Aspirin And Extended-release Dipyridamole

Generic Name: aspirin and extended-release dipyridamole

Nonsteroidal Anti-inflammatory Drug [EPC]Over-the-Counter (OTC)

Brand Names:

Aspirin And Extended-release Dipyridamole

11 DESCRIPTION Aspirin and extended-release dipyridamole is a combination antiplatelet agent intended for oral administration. Each hard gelatin capsule contains 200 mg dipyridamole, USP in an extended-release form and 25 mg aspirin USP, as an immediate-release sugar-coated tablet.

Overview

11 DESCRIPTION Aspirin and extended-release dipyridamole is a combination antiplatelet agent intended for oral administration. Each hard gelatin capsule contains 200 mg dipyridamole, USP in an extended-release form and 25 mg aspirin USP, as an immediate-release sugar-coated tablet.

Uses

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 capsulesis a combination antiplatelet agent 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

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.

Side Effects

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) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or www.avkare.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Interactions

7 DRUG INTERACTIONS Co-administration with anti-coagulants, 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 Adenosine Dipyridamole has been reported to increase the plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage may be necessary. Angiotensin Converting Enzyme (ACE) Inhibitors Due to 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.

Warnings

5 WARNINGS AND PRECAUTIONS Aspirin and extended-release dipyridamole capsulesincreases the risk of bleeding (5.1) Avoid use in patients with severe hepatic or renal insufficiency (5.2, 5.3) Can cause fetal harm when administered to a pregnant woman, especially in the third trimester (5.4) 5.1 Risk of Bleeding Aspirin and extended-release dipyridamole increases the risk of bleeding. Risk factors for bleeding include the use of other drugs that increase the risk of bleeding (e.g., anticoagulants, antiplatelet agents, heparin, anagrelide, fibrinolytic therapy and chronic use of NSAIDs) [see Drug Interactions (7.1) ] . 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.

Pregnancy

8.1 Pregnancy Teratogenic Effects, Pregnancy Category D. [see Warnings and Precautions (5.4) ].

Storage

16 HOW SUPPLIED Aspirin and extended-release dipyridamole capsules, 25 mg/200 mg, are available as two piece hard gelatin capsules, with a red opaque cap and a yellow opaque body, filled with light yellow to yellow extended-release dipyridamole pellets and a white to off-white, round, film-coated, biconvex, unscored, plain aspirin tablet.

Frequently Asked Questions

What is Aspirin And Extended-release Dipyridamole used for?

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 capsulesis a combination antiplatelet agent 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)

What are the side effects of Aspirin And Extended-release Dipyridamole?

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) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or www.avkare.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Can I take Aspirin And Extended-release Dipyridamole during pregnancy?

8.1 Pregnancy Teratogenic Effects, Pregnancy Category D. [see Warnings and Precautions (5.4) ].

What are the important warnings for Aspirin And Extended-release Dipyridamole?

5 WARNINGS AND PRECAUTIONS Aspirin and extended-release dipyridamole capsulesincreases the risk of bleeding (5.1) Avoid use in patients with severe hepatic or renal insufficiency (5.2, 5.3) Can cause fetal harm when administered to a pregnant woman, especially in the third trimester (5.4) 5.1 Risk of Bleeding Aspirin and extended-release dipyridamole increases the risk of bleeding. Risk factors for bleeding include the use of other drugs that increase the risk of bleeding (e.g., anticoagulants, antiplatelet agents, heparin, anagrelide, fibrinolytic therapy and chronic use of NSAIDs) [see Drug Interactions (7.1) ] . 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.

Related Medications

Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.