* Dipyridamole tablets, USP, are available as round, white, film-coated tablets of 25 mg, 50 mg, and 75 mg coded 81/SL, 82/SL, and 83/SL, respectively.
* They are available in unit dose box of 100 tablets as indicated below:
:: 25 mg Tablets (NDC 0904-1086-61)
:: 50 mg Tablets (NDC 0904-1087-61)
:: 75 mg Tablets (NDC 0904-1088-61)
* STORE AT 25°C (77°F); EXCURSIONS PERMITTED TO 15-30°C (59°-86°F) [SEE USP CONTROLLED ROOM TEMPERATURE]. KEEP OUT OF REACH OF CHILDREN.
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* N/A<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
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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.
Drug Interactions
No pharmacokinetic drug-drug interaction studies were conducted with dipyridamole USP Tablets. The following information was obtained from the literature.
Adenosine: Dipyridamole has been reported to increase the plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage may be necessary.
Cholinesterase Inhibitors: Dipyridamole may counteract the anticholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis.
Reproduction studies have been performed in mice, rabbits and rats at oral dipyridamole doses of up to 125 mg/kg, 40 mg/kg and 1000 mg/kg, respectively (about 1 ½ , 2 and 25 times the maximum recommended daily human oral dose, respectively, on a mg/m2 basis) and have revealed no evidence of harm to the fetus due to dipyridamole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, dipyridamole USP should be used during pregnancy only if clearly needed.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dipyridamole (tablet) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Dipyridamole (tablet) during labor and delivery.
Nursing Mothers
As dipyridamole is excreted in human milk, caution should be exercised when dipyridamole USP tablets are administered to a nursing woman.
Pediatric Use
Safety and effectiveness in the pediatric population below the age of 12 years have not been established.
Geriatic Use
There is no FDA guidance on the use of Dipyridamole (tablet) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Dipyridamole (tablet) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Dipyridamole (tablet) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Dipyridamole (tablet) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Dipyridamole (tablet) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Dipyridamole (tablet) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Dipyridamole (tablet) in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Intravenous
Monitoring
There is limited information regarding Monitoring of Dipyridamole (tablet) in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Dipyridamole (tablet) in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
In case of real or suspected overdose, seek medical attention or contact a Poison Control Center immediately. Careful medical management is essential. Based upon the known hemodynamic effects of dipyridamole, symptoms such as warm feeling, flushes, sweating, restlessness, feeling of weakness and dizziness may occur. A drop in blood pressure and tachycardia might also be observed.
Management
Symptomatic treatment is recommended, possibly including a vasopressor drug. Gastric lavage should be considered. Administration of xanthine derivatives (e.g., aminophylline) may reverse the hemodynamic effects of dipyridamole overdose. Since dipyridamole is highly protein bound, dialysis is not likely to be of benefit.
Chronic Overdose
There is limited information regarding Chronic Overdose of Dipyridamole (tablet) in the drug label.
There is limited information regarding Pharmacodynamics of Dipyridamole (tablet) in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Dipyridamole (tablet) in the drug label.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
In studies in which dipyridamole was administered in the feed to mice (up to 111 weeks in males and females) and rats (up to 128 weeks in males and up to 142 weeks in females), there was no evidence of drug-related carcinogenesis. The highest dose administered in these studies (75 mg/kg/day) was, on a mg/m2 basis, about equivalent to the maximum recommended daily human oral dose (MRHD) in mice and about twice the MRHD in rats. Mutagenicity tests of dipyridamole with bacterial and mammalian cell systems were negative. There was no evidence of impaired fertility when dipyridamole was administered to male and female rats at oral doses up to 500 mg/kg/day (about 12 times the MRHD on a mg/m2 basis). A significant reduction in number of corpora lutea with consequent reduction in implantations and live fetuses was, however, observed at 1250 mg/kg (more than 30 times the MRHD on a mg/m2 basis).
Clinical Studies
There is limited information regarding Clinical Studies of Dipyridamole (tablet) in the drug label.
How Supplied
Dipyridamole tablets, USP, are available as round, white, film-coated tablets of 25 mg, 50 mg, and 75 mg coded 81/SL, 82/SL, and 83/SL, respectively.
They are available in unit dose box of 100 tablets as indicated below:
25 mg Tablets (NDC 0904-1086-61)
50 mg Tablets (NDC 0904-1087-61)
75 mg Tablets (NDC 0904-1088-61)
STORE AT 25°C (77°F); EXCURSIONS PERMITTED TO 15-30°C (59°-86°F) [SEE USP CONTROLLED ROOM TEMPERATURE]. KEEP OUT OF REACH OF CHILDREN.
Storage
There is limited information regarding Dipyridamole (tablet) Storage in the drug label.
Images
Drug Images
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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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