Tobramycin Dexamethasone [TOBRADEX] 0.3%/0.1% 2.5mL

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Padagis US LLCSKU: RX-1056

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Description

NDC: 24208-295-25

Tobramycin 0.3% / Dexamethasone 0.1% Ophthalmic Suspension, 2.5 mL — Bausch & Lomb

Active ingredients Tobramycin 0.3% (3 mg/mL) and dexamethasone 0.1% (1 mg/mL)
Dosage form Ophthalmic suspension
Route Topical ophthalmic
Size 2.5 mL
Manufacturer Bausch & Lomb
NDC 24208-295-25

Indications and Usage

Indicated for steroid-responsive inflammatory ocular conditions of the eye and adnexa where a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of infection exists.

Dosage and Administration

Instill one or two drops into the conjunctival sac every 4 to 6 hours. During the initial 24 to 48 hours the dose may be increased to one or two drops every 2 hours, then reduced as inflammation subsides; do not discontinue prematurely.

Warnings and Precautions

  • For topical ophthalmic use only; not for injection into the eye
  • Prolonged corticosteroid use may cause glaucoma with optic nerve damage, visual defects, posterior subcapsular cataract, and secondary ocular infection
  • Corticosteroids may slow corneal and scleral healing and may mask or exacerbate infection
  • Possible aminoglycoside hypersensitivity; avoid contact lens wear during treatment

Contraindications

Contraindicated in epithelial herpes simplex keratitis, vaccinia, varicella and most other viral corneal and conjunctival diseases, mycobacterial eye infection, fungal eye disease, and hypersensitivity to any component.

Adverse Reactions

The most common reactions are hypersensitivity and localized ocular toxicity such as lid itching and swelling and conjunctival erythema. Secondary infection and, rarely, anaphylaxis have occurred.

Storage and Handling

Store at 8°C to 27°C (46°F to 80°F) in an upright position; shake well before use.

How Supplied

Sterile ophthalmic suspension in plastic dropper bottles, including 2.5 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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