A fixed-dose combination ophthalmic suspension containing a site-specific soft corticosteroid (Loteprednol etabonate) and a broad-spectrum aminoglycoside antibiotic (Tobramycin). It is designed for the treatment of steroid-responsive inflammatory ocular conditions where the risk of superficial bacterial infection is high or where there is an existing bacterial infection. Loteprednol etabonate is a 'soft drug' engineered to undergo rapid hydrolysis to inactive metabolites after exerting its therapeutic effect, thereby minimizing systemic side effects. Tobramycin provides bactericidal coverage against a wide range of Gram-negative and some Gram-positive ocular pathogens.
Adult: One drop instilled into the affected eye(s) 4 times daily. In severe inflammation, dosing may be initiated at one drop every 1-2 hours during waking hours, then tapered. Do not discontinue abruptly; taper frequency.
Note: 1. Wash hands. 2. Shake the suspension well before use. 3. Tilt head back, pull lower eyelid down to form a pouch. 4. Instill one drop without touching the dropper tip to eye or any surface. 5. Close eyes gently for 1-2 minutes, applying gentle pressure to the nasolacrimal duct (inner corner of eye) to minimize systemic absorption. 6. Wait at least 5-10 minutes before instilling any other ophthalmic medication.
Loteprednol etabonate binds to glucocorticoid receptors in ocular tissues, leading to the induction of phospholipase A2 inhibitory proteins (lipocortins). This inhibition blocks the release of arachidonic acid from membrane phospholipids, thereby preventing the synthesis of potent mediators of inflammation such as prostaglandins and leukotrienes. Tobramycin is a bactericidal aminoglycoside that binds irreversibly to the 30S ribosomal subunit of susceptible bacteria, inhibiting protein synthesis and causing misreading of the genetic code.
Pregnancy: Category C (US FDA). Animal studies have shown adverse effects. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Systemic corticosteroids have been associated with cleft palate. Use minimal effective dose for shortest duration.
Driving: May cause temporary blurred vision immediately after instillation. Patients should not drive or operate machinery until vision clears.
| Other topical ophthalmic NSAIDs (e.g., Ketorolac, Nepafenac) | Increased risk of corneal healing impairment and potential for corneal melt/perforation. | Major |
| Systemic or other topical corticosteroids | Additive risk of elevated IOP, cataract, and systemic corticosteroid side effects. | Moderate |
| Other aminoglycosides (topical or systemic) | Additive risk of ototoxicity and nephrotoxicity (though low with topical use, caution in patients with renal impairment). | Moderate |
| Neuromuscular blocking agents (e.g., Succinylcholine, Atracurium) | Tobramycin may potentiate neuromuscular blockade, leading to respiratory depression. | Major (for systemic tobramycin; theoretical risk with topical). |
| Loop diuretics (e.g., Furosemide) | Increased risk of ototoxicity and nephrotoxicity with systemic aminoglycosides. | Moderate (theoretical risk with topical). |