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* Drug
* No pharmacokinetic drug-drug interaction studies were conducted with dipyridamole USP Tablets. The following information was obtained from the literature.
:* Description
 
* 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.


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|nonClinToxic=
|nonClinToxic=


There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
* 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-->
<!--Clinical Studies-->

Revision as of 22:54, 13 July 2014

Dipyridamole (tablet)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

Disclaimer

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Overview

Dipyridamole (tablet) is a platelet aggregation inhibitor that is FDA approved for the {{{indicationType}}} of postoperative thromboembolic complications of cardiac valve replacement. Common adverse reactions include chest pain, electrocardiogram abnormalities, flushing, rash, abdominal discomfort, dizziness, headache, and dyspnea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement
  • Dosing Information
  • The recommended dose is 75-100 mg four times daily as an adjunct to the usual warfarin therapy.
  • Please note that aspirin is not to be administered concomitantly with coumarin anticoagulants.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Prophylaxis of Cerebrovascular Accident
  • Developed by: ACCP
  • Class of Recommendation: Class IIb
  • Strength of Evidence: Category B
  • Dosing Information
  • 200 milligrams (mg) twice daily combined with aspirin 25 mg twice daily[1][2]

Non–Guideline-Supported Use

Peripheral Arterial Occlusive Disease
  • Dosing Information
  • 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

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:
File:Dipyridamole (tablet)02.png
This image is provided by the National Library of Medicine.
  • 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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • 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

There is no FDA guidance on the use of Dipyridamole (tablet) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Dipyridamole (tablet) with respect to pediatric patients.

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.

Condition1
  • Description

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.

Pharmacology

Template:Px
Template:Px
Dipyridamole (tablet)
Systematic (IUPAC) name
2,2',2'',2'''-(4,8-di(piperidin-1-yl)pyrimido[5,4-d]pyrimidine-2,6-diyl)bis(azanetriyl)tetraethanol
Identifiers
CAS number 58-32-2
ATC code B01AC07
PubChem 3108
DrugBank DB00975
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 504.626 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability ?
Protein binding 99%
Metabolism Hepatic
Half life Alpha (40 mins), Beta (10 Hours)
Excretion ?
Therapeutic considerations
Pregnancy cat.

B

Legal status

POM(UK) [[Prescription drug|Template:Unicode-only]](US)

Routes oral, IV

Mechanism of Action

Structure

File:Dipyridamole (tablet)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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.

Condition1
  • Description

How Supplied

Storage

There is limited information regarding Dipyridamole (tablet) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Dipyridamole (tablet) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Dipyridamole (tablet) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Dipyridamole (tablet) in the drug label.

Precautions with Alcohol

  • Alcohol-Dipyridamole (tablet) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Persantine®[5]

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Diener, H. C. (2001-04). "Cardiac safety in the European Stroke Prevention Study 2 (ESPS2)". International Journal of Clinical Practice. 55 (3): 162–163. ISSN 1368-5031. PMID 11351768. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  2. ↑ Diener, H. C. (1998-09). "Dipyridamole trials in stroke prevention". Neurology. 51 (3 Suppl 3): –17-19. ISSN 0028-3878. PMID 9744826. Check date values in: |date= (help)
  3. ↑ 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. ISSN 0140-6736. PMID 2857803. Unknown parameter |coauthors= ignored (help)
  4. ↑ Norcott, H. C. (1982-12-27). "Platelet inhibitory drugs: an in vivo method of evaluation in patients". Thrombosis and Haemostasis. 48 (3): 307–310. ISSN 0340-6245. PMID 6761890. Unknown parameter |coauthors= ignored (help)
  5. ↑ "DIPYRIDAMOLE tablet, film coated".
  6. ↑ "http://www.ismp.org". External link in |title= (help)


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