INDICATIONS AND USAGE
Abciximab is indicated as an adjunct to percutaneous coronary intervention for the prevention of cardiac ischemic complications.
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in patients undergoing percutaneous coronary intervention
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in patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours
Safety and efficacy ofAbciximab use in patients not undergoing percutaneous coronary intervention have not beenestablished.
Abciximab is intended for use with aspirin and heparin and has been studied only in that setting, as described in CLINICAL STUDIES.
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DOSAGE AND ADMINISTRATION
The safety and efficacy of Abciximab have only been investigated with concomitant administration of heparin and aspirin as described in CLINICAL STUDIES.
In patients with failed PCIs, the continuous infusion of Abciximab should be stopped because there is no evidence for Abciximab efficacy in that setting.
In the event of serious bleeding that cannot be controlled by compression, Abciximab and heparin should be discontinued immediately.
The recommended dosage of Abciximab in adults is a 0.25 mg/kg intravenous bolus administered 10-60 minutes before the start of PCI, followed by a continuous intravenous infusion of 0.125 µg/kg/min (to a maximum of 10 µg/min) for 12 hours.
Patients with unstable angina not responding to conventional medical therapy and who are planned to undergo PCI within 24 hours may be treated with an Abciximab 0.25 mg/kg intravenous bolus followed by an 18- to 24-hour intravenous infusion of 10 µg/min, concluding one hour after the PCI.
INSTRUCTIONS FOR ADMINISTRATION
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Parenteral drug products should be inspected visually for particulate matter prior to administration. Preparations of Abciximab containing visibly opaque particles should NOT be used.
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Hypersensitivity reactions should be anticipated whenever protein solutions such as Abciximab are administered. Epinephrine, dopamine, theophylline, antihistamines and corticosteroids should be available for immediate use. If symptoms of an allergic reaction or anaphylaxis appear, the infusion should be stopped and appropriate treatment given.
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As with all parenteral drug products, aseptic procedures should be used during the administration of Abciximab.
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Withdraw the necessary amount of Abciximab for bolus injection into a syringe. Filter the bolus injection using a sterile, non-pyrogenic, low protein-binding 0.2 or 5µm syringe filter (Millipore SLGV025LS or SLSV025LS or equivalent).
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Withdraw the necessary amount of Abciximab for the continuous infusion into a syringe. Inject into an appropriate container of sterile 0.9% saline or 5% dextrose and infuse at the calculated rate via a continuous infusion pump. The continuous infusion should be filtered either uponadmixture using a sterile, non-pyrogenic, low protein-binding 0.2 or 5 µm syringe filter (Millipore SLGV025LS or SLSV025LS or equivalent) or upon administration using an in-line, sterile, non-pyrogenic, low protein-binding 0.2 or 0.22 µm filter (Abbott #4524 or equivalent). Discard the unused portion at the end of the infusion.
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No incompatibilities have been shown with intravenous infusion fluids or commonly used cardiovascular drugs. Nevertheless, Abciximab should be administered in a separate intravenous line whenever possible and not mixed with other medications.
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No incompatibilities have been observed with glass bottles or polyvinyl chloride bags and administration sets.
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