Composition

Each 1 ml or 1 g contains:
Tobramycin .......................... 3 mg
Dexamethasone .................. 1 mg
Inactive ingredients:
DEXATOBRIN Sterile Ophthalmic Suspension: Benzalkonium chloride, polysorbate 80, disodium edetate, hydroxypropyl methylcellulose E4, sodium chloride, sodium sulfate anhydrous, sulfuric acid or sodium hydroxide, water for injection.
DEXATOBRIN Sterile Eye Ointment: Anhydrous lanolin, chlorobutanol, yellow soft paraffin.

Therapeutic Indications

Ocular inflammations with bacterial infections due to bacteria susceptible to tobramycin, such as infections of palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
Chronic anterior uveitis and corneal injury from chemicals, radiation, burns, or penetration of foreign bodies.

Dosage and Administration

DEXATOBRIN Sterile Ophthalmic Suspension:
Starting dose: 1-2 drops every 2 hours till improvement occurs. Then the dosage may be decreased to 1-2 drops every 4-6 hours.
DEXATOBRIN Sterile Eye Ointment:
A small amount of the ointment (1-1.5 cm) should be applied to the lower eyelid twice daily in the morning and just before bedtime.

Contraindications

Hypersensitivity to the product.
Mycobacterial infections of the eye.
Fungal and viral infections of the eye (e.g. Herpes simplex or dendritic keratitis).

Warnings and Precautions

Prolonged therapy with DEXATOBRIN, as with other antibiotics, may result in superinfection with nonsusceptible organisms, including fungi.
Extended use of topical corticosteroid may cause glaucoma.
DEXATOBRIN should be used with caution in patients suffering from glaucoma.
Contact lenses should be removed prior to administration of DEXATOBRIN.
Lenses may be reinserted 15 minutes following administration of the drug.

Pregnancy and Lactation

DEXATOBRIN (Category C) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.