This preparation is indicated for steroid-responsive inflammatory conditions of the eye, including the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, where a superficial bacterial infection is present. It is also used in chronic anterior uveitis and in corneal injuries caused by chemical, radiation, or thermal burns, as well as injuries from foreign body penetration. The combination with an anti-infective agent is recommended when there is a high risk of superficial ocular infection.

Like other aminoglycosides, Tobramycin produces its bactericidal effect by inhibiting normal protein synthesis in susceptible bacteria, although the exact mechanism is not fully understood. It is believed that this inhibition occurs through action on the ribosomes, leading to incorrect reading of messenger RNA by the bacteria. Dexamethasone works by inhibiting phospholipase A2, which is the first step in prostaglandin synthesis. It also suppresses the chemotactic migration of neutrophils to the site of inflammation. As a result, its anti-inflammatory activity is about 25 times stronger, and its overall therapeutic effectiveness is 8–10 times greater than that of hydrocortisone.

Eye Drops: Insert 1 drop into the conjunctival sac 3-5 times per day. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every 2 hours.

Eye Ointment: Apply a small amount into the conjunctival sac 3-4 times per day. Slowly close your eyes without blinking. Keep your eyes closed for 1 to 2 minutes.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

No specific drug interaction studies have been conducted for this combination eye drop. If it is used together with other topical ophthalmic medications, a gap of at least 10 minutes should be maintained between each application.

Contraindicated in epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and other viral infections of the cornea and conjunctiva. It is also not recommended in ocular mycobacterial infections or in patients with hypersensitivity to any component of the medication.

The most common adverse reactions to topical ocular tobramycin include hypersensitivity reactions and localized eye toxicity, such as eyelid itching, swelling, and conjunctival redness. These occur in fewer than 4% of patients. Side effects related to the steroid component include increased intraocular pressure with possible development of glaucoma and, in rare cases, optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Pregnancy: There are no adequate, well-controlled studies in pregnant women. This ophthalmic solution should be used during pregnancy only if the potential benefits outweigh the possible risks to the fetus.

Nursing Mothers: It is not known whether topical corticosteroid use leads to sufficient systemic absorption to produce measurable levels in human breast milk. Since many drugs are excreted in breast milk, caution is advised when this ophthalmic solution is used in breastfeeding women.

The possibility of corneal fungal infections should be considered following prolonged use of steroids. As with other antibiotic preparations, extended use may lead to the overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate treatment should be started. Cross-sensitivity with other aminoglycoside antibiotics may also occur. If hypersensitivity develops to this product, it should be discontinued and suitable therapy initiated.

No cases of overdose through local (topical) administration are known. In the event of accidental oral ingestion, appropriate measures should be taken to reduce absorption. There is no specific antidote available.

Ophthalmic steroid - antibiotic combined preparations

Store at room temperature. Close the bottle immediately after use. Do not use for longer than one month after opening the bottle.