OFLOX 0.3% EYE DROPS 5ML

Indications

Approved Uses

Bacterial conjunctivitis and bacterial corneal ulcer (bacterial keratitis) caused by susceptible organisms.

Dosage & Administration

Dosing by Condition

Bacterial conjunctivitis: Days 1-2: 1-2 drops in affected eye(s) every 2-4 hours while awake; Days 3-7: 1-2 drops 4 times daily. Corneal ulcer: Days 1-2: 1-2 drops every 30 minutes while awake and 4-6 hours after retiring; Days 3-7(-9): 1-2 drops every hour while awake; then 1-2 drops 4 times daily until clinical cure (duration individualized).

Initial Dose

1-2 drops in affected eye(s) every 2-4 hours while awake

Maintenance Dose

1-2 drops in affected eye(s) 4 times daily

Maximum Dose

No systemic maximum dose applies; ophthalmic regimens may be as frequent as 1-2 drops every 30 minutes initially for bacterial corneal ulcer, then tapered per response/prescriber direction.

Children's Dosage

Safety and effectiveness in infants below 1 year have not been established; use in children 1 year and older has not been explicitly confirmed in provided sources as using the same adult dosing regimen

Dose Adjustment Notes

No dose adjustment is required for renal or hepatic impairment with ophthalmic use.

How to Take

Wash hands. Tilt head back and pull down the lower eyelid to form a pocket. Instill 1 drop (or as prescribed) into the conjunctival sac without touching the dropper tip to the eye/skin/surfaces. Close the eye gently and apply nasolacrimal occlusion (press inner corner) for 1-2 minutes. If using other eye drops, separate by at least 5 minutes.

Side Effects

Common Side Effects

Transient ocular burning/stinging/discomfort, conjunctival hyperemia (redness), itching, tearing (lacrimation), blurred vision, photophobia; foreign-body sensation may occur.

Side Effect Frequency

Common (≥1% to <10%): transient ocular burning/stinging/irritation or discomfort after instillation; other reported reactions include conjunctival hyperemia/redness, pruritus, tearing, foreign body sensation, blurred vision, photophobia; less common/uncommon: corneal changes (e.g., keratitis/corneal infiltrates) and hypersensitivity reactions.

Safety & Warnings

Contraindications

Hypersensitivity to ofloxacin, other quinolones/fluoroquinolones, or any component of the formulation.

Warnings & Precautions

For ophthalmic use only (not for injection); avoid contaminating the dropper tip; discontinue at first sign of hypersensitivity; prolonged use may cause overgrowth of non-susceptible organisms including fungi; remove contact lenses before use and reinsert after ~15 minutes (and avoid lenses in active infection).

Age Restriction

Safety and effectiveness in infants <1 year have not been established (use only if clearly needed under specialist supervision).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically significant drug interactions are unlikely due to minimal systemic absorption; if using other ophthalmic products, separate administrations by at least 5 minutes (ointment last).

Interaction Severity

MINOR: Concurrent ophthalmic products can dilute/wash out the drop; administer different eye drops at least 5 minutes apart (ointments last).

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Children

Safety and effectiveness in infants below 1 year have not been established; use in children 1 year and older has not been explicitly confirmed in provided sources as using the same adult dosing regimen

Elderly

Standard adult dosing. No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Kidney Impairment

No dose adjustment needed for renal impairment for ophthalmic use.

Liver Impairment

No dose adjustment needed for hepatic impairment for ophthalmic use.

Storage & Patient Advice

Missed Dose

Use 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.

Overdose

Ophthalmic overdose is unlikely; if excessive drops are used, rinse/flush the eye with water/saline. If accidentally swallowed, seek medical advice-management is supportive.

Patient Counseling

Use exactly as prescribed and complete the course. Wash hands; avoid touching the dropper tip. Remove contact lenses before use and generally avoid wearing lenses during active infection; if advised to resume, wait at least 15 minutes after dosing. Apply nasolacrimal occlusion for 1-2 minutes. Separate from other eye drops by ≥5 minutes. Temporary blurred vision may occur-avoid driving until clear. Seek care urgently for severe pain, worsening redness/swelling, photophobia, or vision changes. Discard the bottle 28 days after opening (or per local label).

Monitoring Requirements

Monitor clinical response (symptom improvement, reduced discharge/redness); if no improvement or worsening within 48-72 hours, reassess diagnosis/adherence and consider culture/referral; monitor for hypersensitivity or superinfection.

Pharmacology

Mechanism of Action

Inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for DNA replication, transcription, repair, and recombination, leading to bacterial cell death

Onset of Action

Begins within minutes after instillation (antibacterial activity starts immediately on contact with ocular tissues).

Half-Life

Ophthalmic half-life: not well established/clinically not defined; systemic elimination half-life is approximately 5-7 hours.

Bioavailability

Minimal systemic absorption after ophthalmic administration (systemic exposure is very low).

Excretion

If systemically absorbed, ofloxacin is eliminated primarily by renal excretion, largely unchanged in urine (majority of dose; commonly cited ~65-80% unchanged).

Protein Binding

Approximately 32% for systemic ofloxacin.

Product Information

Available Dosage Forms

For this SFDA product: Eye drops, solution (ophthalmic).

Composition per Dose

Each mL: 3 mg ofloxacin (0.3%) in aqueous solution

Target Organ

Eye

Preservative Free

No

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