OPTIDEX-T EYE DROPS 5ML

Indications

Approved Uses

Steroid-responsive inflammatory conditions of the conjunctiva/cornea/anterior segment where superficial bacterial infection is present or there is a risk of bacterial infection (e.g., bacterial conjunctivitis/blepharoconjunctivitis with marked inflammation; post‑operative inflammation when infection risk exists).

Dosage & Administration

Dosing by Condition

Ocular inflammation with bacterial infection/risk: 1-2 drops in affected eye(s) every 4-6 hours; in severe cases, 1-2 drops every 2 hours while awake for the first 24-48 hours, then taper to every 4-6 hours as improvement occurs.

Initial Dose

1-2 drops into the affected eye(s) every 2 hours during waking hours for severe cases, or every 4-6 hours for mild-to-moderate cases

Maintenance Dose

1-2 drops into the affected eye(s) every 4-6 hours

Maximum Dose

Initial: 1-2 drops every 2 hours while awake for severe inflammation, then reduce to 1-2 drops every 4-6 hours as improvement occurs; do not continue beyond ~14 days without ophthalmic reassessment.

Dose Adjustment Notes

May increase dosing frequency during the first 24-48 hours in severe inflammation, then taper frequency as signs/symptoms improve; reassess if no clinical improvement within ~48 hours or if worsening occurs.

How to Take

Wash hands; shake well before each use (suspension). Tilt head back, pull down lower eyelid, instill 1-2 drops into the conjunctival sac without touching the dropper tip. Close eye gently and perform nasolacrimal occlusion (press inner canthus) for 1-2 minutes. Recap immediately. If using other ophthalmic products, separate by at least 5-10 minutes (apply drops before ointments).

How to Prepare

Shake well before each use (ophthalmic suspension).

Side Effects

Common Side Effects

Transient ocular burning/stinging/irritation, blurred vision, eye redness, tearing, itching, eyelid itching/swelling (hypersensitivity).

Side Effect Frequency

Most common: local ocular irritation/discomfort (burning/stinging), transient blurred vision, conjunctival hyperemia, pruritus/tearing, eyelid edema; frequency varies by source and is often reported as common/very common for local irritation, while steroid-related events (increased intraocular pressure, cataract with prolonged use, delayed healing, secondary infection) are uncommon/rare but clinically important.

Safety & Warnings

Contraindications

Hypersensitivity to tobramycin, dexamethasone, other aminoglycosides, or excipients; epithelial herpes simplex keratitis; vaccinia, varicella, and other viral diseases of cornea/conjunctiva; mycobacterial ocular infection; fungal diseases of ocular structures.

Warnings & Precautions

Monitor IOP if used ≥10 days; prolonged use may cause glaucoma/optic nerve damage, cataract, and secondary infection; use caution with corneal thinning disorders (perforation risk); avoid contact lenses during active infection/inflammation and if product contains benzalkonium chloride; sensitivity to topical aminoglycosides can occur; for ophthalmic use only (not for injection).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically significant interactions are unlikely due to minimal systemic absorption; use caution with concomitant systemic aminoglycosides (theoretical additive toxicity if systemic exposure occurs), topical NSAIDs (may increase corneal healing complications), and strong CYP3A4 inhibitors (theoretical increase in systemic steroid effects with prolonged/high-frequency use).

Interaction Severity

MODERATE: Strong CYP3A4 inhibitors (e.g., ritonavir/cobicistat) may increase systemic corticosteroid effects even with topical ocular steroids (rare but reported). MINOR/CLINICALLY LOW: Concomitant systemic aminoglycosides-additive oto/nephrotoxicity is unlikely due to minimal ocular absorption but use caution in prolonged/high-frequency use or compromised ocular surfaces; Ophthalmic NSAIDs with topical steroids may increase corneal adverse-event risk in susceptible patients.

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Kidney Impairment

No dose adjustment needed (ophthalmic use).

Liver Impairment

No dose adjustment needed (ophthalmic use).

Storage & Patient Advice

Preparation Instructions

Shake well before each use (ophthalmic suspension).

Missed Dose

Instill the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule; do not double doses.

Stopping the Medicine

Do not stop abruptly after prolonged/frequent use; taper as directed by an ophthalmologist.

Overdose

Topical overdose: rinse/flush the eye with water or saline; systemic toxicity is unlikely; if ingested, seek medical advice/poison center and provide supportive care.

Patient Counseling

Shake well; wash hands; avoid touching the tip; instill as directed and perform nasolacrimal occlusion 1-2 minutes. Avoid contact lenses during active infection/inflammation unless prescriber advises otherwise. Expect brief blurred vision-use caution with driving until clear. Use only for the prescribed duration; prolonged use can increase eye pressure and cataract risk-seek care for eye pain, worsening redness/discharge, or vision changes. If using other eye meds, separate by 5-10 minutes. Store below 30°C.

Monitoring Requirements

If used for ≥10 days or repeated courses: monitor intraocular pressure; consider slit-lamp/corneal evaluation in patients with corneal disease or if symptoms persist/worsen; monitor for signs of superinfection (including fungal) with prolonged use.

Pharmacology

Mechanism of Action

Tobramycin: aminoglycoside antibiotic that binds the 30S ribosomal subunit, inhibiting protein synthesis and causing bactericidal activity. Dexamethasone: corticosteroid that suppresses ocular inflammation by inhibiting inflammatory mediator production and leukocyte activity (e.g., via phospholipase A2 pathway).

Half-Life

Ocular (topical) half-life is not well-defined/clinically used; if systemically absorbed: tobramycin plasma half-life is ~2 hours in normal renal function, and dexamethasone plasma half-life is ~3-4.5 hours (biologic effect longer).

Bioavailability

Systemic absorption is generally minimal after ophthalmic administration; absorption may increase with frequent dosing, prolonged therapy, nasolacrimal drainage, or damaged/inflamed ocular surfaces-nasolacrimal occlusion reduces systemic exposure.

Metabolism

Tobramycin: not significantly metabolized; Dexamethasone: hepatically metabolized (primarily CYP3A4) if systemically absorbed; overall systemic metabolism after ophthalmic dosing is minimal due to low absorption.

Excretion

For ophthalmic use, systemic excretion is not clinically meaningful due to low absorption; if systemically absorbed: tobramycin is eliminated primarily by renal excretion largely unchanged, and dexamethasone is eliminated mainly in urine as metabolites (after hepatic metabolism).

Protein Binding

Not clinically relevant for ophthalmic use; if systemically absorbed: tobramycin has low protein binding (generally <10%) and dexamethasone is moderately/highly protein bound (commonly ~70-80%).

Product Information

Available Dosage Forms

Eye drops, suspension (5 mL dropper container).

Composition per Dose

Each ml of suspension: Tobramycin 3 mg (0.3%) + Dexamethasone 1 mg (0.1%)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Target Organ

Eye

Preservative Free

No

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