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If you have any questions about TOBRADEX®, call us at 1-833-442-7769 (1-833-4HARROW). You can also fill out the form below and click submit.

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Indication and Usage

TOBRADEX^® ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05% is a topical antibiotic and corticosteroid combination 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.

Important Safety Information

CONTRAINDICATIONS:

Most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. Hypersensitivity to any components of the medication.

WARNINGS & PRECAUTIONS:

Intraocular Pressure (IOP) Increase—Prolonged use may result in glaucoma with damage to the optic nerve, and defects in visual acuity and fields of vision. IOP should be monitored.
Aminoglycoside Sensitivity—Sensitivity to topically applied aminoglycosides may occur.
Cataracts—Posterior subcapsular cataract formation may occur.
Delayed Healing—May delay healing and increase the incidence of bleb formation. Perforations of the cornea or sclera have occurred. Slit lamp biomicroscopy and fluorescein staining should be conducted.
Bacterial Infections—May suppress host response and increase secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, then the patient should be re-evaluated.
Viral Infections—Use with a history of herpes simplex requires great caution. The course and severity of many viral infections of the eye (including herpes simplex) may be exacerbated.
Fungal Infections—Fungal infections of the cornea may occur and should be considered in any persistent corneal ulceration.
Vision Blurred—Vision may be temporarily blurred following dosing with TOBRADEX^® ST. Care should be exercised in operating machinery or driving a motor vehicle.
Risk of Contamination—Do not touch the dropper tip of the bottle to any surface, as this may contaminate the contents.
Contact Lens Use—TOBRADEX^® ST contains benzalkonium chloride, an antimicrobial preservative, which may be absorbed by soft contact lenses. Contact lenses should not be worn during the use of TOBRADEX^® ST.

ADVERSE REACTIONS:

The most frequent adverse reactions (<4%) to topical ocular tobramycin are hypersensitivity and localized ocular toxicity, including eye pain, eyelid pruritus, eyelid edema, and conjunctival hyperemia.

The reactions due to the steroid component are increased IOP with possible damage to optic nerve and development of glaucoma, subcapsular cataract, and impaired healing.

The development of secondary infection has occurred. Fungal infections of the cornea may occur. Secondary bacterial ocular infection following suppression of host responses also occurs.

Non-ocular adverse events (0.5% to 1%) included headache and increased blood pressure.

The following additional adverse reactions have been reported with the individual components below:

Aminoglycosides: Neurotoxicity, ototoxicity, and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, because of their potential effect on neuromuscular function.
Dexamethasone: Cushing’s syndrome and adrenal suppression may occur after the use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors.

POSTMARKETING EXPERIENCE:

The following adverse reactions have been identified during postapproval use of TOBRADEX^® ST. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Additional adverse reactions identified from postapproval use include anaphylactic reaction and erythema multiforme.

Please see the full Prescribing Information.