TOBRACIN 0.3% EYE DROPS 10ML

Indications

Approved Uses

Treatment of external bacterial infections of the eye and its adnexa caused by susceptible organisms (e.g., bacterial conjunctivitis/blepharitis/blepharoconjunctivitis; may be used for superficial keratitis per product labeling in many references).

Dosage & Administration

Dosing by Condition

Bacterial Conjunctivitis (Mild to Moderate): Instill 1-2 drops into the affected eye(s) every 4 hours. Bacterial Conjunctivitis (Severe): Instill 2 drops into the eye(s) hourly until improvement, then reduce frequency.

Initial Dose

1-2 drops in the affected eye(s) every 4 hours (mild-moderate); every 1 hour (severe infection)

Maintenance Dose

1-2 drops every 4 hours.

Maximum Dose

Severe infections: 2 drops in the affected eye(s) every hour; reduce frequency as improvement occurs.

Children's Dosage

Approved for use in children. Clinical studies have shown tobramycin to be safe and effective for use in children.

Dose Adjustment Notes

No dose adjustment is generally required in renal or hepatic impairment for ophthalmic use because systemic absorption is minimal; use caution with prolonged/high-frequency use or if combined with systemic aminoglycosides.

How to Take

Wash hands. Tilt head back, pull down lower eyelid to form a pocket, instill the prescribed number of drops into the conjunctival sac. Avoid touching the dropper tip to the eye/skin/any surface. Close the eye gently and apply nasolacrimal occlusion (press inner corner near the nose) for 1-2 minutes. Replace cap immediately.

Side Effects

Common Side Effects

Transient ocular burning/stinging/irritation or discomfort, conjunctival redness (erythema), tearing (lacrimation), eyelid itching and eyelid swelling.

Side Effect Frequency

Common (≥1% to <10%): ocular irritation/discomfort including burning/stinging, conjunctival hyperemia/erythema, lacrimation/tearing, eyelid itching/pruritus and eyelid edema/swelling; Uncommon (<1%): keratitis/corneal epithelial toxicity (e.g., corneal abrasion), hypersensitivity reactions, blurred vision/visual disturbance, conjunctival edema, dry eye, eye pain, and superinfection with prolonged use.

Safety & Warnings

Contraindications

Hypersensitivity to tobramycin, other aminoglycosides, or any component of the formulation.

Warnings & Precautions

For ophthalmic use only (not for injection/oral use); avoid contamination of dropper tip; discontinue if hypersensitivity occurs; prolonged use may cause overgrowth of non-susceptible organisms including fungi; cross-sensitivity with other aminoglycosides may occur; remove contact lenses before use and reinsert after an appropriate interval if permitted by clinician.

Age Restriction

No specific minimum age restriction in labeling; may be used in pediatrics including infants when clinically indicated, with caution in neonates/young infants.

Drug Interactions

Drug Interactions

Clinically significant interactions are unlikely with ophthalmic use; use caution/monitoring if used concurrently with systemic aminoglycosides or other nephrotoxic/ototoxic agents, especially with prolonged/high-frequency dosing or compromised ocular surface.

Interaction Severity

MINOR/clinically unlikely: concomitant systemic aminoglycosides may theoretically increase additive nephro/ototoxicity, but systemic exposure from eye drops is minimal; consider caution with prolonged intensive ophthalmic dosing.

Food Interaction

No restriction

Special Populations

Children

Approved for use in children. Clinical studies have shown tobramycin to be safe and effective for use in children.

Kidney Impairment

No adjustment needed for ophthalmic use.

Storage & Patient Advice

Missed Dose

Instill the missed dose as soon as remembered; if it is close to the next dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Complete the prescribed course; do not stop early unless hypersensitivity/serious adverse effects occur or prescriber advises.

Overdose

Ocular overdose may cause increased local irritation (e.g., punctate keratitis, redness, tearing, lid edema/itching); manage by flushing the eye with lukewarm water/saline; systemic toxicity is unlikely, and accidental ingestion is usually low risk but seek advice if large amount or symptoms occur.

Patient Counseling

Use exactly as prescribed and complete the course. Wash hands; avoid touching the dropper tip; close eye and press inner corner 1-2 minutes after dosing. Remove contact lenses before use and generally avoid lens wear during active infection; if permitted, wait at least 15 minutes before reinsertion. Seek care urgently for worsening pain, swelling, rash, vision changes, or no improvement within 48 hours; do not share drops.

Monitoring Requirements

No routine laboratory monitoring is required for ophthalmic use; clinically monitor for improvement within 48 hours, hypersensitivity, and superinfection (including fungal overgrowth) with prolonged use.

Pharmacology

Mechanism of Action

Aminoglycoside antibiotic that binds the bacterial 30S ribosomal subunit, inhibiting protein synthesis and causing misreading of mRNA, leading to bactericidal cell death.

Onset of Action

Within minutes after instillation (local antibacterial activity begins promptly).

Duration of Effect

Approximately 4 hours per dose (hence typical dosing every 4 hours; may be more frequent initially in severe infections as prescribed).

Half-Life

Systemic elimination half-life is ~2 hours (about 2-3 hours) when systemically absorbed; after ophthalmic use, systemic absorption is minimal and no clinically meaningful systemic half-life is typically observed.

Bioavailability

Minimal systemic absorption after ophthalmic administration; primarily local ocular exposure.

Metabolism

Not significantly metabolized; eliminated largely unchanged (primarily via renal excretion if systemically absorbed).

Excretion

If systemically absorbed, tobramycin is eliminated primarily by the kidneys as unchanged drug via glomerular filtration.

Protein Binding

Less than 10%.

Product Information

Available Dosage Forms

Eye drops (solution)

Composition per Dose

Each mL: Tobramycin 3 mg (0.3%)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Target Organ

Eye

Preservative Free

No

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