TOBRADEX- tobramycin and dexamethasone suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TOBRAMYCIN (UNII: VZ8RRZ51VK) (TOBRAMYCIN - UNII:VZ8RRZ51VK), DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Available from:

Novartis Pharmaceuticals Corporation

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND USAGE: TOBRADEX® (tobramycin and dexamethasone ophthalmic suspension) 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 conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active agains

Product summary:

HOW SUPPLIED: Sterile ophthalmic suspension in 2.5 mL (NDC 0078-0953-40), 5 mL (NDC 0078-0953-25) and 10 mL (NDC 0078-0953-26) dispensers. STORAGE: Store at 8°C to 27°C (46°F to 80°F). Store suspension upright and shake well before using. After opening, TOBRADEX® (tobramycin and dexamethasone ophthalmic suspension) can be used until the expiration date on the bottle. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis Revised: June 2021 T2021-78

Authorization status:

New Drug Application

Summary of Product characteristics

TOBRADEX- TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS
NOVARTIS PHARMACEUTICALS CORPORATION
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TOBRADEX
(TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION) STERILE
DESCRIPTION: TOBRADEX (tobramycin and dexamethasone ophthalmic
suspension)
is a sterile, multiple dose antibiotic and steroid combination for
topical ophthalmic use.
The chemical structures for tobramycin and dexamethasone are presented
below:
Tobramycin
Empirical Formula: C
H
N O
Chemical Name:
_O_-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)-_O_-[2,6-diamino-2,3,6-
trideoxy-α-D-_ribo_-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine
Molecular Weight: 467.52 g/mol
Dexamethasone
Empirical Formula: C
H
FO
Chemical Name:
9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione
Molecular Weight:392.47 g/mol
EACH ML OF TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC
SUSPENSION) CONTAINS: ACTIVES: tobramycin 0.3% (3 mg) and
dexamethasone 0.1%
(1 mg). PRESERVATIVE: benzalkonium chloride 0.01%. INACTIVES: edetate
disodium,
hydroxyethyl cellulose, purified water, sodium chloride, sodium
sulfate, sulfuric acid
and/or sodium hydroxide (to adjust pH), and tyloxapol.
®
®
18
37
5
9
22
29
5
®
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. Dexamethasone 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