Aggrenox: Dual-Antiplatelet Therapy for Stroke Prevention
| Product dosage: 225mg | |||
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Synonyms | |||
Aggrenox is a prescription medication specifically formulated for secondary stroke prevention in patients who have experienced a transient ischemic attack (TIA) or ischemic stroke. It combines two antiplatelet agents—aspirin and dipyridamole—in an extended-release formulation designed to work synergistically to reduce the risk of recurrent cerebrovascular events. This combination offers a targeted therapeutic approach by inhibiting platelet aggregation through complementary mechanisms, thereby providing robust protection against thrombotic complications. Clinical trials have demonstrated its superior efficacy over monotherapy with either component alone, establishing it as a cornerstone in neurology and cardiology practice for high-risk patients.
Features
- Contains a fixed-dose combination of 25 mg aspirin and 200 mg extended-release dipyridamole per capsule
- Utilizes a proprietary extended-release formulation for consistent dipyridamole delivery
- Designed for twice-daily oral administration, typically in the morning and evening
- Available in bottle packaging with desiccant to maintain stability
- Manufactured under strict pharmaceutical quality control standards
- Includes enteric-coated aspirin to reduce gastric irritation
Benefits
- Significantly reduces the risk of recurrent stroke compared to aspirin monotherapy
- Provides dual mechanism platelet inhibition for comprehensive antithrombotic protection
- Offers convenient twice-daily dosing that supports medication adherence
- Demonstrated long-term efficacy in maintaining vascular protection
- May reduce hospitalization rates and healthcare costs associated with recurrent strokes
- Supported by extensive clinical evidence from landmark stroke prevention trials
Common use
Aggrenox is primarily indicated for secondary prevention of ischemic stroke in patients who have experienced a TIA or completed ischemic stroke. It is prescribed to reduce the risk of recurrent cerebrovascular events by approximately 25-37% compared to aspirin alone, as demonstrated in the ESPS-2 and ESPRIT trials. The medication is typically initiated within weeks following the qualifying event and continued long-term unless contraindications develop. Healthcare providers may consider Aggrenox particularly for patients with additional vascular risk factors, including hypertension, diabetes, or established cardiovascular disease, where comprehensive antiplatelet protection is warranted.
Dosage and direction
The recommended adult dosage is one capsule taken orally twice daily, approximately 12 hours apart, with a full glass of water. Capsules should be swallowed whole and not crushed, chewed, or opened. Administration with food may help minimize gastrointestinal discomfort, though consistency in timing relative to meals is recommended. Treatment is typically initiated as soon as the acute phase of stroke recovery permits, often within days to weeks post-event. Dose adjustment is not required for elderly patients, though careful monitoring is advised. Renal or hepatic impairment does not typically necessitate dosage modification, but increased vigilance for adverse effects is warranted.
Precautions
Patients should be carefully evaluated for bleeding risk factors before initiation, including history of gastrointestinal ulcers, bleeding disorders, or concomitant anticoagulant therapy. Regular monitoring of complete blood count is recommended during treatment. Caution is advised in patients with severe hepatic or renal impairment, coronary artery disease (due to potential for dipyridamole-induced coronary steal), hypotension, or obstructive pulmonary disease. The medication should be used with caution in patients scheduled for surgical procedures; discontinuation 5-7 days prior to elective surgery may be considered. Patients should be advised to report any signs of bleeding, unusual bruising, or persistent headache.
Contraindications
Aggrenox is contraindicated in patients with known hypersensitivity to aspirin, dipyridamole, or any component of the formulation. It must not be used in patients with asthma exacerbated by NSAIDs or salicylates, active peptic ulcer disease, or hemorrhagic diatheses. Contraindications include severe hepatic failure, severe renal failure (CrCl <30 mL/min), and third trimester of pregnancy. The combination is also contraindicated in patients receiving concomitant methotrexate at doses >15 mg/week due to increased toxicity risk. Use should be avoided in children and adolescents with viral infections due to risk of Reye’s syndrome.
Possible side effects
The most frequently reported adverse reactions include headache (approximately 30-40% of patients), gastrointestinal disturbances (dyspepsia, abdominal pain, nausea, diarrhea in 15-20%), and bleeding complications (ecchymosis, epistaxis in 5-10%). Less common effects include dizziness, fatigue, and flushing. Serious but rare adverse events include gastrointestinal hemorrhage, intracranial hemorrhage, severe hypersensitivity reactions, and hepatotoxicity. Headache typically diminishes with continued treatment over 1-2 weeks. Patients should be monitored for signs of bleeding, including unusual bruising, blood in stool, or hemorrhagic stroke symptoms.
Drug interaction
Significant interactions occur with anticoagulants (warfarin, dabigatran, rivaroxaban) and other antiplatelet agents, increasing bleeding risk. Concurrent NSAID use may enhance gastrointestinal toxicity and bleeding potential. ACE inhibitors may have reduced antihypertensive effect when combined with aspirin. Dipyridamole may potentiate effects of adenosine and other coronary vasodilators. Aspirin may increase methotrexate toxicity and reduce uricosuric effect of probenecid. Caution is warranted with selective serotonin reuptake inhibitors due to increased bleeding risk. Pharmacists should conduct comprehensive medication reviews before initiation.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not double the dose to make up for a missed administration. Consistent timing is important for maintaining therapeutic antiplatelet effects, but occasional missed doses are unlikely to significantly impact overall stroke protection. Patients should be educated about the importance of adherence and provided with strategies such as pill organizers or reminder systems.
Overdose
Overdose may manifest as salicylate intoxication (tinnitus, hyperventilation, metabolic acidosis) from aspirin component and vasodilation/hypotension from dipyridamole. Symptoms may include severe dizziness, respiratory alkalosis followed by metabolic acidosis, hypoglycemia, bleeding complications, and cardiovascular collapse. Management requires immediate medical attention with gastric lavage or activated charcoal if presented early. Supportive care includes fluid replacement, correction of acid-base balance, and monitoring of coagulation parameters. Hemodialysis may be effective for salicylate removal. Specific antidotes such as vitamin K may be considered for bleeding complications.
Storage
Store at controlled room temperature (20-25°C or 68-77°F) in the original container with tight closure. Protect from moisture and excessive heat. Keep the desiccant canister in the bottle to maintain stability. Do not transfer capsules to other containers. Keep out of reach of children and pets. Do not use beyond the expiration date printed on packaging. Avoid storage in bathrooms or other humid environments. Proper storage ensures maintenance of the extended-release properties and chemical stability of both active components.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Individual patient responses may vary. Healthcare providers should exercise professional judgment in treatment decisions based on specific patient circumstances. Full prescribing information should be consulted before initiation. Patients should not alter their medication regimen without consulting their healthcare provider. The efficacy and safety data are based on clinical trials and post-marketing experience; ongoing monitoring is essential.
Reviews
Clinical studies demonstrate consistent efficacy in stroke prevention, with the ESPS-2 trial showing 37% relative risk reduction compared to placebo and 23% compared to aspirin alone. Neurologists frequently report satisfactory patient outcomes with appropriate patient selection. Some practitioners note challenges with headache as an initial side effect, though this typically resolves with continued use. The twice-daily dosing is generally well-accepted by patients, with adherence rates comparable to other chronic medications. Cost considerations may influence prescribing patterns in some healthcare systems. Overall, Aggrenox remains a valuable option in the secondary stroke prevention arsenal.