Dexagen T

Approved Indications

• Treatment of bacterial infections of the eye caused by susceptible organisms (e.g., conjunctivitis, blepharitis, keratitis) accompanied by significant inflammation requiring corticosteroid therapy.
• Management of ocular inflammatory conditions where anti-inflammatory effects of corticosteroids are needed alongside antibiotic coverage to prevent or treat secondary bacterial infections.
• Postoperative ocular inflammation and infection prophylaxis after eye surgery.

Important Off-Label Uses

• Mixed ocular infections with inflammation.
• Severe blepharitis or meibomian gland dysfunction with bacterial involvement.
• Inflammatory conditions with secondary bacterial superinfection.

Ophthalmic Solution (Eye Drops)

• Adults and children >2 years: Instill 1-2 drops into the affected eye every 4 to 6 hours.
• Frequency may be adjusted by clinician based on severity and clinical response.
• Treatment duration typically 7-10 days; do not exceed 14 days to avoid steroid complications.

Ophthalmic Ointment

• Apply a small ribbon of ointment (about 0.5 inch) into the conjunctival sac 1 to 4 times daily.

Special Populations

• Safety and efficacy in children under 2 years not established; use with caution.
• No dosage adjustment needed for renal or hepatic impairment due to topical route.

Administration Tips

• Shake well before use.
• Avoid touching the dropper tip to the eye or any surface to prevent contamination.
• Remove contact lenses prior to administration and wait 15 minutes before reinsertion.

• Dexamethasone: A potent glucocorticoid that binds to intracellular glucocorticoid receptors, modulating gene transcription to suppress pro-inflammatory cytokines and inhibit leukocyte infiltration, thereby reducing inflammation, edema, and pain in ocular tissues.
• Tobramycin: An aminoglycoside antibiotic that binds irreversibly to the 30S ribosomal subunit of susceptible bacteria, inhibiting protein synthesis and leading to bacterial cell death. It is effective against many Gram-negative and some Gram-positive bacteria.

The combination simultaneously controls inflammation and eradicates bacterial infection in ocular tissues.

• Absorption:
• Minimal systemic absorption after topical ocular administration.
• Achieves therapeutic concentrations primarily in conjunctiva and cornea.
• Distribution:
• Concentrated locally at the site of application with negligible systemic distribution.
• Metabolism:
• Negligible systemic metabolism due to minimal absorption.
• Elimination:
• If absorbed systemically, tobramycin is primarily excreted unchanged by renal filtration.

• Pregnancy:
• Classified as FDA Pregnancy Category C for systemic corticosteroids.
• Topical ocular administration results in minimal systemic exposure; use only if benefits outweigh risks.
• Tobramycin safety in pregnancy via topical route has limited data; caution advised.
• Lactation:
• Minimal systemic absorption suggests low risk during breastfeeding.
• Use cautiously and avoid direct contact with breast tissue.

• Dexamethasone: Corticosteroid, Glucocorticoid
• Tobramycin: Antibiotic, Aminoglycoside
• Combination: Topical corticosteroid-antibiotic ophthalmic preparation

• Known hypersensitivity to dexamethasone, tobramycin, or formulation excipients
• Viral infections of the eye (e.g., herpes simplex keratitis)
• Fungal eye infections
• Tuberculosis of the eye
• Hypersensitivity to other aminoglycosides

• Prolonged corticosteroid use may cause increased intraocular pressure, glaucoma, and cataracts; monitor intraocular pressure during extended therapy.
• Risk of secondary ocular infections due to immunosuppressive effects of corticosteroids; discontinue if infection worsens.
• Tobramycin may cause rare allergic reactions or ocular toxicity; use cautiously in patients with known aminoglycoside hypersensitivity.
• Avoid use with contact lenses during active infection.
• Monitor for signs of superinfection or hypersensitivity reactions.

Common

• Burning, stinging, or irritation upon instillation
• Eye redness, itching, or discomfort
• Transient blurred vision

Less Common

• Increased intraocular pressure
• Dry eyes
• Allergic conjunctivitis or eyelid edema

Rare

• Secondary fungal or bacterial infection
• Corneal thinning or perforation with prolonged steroid use

• Minimal systemic absorption reduces systemic drug interactions.
• Avoid concurrent use with other topical ocular medications unless advised.
• Caution with systemic aminoglycosides or corticosteroids to avoid additive effects.

• Ongoing recommendations support use of combined corticosteroid-antibiotic eye drops for bacterial conjunctivitis with inflammation.
• Emphasis on limiting steroid use duration to prevent ocular hypertension and cataracts.
• Recent clinical data support good efficacy and safety profile when used appropriately.

• Store at 20°C to 25°C (68°F to 77°F)
• Protect from light and moisture
• Keep container tightly closed
• Do not freeze
• Keep out of reach of children
• Discard 28 days after opening to prevent contamination