TOBRADEX STERILE OPHTHALMIC SUSPENSION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DEXAMETHASONE; TOBRAMYCIN

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

S01CA01

Dosage:

0.10%

Pharmaceutical form:

SOLUTION

Composition:

DEXAMETHASONE 0.1%; TOBRAMYCIN 0.3%

Administration route:

OPHTHALMIC

Prescription type:

Prescription Only

Manufactured by:

ALCON-COUVREUR NV

Authorization status:

ACTIVE

Authorization date:

1990-05-21

Patient Information leaflet

KAPVORM
140 x 335 / 140 x 22 mm
AANTAL KLEUREN :  1
WS / 10.01.2012
SGP
recto-verso
Tobradex 5 ml / 3,5 g
-DRAFT-
35701-1
BELGIUM
V4
PMS ZWART
à 100 %
35701-1
TobraDex
®
(Tobramycin and Dexamethasone)
Sterile Ophthalmic Suspension and Ointment
DESCRIPTION :
TOBRADEX
®
(Tobramycin* and Dexamethasone) Ophthalmic Suspension and Ointment are
sterile,
multiple dose antibiotic and steroid combinations for topical
ophthalmic use. 
The chemical structures for tobramycin and dexamethasone are presented
below : 
Each ml of TOBRADEX
®
Suspension contains :
Actives : Tobramycin 0.3 % (3 mg) and Dexamethasone 0.1 % (1 mg).
Preservative : Benzalkonium Chloride 0.01 %.
Inactives : Tyloxapol, Edetate Disodium, Sodium Chloride,
Hydroxyethyl Cellulose, Sodium Sulfate,
Sulfuric Acid and /or Sodium Hydroxide (to adjust pH) and Purified
Water. 
Each gram of TOBRADEX
®
Ointment contains :
Actives : Tobramycin 0.3 % (3 mg) and Dexamethasone 0.1 % (1 mg).
Preservative : Chlorobutanol 0.5 %.
Inactives : Mineral Oil and White Petrolatum. 
CLINICAL PHARMACOLOGY:
Corticoids suppress the inflammatory response to a variety of agents
and they probably delay or slow
healing. Since corticoids may inhibit the body’s defense mechanism
against infection, a concomitant
antimicrobial drug may be used when this inhibition is considered to
be clinically significant. Dexametha-
sone is a potent corticoid.
The antibiotic component in the combination (tobramycin) is included
to provide action against susceptible
organisms. In vitro studies have demonstrated that tobramycin is
active against susceptible strains of the
following microorganisms :
Staphylococci, including S. aureus and S.
epidermidis (coagulase-positive and coagulase-negative),
including penicillin-resistant strains.
Streptococci, including some of the Group A beta-hemolytic species,
some nonhemolytic species, and
some Streptococcus pneumoniae.
Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae,
Enterobacter aerogenes, Proteus
mirabilis, Mo

Summary of Product characteristics

Tobradex May 2021.SIN
Page 1 of 14
1. NAME OF THE MEDICINAL PRODUCT
TOBRADEX STERILE OPHTHALMIC SUSPENSION
TOBRADEX OPHTHALMIC OINTMENT
TOBRADEX
®
(Tobramycin
®
and Dexamethasone) Ophthalmic Suspension and Ointment are sterile,
multiple dose antibiotic and steroid combinations for topical
ophthalmic use.
2. QUALITATIVE AND QUANTITAVE COMPOSITION
TOBRADEX
® OPHTHALMIC SUSPENSION
1 mL of suspension contains 3 mg of tobramycin and 1 mg of
dexamethasone.
Preservative: 1 mL of suspension contains 0.1 mg benzalkonium
chloride.
TOBRADEX
® OPHTHALMIC OINTMENT
1 gram of ointment contains 3 mg of tobramycin and 1 mg of
dexamethasone. Preservative: 1 g of
ointment contains 5 mg chlorobutanol.
For the full list of excipients, see section 6.1.
The chemical structures for tobramycin and dexamethasone are presented
below:
Empirical Formula : C18H37N5O9 Chemical
Name :
0-3-Amino-3-deoxy-α-D-glucopyranosyl-(1-.4)-0-
(2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyra-
nosyl-(1-.6)-2-deoxy-L-streptamine
Empirical
Formula
:
C22H29FO5
Chemical name:
9-Fluoro-11β,17,21-trihydroxy-
16αmethylpregna- 1,4-diene-3,20-
dione
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Page 2 of 14
3. PHARMACEUTICAL FORM
TOBRADEX OPHTHALMIC SUSPENSION
Sterile ophthalmic suspension. White to off-white suspension.
TOBRADEX OPHTHALMIC OINTMENT
Sterile ophthalmic ointment.
White to off-white homogeneous ointment
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TOBRADEX
®
contains tobramycin, an antibiotic, and dexamethasone, a
corticosteroid.
TOBRADEX
®
is indicated for steroid-responsive inflammatory ocular conditions for
which a corticosteroid
is indicated and where superficial bacterial ocular infection or a
risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the
palpebral and bulbar conjunctiva, cornea
and anterior segment of the globe where the inherent risk of steroid
use in certain infective conjunctivitis
is accepted to obtain a diminution in edema and inflammation. They are
also indicated in chronic
anterior uveitis