Tobradex

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Side Effects & Adverse Reactions

NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction does occur, discontinue use.

Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Intraocular pressure should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

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 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.

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History

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Other Information

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.

Sources

Tobradex Manufacturers

Rebel Distributors Corp

Tobradex | Rebel Distributors Corp

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 1/2 inch) of TOBRADEX (tobramycin and dexamethasone 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.

No Recall
Rebel Distributors Corp

Tobradex | Rebel Distributors Corp

One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

No Recall
Alcon Laboratories, Inc.

Tobradex | Chain Drug Consortium

adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to four times a day children under 6 years of age: consult a doctor

No Recall
Alcon Laboratories, Inc.

Tobradex | Energique, Inc.

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional.

Consult a physician for use in children under 12 years of age.

No Recall
Stat Rx Usa Llc

Tobradex | Stat Rx Usa Llc

One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

No Recall
A-s Medication Solutions Llc

Tobradex | A-s Medication Solutions Llc

One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

No Recall
A-s Medication Solutions Llc

Tobradex | A-s Medication Solutions Llc

One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

No Recall
A-s Medication Solutions Llc

Tobradex | A-s Medication Solutions Llc

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) :

1. Tilt your head back.

2. 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.

3. Place a small amount (about 1/2 inch) of TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment) in the "V" pocket. Do not let the tip of the tube touch your eye.

4. 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.

No Recall