aspirin-dipyridamole

ASPIRIN-DIPYRIDAMOLE

Manufacturer: Zydus Pharmaceuticals USA Inc.

Score: 141.0

Quick Summary

Aspirin-dipyridamole is a combination antiplatelet agent used to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. The recommended dose is one capsule twice daily, and it is not interchangeable with the individual components of aspirin and dipyridamole tablets. The drug has several contraindications, including hypersensitivity to any product ingredients, known allergy to NSAIDs, and the syndrome of asthma, rhinitis, and nasal polyps. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Reduces the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis
Combination antiplatelet agent

Important Safety Information

Warning

Increases the risk for bleeding

Contraindications

Hypersensitivity to any product ingredients
Known allergy to NSAIDs
The syndrome of asthma, rhinitis, and nasal polyps

Adverse Reactions

Headache
Dyspepsia
Abdominal pain
Nausea
Diarrhea

Dosing Recommendations

General Guidance

In case of intolerable headaches during initial treatment, switch to one capsule at bedtime and low-dose aspirin in the morning; resume BID dosing within one week

Stroke prevention

Adult Dose

One capsule twice daily

Pediatric Dose

Not recommended

Special Population Considerations

Pregnancy

Available data from published studies and postmarketing experience with aspirin and extended-release dipyridamole capsule use during pregnancy have not identified a clear association between aspirin and extended-release dipyridamole capsule use and major birth defects, miscarriage, or adverse maternal or fetal outcomes

Nursing Mothers

No information available

Pediatric Use

Safety and effectiveness of aspirin and extended-release dipyridamole capsules in pediatric patients have not been studied; use is not recommended

Geriatric Use

Of the total number of subjects in ESPS2, 61% were 65 and over, while 27% were 75 and over; no overall differences in safety or effectiveness were observed between these subjects and younger subjects

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