Applies to the following strengths: 2 mg/mL
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for High Risk Percutaneous Transluminal Angioplasty
Loading dose: 0.25 mg/kg IV one time 10 to 60 minutes before the start of PTCA.
Maintenance dose: 10 mcg/min by continuous IV infusion for 12 hours.
Patients with unstable angina refractory to conventional medical therapy in whom PTCA is planned within 24 hours should receive the same initial recommended dosage of 0.25 mg/kg ideal body weight intravenously once as a loading dose, followed by a 10 mcg/min continuous intravenous infusion for 18 to 24 hours before the PTCA and concluding 1 hour after the procedure.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Use of abciximab is contraindicated in the following situations: active internal bleeding; clinically significant GI or GU bleeding within 6 weeks; a history of cerebrovascular accident (CVA) within 2 years or CVA with a residual neurological deficit; bleeding diathesis; administration of oral anticoagulants within 7 days unless the prothrombin time is less than or equal to 1.2 times control; thrombocytopenia (less than 100,000 cells/mcL); major surgery or trauma within 6 weeks; intracranial neoplasm, arteriovenous malformation, or aneurysm; severe uncontrolled hypertension; presumed or documented history of vasculitis; use of IV dextran before PTCA or intent to use it during PTCA.
Administration of abciximab is associated with an increased frequency of major bleeding complications, including retroperitoneal bleeding, spontaneous gastrointestinal (GI) and genitourinary (GU) bleeding, and bleeding at the arterial access site. This risk is further increased when abciximab is used in combination with heparin and aspirin, other anticoagulants, or thrombolytics. However, as demonstrated in the EPILOG trial using weight adjusted abciximab infusion and low-dose weight adjusted heparin dosing, this risk can be minimized by the use of appropriate abciximab and heparin dosing and other precautionary measures. Most major bleeding occurs at the site of vascular access. The risk of major bleeding is increased in patients who weigh less than 75 kg (associated with standard heparin dosing), who are greater than 65 years old, female, those presenting with an acute myocardial infarction, or when the coronary intervention procedure is prolonged. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities and qualified physicians are readily available.
Risk factors for bleeding events in patients treated with glycoprotein (GP) IIb/IIIa inhibitors undergoing percutaneous coronary intervention (PCI) have been identified and include advanced age, renal dysfunction, female gender, peripheral vascular disease, lower body weight, lower baseline hemoglobin, diabetes, and elevated peak activated clotting time. According to one study (CRUSADE trial) involving patients with non ST segment elevation acute coronary syndrome (NSTEACS) treated with a GPIIb/IIIa inhibitor, women are at a greater risk of bleeding than men, primarily because of excessive dosing. Results of another study indicate that among patients with NSTEACS undergoing a PCI, compared with men, women experienced a greater incidence of major and minor bleeding complications and required more transfusions of blood products.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Data not available
The safety and efficacy of abciximab has only been investigated with concomitant administration of heparin and aspirin.
In patients with failed PTCAs, 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.
In patients with non ST segment elevation acute coronary syndrome (NSTEACS) undergoing a percutaneous coronary intervention (PCI), use of abciximab in men provides greater benefit and is associated with a lower risk of bleeding complications than women.
The results of a retrospective analysis indicate that in patients with NSTEACS undergoing PCI, abciximab efficacy appears to be age dependent, with greater benefit in younger patients (age 70 years or younger). Patients older than 70 years had a greater incidence of death, bleeding, and thrombocytopenia than younger patients. In addition, older patients required blood transfusions more often than younger patients within 30 days after PCI.
Monitor platelet counts prior to treatment with abciximab, 2 to 4 hours after the bolus dose, and at 24 hours or before discharge, whichever occurs first.
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