AROX 0.5% EYE DROPS 5ML

Indications

Approved Uses

Bacterial conjunctivitis caused by susceptible microorganisms.

Dosage & Administration

Dosing by Condition

Bacterial conjunctivitis: Instill one drop in the affected eye 3 times a day for 7 days.

Initial Dose

1 drop in affected eye(s) 3 times daily

Maintenance Dose

1 drop in affected eye(s) 3 times daily

Maximum Dose

1 drop in the affected eye(s) three times daily (typical regimen for bacterial conjunctivitis).

Children's Dosage

Approved for children aged 1 year and older: same dosing as adults (1 drop 3 times daily for 2 days, then 2 times daily for 5 days)

Dose Adjustment Notes

No dose adjustment is required in renal or hepatic impairment (minimal systemic absorption with ophthalmic use).

How to Take

Wash hands. Tilt head back, pull down lower eyelid to form a pocket, instill 1 drop 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 near the nose) for about 1-2 minutes to reduce drainage/systemic absorption.

Side Effects

Common Side Effects

Ocular irritation/burning/stinging, eye pain or discomfort, conjunctival hyperemia (redness), pruritus (itching), dry eye, blurred vision, increased lacrimation (watery eyes).

Side Effect Frequency

Common (≥1% to <10%): ocular irritation/burning/stinging, eye pain/discomfort, conjunctival hyperemia, pruritus, dry eye, blurred vision, increased lacrimation. Uncommon (<1%): keratitis/corneal disorders (e.g., deposits), reduced visual acuity, hypersensitivity reactions, headache.

Safety & Warnings

Contraindications

Hypersensitivity to moxifloxacin, other fluoroquinolones, or any component of the formulation

Warnings & Precautions

For ophthalmic use only (not for injection/oral use); avoid contaminating the dropper tip; avoid contact lens wear during active bacterial conjunctivitis; discontinue and seek care if hypersensitivity occurs; prolonged use may cause overgrowth of non-susceptible organisms (including fungi).

Age Restriction

Safety and efficacy established in patients of all ages including neonates.

Drug Interactions

Drug Interactions

No clinically meaningful drug interactions are expected; formal interaction studies with ophthalmic moxifloxacin have not been conducted and systemic absorption is low.

Interaction Severity

No clinically significant drug interactions are expected with ophthalmic moxifloxacin due to minimal systemic absorption; separate different eye drops by at least 5 minutes to avoid washout.

Food Interaction

No food interactions (ophthalmic use).

Special Populations

Children

Approved for children aged 1 year and older: same dosing as adults (1 drop 3 times daily for 2 days, then 2 times daily for 5 days)

Kidney Impairment

No adjustment needed.

Storage & Patient Advice

Stopping the Medicine

Complete the prescribed course; do not stop early even if symptoms improve, and seek reassessment if symptoms worsen or fail to improve within 48-72 hours.

Patient Counseling

Use exactly as prescribed and complete the course. Wash hands; avoid touching the dropper tip. Remove contact lenses and avoid wearing them during active infection/treatment unless the prescriber advises otherwise. If using other eye meds, separate by at least 5 minutes. Temporary blurred vision may occur-wait for clear vision before driving. Seek care urgently for severe pain, photophobia, vision changes, swelling/rash, or if symptoms worsen or fail to improve within 2-3 days.

Monitoring Requirements

No routine monitoring required; monitor for clinical improvement within 2-3 days

Pharmacology

Mechanism of Action

A fourth-generation fluoroquinolone that inhibits the bacterial enzymes DNA gyrase (topoisomerase II) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.

Onset of Action

Symptomatic improvement is often seen within 48-72 hours, though full resolution may take up to 5-7 days; reassess if no improvement within 2-3 days or if worsening occurs.

Duration of Effect

Not precisely defined clinically; moxifloxacin achieves and maintains antibacterial concentrations in tear film/ocular tissues for several hours after a dose, supporting multiple-daily dosing regimens.

Half-Life

Systemic elimination half-life is approximately 12-13 hours (based on systemic administration); this is of limited clinical relevance for ophthalmic use due to minimal systemic absorption.

Bioavailability

Very low systemic bioavailability after ophthalmic administration; estimated to be <1% (systemic exposure is ~1,000-1,600 times lower than after a 400 mg oral dose).

Metabolism

Moxifloxacin undergoes phase II metabolism (primarily glucuronide and sulfate conjugation); cytochrome P450 enzymes are not meaningfully involved.

Product Information

Available Dosage Forms

Ophthalmic solution (eye drops)

Composition per Dose

Each mL: 5 mg moxifloxacin as moxifloxacin hydrochloride (0.5% w/v)

Generic Availability

Yes

OTC Alternatives

No OTC alternative (prescription required for ophthalmic fluoroquinolones)

Target Organ

Eye

Preservative Free

No

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