Indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.

AGGRENOX is not interchangeable with the individual components of aspirin and dipyridamole tablets.

In the event of intolerable headaches during initial treatment, switch to one capsule at bedtime and low dose aspirin in the morning. Because there are no outcome data with this regimen and headaches become less of a problem as treatment continues, patients should return to the usual regimen as soon as possible, usually within one week.

Aspirin is contraindicated in patients with known allergy to nonsteroidal anti inflammatory drug (NSAID) products and in patients with the syndrome of asthma, rhinitis, and nasal polyps. Aspirin may cause severe urticaria, angioedema or bronchospasm.

Do not use aspirin in children or teenagers with viral infections because of the risk of Reye syndrome.

Avoid using aspirin in patients with a history of active peptic ulcer disease, which can cause gastric mucosal irritation and bleeding.

Aggrenox increases the risk of bleeding. Risk factors for bleeding include the use of other drugs that increase the risk of bleeding (e.g., antiplatelet agents, anticoagulants heparin, fibrinolytic therapy, and chronic use of NSAIDs).

GI side effects include stomach pain, heartburn, nausea, vomiting, and gross GI bleeding.

Because AGGRENOX contains aspirin, counsel patients who consume three or more alcoholic drinks every day about the bleeding risks involved with chronic, heavy alcohol use while taking aspirin.

Avoid aspirin in patients with severe renal failure (glomerular filtration rate less than 10 mL/minute).

Elevations of hepatic enzymes and hepatic failure have been reported in association with dipyridamole administration.

Dipyridamole has a vasodilatory effect. Chest pain may be precipitated or aggravated in patients with underlying coronary artery disease who are receiving dipyridamole.

For stroke or TIA patients for whom aspirin is indicated to prevent recurrent myocardial infarction (MI) or angina pectoris, the aspirin in this product may not provide adequate treatment for the cardiac indications.

Dipyridamole produces peripheral vasodilation, which can exacerbate pre-existing hypotension.

Dipyridamole has been reported to increase the plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage may be necessary.

Dipyridamole also increases the cardiovascular effects of regadenoson, an adenosine A2A-receptor agonist. The potential risk of cardiovascular side effects with intravenous adenosinergic agents may be increased during the testing period when dipyridamole is not held 48 hours prior to stress testing.

Because of the indirect effect of aspirin on the renin-angiotensin conversion pathway, the hyponatremic and hypotensive effects of ACE inhibitors may be diminished by concomitant administration of aspirin.

Concurrent use of aspirin and acetazolamide can lead to high serum concentrations of acetazolamide (and toxicity) due to competition at the renal tubule for secretion.

Patients taking AGGRENOX in combination with anticoagulants, antiplatelets, or any substance impacting coagulation are at increased risk for bleeding. Aspirin can displace warfarin from protein binding sites, leading to prolongation of both the prothrombin time and the bleeding time. Aspirin can increase the anticoagulant activity of heparin, increasing bleeding risk.

Patients taking aspirin in combination with anagrelide are at an increased risk of bleeding.

Salicylic acid can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic acid levels.

The hypotensive effects of beta blockers may be diminished by the concomitant administration of aspirin due to inhibition of renal prostaglandins, leading to decreased renal blood flow and salt and fluid retention.

Dipyridamole may counteract the anticholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis.

The effectiveness of diuretics in patients with underlying renal or cardiovascular disease may be diminished by the concomitant administration of aspirin due to inhibition of renal prostaglandins, leading to decreased renal blood flow and salt and fluid retention.

Salicylate can inhibit renal clearance of methotrexate, leading to bone marrow toxicity, especially in the elderly or renal impaired.

The concurrent use of aspirin with other NSAIDs may increase bleeding or lead to decreased renal function.

Moderate doses of aspirin may increase the effectiveness of oral hypoglycemic drugs, leading to hypoglycemia.

Salicylates antagonize the uricosuric action of uricosuric agents.

Clinical experience suggests that patients being treated with AGGRENOX who also require pharmacological stress testing with intravenous dipyridamole or other adenosinergic agents (e.g. adenosine, regadenoson) should interrupt AGGRENOX for 24-48 hours prior to stress testing. Intake of AGGRENOX 24-48 hours prior to stress testing with intravenous dipyridamole or other adrenosinergic agents may increase the risk for cardiovascular side effects of these agents and impair the sensitivity of the test.

AGGRENOX, which contains dipyridamole and low-dose aspirin, increases the risk for bleeding. Maternal use of high-dose aspirin can result in excessive blood loss at delivery, prolonged gestation, prolonged labor, intracranial hemorrhage in premature infants, low birth weight, stillbirth, and neonatal death.

Nonclinical data are suggestive of a possible potentiation of aspirin-related fetal toxicity when combined with dipyridamole.

The metabolite salicylic acid is present in human milk in low levels. Dipyridamole is also present in human milk.

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• Use in patients under the age of 18. GoToSource

• Anticancer agent. GoToSource

• Carotid or vertebral atherosclerosis. GoToSource

• Prevention of stenosis to prolong survival of arteriovenous grafts. GoToSource

• Chronic heart failure. GoToSource

• Amelioration of renal function in moderately proteinuric patients with mild histological IgA nephropathy. GoToSource

• Community-acquired pneumonia and acute respiratory disease. GoToSource

Gastrointestinal bleeding and intracranial hemorrhage. GoToSource

Stevens–johnson syndrome (severe skin disorder). GoToSource  

Urticaria (hives), severe bronchospasm and angioedema (swelling in deep layers of skin). GoToSource

Hypotension (low blood pressure). GoToSource

Chest pain, gastrointestinal upset and pruritus (severe itching). GoToSource

Acute kidney failure. GoToSource

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