Eyeworld Daily News

TOBRADEX ® ST (tobramycin/dexamethasone ophthalmic suspension) 0.3%/0.05% Brief Summary This Brief Summary does not include all the information needed to use TOBRADEX ST safely and effectively. Please see Full Prescribing Information for TOBRADEX ST at MyTobraDexST.com. INDICATIONS AND USAGE TOBRADEX ST 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. 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. DOSAGE AND ADMINISTRATION Recommended Dosing: Instill one drop into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, dosage may be increased to one drop every 2 hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely. CONTRAINDICATIONS Nonbacterial Etiology: TOBRADEX ST is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Hypersensitivity: Hypersensitivity to any component of the medication. WARNINGS AND PRECAUTIONS IOP increase: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. IOP should be monitored. Aminoglycoside sensitivity: Sensitivity to topically applied aminoglycosides may occur. Cataracts: May result in posterior subcapsular cataract formation. Delayed healing: May delay healing and increase the incidence of bleb formation after cataract surgery. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. Bacterial infections: May suppress the host response and thus increase the hazard of 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, the patient should be re-evaluated. Viral infections: Treatment in patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungal infections: Fungal infections of the cornea are particularly prone to develop with long-term use. Fungal invasion must be considered in any persistent corneal ulceration. Use with systemic aminoglycosides: Use with systemic aminoglycoside antibiotics requires monitoring for total serum concentration of tobramycin. ADVERSE REACTIONS The most frequent adverse reactions to topical ocular tobramycin (TOBREX ® ) are hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritis, eyelid edema, and conjunctival hyperemia. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Non-ocular adverse events occurring at an incidence of 0.5% to 1% included headache and increased blood pressure. The reactions due to the steroid component are: increased intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve disorder; subcapsular cataract; and impaired healing. Secondary Infection. The development of secondary infection has occurred. Fungal infections of the cornea are particularly prone to develop with long-term use. Fungal invasion must be considered in any persistent corneal ulceration. Secondary bacterial ocular infection following suppression of host responses also occurs. USE IN SPECIFIC POPULATIONS Pregnancy and Nursing Mothers There are no adequate and well controlled studies in pregnant women. TOBRADEX ® ST ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when TOBRADEX ® ST is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 years have not been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients. Rx Only Distributed by: Eyevance Pharmaceuticals LLC. Fort Worth, TX 76102 © 2020 Eyevance Pharmaceuticals LLC. All rights reserved. TOBRADEX ® ST is a trademark of Eyevance Pharmaceuticals LLC. All other trademarks are the property of their respective owners. TST-01-20-MS-05

• Cover