NEODEX EYE/EAR DROPS 5ML

Indications

Approved Uses

Steroid-responsive inflammatory conditions of the eye and/or external ear where bacterial infection is present or suspected (e.g., bacterial conjunctivitis/blepharoconjunctivitis/keratoconjunctivitis with inflammation; otitis externa or infected eczematous conditions of the external ear canal).

Dosage & Administration

Dosing by Condition

Eye: 1-2 drops in affected eye(s) every 4-6 hours; in severe inflammation, may use every 1-2 hours initially then taper. Ear (otitis externa): 3-4 drops into affected ear 3-4 times daily; typical duration ~7-10 days with reassessment if not improving.

Initial Dose

1-2 drops into the affected eye(s) or 3-4 drops into the affected ear every 4-6 hours

Maintenance Dose

1-2 drops (ophthalmic) or 3-4 drops (otic) 3-4 times daily after initial response

Maximum Dose

Ophthalmic: 1-2 drops may be used as often as every 1-2 hours initially in severe inflammation, then taper; reassess if no improvement and avoid prolonged use (e.g., >7-10 days) without review/IOP monitoring. Otic dosing is condition-specific and physician-directed.

Children's Dosage

Use with caution in children; same drop dosing as adults but duration should be minimized. Not recommended in neonates without specialist supervision due to risk of systemic corticosteroid absorption.

Dose Adjustment Notes

No routine renal/hepatic dose adjustment is required for topical ophthalmic/otic use; taper frequency as symptoms improve, especially if used more than a few days, to reduce rebound inflammation and steroid-related adverse effects.

How to Take

Wash hands. For eye: tilt head back, pull down lower eyelid to form a pocket, instill prescribed drops without touching the tip, close eye gently 1-2 minutes and (optionally) apply nasolacrimal occlusion; recap immediately. For ear: warm bottle in hand, lie/tilt with affected ear up, instill drops without touching tip, keep position 2-5 minutes; recap. Separate from other eye drops by at least 5 minutes.

Side Effects

Common Side Effects

Local burning/stinging/irritation, itching/redness, transient blurred vision (eye use), increased tearing; hypersensitivity/contact dermatitis (notably neomycin); with prolonged ocular use: increased intraocular pressure, cataract risk, delayed healing/secondary infection; with ear use: local irritation.

Side Effect Frequency

Frequency is product-label dependent and often not precisely quantifiable; commonly reported: transient burning/stinging/irritation, itching, blurred vision (ocular use) or local irritation (auricular use). Less common/rare but clinically important with prolonged use: hypersensitivity/contact dermatitis (neomycin), secondary infection, delayed healing; for ocular use specifically: increased intraocular pressure/glaucoma, cataract, corneal/scleral thinning/perforation.

Safety & Warnings

Contraindications

Hypersensitivity to dexamethasone, neomycin/other aminoglycosides, or excipients; viral disease of cornea/conjunctiva (e.g., epithelial herpes simplex keratitis, vaccinia, varicella); fungal infection; mycobacterial ocular infection; and (for ear use) suspected/known tympanic membrane perforation.

Warnings & Precautions

Avoid use in viral/fungal/mycobacterial ocular disease; monitor intraocular pressure if used ~10 days or longer or in glaucoma risk; taper after prolonged/intensive use; discontinue if hypersensitivity/sensitization to neomycin occurs; do not use otically with suspected/known tympanic membrane perforation; avoid contact lenses during treatment (especially soft lenses) and remove lenses before instillation; space other eye drops by 5-15 minutes.

Age Restriction

No fixed minimum age in labeling; pediatric use (including infants) only if clearly needed and under physician supervision.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically significant systemic interactions are unlikely; separate from other topical eye products by 5-15 minutes; use caution with concurrent systemic corticosteroids or systemic aminoglycosides only in prolonged/high-dose use where absorption could be clinically relevant.

