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Product Name
:
ELSANTIN
Chemical Name
:
Dipyridamole
Therapeutic Category
:
Cardiovascular drugs
Pharmacologic Category
:
Antiplatelet Agent - Vasodilator
Pharmaceutical Form
:
Tablets
Composition
:
Dipyridamole 25mg / 75mg
Monitoring Parameters
Dosing
 
Dosing: Adult
Adjunctive therapy for prophylaxis of thromboembolism with cardiac valve replacement: Oral: 75-100 mg 4 times/day

Dosing: Pediatric

Adjunctive therapy for prophylaxis of thromboembolism with cardiac valve replacement: Oral: Children ≥12 years: Refer to adult dosing.

Dosing: Geriatric

Refer to adult dosing.
Use
 
Oral: Used with warfarin to decrease thrombosis in patients after artificial heart valve replacement
Use - Unlabeled/Investigational
Stroke prevention (in combination with aspirin)
Adverse Reactions
 
Oral:
>10%: Dizziness (14%)
1% to 10%:
Central nervous system: Headache (2%)
Dermatologic: Rash (2%)
Gastrointestinal: Abdominal distress (6%)
Frequency not defined: Diarrhea, vomiting, flushing, pruritus, angina pectoris, liver dysfunction
Postmarketing and/or case reports: Alopecia, arthritis, cholelithiasis, dyspepsia, fatigue, hepatitis, hypersensitivity reaction, hypotension, larynx edema, malaise, myalgia, nausea, palpitation, paresthesia, tachycardia, thrombocytopenia
Contraindications
 
Hypersensitivity to dipyridamole or any component of the formulation
Warnings / Precautions Drug
 
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with hypotension, unstable angina, and/or recent MI.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
Concurrent drug therapy issues:
• Antiplatelet agents/anticoagulants: Use with caution in patients on other antiplatelet agents or anticoagulation.
Special populations:
• Elderly: May be inappropriate in this age group due to risk of orthostatic hypotension (Beers Criteria).
Metabolism/Transport Effects
Inhibits ABCG2, P-glycoprotein
Interactions
 
