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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Sixty-eight percent were men.
Guidelines for the diagnosis and management of unstable angina and non-Q-wave myocardial infarction: Different dose regimens of eptifibatide were used in the major intrgrilin studies. The following serious adverse reaction is also discussed elsewhere in the labeling:. Discard any unused portion left in the vial.
Infusion should be continued inserr hospital discharge, or for up to 18 to 24 hours, whichever comes first. Use contraindicated in patients undergoing renal dialysis. 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.
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. For continuous IV insdrt, spike the mL integrliin with a vented infusion set; center spike within the circle on stopper top. Trials in myocardial infarction.
No substantial differences in efficacy relative to younger adults.
Integrilin Monograph for Professionals –
Percutaneous Coronary Intervention PlavixclopidogrelAngiomaxbivalirudineptifibatidecangrelorMore Product information form for American hospital formulary service: All of the effect of Integrilin was established within 72 hours during the period of packaeg infusionregardless of management strategy.
Table 5 also shows the incidence of the components of the primary endpoint, death whether or not preceded by an MI and new MI in surviving patients at 30 days. An interchain disulfide bridge is formed between the cysteine amide and the inttegrilin moieties. 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.
If bleeding cannot be controlled by pressure, discontinue eptifibatide and concomitant heparin immediately. This was a “real world” study; each patient was managed according to the usual standards of the investigational site; frequencies of angiography, PCI, and CABG therefore differed widely from site to site and from country to country.
Pharmacokinetic or pharmacodynamic e. When obtaining intravenous access, avoid non-compressible sites e. This relationship was most apparent for patients weighing less than 70 kg.
Monitor serial platelet counts, assess the presence of drug-dependent antibodies, and treat as appropriate [see Adverse Inseft 6. Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl des-amino cysteinyl residue. Platelet aggregation usually returns to normal within 4—8 hours after discontinuing therapy. Administration of Intevrilin is associated with an insett in major and minor bleeding, as classified by the criteria of the Thrombolysis in Myocardial Infarction Study group TIMI [see Integrilinn Reactions 6.
No incompatibilities observed with IV administration sets; no compatibility studies performed with polyvinyl chloride PVC bags. The activated partial thromboplastin time aPTT should be maintained between 50 and 70 seconds unless PCI is to be performed.
Differences among ethnic groups have not been assessed. A minimum of 12 hours of infusion is recommended. A treatment benefit in patients who received eptifibatide was seen by 48 hours and at the end of the day observation period. No long-term studies in animals have been performed to evaluate the carcinogenic potential of eptifibatide. WB Saunders Company; A total of patients underwent PCI within 72 hours after randomization, in which case they received intravenous heparin to maintain an ACT of to seconds.
There are, however, no adequate and well-controlled studies in pregnant women with Integrilin. Available for Android and iOS devices. Percutaneous coronary intervention and adjunctive pharmacotherapy in women: Most major bleeding associated with Integrilin has been at the arterial access site for cardiac catheterization or from the gastrointestinal or genitourinary tract.
In a baboon model that is refractory to aspirin and heparin, doses of eptifibatide that inhibit aggregation prevented acute thrombosis with only a modest prolongation 2- to 3-fold of the bleeding time. No incompatibilities have been observed with intravenous administration sets. Eli Lilly and Company. Bleeding at “other” locations occurred in 0.
In the PURSUIT study, the greatest increase in major bleeding in Integrilin-treated patients compared to placebo-treated patients was also associated with bleeding at the femoral artery access site 2.
Medical Economics Company Inc; Denominators are based on the total number of patients whose TIMI classification was resolved. This was a “real world” study; each patient was managed according to the usual standards of the investigational site; frequencies of angiography, PCI, and CABG therefore differed widely from site to site and from country to country.
As shown in Table 9, the treatment effect of eptifibatide seen at 48 hours and 30 days appeared preserved at 6 months and 1 year.