EPTIFIBATIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EPTIFIBATIDE (UNII: NA8320J834) (EPTIFIBATIDE - UNII:NA8320J834)

Available from:

Accord Healthcare Inc.

INN (International Name):

EPTIFIBATIDE

Composition:

EPTIFIBATIDE 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 antihypertensive therapy - Major surgery within the preceding 6 weeks - Histo

Product summary:

Eptifibatide injection is supplied as a sterile solution in 10-mL vials containing 20 mg of eptifibatide (NDC 16729-260-03) and 100-mL vials containing either 75 mg of eptifibatide (NDC 16729-259-38) or 200 mg of eptifibatide (NDC 16729-260-38). Vials should be stored refrigerated at 2°-8°C (36°-46°F). Vials may be transferred to room temperature storage 1 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EPTIFIBATIDE- EPTIFIBATIDE INJECTION, SOLUTION
ACCORD HEALTHCARE INC.
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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 <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-use vial for bolus injection ( 3)
75 mg/100 mL (0.75 mg/mL) in a single-use vial for infusion ( 3)
200 mg/100 mL (2 mg/mL) in a single-use 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.