Dexagen L

Approved Indications

• Treatment of bacterial conjunctivitis and other superficial bacterial eye infections caused by susceptible organisms, combined with significant ocular inflammation.
• Management of ocular inflammatory conditions where corticosteroid anti-inflammatory effects are needed alongside antibacterial therapy to control infection and inflammation.
• Postoperative ocular inflammation and infection prophylaxis following ocular surgery or trauma.

Clinically Accepted Off-Label Uses

• Mixed ocular infections with inflammatory components.
• Severe blepharitis with secondary bacterial infection.
• Keratitis with bacterial involvement requiring anti-inflammatory therapy.

Adults and Pediatric Patients (>2 years)

• Instill 1-2 drops into the affected eye every 4 to 6 hours.
• Adjust frequency based on clinical response, gradually taper dexamethasone component as inflammation resolves.
• Treatment duration usually 7-10 days, not exceeding 14 days to minimize steroid-related complications.

Special Populations

• Use with caution in children under 2 years; safety and efficacy not established.
• No dose adjustment required in renal or hepatic impairment due to topical administration.

Administration

• Shake well before use.
• Avoid contamination of dropper tip.
• Remove contact lenses before administration and wait at least 15 minutes before reinsertion.

• Dexamethasone is a potent synthetic glucocorticoid that binds to intracellular glucocorticoid receptors, modulating gene expression to inhibit pro-inflammatory mediators and suppress leukocyte infiltration. This results in decreased ocular inflammation, edema, and redness.
• Levofloxacin is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV enzymes, essential for DNA replication and transcription. This action leads to bactericidal effects against a broad spectrum of Gram-positive and Gram-negative pathogens.

Together, this combination reduces ocular inflammation while effectively eliminating susceptible bacterial pathogens causing or complicating the infection.

• Absorption:
• Minimal systemic absorption via topical ocular route.
• Local ocular tissue concentrations achieve therapeutic levels.
• Distribution:
• Primarily localized to ocular tissues including conjunctiva and cornea.
• Metabolism:
• Systemic metabolism negligible due to minimal absorption.
• Levofloxacin undergoes hepatic metabolism if absorbed systemically.
• Elimination:
• Excreted mainly unchanged in urine when systemic absorption occurs.

• Pregnancy:
• Classified as Category C for systemic corticosteroids; no adequate well-controlled studies in pregnant women.
• Use only if potential benefits justify risks.
• Levofloxacin is generally avoided during pregnancy due to concerns from animal studies but topical ocular use presents minimal risk.
• Lactation:
• Unknown whether dexamethasone or levofloxacin is excreted in breast milk via topical use; systemic exposure minimal.
• Use with caution during breastfeeding.

• Dexamethasone: Corticosteroid, Glucocorticoid
• Levofloxacin: Antibiotic, Fluoroquinolone
• Combination: Topical corticosteroid-antibiotic ophthalmic preparation

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

• Prolonged corticosteroid use can cause increased intraocular pressure, glaucoma, cataracts; monitor intraocular pressure if used long-term.
• Risk of secondary ocular infections or superinfections with corticosteroids; discontinue if infection worsens or new infection develops.
• Use with caution in patients with corneal epithelial defects.
• May cause hypersensitivity reactions including anaphylaxis.
• Avoid contact lens use during active infection.

Common

• Ocular burning, stinging, or discomfort on instillation
• Blurred vision (transient)
• Eye redness or itching

Less Common

• Increased intraocular pressure
• Dry eyes
• Allergic reactions including eyelid edema, rash
• Photophobia

Rare

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

• Minimal systemic absorption reduces potential for systemic drug interactions.
• Avoid concurrent use with other topical ophthalmic medications unless advised.
• Use caution with systemic corticosteroids or fluoroquinolones to avoid additive effects.

• Use supported by major ophthalmology guidelines for combined treatment of bacterial conjunctivitis with significant inflammation.
• Recommendations emphasize limiting duration of corticosteroid use to minimize risks of ocular hypertension and cataract formation.
• Recent studies highlight good efficacy and tolerability profile compared to non-steroid antibiotic combinations.

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