EPTIFIBATIDE injection

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Baxter Healthcare Corporation

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 is contraindicated in patients with: Risk Summary Available data on eptifibatide use in pregnant women from published literature and the pharmacovigilance database are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Untreated myocardial infarction can be fatal to the pregnant woman and fetus (see Clinical Considerations ). In animal reprod

उत्पाद समीक्षा:

Eptifibatide injection is supplied as a refrigerated, premixed, sterile, non-pyrogenic solution in single-dose Galaxy containers packed in individual cartons. The single-dose Galaxy plastic containers are available as follows: Code NDC No. Container Strength Number of Cartons 2G3476 0338-9558-10 Galaxy single-dose 75 mg per 100 mL (0.75 mg per mL) 12 Cartons Galaxy containers should be stored refrigerated at 2-8°C (36-46°F). Galaxy containers may be transferred to room temperature storage1 for a period not to exceed 2 months. Upon transfer, Eptifibatide injection 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. Retain in carton until time of use. Discard unused portion. 1 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

EPTIFIBATIDE- EPTIFIBATIDE INJECTION
BAXTER HEALTHCARE CORPORATION
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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 INFUSION ONLY; NOT FOR
INTRAVENOUS BOLUS USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Eptifibatide injection is a platelet aggregation inhibitor indicated
for:
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DOSAGE AND ADMINISTRATION
Eptifibatide injection in GALAXY container is for intravenous infusion
only, not for intravenous bolus use.
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
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Bleeding and hypotension are the most commonly reported adverse
reactions.(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAXTER HEALTHCARE AT
1-866-888-2472 OR
FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
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)
Injection: 75 mg of eptifibatide per 100 mL in a single-dose GALAXY
container. (3)
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)
Eptifibatide can cause serious bleedin