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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WB Saunders Company; The primary endpoint was the composite of death, MI, or urgent revascularization, analyzed at 30 days after randomization in all patients who received at least 1 dose of study drug.
There have been reports of acute, profound thrombocytopenia immune-mediated and packzge mediated with Eptifibatide Injection. Safety and effectiveness of Eptifibatide Injection in pediatric patients have not been studied.
No long-term studies in animals have been performed to evaluate the carcinogenic potential of eptifibatide. Administration of Integrilin is associated with an increase in major and minor bleeding, as classified by the criteria of the Thrombolysis in Myocardial Infarction Study group TIMI [see Adverse Reactions 6.
The mL vial should be spiked with a vented infusion set. These 16, patients had a mean age of 62 years range: None of these patients experienced an intracranial bleed or other major bleeding. Before infusion of Eptifibatide Injection, the following laboratory tests should be performed to identify pre-existing hemostatic abnormalities: The potential for development of antibodies to eptifibatide has been studied in subjects.
Dilution Eptifibatide – Integrilin ® – GlobalRPH
Clinical pharmacology of eptifibatide. Because many drugs are excreted in human milk, caution should be exercised when Integrilin is administered to a nursing mother. The need for thrombotic “bailout” was significantly reduced with Integrilin at 48 hours 2. 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 Integrilin infusion was continued for 24 hours after the procedure, allowing for a duration of infusion up to 96 hours.
Use the Cockcroft-Gault equation with actual body weight to calculate creatinine clearance: Minimize the use of arterial and venous punctures, intramuscular injections, and the use of urinary catheters, nasotracheal intubation, and nasogastric tubes. Disposition of 14 C-eptifibatide after intravenous administration to healthy men.
Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl des-amino cysteinyl residue. Impact of eptifibatide on early ischemic events in acute ischemic coronary syndromes: Maximal inhibition of platelet aggregation occurs within 15 minutes following IV administration and is rapidly reversible.
Administer Eptifibatide Injection by volume according to patient weight see Table 1. Each vial of either size also contains 5.
Recent antiplatelet drug trials in the acute coronary syndromes. All of the effect of Integrilin was established within 72 hours during the period of drug infusionregardless of management strategy.
In these studies, eptifibatide inhibited ex vivo platelet aggregation induced by adenosine diphosphate ADP and other agonists in a intevrilin and concentration-dependent manner. Administer by IV injection ontegrilin by IV infusion using a controlled-infusion device e. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another integrilln and may not reflect the rates observed in clinical practice.
Eptifibatide Injection Dosage Form: Integrilin should be given concomitantly with heparin dosed to achieve the following parameters:.
Eptifibatide Injection – FDA prescribing information, side effects and uses
Patients were randomly assigned to 1 of 3 treatment regimens, each incorporating a bolus dose initiated immediately prior to PCI followed by a continuous infusion lasting 20 to 24 hours:. Personal communication on tirofiban. Maximum IV infusion of 72 hours. Importance of advising patients of other important precautionary information.
Timing of events after hospitalization for acute coronary syndromes. Eptifibatide Injection is a clear, colorless, sterile, non-pyrogenic solution for intravenous IV use with an empirical formula of C 35 H 49 N 11 O 9 S 2 and a molecular weight of Instruct patients to inform the doctor or paackage provider about any medical conditions, medications, and allergies.
Vials may be transferred to room temperature storage for a period not to exceed 2 months.
A treatment benefit in patients who received Integrilin was seen by innsert hours and at the end of the day observation period. The role of plaque pathology in coronary thrombosis.
In any case, both heparin and Integrilin should be discontinued and sheath hemostasis should be achieved at least 2 to 4 hours before hospital discharge.
Drug Interaction Comments Anticoagulants, oral Potential increased risk of bleeding 1 Use with caution 1 Dipyridamole Potential increased risk of bleeding 1 Use with caution 1 Enoxaparin Pharmacokinetic or pharmacodynamic e. Infegrilin risk-benefit assessment of abciximab in angioplasty.