Inhibits dipyridamole vasodilatory and bronchospastic effects158 165 | Aminophylline used to terminate persistent adverse effects of dipyridamole158 Caffeine or theophylline may lead to false-negative thallium imaging results;158 some clinicians recommend withholding caffeine (e.g., coffee) for 24 hours prior to testing165 |
Warfarin | Possible increased risk of bleeding, particularly during or after surgery; however, concomitant use does not appear to increase frequency or severity of bleeding compared with use of warfarin alone100 | Some clinicians recommend maintenance of PT in the lower end of the therapeutic rangea |
Persantine Pharmacokinetics
Absorption
Bioavailability
Absorption from GI tract is variable and incomplete;101 134 135 137 138 171 37–66% of an oral dose (extended-release capsules containing dipyridamole in fixed combination with aspirin) may be absorbed.171
Following oral administration of conventional tablets, peak plasma concentrations attained in about 45–150 minutes (mean: 75 minutes).100 134 135 136 138 Peak plasma dipyridamole concentrations attained in about 2 hours (range: 1–6 hours) with twice-daily dosing of extended-release capsules containing dipyridamole in fixed combination with aspirin.145
Onset
Injection: Peak increase in coronary blood flow occurs 6.5 minutes after initiation of infusion.158
Duration
Following IV infusion, vital signs return to baseline in approximately 30 minutes.158 165
Food
Capsules containing extended-release dipyridamole in fixed combination with aspirin: High-fat meal reduces peak plasma dipyridamole concentrations and total absorption at steady state by 20–30% compared with fasting state; not clinically relevant.145
Distribution
Extent
In animals, widely distributed into body tissues; small amounts cross placenta.a
Does not cross the blood-brain barrier in animals.145 171
Distributed into milk.100 158 172
Plasma Protein Binding
91–99%,101 134 138 139 158 158 171 principally to α1-acid glycoprotein (α1-AGP) but also to albumin.158 161 162
Elimination
Metabolism
Metabolized in liver principally to monoglucuronide; small amount metabolized to diglucuronide.100 145 158
Elimination Route
Metabolites eliminated principally in feces via biliary excretion100 145 158 and to a much lesser extent in urine.145
Half-life
Conventional tablets: Biphasic; initial half-life approximately 40–80 minutes and terminal half approximately 10–12 hours.100 101 134 138 175 179
Extended-release capsules containing dipyridamole in fixed combination with aspirin: 13.6 hours.145
IV: Triphasic; mean half-lives of 3–12 minutes, 33–62 minutes, and 11.6–15.5 hours.158
Stability
Storage
Oral
Capsules and Tablets
Conventional tablets: 25°C (may be exposed to 15–30°C).100
Extended-release capsules containing dipyridamole in fixed combination with aspirin: 25°C (may be exposed to 15–30°C); protect from excessive moisture.145
Parenteral
Solution for Injection
20–25°C; avoid freezing and protect from light.158
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Parenteral
Do not mix with other drugs in the same syringe or infusion container.158
ActionsActions
Mechanism of antiplatelet effects not fully elucidated.100 101 134 170
Inhibits the uptake and metabolism of adenosine in platelets, endothelial cells and erythrocytes.100 145 171 Increased local concentrations of adenosine at the platelet surface stimulate platelet adenyl cyclase and increase platelet cyclic-3′,5′-adenosine monophosphate (cAMP) concentrations.100 145 171 Increased platelet cAMP concentrations affect platelet-activating factor, collagen, and adenosine diphosphate and inhibit mobilization of free calcium, which is involved in platelet activation.100 170 171 Also stimulates prostacyclin synthesis and potentiates antiplatelet effects of prostacyclin.171
Inhibits platelet cyclic-3′,5′-guanosine monophosphate phosphodiesterase (cGMP-PDE).100 145 171 n Augments increase in platelet cGMP concentrations produced by nitric oxide;100 145 increased cGMP platelet concentrations inhibit platelet activation and aggregation.171 n
Prolongs platelet survival time in patients with prosthetic heart valves or valvular heart disease in whom platelet survival is shortened.100 a
Mediates coronary vasodilation by inhibiting reuptake and thereby allowing accumulation of adenosine in vascular smooth muscle.158 165 n
Methylxanthine derivatives (e.g., theophylline, aminophylline) block adenosine receptors on vascular smooth muscle and abolish vasodilatory effects of dipyridamole.158 165 (See Specific Drugs under Interactions.)
Increases blood flow in normal coronary arteries while producing reduced blood flow in stenotic arteries (“coronary steal”).158 165 Myocardial oxygen consumption and cardiac work not increased.165
Myocardial uptake of thallous (thallium) chloride Tl 201 is directly proportional to coronary blood flow.159 165 Less thallous chloride Tl 201 uptake159 occurs in myocardium perfused by stenotic versus normal coronary arteries.158 159 160 Enhances the differences in blood flow between areas served by stenotic versus normal arteries during thallium testing.158 159 160 165
With IV administration, decreases BP and increases heart rate and cardiac output because of dilation of systemic resistance vessels.158 170 a With usual oral dosages, generally no change in BP or blood flow in peripheral arteries.170 a
Advice to Patients
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.100 145 158
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.100 145 158
Importance of informing patients of other important precautionary information.100 145 158 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 25 mg* | Dipyridamole Tablets | |
Persantine | Boehringer Ingelheim | |||
50 mg* | Dipyridamole Tablets | |||
Persantine | Boehringer Ingelheim | |||
75 mg* | Dipyridamole Tablets | |||
Persantine | Boehringer Ingelheim | |||
Parenteral | Injection, for IV use | 5 mg/mL* | Dipyridamole Injection |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules, extended-release (containing dipyridamole pellets and 25 mg immediate-release aspirin tablet) | 200 mg with Aspirin 25 mg | Aggrenox | Boehringer Ingelheim |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Aggrenox 25-200MG 12-hr Capsules (BOEHRINGER INGELHEIM): 60/$195.99 or 180/$559.95
Dipyridamole 25MG Tablets (TEVA PHARMACEUTICALS USA): 100/$29.99 or 300/$83.97
Dipyridamole 50MG Tablets (GLENMARK PHARMACEUTICALS): 90/$54.99 or 270/$145.96
Dipyridamole 75MG Tablets (GLENMARK PHARMACEUTICALS): 100/$69.99 or 300/$189.98
Persantine 25MG Tablets (BOEHRINGER INGELHEIM): 100/$85.99 or 300/$235.98
Persantine 50MG Tablets (BOEHRINGER INGELHEIM): 100/$139.99 or 300/$399.95
Persantine 75MG Tablets (BOEHRINGER INGELHEIM): 100/$169.99 or 300/$487.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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