Tobradex

Use tobramycin and dexamethasone ophthalmic eye drops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using the eye drops or ointment.

To apply the eye drops:

• Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye, repeat the process with about 5 minutes between drops. If you are using drops in both eyes, repeat the process in the other eye.

To apply the ointment:

• Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before application of the other medication.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye.

Do not use any eyedrop that is discolored or has particles in it.

Store tobramycin and dexamethasone ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye.

Use caution when driving, operating machinery, or performing other hazardous activities. Tobramycin and dexamethasone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment with tobramycin and dexamethasone ophthalmic. After applying the medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Do not use other eye drops or medications during treatment with tobramycin and dexamethasone ophthalmic unless otherwise directed by your doctor.

TobraDex® (tobramycin and dexamethasone ophthalmic suspension) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use.

The chemical structures for tobramycin and dexamethasone are presented below:

Tobramycin

Empirical Formula: C18H37N5O9

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

Dexamethasone

Empirical Formula: C22H29FO5

Chemical Name: 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione

Each mL of TobraDex® (tobramycin and dexamethasone ophthalmic suspension) contains: Actives: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg). Preservative: benzalkonium chloride 0.01%. Inactives: tyloxapol, edetate disodium, sodium chloride, hydroxyethyl cellulose, sodium sulfate, sulfuric acid and/or sodium hydroxide (to adjust pH) and purified water.

FOR TOPICAL OPHTHALMIC USE ONLY. 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 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.

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 [TOBREX® (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. 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 (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.

Contact your doctor if the symptoms begin to get worse or if you do not see any improvement in the condition after a few days.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

Do not use Tobradex if you have a viral or fungal infection in the eye. It is used to treat infections caused by bacteria only. It is not known whether Tobradex will be harmful to an unborn baby. Do not use Tobradex without first talking to your doctor if you are pregnant. It is not known whether tobramycin or dexamethasone passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye. Use caution when driving, operating machinery, or performing other hazardous activities. Tobradex may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment with Tobradex. After applying the medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Do not use other eye drops or medications during treatment with Tobradex unless otherwise directed by your doctor.

Serious side effects are not expected to occur with the use of Tobradex.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of Tobradex side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to dexamethasone / tobramycin ophthalmic: ophthalmic ointment, ophthalmic suspension

Hypersensitivity

Frequency not reported: Hypersensitivity[Ref]

Ocular

Uncommon (0.1% to 1%): Eye pain, eye pruritus, ocular discomfort, ocular hypertension, conjunctival edema, increased intraocular pressure, eye irritation
Rare (less than 0.1%): Keratitis, eye allergy, blurred vision, dry eye, ocular hyperemia
Frequency not reported: Eyelid edema, erythema of the eyelid, mydriasis, increased lacrimation

Dexamethasone:
-Common (1% to 10%): Ocular hyperemia, erythema of eyelid, abnormal sensation in eye, eye pain
-Uncommon (0.1% to 1%): Eye pruritus, ocular discomfort, eye allergy, eyelid edema, conjunctivitis, glare, increased lacrimation, keratitis
-Frequency not reported: Optic nerve damage, posterior subcapsular cataract formation, fungal infections of the cornea, bacterial ocular infection

Tobramycin:
-Common (1% to 10%):
-Frequency not reported: Conjunctival erythema, ocular toxicity[Ref]

Other

Frequency not reported: Swelling face[Ref]

Dermatologic

Frequency not reported: Rash, pruritus[Ref]

General

The most commonly reported side effects were eye irritation, ocular hyperemia, erythema of eyelid, abnormal sensation in eye, ocular hyperemia, and eye pain.[Ref]

Gastrointestinal

Rare (less than 0.1%): Dysgeusia
Frequency not reported: Nausea, abdominal discomfort[Ref]

Immunologic

Dexamethasone:
-Frequency not reported: Delayed wound healing[Ref]

Nervous system

Uncommon (0.1% to 1%): Headache
Frequency not reported: Dizziness[Ref]

Respiratory

Uncommon (0.1% to 1%): Rhinorrhea, laryngospasm[Ref]

Some side effects of TobraDex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Use is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects.