TOBRADEX- tobramycin and dexamethasone ointment

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 ointment) 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 against th

Product summary:

HOW SUPPLIED: 3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap (NDC 0078-0876-01) STORAGE: Store at 2°C to 25°C (36°F to 77°F). After opening, TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) can be used until the expiration date on the tube. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis T2021-62 May 2021

Authorization status:

New Drug Application

Summary of Product characteristics

TOBRADEX- TOBRAMYCIN AND DEXAMETHASONE OINTMENT
NOVARTIS PHARMACEUTICALS CORPORATION
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TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC OINTMENT) STERILE
DESCRIPTION: TOBRADEX (tobramycin and dexamethasone ophthalmic
ointment) is
a sterile, multiple dose antibiotic and steroid combination for
topical ophthalmic use. The
chemical structures for tobramycin and dexamethasone are presented
below:
EACH GRAM OF TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC
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. 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 pneumoniae_.
_Pseudomonas aeruginosa_, _Escherichia coli_, _Klebsiella pneumoniae_,
_Enterobacter_
_aerogenes_, _Proteus mirabilis_, _Morganella morganii_, most _Proteus
vulgaris_ strains,
_Haemophilus influenzae_ and _H. aegyptius_, _Moraxella lacunata_,
_Acinetobacter_
_calcoaceticus_ and some _Neisseria_ species.
No data are available on the extent of systemic absorption from
TOBRADEX
(tobramycin and dexamethasone ophthalmic ointment); however, it is
known that some
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systemic absorption can occur with ocularly applied drugs.
INDICA