VANCOMYCIN HYDROCHLORIDE FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)

Available from:

STERIMAX INC

ATC code:

J01XA01

INN (International Name):

VANCOMYCIN

Dosage:

1G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 1G

Administration route:

INTRAVENOUS

Units in package:

20ML

Prescription type:

Prescription

Therapeutic area:

GLYCOPEPTIDES

Product summary:

Active ingredient group (AIG) number: 0131315009; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-11-28

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
VANCOMYCIN HYDROCHLORIDE FOR INJECTION
(Vancomycin Hydrochloride USP)
500 mg/vial, 1 g/vial, and 10 g/vial Vancomycin
ANTIBIOTIC
SteriMax Inc.
Date of Preparation:
1-2735 Matheson Blvd E
August 20, 2013
Mississauga, ON
L4W 4M8
Control No. 167324
Page 2 of 23
PRODUCT MONOGRAPH
NAME OF DRUG
PR
VANCOMYCIN HYDROCHLORIDE FOR INJECTION
(Vancomycin Hydrochloride USP)
500 mg/vial, 1 g/vial and 10 g/vial Vancomycin
THERAPEUTIC CLASSIFICATION
ANTIBIOTIC
ACTIONS AND CLINICAL PHARMACOLOGY
The bactericidal action of vancomycin against most gram-positive
bacteria results from the
inhibition of the biosynthesis of peptidoglycan polymers during the
second stage of cell wall
synthesis in dividing organisms. This effect occurs at a site
different from that of penicillins and
cephalosporins. The cytoplasmic membrane composition may also be
affected and membrane
permeability altered. There is also evidence that vancomycin
selectively inhibits RNA synthesis.
Vancomycin is a tricyclic glycopeptide antibiotic derived from
_Amycolatopsis orientalis_
(formerly _Nocardia orientalis_). It is primarily active against
gram-positive organisms including
staphylococci and streptococci. It is active against
methicillin-resistant strains of _Staphylococcus _
_aureus_ and _Staphylococcus epidermidis._
Vancomycin is poorly absorbed from the GI tract. It is given
intravenously for therapy of
systemic infections.
Following i.v. administration, vancomycin is widely distributed and
inhibitory concentrations of
vancomycin can be documented in the pericardial, pleural, ascetic and
synovial fluids. Low
concentrations of the drug may appear in CSF if meninges are inflamed.
The volume of
distribution for vancomycin ranges from 0.43 to 1.25 L/kg. At a
concentration of 10 to 100
μ
g/mL _in vitro_, vancomycin is reportedly 52 to 60% bound to serum
proteins.
PHARMACOKINETICS
In subjects with normal kidney function, multiple intravenous dosing
of 1 g vancomycin (15
mg/kg), infused over 60 minutes, produces mean plasma concentrations
of appr