Dipyridamole

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Dipyridamole Recall

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Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Dipyridamole Tablets, USP are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.

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History

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Other Information

Dipyridamole, USP is a platelet inhibitor chemically described as 2,2',2'',2'''-[(4,8-Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula:

Dipyridamole is an odorless yellow crystalline powder, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and practically insoluble in water.

Dipyridamole Tablets USP, 25 mg, 50 mg and 75 mg for oral administration contain 25 mg, 50 mg, and 75 mg of dipyridamole, USP, respectively.

Inactive ingredients for Dipyridamole Tablets USP, 25 mg, 50 mg, and 75 mg: microcrystalline cellulose, povidone, crospovidone, lactose monohydrate, colloidal silicon dioxide, magnesium stearate, FD&C Red # 40 aluminum lake, FD&C Yellow #6 aluminum lake, lecithin, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Sources

Dipyridamole Manufacturers

Lannett Company, Inc.

Dipyridamole | Lannett Company, Inc.

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement

The recommended dose is 75 to 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.

No Recall
Cadila Healthcare Limited

Dipyridamole | Cadila Healthcare Limited

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement:

The recommended dose is 75 to 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.

No Recall
Zydus Pharmaceuticals (Usa) Inc.

Dipyridamole | Zydus Pharmaceuticals (usa) Inc.

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement:
The recommended dose is 75 to 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.

No Recall
West-ward Pharmaceutical Corp.

Dipyridamole | West-ward Pharmaceutical Corp.

The dose of intravenous Dipyridamole Injection as an adjunct to thallium myocardial perfusion imaging should be adjusted according to the weight of the patient. The recommended dose is 0.142 mg/kg/min (0.57 mg/kg total) infused over 4 minutes. Although the maximum tolerated dose has not been determined, clinical experience suggests that a total dose beyond 60 mg is not needed for any patient.
Prior to intravenous administration, Dipyridamole Injection should be diluted in at least a 1:2 ratio with sodium chloride injection 0.45%, sodium chloride injection 0.9% or dextrose injection 5% for a total volume of approximately 20 to 50 mL. Infusion of undiluted dipyridamole may cause local irritation.

Thallium-201 should be injected within 5 minutes following the 4-minute infusion of dipyridamole.

Do not mix Dipyridamole Injection with other drugs in the same syringe or infusion container.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
General Injectables & Vaccines, Inc

Dipyridamole | General Injectables & Vaccines, Inc

The dose of intravenous Dipyridamole Injection as an adjunct to thallium myocardial perfusion imaging should be adjusted according to the weight of the patient. The recommended dose is 0.142 mg/kg/min (0.57 mg/kg total) infused over 4 minutes. Although the maximum tolerated dose has not been determined, clinical experience suggests that a total dose beyond 60 mg is not needed for any patient.
Prior to intravenous administration, Dipyridamole Injection should be diluted in at least a 1:2 ratio with sodium chloride injection 0.45%, sodium chloride injection 0.9% or dextrose injection 5% for a total volume of approximately 20 to 50 mL. Infusion of undiluted dipyridamole may cause local irritation. Thallium-201 should be injected within 5 minutes following the 4-minute infusion of dipyridamole. Do not mix Dipyridamole Injection with other drugs in the same syringe or infusion container.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Roxane Laboratories, Inc.

Dipyridamole | Roxane Laboratories, Inc.

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement. 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.

No Recall
Anazaohealth Corporation

Dipyridamole | Anazaohealth Corporation

The recommended dose is 0.142 mg/kg/minute (0.57 mg/kg total) or 0.568 mg/kg or 60 mg total dose infused over 4 minutes. Although the maximum tolerated dose has not been determined, clinical experience suggests that a total dose beyond 60 mg is not needed for any patient.

Prior to intravenous administration, dipyridamole should be diluted in at least a 1:2 ratio with 0.45% sodium chloride injection, 0.9% sodium chloride injection, or 5% dextrose injection for a total volume of approximately 20 to 50 mL. Infusion of undiluted dipyridamole injection may cause local irritation.

Myocardial perfusion assessment should be started when maximal vasodilation is reached, usually after 3 minutes, which generally occurs approximately 7 minutes from onset of infusion

No Recall
Rising Pharmaceuticals, Inc.

Dipyridamole | Rising Pharmaceuticals, Inc.

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement. The recommended dose is 75 mg to 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.

No Recall
Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Dipyridamole | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement:
The recommended dose is 75 to 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.

No Recall
Avkare, Inc.

Dipyridamole | Avkare, Inc.

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement. The recommended dose is 75 to 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.

No Recall
Cardinal Health

Dipyridamole | Cardinal Health

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement. The recommended dose is 75 to 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.

No Recall
Cardinal Health

Dipyridamole | Cardinal Health

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement.
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.

No Recall
Barr Laboratories Inc.

Dipyridamole | Barr Laboratories Inc.

Adjunctive Use In Prophylaxis Of Thromboembolism After Cardiac Valve Replacement
The recommended dose is 75 to 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.

No Recall
Major Pharmaceuticals

Dipyridamole | Major Pharmaceuticals

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement.
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.

No Recall
Global Pharmaceuticals, Division Of Impax Laboratories Inc.

Dipyridamole | Global Pharmaceuticals, Division Of Impax Laboratories Inc.

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement
The recommended dose is 75 to 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.

No Recall
Avpak

Dipyridamole | Avpak

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement. The recommended dose is 75 to 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.

No Recall