Tobramycin Dexamethasone [TOBRADEX] 0.3%/0.1% 5mL

NDC: 61314-647-05

Tobramycin 0.3% / Dexamethasone 0.1% Ophthalmic Suspension, 5 mL — Sandoz

Active ingredients	Tobramycin 0.3% (3 mg/mL) and dexamethasone 0.1% (1 mg/mL)
Dosage form	Ophthalmic suspension
Route	Topical ophthalmic
Size	5 mL
Manufacturer	Sandoz
NDC	61314-647-05

Indications and Usage

Treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Dosage and Administration

Instill one or two drops into the conjunctival sac(s) every four to six hours; during the initial 24 to 48 hours the dosage may be increased to one or two drops every two hours. Frequency should be reduced gradually as inflammation subsides, and no more than 20 mL should be prescribed initially without further evaluation. Shake well before use.

Warnings and Precautions

• For topical ophthalmic use only; not for injection into the eye
• Prolonged use may cause glaucoma, optic nerve damage, visual defects, and posterior subcapsular cataract formation
• May suppress the host immune response and increase the risk of secondary infections, including fungal
• Steroids may mask or exacerbate acute purulent or parasitic eye infections

Contraindications

Contraindicated in epithelial herpes simplex keratitis, vaccinia, varicella and most other viral corneal and conjunctival diseases, mycobacterial and fungal eye infections, and in patients hypersensitive to any component.

Adverse Reactions

The most common adverse reactions are hypersensitivity and localized ocular toxicity, including lid itching and swelling and conjunctival erythema, occurring in fewer than 4% of patients.

Storage and Handling

Store at 8°C to 27°C (46°F to 80°F); store upright and shake well before use.

How Supplied

Sterile suspension in plastic dropper dispensers, supplied in a 5 mL size.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.

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