Dexatobrin Ophthalmic Suspension: 

Each 1 ml contains:                        

Tobramycin ....................................................... 3 mg

Dexamethasone ...............................................1 mg

Dexatobrin Ophthalmic Ointment:

Each 1 gm contains:                        

Tobramycin ..................................................... 3 mg

Dexamethasone ............................................ 1 mg

Inactive ingredients: 

Dexatobrin Ophthalmic Suspension: Benzalkonium chloride 10%, polysorbate 80, disodium edetate, hydroxypropyl methylcellulose, sodium chloride, sodium sulfate anhydrous, sulfuric acid, sodium hydroxide, water for injection.

Dexatobrin Ophthalmic Ointment: Anhydrous lanolin, chlorobutanol, yellow soft paraffin.

Dexatobrin 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.

Dexatobrin Ophthalmic Suspension: 

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.

Dexatobrin Ophthalmic Ointment:

Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac(s) up to three or four times daily.

Not more than 20 mL of ophthalmic suspension or 8 gm of ophthalmic ointment should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in Warnings and Precautions. 

How to apply Dexatobrin 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 of the ointment (about 1/2 inch) in the "V" pocket. Do not let the tip of the tube touch your eye.

4. Look downward before closing your eye.

How to apply Dexatobrin Ophthalmic Suspension:

1. Wash your hands before you start.

2. Twist off the bottle cap.

3. Hold the bottle pointing down, between your thumb and fingers.

4. Tilt your head back.

5. Pull down your lower eyelid with a finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here.

6. Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.

6. Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops.

7. Gently press on the base of the bottle to release one drop at a time.

8. Do not squeeze the bottle, only a gentle press on the bottom is needed.

9. If you use drops in both eyes, repeat the steps for your other eye. Put the bottle cap firmly back on immediately after use.

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.

Warnings:

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 (IOP) 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.

Precautions:

General: 

The possibility of fungal infections of the cornea should be considered after long-term steroid dosing. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. When multiple prescriptions are required, or whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

Ophthalmic ointment may retard corneal wound healing.

Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection.

Dexatobrin Ophthalmic Suspension contains benzalkonium chloride which may cause eye irritation. Avoid contact with soft contact lenses, as it is known to discolor soft lenses. Remove contact lenses before using and wait at least 15 minutes before reinsertion. 

Information for Patients: 

Do not touch dropper tip to any surface, as this may contaminate the contents. 

Do not touch tube tip to any surface, as this may contaminate the contents. 

Contact lenses should not be worn during the use of this product.

Pregnancy: 

There are no adequate and well controlled studies in pregnant women. Dexatobrin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation:

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dexatobrin 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 clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

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 are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

The reactions due to the steroid component are: elevation of intraocular pressure 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.

Clinically apparent signs and symptoms of an overdose of tobramycin and dexamethasone (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant. Dexamethasone is a potent corticoid.

The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms:

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.

Bacterial susceptibility studies demonstrate that in some cases microorganisms resistant to gentamicin remain susceptible to tobramycin.

No data are available on the extent of systemic absorption from tobramycin and dexamethasone ophthalmic suspension or ointment; however, it is known that some systemic absorption can occur with ocularly applied drugs. The usual physiologic replacement dose is 0.75 mg daily. The administered dose for Dexatobrin in both eyes four times daily would be 0.4 mg of dexamethasone daily.

Ophthalmic Suspension: Store at a temperature not exceeding 30^°C, and to be used within 28 days after opening, when stored at a temperature not exceeding 30^°C.

Ophthalmic Ointment:  Store at a temperature 15^°C - 30^°C.

Dexatobrin Ophthalmic Suspension: 5 ml Plastic dropper bottle.

Dexatobrin Ophthalmic Ointment: Ophthalmic tube of 5 g.