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:

Rebel Distributors Corp

INN (International Name):

tobramycin

Composition:

tobramycin 3 mg in 1 g

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 the following common bacte

Product summary:

3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 21695-628-35). Store at 8° - 27°C (46°- 80°F). Rx Only U.S. Patent No. 5,149,694 © 2002, 2003 Alcon, Inc. Alcon ® Manufactured for: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Manufactured by: S.A. ALCON-COUVREUR N.V. Puurs, Belgium October 2003 1002          44281-A Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

New Drug Application

Summary of Product characteristics

TOBRADEX- TOBRAMYCIN AND DEXAMETHASONE OINTMENT
REBEL DISTRIBUTORS CORP
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TOBRADEX
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% (3mg) and dexamethasone 0.1% (1mg).
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.
Bacterial susceptibility studies demonstrate that in some cases
microorganisms resistant to gentamicin
remain susceptible to tobramycin.
No data are available on the extent of systemic absorption from
TOBRADEX (tobramycin and
dexamethasone ophthalmic ointment); however, it is known that some
systemic absorption can occ