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Tobradex Ophthalmic Ointment
TOBRADEX® (tobramycin and dexamethasone opthalmic ointment) (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 bacterial eye pathogens:
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.
DOSAGE AND ADMINISTRATION
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac(s) up to three or four times daily.
How to apply TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment):
- Tilt your head back.
- Place a finger on your cheek just under your eye and gently pull down until a "V" pocket is formed between your eyeball and your lower lid.
- Place a small amount (about ½ inch) of TOBRADEX® (tobramycin and dexamethasone opthalmic ointment) Ophthalmic Ointment in the "V" pocket. Do not let the tip of the tube touch your eye.
- Look downward before closing your eye.
Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and polyethylene white cap. (NDC 0065-0648-35).
STORAGE: Store at 8° - 27°C (46 °- 80°F).
Manufactured for: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA. Manufactured By: S.A. ALCON-COUVREUR N.V. Puurs, Belgium. Revised: October 2003. FDA Rev date: 7/15/2004This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/2/2008
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