EPTIFIBATIDE INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

EPTIFIBATIDE

Disponibil de la:

OMEGA LABORATORIES LIMITED

Codul ATC:

B01AC16

INN (nume internaţional):

EPTIFIBATIDE

Dozare:

2MG

Forma farmaceutică:

SOLUTION

Compoziție:

EPTIFIBATIDE 2MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

100ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PLATELET AGGREGATION INHIBITORS

Rezumat produs:

Active ingredient group (AIG) number: 0137621002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2013-08-08

Caracteristicilor produsului

1
PRODUCT MONOGRAPH
Pr
EPTIFIBATIDE INJECTION
Intravenous Solution
2 mg/mL bolus Injection
0.75 mg/mL Injection (as infused)
PLATELET AGGREGATION INHIBITOR
Omega Laboratories Ltd.
11 177 Hamon Street
Montréal, Québec
H3M 3E4
Date of Revision:
July 29, 2013
Control # : 157026
2
PRODUCT MONOGRAPH
Pr
EPTIFIBATIDE INJECTION
PLATELET AGGREGATION INHIBITOR
ACTION AND CLINICAL PHARMACOLOGY
GENERAL: Eptifibatide reversibly inhibits platelet aggregation by
preventing the binding of
fibrinogen, von Willebrand factor and other adhesive ligands to
glycoprotein IIb/IIIa (GP
IIb/IIIa). When administered intravenously, eptifibatide inhibits _ex
vivo _platelet aggregation in
a dose- and concentration-dependent manner. Platelet aggregation
inhibition is reversible
following cessation of eptifibatide; this is thought to result from
dissociation of eptifibatide
from the platelet receptor.
PHARMACODYNAMICS:
Eptifibatide
inhibits
platelet
aggregation
induced
by
adenosine
diphosphate (ADP) and other agonists in a dose- and
concentration-dependent manner. The
effect of eptifibatide is observed immediately after administration of
a 180 μg/kg intravenous
bolus. When followed by a 2.0 μg/kg/min continuous infusion, this
regimen produces a >80%
inhibition of 20 μM ADP-induced _ ex vivo _ platelet aggregation, (at
physiologic calcium
concentrations) in more than 80% of patients, after more than 8 hours
of infusion. Platelet
inhibition was reversed, with a >50% return of platelet function
towards baseline 4 hours after
discontinuation of an infusion of 2.0 μg/kg/min.
The eptifibatide dosing regimen used in the ESPRIT study was similar
to that used in the
PURSUIT study (a 180 μg/kg bolus followed by a 2.0 μg/kg/min
infusion), but added a
second 180 μg/kg bolus ten minutes after the first bolus to avoid a
transient decrease in
platelet aggregation inhibition before reaching steady-state with the
continuous 2.0 μg/kg/min
infusion. This dosing regimen is recommended in order to maintain
platelet aggregation
inhibition above 80% in the