Tobramycin and Dexamethasone

INDICATIONS AND USAGE Tobramycin and dexamethasone 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.

DOSAGE AND ADMINISTRATION: 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.

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.

ADVERSE REACTIONS Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available. The most frequent adverse reactions to topical ocular tobramycin (tobramycin ophthalmic solution) are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than 4% of patients. The reactions due to the steroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs. Postmarketing Experience: Additional adverse reactions identified from postmarketing use include anaphylactic reaction and erythema multiforme. The following additional adverse reactions have been reported with the individual components listed below: Dexamethasone : Cushing’s syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors. 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. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DESCRIPTION: Tobramycin and dexamethasone ophthalmic suspension USP is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use with a pH of approximately 5.5 and an osmolality of approximately 300 mOsm/kg. The chemical structures for tobramycin and dexamethasone are presented below: Tobramycin Empirical Formula: C 18 H 37 N 5 O 9 Chemical Name: O -3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)- O -[2,6-diamino-2,3,6-trideoxy-α-D- ribo -hexopyranosyl-(1→6)]-2-deoxy-L-streptamine MW: 467.52 Dexamethasone Empirical Formula: C 22 H 29 FO 5 Chemical Name: 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione MW: 392.47 Each mL of Tobramycin and dexamethasone ophthalmic suspension contains: Actives: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg). Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium dihydrate, hydroxyethyl cellulose, sodium chloride, sodium sulfate anhydrous, sulfuric acid and/or sodium hydroxide (to adjust pH), tyloxapol, and water for injection. tobramycin dexamethasone

OVERDOSAGE Clinically apparent signs and symptoms of an overdosage of Tobramycin and Dexamethasone Ophthalmic Suspension punctate keratitis, erythema, increased lacrimation, edema and lid itching may be similar to adverse reaction effects seen in some patients.

HOW SUPPLIED: Tobramycin and dexamethasone ophthalmic suspension, USP is sterile ophthalmic suspension supplied as a 2.5 mL, 5 mL, or 10 mL suspension in a 5 mL, 10 mL or 10 mL natural polyethylene bottle respectively with a natural polyethylene controlled drop tip and a white polypropylene cap. NDC 72162-1128-2: 10 mL NDC 72162-1128-4: 5 mL NDC 72162-1128-7: 2.5 mL STORAGE: Store at 8°C to 27°C (46°F to 80°F). Store suspension upright and shake well before using. After opening, tobramycin and dexamethasone ophthalmic suspension can be used until the expiration date on the bottle. Rx Only Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504