Country: United States
Language: English
Source: NLM (National Library of Medicine)
EPTIFIBATIDE (UNII: NA8320J834) (EPTIFIBATIDE - UNII:NA8320J834)
Hainan Poly Pharm. Co., Ltd.
INTRAVENOUS
PRESCRIPTION DRUG
Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new MI, or need for urgent intervention in patients undergoing PCI, including those undergoing intracoronary stenting [see Clinical Studies ( 14.1, 14.2)] . Treatment with eptifibatide injection 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 antihyperte
Eptifibatide injection is supplied as a sterile solution in 10-mL vials containing 20 mg of eptifibatide (NDC 14335-070-01) and 100-mL vials containing 75 mg of eptifibatide (NDC 14335-071-01). Vials should be stored refrigerated at 2-8°C (36-46°F). Vials may be transferred to room temperature storage* for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a “DISCARD BY” date (2 months from the transfer date or the labeled expiration date, whichever comes first). Protect from light until administration. *Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
EPTIFIBATIDE- EPTIFIBATIDE INJECTION HAINAN POLY PHARM. CO., LTD. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE EPTIFIBATIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EPTIFIBATIDE INJECTION. EPTIFIBATIDE INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1998 INDICATIONS AND USAGE Eptifibatide injection is a platelet aggregation inhibitor indicated for: Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) ( 1.1) Treatment of patients undergoing PCI (including intracoronary stenting) ( 1.2) DOSAGE AND ADMINISTRATION 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) DOSAGE FORMS AND STRENGTHS 20 mg/10 mL (2 mg/mL) in a single-dose vial for bolus injection. ( 3) 75 mg/100 mL (0.75 mg/mL) in a single-dose vial for infusion. ( 3) CONTRAINDICATIONS 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) WARNINGS AND PRECAUTIONS Eptifibatide injection can cause serious bleeding. If bleeding cannot be controlled, discontinue eptifibatide injection immediately. Minimize vascular and other traumas. If heparin is given concomitantly, monitor aPTT or ACT. ( 5.1) Thrombocytopenia: Discontinue eptifibatide injection and heparin. Monitor and treat condition appropriately. ( 5.2) ADVERSE REACTIONS Bleeding and hypotension are the most commonly reported adverse reactions. ( 6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTA Read the complete document