ANNEX I. SUMMARY OF PRODUCT CHARACTERISTICS. 1 INTEGRILIN is indicated for the prevention of early myocardial infarction in adults presenting. Package leaflet: Information for the patient. Integrilin mg/ml solution for infusion eptifibatide. Read all of this leaflet carefully before you start using this. 1. Package leaflet: Information for the patient. Eptifibatide Accord 2 mg/ml solution for injection eptifibatide. Read all of this leaflet carefully before you start using.
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A target aPTT of 50 to 70 seconds was recommended. Subscribe to receive email notifications whenever new articles are published. Minimize the use of arterial and venous punctures, intramuscular injections, and the use of urinary catheters, nasotracheal intubation, and nasogastric tubes. Vials may be transferred to room temperature storage for a period not to exceed 2 months.
Pursuing progress in acute coronary syndromes. After PCI, Integrilin infusion should be continued until hospital discharge or up to 18 to 24 hours, whichever comes first. Risk factors for bleeding include older age, a history of bleeding disorders, and concomitant use of drugs that increase the risk of bleeding thrombolytics, oral anticoagulants, nonsteroidal anti-inflammatory drugs, and P2Y 12 inhibitors.
Patients Overall incidence of major bleeding 9. Percutaneous Coronary Intervention PlavixclopidogrelAngiomaxbivalirudineptifibatidecangrelorMore Increased risk of bleeding, including that requiring blood transfusions 1 5 Unstable angina and non-Q wave myocardial infarction: No long-term studies in animals have been performed to evaluate the carcinogenic potential of eptifibatide.
This relationship was most apparent for patients weighing less than 70 kg. Receptor Suppression Using Integrilin Therapy.
Recent antiplatelet drug trials integriln the acute coronary syndromes. Timing of events after hospitalization for acute coronary syndromes. A minimum of 12 hours of infusion is recommended.
Safety and effectiveness of Eptifibatide Injection in pediatric patients have not been studied. Pavkage reduction in the incidence of endpoint events in patients receiving eptifibatide was evident early during treatment, and this reduction was maintained through at least 30 days see Figure 1.
Not known whether eptifibatide is distributed into breast milk. No compatibility studies have been performed with PVC bags. In patients undergoing PCI, use caution in the placement, maintenance, and removal of vascular access sheath.
Most of the serious nonbleeding adverse reactions consisted of cardiovascular reactions typical of a UA population. Eptifibatide Injection Dosage Form: The ESPRET study was a multicenter, double-blind, randomized, placebo-controlled study conducted in the United States and Canada that enrolled inserrt undergoing elective or urgent PCI with intended intracoronary stent placement.
Platelet aggregation usually returns to normal within 4—8 hours after discontinuing therapy.
Administer Integrilin by volume according to patient weight see Table 1. For continuous IV infusion, spike the mL vial with a vented infusion set; center spike within the circle on stopper top. In both cases, plasma for antibody detection was collected approximately 30 days after each dose. Prior aspirin use predicts worse outcomes in patients with non-ST elevation acute coronary lnsert.
Integrilin – FDA prescribing information, side effects and uses
Different dose regimens of eptifibatide were used in the major clinical studies. Population pharmacokinetics PK and paackage PD of integrelin, a platelet aggregation inhibitor. Most of the benefit was in reduction of MI.
Acute profound thrombocytopenia, as well as immune-mediated thrombocytopenia, has been reported [see Adverse Reactions 6. History of stroke within 30 days or any history of hemorrhagic stroke.
Dilution Eptifibatide – Integrilin ® – GlobalRPH
Clinical pharmacology of eptifibatide. Denominator is based on patients for whom data are available. West Point, PA; The infusion was continued for 72 hours, until hospital discharge, or until the time of CABG, whichever occurred first, except that if PCI was performed, the eptifibatide infusion was continued for 24 hours after the procedure, allowing for a duration of infusion up to 96 hours.
Monitor serial platelet counts, assess the presence of drug-dependent antibodies, and treat as appropriate [see Adverse Reactions 6.
The ESPRIT study was a multicenter, double-blind, randomized, placebo-controlled study conducted in the United States and Canada that enrolled patients undergoing elective or urgent PCI with intended intracoronary stent placement. There was no apparent difference in efficacy between older and younger patients treated with Integrilin. Packaeg, NJ; Mar. If a patient with low platelet counts is receiving Eptifibatide Injection, their platelet count should be monitored closely.
Unstable angina in the US: Goa KL, Noble S. There has been only limited experience with overdosage of Integrilin.