Eptifibatide is a platelet aggregation inhibitor sold in the U.S. under 2 brand and generic names, for unstable angina, coronary disease and myocardial infarction. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Eptifibatide (application ANDA203258). Other eptifibatide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Before infusion of eptifibatide injection, the following laboratory tests should be performed to identify pre-existing hemostatic abnormalities: hematocrit or hemoglobin, platelet count, serum creatinine, and PT/aPTT. In patients undergoing PCI, the activated clotting time (ACT) should also be measured. The activated partial thromboplastin time (aPTT) should be maintained between 50 and 70 seconds unless PCI is to be performed. In patients treated with heparin, bleeding can be minimized by close monitoring of the aPTT and ACT. ACS or PCI: 180 mcg/kg IV bolus as soon as possible after diagnosis followed by infusion at 2 mcg/kg/min. ( 2.1 , 2.2 ) PCI: Add a second 180 mcg/kg bolus at 10 minutes. ( 2.2 ) In patients with creatinine clearance less than 50 mL/min, reduce the infusion to 1 mcg/kg/min. ( 2.1 , 2.2 , 2.3 ) 2.1 Dosage in Acute Coronary Syndrome (ACS) Indication Normal Renal Function Creatinine Clearance less than 50 mL/min Patients with ACS 180 mcg/kg intravenous (IV) bolus as soon as possible after diagnosis, followed by continuous infusion of 2 mcg/kg/min 180 mcg/kg IV bolus as soon as possible after diagnosis, followed by continuous infusion of 1 mcg/kg/min • Infusion should continue until hospital discharge or initiation of coronary artery bypass graft surgery (CABG), up to 72 hours • If a patient is to undergo PCI, the infusion should be continued until hospital…
The following serious adverse reaction is also discussed elsewhere in the labeling: • Bleeding [see Contraindications (4) and Warnings and Precautions (5.1) ] Bleeding and hypotension are the most commonly reported adverse reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. A total of 16,782 patients were treated in the Phase III clinical trials (Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Eptifibatide Therapy (PURSUET), Enhanced Suppression of the Platelet IIb/IIIa Receptor with Eptifibatide Therapy (ESPRET), and Eptifibatide to Minimize Platelet Aggregation and Prevent Coronary Thrombosis II (EMPACT II)) [see Clinical Studies (14)] . These 16,782 patients had a mean age of 62 years (range: 20 to 94 years). Eighty-nine percent of the patients were Caucasian, with the remainder being predominantly Black (5%) and Hispanic (5%). Sixty-eight percent were men. Because of the different regimens used in PURSUET, EMPACT II, and ESPRET, data from…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 60/100 | Prescription | Injectable | — | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | — | — | View → |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Eptifibatide Injection
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Slate Run Pharmaceuticals · Feb 12, 2026
Eptifibatide injection 20mg/10mL (2mg/mL)
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Eugia US LLC · May 22, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Treatment with eptifibatide is contraindicated in patients with: • A history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days • Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) not adequately controlled on antihypertensive therapy • Major surgery within the preceding 6 weeks • History of stroke within 30 days or any history of hemorrhagic stroke • Current or planned administration of another parenteral GP IIb/IIIa inhibitor • Dependency on renal dialysis • Hypersensitivity to eptifibatide or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria) • Bleeding diathesis or bleeding within the previous 30 days ( 4 ) • Severe uncontrolled hypertension ( 4 ) • Major surgery within the preceding 6 weeks ( 4 ) • Stroke within 30 days or any history of hemorrhagic stroke ( 4 ) • Coadministration of another parenteral GP IIb/IIIa inhibitor ( 4 ) • Dependency on renal dialysis ( 4 ) • Known hypersensitivity to any component of the product ( 4 )
Coadministration of antiplatelet agents, thrombolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. Avoid concomitant use with other glycoprotein (GP) IIb/IIIa inhibitors. ( 7.1 ) 7.1 Use of Thrombolytics, Anticoagulants, and Other Antiplatelet Agents Coadministration of antiplatelet agents, thrombolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. Concomitant treatment with other inhibitors of platelet receptor GP IIb/IIIa should be avoided.