Dipyridamole

Pregnancy Category: B

Lactation: enters breast milk; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Dipyridamole is a prescription medication used to reduce the risk of blood clots after heart valve replacement.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with dipyridamole. See "Dipyridamole Precautions" section.

Common side effects of dipyridamole include:

• Dizziness
• Rash
• Headache
• Stomach upset

This is not a complete list of dipyridamole side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Do not use this medication if you are allergic to dipyridamole.

If you have any of these other conditions, you may not be able to use dipyridamole, or you may need a dose adjustment or special tests to safely take this medication:

• liver disease;
• low blood pressure;
• severe coronary artery disease (also called atherosclerosis);
• uncontrolled chest pain (angina); or
• if you have recently had a heart attack.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Dipyridamole can pass into breast milk and may harm a nursing infant. Do not take this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 12 years old without the advice of a doctor.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Dipyridamole is often taken together with other medications to prevent blood clots. To best treat your condition, use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

While using dipyridamole, you may need frequent blood tests.

Store at room temperature away from moisture and heat.

Other drugs may interact with dipyridamole, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement

The recommended dose is 75 to 100 mg four times daily as an adjunct to the usual warfarin therapy. Please note that aspirin is not to be administered concomitantly with coumarin anticoagulants.

Dipyridamole Tablets USP, 25 mg are available as white, round, film-coated, unscored, biconvex tablets, debossed with “252” on one side and “stylized b” on the other side, available in bottles of 100 (NDC 0555-0252-02) tablets.

Dipyridamole Tablets USP, 50 mg are available as white, round, film-coated, unscored, biconvex tablets, debossed with “285” on one side and “stylized b” on the other side, available in bottles of 100 (NDC 0555-0285-02) tablets.

Dipyridamole Tablets USP, 75 mg are white, round, film-coated, unscored, biconvex tablet. Debossed with “286” on one side and “BARR” on the other side, available in bottles of 100 (NDC 0555-0286-02) tablets.

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. A 5/2016

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Stroke (prevention, in combination with aspirin)

A meta-analysis of clinical trials conducted using both immediate and extended release formulations of dipyridamole (in combination with immediate release aspirin) demonstrated that the combination of dipyridamole and aspirin is more effective than aspirin alone in preventing recurrent cerebral and systemic vascular events in patients with previous noncardioembolic ischemic stroke or TIA [Verro 2008].

Based on the American College of Chest Physicians Evidence-Based Clinical Practice Guidelines on Antithrombotic Therapy and Prevention of Thrombosis 9th ed, aspirin/extended-release dipyridamole (eg, Aggrenox) is effective and recommended for the secondary prevention of stroke in patients with a history of noncardioembolic ischemic stroke or TIA.

Applies to dipyridamole: compounding powder, intravenous solution, oral tablet

General

Generally, oral administration of dipyridamole has been well tolerated. Adverse effects during intravenous (IV) administration have occurred in 40% to 55% of patients. The majority of dipyridamole-induced adverse effects resulting from IV administration can be reversed by intravenous aminophylline.[Ref]

Cardiovascular

Cardiovascular symptoms have been the most frequently reported adverse effects associated with dipyridamole, particularly when given intravenously. Ischemia and angina have been reported following oral administration. Intravenous administration has been associated with chest pain (20% to 25%), ST segment depression (8% to 20%), facial flushing (2%), and severe ischemia (2.5%). Atrial and ventricular premature beats, ventricular tachycardia, ventricular fibrillation, bradycardia, asystole, sinus arrest, and myocardial infarction have also been reported. Hypotension may occur, with an average decrease in mean arterial pressure of 5% to 10%.[Ref]

Chest pain, ischemia, and myocardial infarction associated with dipyridamole may be due to a phenomenon known as coronary "steal". Coronary steal involves shunting of blood flow away from an ischemic area where diseased vessels are already maximally dilated, to non-diseased areas when dipyridamole administration has resulted in vasodilation. Myocardial infarction has been reported in patients with unstable angina.

Aminophylline, an adenosine-receptor antagonist, may be used to reverse some of the effects of dipyridamole, including chest pain and bronchospasm. Intravenous aminophylline should be available during myocardial imaging.[Ref]

Nervous system

Nervous system effects have occurred following intravenous and oral administration of dipyridamole and included headache (12.2%), lightheadedness or dizziness (11.8%), and paresthesias (1.3%). Cerebrovascular accident following intravenous administration also has been reported.[Ref]

Respiratory

In one case report, a patient with asthma developed sudden bronchospasm with wheezing, coughing, and dyspnea immediately after receiving IV dipyridamole during thallium stress testing. Symptoms and hypoxemia resolved within 5 minutes after administration of IV aminophylline.[Ref]

Respiratory tract adverse effects may occur, especially in patients with pre-existing asthma or chronic obstructive pulmonary disease. Dyspnea, bronchospasm, and respiratory arrest have been reported.[Ref]

Gastrointestinal

Gastrointestinal disturbances associated with dipyridamole therapy have included nausea and vomiting in up to 5% of patients. Gallstones containing dipyridamole have been reported in patients on long-term dipyridamole therapy.[Ref]

Hematologic

Hematologic abnormalities have included rare bleeding complications due to the platelet inhibitory effects of dipyridamole.[Ref]

Renal

In one small study, dipyridamole induced a marked but reversible reduction in glomerular filtration rate in patients with elevated renin-angiotensin activity and ascites due to cirrhosis. Sodium and free water excretion were reduced as well.[Ref]

Hypersensitivity

Hypersensitivity reactions have been reported rarely and included angioedema and anaphylaxis.[Ref]

Some side effects of dipyridamole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Thromboembolic prophylaxis: 75 to 100 mg orally 3 to 4 times a day. Given as an adjunct to warfarin. Aspirin 80 to 100 mg may be given instead of dipyridamole.