Tobracalm D Eye/Ear Drop (Tobramycin 0.3% w/v + Dexamethasone Sodium Phosphate 0.1% w/v)

Composition

Each mL of sterile solution contains:

Tobramycin IP — 0.3% w/v (3 mg/mL)

Dexamethasone Sodium Phosphate IP — 0.1% w/v (1 mg/mL)

Benzalkonium Chloride — 0.01% w/v (as preservative)

Excipients: Sodium chloride, disodium edetate, water for injection — q.s.

 Therapeutic Category

Ophthalmic / Otic Antibacterial and Corticosteroid Combination.

Dosage & Administration

Route: Ophthalmic or Otic (for external use only)

Do not touch the dropper tip to any surface or eye/ear.

Shake gently before use.

Continue therapy for 48 hours after symptoms resolve unless otherwise directed.

 Warnings & Precautions

Prolonged use may cause increased intraocular pressure, optic nerve damage, or secondary fungal infections.

Superinfection: Overuse may promote nonsusceptible bacterial or fungal overgrowth.

Contact lenses: Remove before instillation and reinsert after at least 15 minutes.

Monitoring: Check intraocular pressure if used for >10 days.

Ear use: Avoid if tympanic membrane integrity is uncertain.

Do not inject or ingest.

 Adverse Effects

Ocular: Burning, stinging, irritation, redness, blurred vision, photophobia.

Aural: Transient irritation, itching, discomfort.

Systemic: Rare; minimal absorption from topical use.

Prolonged use: Risk of glaucoma, cataract formation, or secondary infection.

Overdosage

Symptoms: Excessive local irritation, burning, or redness.
Treatment: Rinse the affected area with sterile saline or water; discontinue temporarily. No systemic toxicity expected.

Storage

Store below 25°C, in a cool and dry place, protected from light.
Do not freeze.
Discard 4 weeks after opening.
Keep out of reach of children.