SANDOZ TOBRAMYCIN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TOBRAMYCIN

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

S01AA12

INN (International Name):

TOBRAMYCIN

Dosage:

0.3%

Pharmaceutical form:

SOLUTION

Composition:

TOBRAMYCIN 0.3%

Administration route:

OPHTHALMIC

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

Active ingredient group (AIG) number: 0110230005; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-10-04

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
SANDOZ TOBRAMYCIN
Tobramycin Ophthalmic Solution, USP
0.3% w/v
Antibacterial (ophthalmic)
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Revision
May 27, 2020
Submission Control No.: 238817
_Sandoz Tobramycin Product Monograph _
_ _
2
PRODUCT MONOGRAPH
Pr SANDOZ TOBRAMYCIN
Tobramycin Ophthalmic Solution, USP
ACTION AND CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Like other aminoglycosides, the bactericidal activity of tobramycin is
accomplished by specific
inhibition of normal protein synthesis in susceptible bacteria, but at
the present time, very little is
known about 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.
CLINICAL PHARMACOLOGY
Pharmacodynamics
Because the ocular concentrations of tobramycin achieved after topical
application are higher
than those which can be safely used in systemic therapy, standardized
susceptibility tests may
not be appropriate to predict the effectiveness of tobramycin.
The gram positive bacteria against which tobramycin solution is
clinically effective include the
coagulase-positive and coagulase-negative staphylococci, including
penicillin-resistant strains,
_Streptococcus pneumoniae_, other alpha-hemolytic streptococci, and
Group A beta-hemolytic and
non-hemolytic streptococci. The gram-negative bacteria against which
tobramycin solution has
been shown to have clinical effectiveness include most strains of
_Pseudomonas aeruginosa, _
_Escherichia coli, Klebsiella pneumonia, Enterobacter aerogenes,
Proteus mirabilis_ (indole
negative) and indole-positive _Proteus_ species, as well as
_Haemophilus _spp., _Moraxella_ spp., and
_Acinetobacter calcoacetius (Herellea vaginicoli)._ Bacterial
susceptibility studies show that many
microorganisms resistant to gentamicin retain susceptibility to
tobramycin. A significant
population resistant to tobramycin has not emerged; however, bacterial
resistance may develop
upon prolonged use.
_ _
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Pha