TOBRADEX® OPHTHALMIC SUSPENSION 0.3%, 0.1% (Non-English)

Tobradex ophthalmic suspension is used to prevent and treat inflammation and to prevent possible infection of the eye after cataract surgery in adults and children from 2 years of age.

TOBRADEX® 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 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.

1 mL of suspension contains 3 mg of tobramycin and 1 mg of dexamethasone.

• For ocular use only. NOT FOR INJECTION INTO THE EYE
• The bottle must be well shaken before use.
• After cap is removed, if tamper evident snap collar is loose, it should be removed before using the product.
• Keep the bottle tightly closed when not in use.
• To avoid contamination, the dropper tip should not touch any surface. The tip of the dropper/ tube should also not come into contact with the eye as this may cause injury to the eye.
• Either nasolacrimal occlusion or gently closing the eyelid(s) after administration is recommended.
• This may reduce the systemic absorption of medicinal products administered via ocular route and result in a decrease in systemic adverse reactions.
• If more than one topical ophthalmic medicinal products is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.
• Do not touch dropper tip to any surface, as this may contaminate the contents. Contact lenses should not be worn during the use of this product.
• 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.

Contraindications

• Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva.
• Mycobacterial infection of the eye.
• Fungal diseases of ocular structures.
• Hypersensitivity to a component of the medication.

After-care

Post-Application: After using TobraDex, keep the eyelid closed, while simultaneously applying gentle pressure with a finger to the corner of your eye, by the nose. This helps to prevent the medication from draining out.

Storage: After opening, TobraDex can be used until the expiration date on the bottle.