:* Dipyridamole has been associated with elevated hepatic enzymes.
:* Dipyridamole has been associated with elevated hepatic enzymes.
<!--Adverse Reactions-->
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There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
* Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of dipyridamole USP tablets initial side effects usually disappear. The following reactions in Table 1 were reported in two heart valve replacement trials comparing dipyridamole USP tablets and warfarin therapy to either warfarin alone or warfarin and placebo:
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
: [[File:{{PAGENAME}}02.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
=====Miscellaneous=====
* Other reactions from uncontrolled studies include diarrhea, vomiting, flushing and pruritus. In addition, angina pectoris has been reported rarely and there have been rare reports of liver dysfunction. On those uncommon occasions when adverse reactions have been persistent or intolerable, they have ceased on withdrawal of the medication.
* When dipyridamole USP tablets were administered concomitantly with warfarin, bleeding was no greater in frequency or severity than that observed when warfarin was administered alone. In rare cases, increased bleeding during or after surgery has been observed. In post-marketing reporting experience, there have been rare reports of hypersensitivity reactions (such as rash, urticaria, severe bronchospasm, and angioedema), larynx edema, fatigue, malaise, myalgia, arthritis, nausea, dyspepsia, paresthesia, hepatitis, thrombocytopenia, alopecia, cholelithiasis, hypotension, palpitation, and tachycardia.
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There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
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75 mg daily and aspirin 330 mg daily for 2 years[3]
Prophylaxis of Vascular Graft Occlusion
Dosing Information
100 mg 4 times per day before the operation followed by DIPYRIDAMOLE 75 mg 3 times per day plus ASPIRIN 325 mg 3 times per day after the operation[4]
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness in the pediatric population below the age of 12 years have not been established.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Dipyridamole (tablet) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Dipyridamole (tablet) in pediatric patients.
Contraindications
Hypersensitivity to dipyridamole and any of the other components.
Warnings
Precautions
General
Coronary Artery Disease: Dipyridamole has a vasodilatory effect and should be used with caution in patients with severe coronary artery disease (e.g., unstable angina or recently sustained myocardial infarction). Chest pain may be aggravated in patients with underlying coronary artery disease who are receiving dipyridamole.
Hepatic Insufficiency: Elevations of hepatic enzymes and hepatic failure have been reported in association with dipyridamole administration.
Hypotension: Dipyridamole should be used with caution in patients with hypotension since it can produce peripheral vasodilation.
Laboratory Tests
Dipyridamole has been associated with elevated hepatic enzymes.
Adverse Reactions
Clinical Trials Experience
Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of dipyridamole USP tablets initial side effects usually disappear. The following reactions in Table 1 were reported in two heart valve replacement trials comparing dipyridamole USP tablets and warfarin therapy to either warfarin alone or warfarin and placebo:
Other reactions from uncontrolled studies include diarrhea, vomiting, flushing and pruritus. In addition, angina pectoris has been reported rarely and there have been rare reports of liver dysfunction. On those uncommon occasions when adverse reactions have been persistent or intolerable, they have ceased on withdrawal of the medication.
When dipyridamole USP tablets were administered concomitantly with warfarin, bleeding was no greater in frequency or severity than that observed when warfarin was administered alone. In rare cases, increased bleeding during or after surgery has been observed. In post-marketing reporting experience, there have been rare reports of hypersensitivity reactions (such as rash, urticaria, severe bronchospasm, and angioedema), larynx edema, fatigue, malaise, myalgia, arthritis, nausea, dyspepsia, paresthesia, hepatitis, thrombocytopenia, alopecia, cholelithiasis, hypotension, palpitation, and tachycardia.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Dipyridamole (tablet) in the drug label.
The contents of this FDA label are provided by the National Library of Medicine.
↑Diener, H. C. (2001-04). "Cardiac safety in the European Stroke Prevention Study 2 (ESPS2)". International Journal of Clinical Practice. 55 (3): 162–163. ISSN1368-5031. PMID11351768. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
↑Diener, H. C. (1998-09). "Dipyridamole trials in stroke prevention". Neurology. 51 (3 Suppl 3): –17-19. ISSN0028-3878. PMID9744826. Check date values in: |date= (help)
↑Hess, H. (1985-02-23). "Drug-induced inhibition of platelet function delays progression of peripheral occlusive arterial disease. A prospective double-blind arteriographically controlled trial". Lancet. 1 (8426): 415–419. ISSN0140-6736. PMID2857803. Unknown parameter |coauthors= ignored (help)
↑Norcott, H. C. (1982-12-27). "Platelet inhibitory drugs: an in vivo method of evaluation in patients". Thrombosis and Haemostasis. 48 (3): 307–310. ISSN0340-6245. PMID6761890. Unknown parameter |coauthors= ignored (help)
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