PIPERACILLIN FOR INJECTION POWDER FOR SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

PIPERACILLIN (PIPERACILLIN SODIUM)

Verfügbar ab:

FRESENIUS KABI CANADA LTD

ATC-Code:

J01CA12

INN (Internationale Bezeichnung):

PIPERACILLIN

Dosierung:

2G

Darreichungsform:

POWDER FOR SOLUTION

Zusammensetzung:

PIPERACILLIN (PIPERACILLIN SODIUM) 2G

Verabreichungsweg:

INTRAMUSCULAR

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

EXTENDED-SPECTRUM PENICILLINS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0115403001; AHFS:

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2021-10-07

Fachinformation

PRODUCT MONOGRAPH
PR
PIPERACILLIN FOR INJECTION
USP
2 g, 3 g and 4 g Single-Use Vial
40 g Pharmacy Bulk Vial
Antibiotic
FRESENIUS KABI CANADA LTD.
Date of Revision:
165 Galaxy Blvd, Suite 100
April 14, 2020
Toronto, ON M9W 0C8
Submission Control Number: 233968
Piperacillin for Injection - Product Monograph_ _Page 2 of 38
PRODUCT MONOGRAPH
PR
PIPERACILLIN FOR INJECTION
2 g, 3 g and 4 g Single-Use Vial
40 g Pharmacy Bulk Vial
Antibiotic
ACTIONS AND CLINICAL PHARMACOLOGY
Piperacillin is a semi-synthetic beta-lactam antibiotic which is
bactericidal and exerts its
antibacterial action by inhibiting both septum and cell-wall synthesis
in the bacterial cell.
Piperacillin was shown to have a particularly high affinity for PBP-3
and also a high affinity for
PBP-1A, -1B and -2 of _Escherichia coli_ and _pseudomonas_. These
results indicate that the
enzymes involved in septum (PBP-3) and cell-wall (PBP-1A, -1B)
synthesis and in the
maintenance of the shape (PBP-2) of the bacterium are the primary
sites of action of piperacillin.
Piperacillin is eliminated primarily (60 ‒ 80%) by glomerular
filtration and tubular secretion as
unchanged drug in the urine. The mean elimination half-life is 54
minutes after the
administration of 2 grams and 63 minutes following 6 grams. The
elimination half-life is
increased two-fold in mild to moderate renal impairment and five- to
six-fold in severe renal
impairment.
INDICATIONS AND CLINICAL USES
Piperacillin for Injection is recommended for the treatment of
systemic and local infections due
to susceptible strains of gram-negative and gram-positive aerobic and
anaerobic bacteria listed
below. Because of its broad spectrum activity, Piperacillin for
Injection is also suitable for the
therapy of mixed infections, and the presumptive therapy of serious
infections, when
piperacillin-sensitive pathogens are suspected as the cause of
disease.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Piperacillin for Injection and other antibacterial drugs, Piperacilli