Polymyxin B Sulf/Trimeth Sulfate 0.1% 10mL

NDC: 61314-628-10

Polymyxin B Sulfate / Trimethoprim Ophthalmic Solution, 10 mL — Sandoz

Active ingredients	Polymyxin B sulfate 10,000 units/mL and trimethoprim 1 mg/mL
Dosage form	Ophthalmic solution
Route	Topical ophthalmic
Size	10 mL
Manufacturer	Sandoz
NDC	61314-628-10

Indications and Usage

Treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis and blepharoconjunctivitis, caused by susceptible strains of bacteria.

Dosage and Administration

In mild to moderate infections, instill one drop in the affected eye(s) every three hours, to a maximum of six doses per day, for seven to ten days.

Warnings and Precautions

• Not for injection into the eye
• Discontinue use if a hypersensitivity reaction occurs
• Not indicated for prophylaxis or treatment of ophthalmia neonatorum
• Prolonged use may cause overgrowth of nonsusceptible organisms, including fungi

Contraindications

Contraindicated in patients with known hypersensitivity to any of the components.

Adverse Reactions

The most common adverse reaction is local irritation with increased redness, burning, stinging, or itching; hypersensitivity reactions such as lid edema and tearing may also occur.

Storage and Handling

Store at 15°C to 25°C (59°F to 77°F) and protect from light.

How Supplied

Sterile solution in a plastic dropper bottle, supplied in a 10 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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