EPTIFIBATIDE INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

EPTIFIBATIDE

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

B01AC16

INN (nume internaţional):

EPTIFIBATIDE

Dozare:

0.75MG

Forma farmaceutică:

SOLUTION

Compoziție:

EPTIFIBATIDE 0.75MG

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: 0137621001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2018-04-30

Caracteristicilor produsului

1
PRODUCT MONOGRAPH
Pr
EPTIFIBATIDE INJECTION
(eptifibatide)
Intravenous Solution
2 mg/mL Bolus Injection
0.75 mg/mL Injection (as infused)
PLATELET AGGREGATION INHIBITOR
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
April 12, 2013
Toronto, Ontario
M1B 2K9
Control Number: 129162, 153988
2
PRODUCT MONOGRAPH
PR
EPTIFIBATIDE INJECTION
(EPTIFIBATIDE)
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
agg