ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Score: 141.0

Quick Summary

Aspirin and extended-release dipyridamole capsules are a combination of aspirin and dipyridamole, antiplatelet agents, indicated 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 given orally twice daily, one in the morning and one in the evening. The drug has several adverse reactions, including headache, dyspepsia, abdominal pain, nausea, and diarrhea, and is contraindicated in patients with known hypersensitivity to any of the product components, patients with known allergy to nonsteroidal anti-inflammatory drug (NSAID) products, and patients with the syndrome of asthma, rhinitis, and nasal polyps.

Key Clinical Findings and Indications

Reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis
Antiplatelet agents

Important Safety Information

Warning

The drug can increase the risk of bleeding and is contraindicated in patients with known hypersensitivity to any of the product components

Contraindications

Hypersensitivity to any product ingredients
Patients with known allergy to NSAIDs
Patients with 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 or TIA

Adult Dose

One capsule given orally twice daily, one in the morning and one in the evening

Pediatric Dose

Not recommended for pediatric patients

Special Population Considerations

Pregnancy

Available data from published studies and postmarketing experience with Aspirin and extended-release dipyridamole capsules use during pregnancy have not identified a clear association between Aspirin and extended-release dipyridamole capsules 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

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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