aspirin/dipyridamole (Rx)

Brand and Other Names:Aggrenox
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

aspirin/dipyridamole

capsule, extended release

  • 25mg/200mg

Stroke

Secondary prophylaxis of transient ischemic attack (TIA) or cerebrovascular accident (CVA)

1 capsule PO q12hr

Dosing considerations

  • Not interchangeable with individual components of aspirin/dipyridamole
  • Intolerable headaches during initial treatment: Switch to 1 capsule PO at bedtime; patient should return to normal regimen when possible (usually 1 week)

Dosing Modifications

GFR <10 mL/min: Use not recommended

Administration

Swallow capsules whole, without chewing

Safety and efficacy not established

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Interactions

Interaction Checker

and aspirin/dipyridamole

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Headache (10-39%)

            Dyspepsia (4-18%)

            Abdominal pain (4-18%)

            Nausea (6-16%)

            Diarrhea (13%)

            1-10%

            Vomiting (3-8%)

            Pain (6%)

            Fatigue (6%)

            Arthralgia (5%)

            Back pain (5%)

            Hemorrhage, nonspecific (3%)

            Accidental injury (3%)

            Epistaxis (3%)

            Amnesia (3%)

            Arthritis (2%)

            Melena (2%)

            Asthenia (2%)

            Convulsions (2%)

            Neoplasm, nonspecific (2%)

            Anemia (2%)

            Rectal hemorrhage (2%)

            Malaise (2%)

            Cardiac failure (2%)

            Coughing (2%)

            Purpura (1%)

            GI hemorrhage (1%)

            Anorexia (1%)

            Somnolence (1%)

            Myalgia (1%)

            Arthrosis (1%)

            Confusion (1%)

            Hemorrhoids (1%)

            Syncope (1%)

            Upper respiratory tract infection (1%)

            Postmarketing Reports

            Body as whole: Hypothermia, chest pain

            Cardiovascular: Angina pectoris, tachycardia, palpitation

            CNS: Cerebral edema, dizziness, cerebral hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage

            Fluid and electrolyte: Hyperkalemia, metabolic acidosis, respiratory alkalosis, hypokalemia

            Psychiatric Disorders: Confusion, agitation

            GI: Pancreatitis, Reye syndrome, hematemesis, gastritis, ulceration and perforation, hemorrhage rectum, melena, GI hemorrhage

            General: Hearing loss, anorexia, migraine

            Immune: Hypersensitivity, acute anaphylaxis, laryngeal edema

            Hepatic: Hepatitis, hepatic failure, cholelithiasis, jaundice, hepatic function abnormal

            Musculoskeletal: Rhabdomyolysis

            Metabolic: Hypoglycemia, dehydration

            Reproductive: Prolonged pregnancy and labor, stillbirths, lower-birth-weight infants, antepartum and postpartum bleeding

            Respiratory: Tachypnea, dyspnea

            Skin: Rash, alopecia, angioedema, Stevens-Johnson syndrome, skin hemorrhage (eg, bruising, ecchymosis, hematoma), pruritus, urticaria

            Urogenital: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, hematuria

            Platelet, bleeding and clotting disorders: Hematoma, gingival bleeding, epistaxis, purpura, aplastic anemia, pancytopenia, thrombocytosis, allergic vasculitis, prothrombin time (PT) prolongation, disseminated intravascular coagulation (DIC), coagulopathy, thrombocytopenia

            Vascular (Extracardiac) Disorders:Flushing

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            Warnings

            Contraindications

            Hypersensitivity to aspirin, dipyridamole, or NSAIDs

            Syndrome of asthma, rhinitis, and nasal polyps

            Children younger than 16 years with viral infections (risk of Reye syndrome)

            Cautions

            Discontinue if tinnitus or impaired hearing occurs

            Use with caution in patients with cardiovascular or GI diseases or bleeding disorders

            Risk of precipitation of chest pain in patients with underlying coronary artery disease (CAD)

            Dosage in drug may not be adequate in patients with history of stroke or TIA for whom aspirin is indicated to prevent recurrent MI or angina pectoris

            Preexisting hypotension may be exacerbated by peripheral vasodilation

            Increased bleeding risk when drug coadministered with antiplatelet agents (eg, anagrelide), anticoagulants (eg, heparin), fibrinolytic agents, or NSAIDs (in long-term use)

            When possible, surgical patients should not receive aspirin 2 weeks before undergoing a surgical procedure

            Increased bleeding risk with chronic heavy alcohol use (>3 alcoholic drinks/day)

            Risk of elevated liver function test values or hepatic failure with dipyridamole administration

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            Pregnancy & Lactation

            Pregnancy

            Available data from published studies and postmarketing experience with use during pregnancy have not identified clear association between drug use and major birth defects, miscarriage, or adverse maternal or fetal outcomes drug combination contains low-dose aspirin which is an NSAID

            Increases 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

            Animal data

            • In animal reproduction studies, there were adverse developmental effects with administration of aspirin in rats and rabbits at doses about 66 and 44 times, respectively, the human exposure at maximum recommended daily dose; reproduction studies with dipyridamole in mice, rabbits, and rats have revealed no evidence of harm to fetus up to doses about 25 times maximum recommended daily human dose; nonclinical data are suggestive of possible potentiation of aspirin-related fetal toxicity when combined with dipyridamole

            Lactation

            Based on data from a clinical lactation study in breastfeeding women taking low-dose aspirin, the metabolite salicylic acid is present in human milk in low levels; dipyridamole is also present in human milk; there is no information on the effects of drug combination components on breastfed infant or on milk production; there is insufficient information to determine effects of aspirin on breastfed infant and no information on effects of aspirin on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

            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.

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            Pharmacology

            Mechanism of Action

            Aspirin: Inhibits platelet cyclooxygenase and thus inhibits generation of thromboxane A2, a powerful inducer of platelet aggregation and vasoconstriction, leading to abrogation of platelet aggregation

            Dipyridamole: Inhibits uptake of adenosine into platelets, endothelial cells, and erythrocytes

            Combination of aspirin and dipyridamole produces additive antiplatelet effects

            Absorption

            Peak plasma levels: Dipyridamole, 2 hr

            Distribution

            Protein bound: Dipyridamole, 99%

            Vd: Dipyridamole, 92 L

            Metabolism

            Metabolized by liver: Dipyridamole

            Elimination

            Dipyridamole: Feces (95%), urine (5%)

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.