Adenosine: Dipyridamole may enhance the therapeutic effect of Adenosine. Dose reduction of adenosine may be needed. Management: Reduction of the initial dose of adenosine may be warranted. Risk D: Consider therapy modification
Anticoagulants: Antiplatelet Agents may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy
Antiplatelet Agents: May enhance the anticoagulant effect of other Antiplatelet Agents. Risk C: Monitor therapy
Beta-Blockers: Dipyridamole may enhance the bradycardic effect of Beta-Blockers. Exceptions: Levobunolol; Metipranolol. Risk C: Monitor therapy
Colchicine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Colchicine. Colchicine distribution into certain tissues (e.g., brain) may also be increased. Management: Colchicine is contraindicated in patients with impaired renal or hepatic function who are also receiving a p-glycoprotein inhibitor. In those with normal renal and hepatic function, reduce colchicine dose as directed. Risk D: Consider therapy modification
Collagenase (Systemic): Antiplatelet Agents may enhance the adverse/toxic effect of Collagenase (Systemic). Specifically, the risk of injection site bruising and/or bleeding may be increased. Risk C: Monitor therapy
Dabigatran Etexilate: P-glycoprotein/ABCB1 Inhibitors may increase serum concentrations of the active metabolite(s) of Dabigatran Etexilate. Management: Dabigatran dose reductions may be needed. According to Canadian labeling, dabigatran dose for prevention of venous thromboembolism post hip or knee replacement should be reduced to 150 mg/day in patients receiving amiodarone, verapamil, or quinidine. Risk D: Consider therapy modification
Dasatinib: May enhance the anticoagulant effect of Antiplatelet Agents. Risk C: Monitor therapy
Drotrecogin Alfa: Antiplatelet Agents may enhance the adverse/toxic effect of Drotrecogin Alfa. Bleeding may occur. Management: When possible, avoid use of drotrecogin within 7 days of use of any IIb/IIIa antagonists, higher dose aspirin (more than 650 mg/day), or use of other antiplatelet agents. Risk D: Consider therapy modification
Everolimus: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Everolimus. Management: Everolimus dose reductions are required for patients being treated for subependymal giant cell astrocytoma or renal cell carcinoma. See prescribing information for specific dose adjustment and monitoring recommendations. Risk D: Consider therapy modification
Glucosamine: May enhance the antiplatelet effect of Antiplatelet Agents. Risk C: Monitor therapy
Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Antiplatelet Agents. Bleeding may occur. Risk D: Consider therapy modification
Hypotensive Agents: May enhance the adverse/toxic effect of other Hypotensive Agents. Risk C: Monitor therapy
Ibritumomab: Antiplatelet Agents may enhance the adverse/toxic effect of Ibritumomab. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May enhance the adverse/toxic effect of Antiplatelet Agents. An increased risk of bleeding may occur. Nonsteroidal Anti-Inflammatory Agents may diminish the cardioprotective effect of Antiplatelet Agents. This interaction is likely specific to aspirin, and not to other antiplatelet agents. Risk C: Monitor therapy
Omega-3-Acid Ethyl Esters: May enhance the antiplatelet effect of Antiplatelet Agents. Risk C: Monitor therapy
Pentosan Polysulfate Sodium: May enhance the adverse/toxic effect of Antiplatelet Agents. Specifically, the risk of bleeding may be increased by concurrent use of these agents. Risk C: Monitor therapy
Pentoxifylline: May enhance the antiplatelet effect of Antiplatelet Agents. Risk C: Monitor therapy
P-glycoprotein/ABCB1 Substrates: May increase the serum concentration of P-glycoprotein/ABCB1 Inhibitors. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy
Prostacyclin Analogues: May enhance the antiplatelet effect of Antiplatelet Agents. Risk C: Monitor therapy
Regadenoson: Dipyridamole may enhance the therapeutic effect of Regadenoson. Risk D: Consider therapy modification
Rivaroxaban: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Rivaroxaban. Risk C: Monitor therapy
Salicylates: Antiplatelet Agents may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Risk C: Monitor therapy
Silodosin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Silodosin. Risk X: Avoid combination
Thrombolytic Agents: Antiplatelet Agents may enhance the anticoagulant effect of Thrombolytic Agents. Risk C: Monitor therapy
Topotecan: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Topotecan. Risk X: Avoid combination
Topotecan: BCRP/ABCG2 Inhibitors may increase the serum concentration of Topotecan. Risk D: Consider therapy modification
Tositumomab and Iodine I 131 Tositumomab: Antiplatelet Agents may enhance the adverse/toxic effect of Tositumomab and Iodine I 131 Tositumomab. Specifically, the risk of bleeding-related adverse events may be increased. Risk C: Monitor therapy
Vitamin E: May enhance the antiplatelet effect of Antiplatelet Agents. Risk C: Monitor therapy
Pregnancy
 
B
Pregnancy Implications
Teratogenic effects were not observed in animal studies.
Lactation
 
Enters breast milk/use caution
Breast-Feeding Considerations
Excretion in breast milk is reported to be minimal.
Mechanism of Action
 
Inhibits the activity of adenosine deaminase and phosphodiesterase, which causes an accumulation of adenosine, adenine nucleotides, and cyclic AMP; these mediators then inhibit platelet aggregation and may cause vasodilation; may also stimulate release of prostacyclin or PGD2; causes coronary vasodilation
Pharmacodynamics / Kinetics
 
Absorption: Readily, but variable
Distribution: Adults: Vd: 2-3 L/kg
Protein binding: 91% to 99%
Metabolism: Hepatic
Half-life elimination: Terminal: 10-12 hours
Time to peak, serum: 2-2.5 hours
Excretion: Feces (as glucuronide conjugates and unchanged drug)
 
   
 
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