This combination 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 such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, and cyclitis. It is also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. This combination is also indicated for the treatment of post-operative inflammation following ocular surgery.

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A₂ inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.

Tobramycin is a member of the aminoglycoside class which shows bactericidal activity by inhibiting protein synthesis of bacteria.

Shake well before use. Apply one drop into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours.

Since Loteprednol Etabonate is not detected in plasma following topical administration, it is not expected to affect the pharmacokinetics of systemically administered medicinal products.

Contraindicated in most viral diseases of the cornea and conjunctiva. Also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Increased intraocular pressure, burning and stinging upon instillation, vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders may occur. The incidence of non-ocular adverse events (headache) has also been reported.

Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Loteprednol Etabonate & Tobramycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation: Caution should be exercised when Loteprednol Etabonate & Tobramycin is administered to a nursing mother.

• For ophthalmic use only.
• If this product is used for 10 days or longer, intraocular pressure should be monitored.
• Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of topical steroids.
• Prolonged use may result in overgrowth of non-susceptible organisms including fungi. If superinfection occurs, appropriate therapy should be initiated.
• Cross-sensitivity to other aminoglycoside antibiotics may occur.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Ophthalmic steroid - antibiotic combined preparations

Store at room temperature and protect from light. Do not touch the dropper tip to any surface. It is desirable that the contents should not be used four weeks after the first opening of the bottle. Protect from freezing.