Abciximab for Injection
Clotinab (abxicimab) is indicated as an adjunct to percutaneous coronary intervention for the prevention of cardiac ischemic complications:
• in patients undergoing percutaneous coronary intervention
• in patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours Safety and efficacy of Clotinab use in patients not undergoing percutaneous coronary intervention have not been established. Clotinab is intended for use with aspirin and heparin and has been studied only in that setting.
The safety and efficacy of Clotinab (abciximab) have only been investigated with concomitant administration of heparin and aspirin. In patients with failed percutaneous coronary interventions, the continuous infusion of Clotinab should be stopped because there is no evidence for Clotinab efficacy in that setting. In the event of serious bleeding that cannot be controlled by compression, Clotinab and heparin should be discontinued immediately.
The recommended dosage of Clotinab in adults is a 0.25 mg/kg intravenous bolus administered 10-60 minutes before the start of percutaneous coronary intervention, 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 percutaneous coronary intervention within 24 hours may be treated with an Clotinab 0.25 mg/kg intravenous bolus followed by an 18 to 24-hour intravenous infusion of 10 μg/min, concluding one hour after the percutaneous coronary intervention.
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