Interaction Severity

Clinically relevant interactions are uncommon with topical use; potential MODERATE interactions include: topical ophthalmic NSAIDs (may increase risk of corneal healing complications when combined with steroids) and strong CYP3A4 inhibitors (may increase systemic corticosteroid effects if significant absorption occurs, especially with prolonged/high-frequency use).

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Use with caution in children; same drop dosing as adults but duration should be minimized. Not recommended in neonates without specialist supervision due to risk of systemic corticosteroid absorption.

Elderly

Standard adult dosing; monitor intraocular pressure more closely due to higher risk of glaucoma in elderly patients

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Storage Conditions

Do not store above 30°C; keep container tightly closed. In-use discard period is label-specific and cannot be confirmed from the provided SFDA API fields (shelf life: 24 months unopened per SFDA data).

Missed Dose

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

Stopping the Medicine

If used for more than a short course or at high frequency, taper rather than stop abruptly; otherwise stopping after the prescribed short course is acceptable.

Overdose

Topical overdose is unlikely to cause systemic toxicity; manage by rinsing/irrigating the eye/ear with water or saline; accidental ingestion is usually low risk but warrants medical advice/poison center contact, especially in children.

Patient Counseling

Use exactly as prescribed; do not share. Avoid touching dropper tip; recap promptly. Remove contact lenses before eye use and wait at least 15 minutes before reinserting (and avoid lenses during active infection if advised). Temporary blurred vision may occur-avoid driving until clear. Seek care if worsening pain/redness, vision changes, no improvement in 48-72 hours, or signs of allergy (rash/swelling). Do not use for suspected viral/fungal eye infection unless directed. For ear use, do not use if eardrum perforation/ear tubes are suspected unless clinician confirms safety. Discard after the in-use period per local labeling (commonly 28 days after opening unless the product leaflet states otherwise).

Monitoring Requirements

If ocular use for ≥10 days or repeated courses: monitor intraocular pressure and assess for cataract/secondary infection or delayed healing; for ear use: monitor clinical response and avoid use if tympanic membrane perforation is suspected.

Pharmacology

Mechanism of Action

Dexamethasone: glucocorticoid that suppresses inflammatory gene expression and mediator production (e.g., via inhibition of phospholipase A2/COX-2 pathways), reducing edema, redness, and pain. Neomycin: aminoglycoside that binds the 30S ribosomal subunit, causing misreading of mRNA and inhibition of bacterial protein synthesis (bactericidal against susceptible organisms).

Onset of Action

Symptomatic relief may begin within 1-3 hours; clinically noticeable improvement is usually seen within 24-48 hours.

Duration of Effect

Local effect typically lasts about 4-6 hours, consistent with usual dosing intervals (may be shorter in severe inflammation requiring more frequent dosing).

Half-Life

Not well-defined for topical eye/ear use; if systemically absorbed: dexamethasone biological half-life ~36-54 hours (plasma half-life ~3-5 hours), and neomycin elimination half-life ~2-3 hours in normal renal function.

Bioavailability

Topical ophthalmic/otic administration; systemic absorption can occur but is generally low/minimal with short-term use on intact ocular/auricular epithelium (may increase with prolonged use, inflamed tissue, occlusion, or tympanic membrane perforation).

Metabolism

Dexamethasone: hepatic metabolism (primarily CYP3A4) if systemically absorbed; Neomycin: not significantly metabolized (excreted largely unchanged).

Excretion

If systemically absorbed: dexamethasone metabolites are eliminated mainly in urine; neomycin is eliminated renally largely unchanged (active).

Protein Binding

Dexamethasone: moderately protein bound (~70-80%); Neomycin: negligible/very low protein binding.

Product Information

Available Dosage Forms

Ear/eye drops, solution (dropper container).

Composition per Dose

Each ml: Dexamethasone 1mg (0.1%) + Neomycin Sulfate 5mg (0.5% as neomycin sulfate equivalent to approximately 3.5mg neomycin base)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Target Organ

Both

Preservative Free

No

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