ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE 25 mg/1
ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE · CAPSULE · Glenmark Pharmaceuticals Inc., USA
ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE is a prescription capsule containing asprin and extended-release dipyridamole at 25 mg/1, taken oral. Manufactured by Glenmark Pharmaceuticals Inc., USA.
Key Facts
- Brand Name
- ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE
- Generic Name
- ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE
- NDC Code (Product)
68462-405- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Strength
- 25 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA210318
- Drug Class
- Anti-Inflammatory Agents; Non-Steroidal [CS]
- Marketing Start
- 05/24/2019
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. • 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 ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Aspirin and extended-release dipyridamole capsules are not interchangeable with the individual components of aspirin and dipyridamole tablets. The recommended dose of aspirin and extended-release dipyridamole capsules is one capsule given orally twice daily, one in the morning and one in the evening. Swallow capsules whole without chewing. Aspirin and extended-release dipyridamole capsules can be administered with or without food. • One capsule twice daily (morning and evening) with or without food ( 2 ) • 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 ( 2.1 ) • Do not chew capsule ( 2 ) • Not interchangeable with the individual components of aspirin and dipyridamole tablets ( 2 ) • Dispense in this unit-of-use container ( 16 ) 2.1 Alternative Regimen in Case of Intolerable Headaches 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 sho…
Contraindications
4 CONTRAINDICATIONS • Hypersensitivity to any product ingredients ( 4.1 ) • Patients with known allergy to NSAIDs ( 4.2 ) • Patients with the syndrome of asthma, rhinitis, and nasal polyps ( 4.2 ) 4.1 Hypersensitivity Aspirin and extended-release dipyridamole capsules are contraindicated in patients with known hypersensitivity to any of the product components. 4.2 Allergy 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 . 4.3 Reye Syndrome Do not use aspirin in children or teenagers with viral infections because of the risk of Reye syndrome.
Drug Interactions
7 DRUG INTERACTIONS • Co-administration with anticoagulants, antiplatelets, or NSAIDs can increase risk of bleeding ( 7.1 ) • Decreased renal function can occur with co-administration with NSAIDs ( 7.1 ) 7.1 Drug Interaction Study Information Obtained From Literature Adenosinergic agents (e.g. adenosine, regadenoson) 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 A 2A -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. Angiotensin Converting Enzyme (ACE) Inhibitors 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. Acetazolamide Concurrent use of aspirin and acetazolamide can lead to high serum concentrations of acetazolamide (and toxicity) due to competition at the renal tubule for sec…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: • Hypersensitivity [ see Contraindications (4.1) ] • Allergy [ see Contraindications (4.2) ] • Risk of Bleeding [ see Warnings and Precautions (5.1) ] • The most frequently reported adverse reactions (>10% and greater than placebo) were headache, dyspepsia, abdominal pain, nausea, and diarrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The efficacy and safety of aspirin and extended-release dipyridamole was established in the European Stroke Prevention Study-2 (ESPS2). ESPS2 was a double-blind, placebo-controlled study that evaluated 6602 patients over the age of 18 years who had a previous ischemic stroke or transient ischemic attack within ninety days prior to entry. Patients were ran…
Frequently Asked Questions
What is ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE used for?
ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE contains ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE. It is a capsule taken oral. Consult your doctor for specific uses.
Is ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE a controlled substance?
ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE is not classified as a controlled substance by the DEA.
What is the generic name for ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE?
The generic name for ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE is ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE. There are no other listed brand versions of ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE.
What is the NDC code for ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE 25 mg/1?
The NDC (National Drug Code) for ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE 25 mg/1 is 68462-405, listed by Glenmark Pharmaceuticals Inc., USA.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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