TOBRAMYCIN INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TOBRAMYCIN (TOBRAMYCIN SULFATE)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

J01GB01

INN (International Name):

TOBRAMYCIN

Dosage:

40MG

Pharmaceutical form:

SOLUTION

Composition:

TOBRAMYCIN (TOBRAMYCIN SULFATE) 40MG

Administration route:

INTRAMUSCULAR

Units in package:

10X2ML 1X30ML

Prescription type:

Prescription

Therapeutic area:

AMINOGLYCOSIDES

Product summary:

Active ingredient group (AIG) number: 0110230001; AHFS:

Authorization status:

APPROVED

Authorization date:

1999-11-10

Summary of Product characteristics

_Tobramycin Injection USP _
_ _
_Page 1 of 25 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TOBRAMYCIN INJECTION USP
(Tobramycin as Tobramycin Sulfate)
10 mg/mL and 40 mg/mL
Antibiotic
Sandoz Canada Inc.
Date of Revision: July 17, 2017
145 Jules-Léger
Boucherville, QC
J4B 7K8
Control number: 201425
_Tobramycin Injection USP _
_ _
_ Page 2 of 25 _
PR TOBRAMYCIN INJECTION USP
(Tobramycin as Tobramycin Sulfate)
10 mg/mL and 40 mg/mL
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
The bactericidal activity of tobramycin, like that of other
aminoglycosides, is accomplished by
specific inhibition of normal protein synthesis in susceptible
bacteria. However, at the present time,
very little is known about the specific site(s) of this action. It is
thought that inhibition of synthesis is
due to an action on ribosomes that, in turn, causes bacterial
misreading of messenger RNA.
INDICATIONS
Tobramycin Injection USP may be indicated for the treatment of the
following infections when
caused by susceptible organisms: septicemia, complicated and recurrent
urinary tract infections,
lower respiratory infections, serious skin and soft tissue infections
including burns and peritonitis and
central nervous system infections caused by organisms resistant to
antibiotics usually considered
efficacious in these infections.
Tobramycin is usually active against most strains of the following
organisms _in vitro_ and in clinical
infections:

_Pseudomonas aeruginosa _

_Proteus_ sp. (indole-positive and indole-negative), including
_Proteus mirabilis, _
_Morganella morganii, Providencia rettgeri_, and _Proteus vulgaris _

_Escherichia coli _

_Klebsiella-Enterobacter-Serratia_ group

_Citrobacter_ sp.

_Providencia_ sp.

_Staphylococci_, including _Staphylococcus aureus_ (coagulase-positive
and coagulase-
negative)
Tobramycin Injection USP may be considered in serious staphylococcal
infections when penicillin or
other potentially less toxic drugs are contraindicated and when
bacterial susceptibility testing