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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For IV injection, withdraw appropriate dose from the mL vial and administer undiluted. If a patient with low platelet counts is receiving Integrilin, their platelet count should be monitored closely.
Stroke in patients with acute coronary syndromes: Drug Interaction Comments Integdilin, 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. Instruct patients to inform the doctor or healthcare provider about any medical conditions, medications, and allergies. Aspirin, to mg, should be given 1 to 24 hours prior to PCI and daily thereafter.
Integrilin – FDA prescribing information, side effects and uses
Percutaneous Coronary Intervention PlavixclopidogrelAngiomaxbivalirudineptifibatidecangrelorMore Patients in clinical studies were older range: The incidence of bleeding complications was higher in the elderly in both pckage and Integrilin groups, and the incremental risk of Integrilin-associated bleeding was greater in the older patients.
Elderly patients with coronary artery disease demonstrated higher plasma levels and lower total body clearance of eptifibatide when given the same dose as younger patients.
An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Platelet aggregation inhibition is reversible following cessation of the eptifibatide infusion; this is thought to result from dissociation of eptifibatide from the platelet.
Receptor Suppression Using Eptifibatide Therapy. Low molecular weight heparin in acute coronary syndrome: 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:.
ReoPro abciximab injection for intravenous administration prescribing information. The overall incidence of stroke was 0. The ESPRET study was a multicenter, double-blind, randomized, placebo-controlled study conducted in the United States and Canada that enrolled patients undergoing elective integripin urgent PCI with intended intracoronary stent placement.
The eptifibatide peptide is produced by solution-phase peptide synthesis, and is purified by preparative reverse-phase liquid chromatography and lyophilized. Safety and effectiveness of Eptifibatide Injection in pediatric patients have not been studied. There have been reports of acute, profound thrombocytopenia immune-mediated and non-immune mediated with Integrilin. Kaul S, Shah PK.
Administer Integrilin by volume according to patient weight lackage Table 1. Print this page Add to My Med List. Plavix clopidogrel bisulfate tablets prescribing information. Patients received a wide variety of stents. These findings suggest acute thrombocytopenia after the administration of Eptifibatide Injection can develop as a result of naturally occurring drug-dependent antibodies or those induced by prior exposure to Eptifibatide Injection.
Monitor serial platelet counts, assess the presence of drug-dependent antibodies, and treat as appropriate [see Adverse Reactions 6.
In patients undergoing PCI, treatment with Integrilin is associated with an increase in major and minor bleeding at the site of arterial sheath placement. To avoid vascular and other trauma, minimize needle punctures e. A total of patients underwent PCI within 72 hours after randomization, in which case they received intravenous heparin to maintain an ACT of to packagr.
Eptifibatide was studied in 3 placebo-controlled, randomized studies. Heparin use is discouraged after the PCI procedure. From in vitro studies, eptifibatide is not extensively bound to plasma proteins and thus may be cleared from plasma inserh dialysis.
Dilution Eptifibatide – Integrilin ® – GlobalRPH
The development of antibodies to eptifibatide at higher doses has not packwge evaluated. It is not known whether eptifibatide is excreted in human milk.
pacakge The majority of patients received aspirin mg once daily. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients.
Patients Overall incidence imtegrilin major bleeding 9. Loscalzo J, Braunwald E. Summary basis of approval: Each vial of either size also contains 5. There has been only limited experience with overdosage of Integrilin. If a patient with low platelet counts is receiving Eptifibatide Injection, their platelet count should be monitored closely.