Ofloxacin 0.3%, 10mL Ophthalmic Solution, Sola Pharmaceuticals

NDC: 70512-793-10

Ofloxacin 0.3% Ophthalmic Solution, 10 mL — Sola Pharmaceuticals

Active ingredients	Ofloxacin 0.3% (3 mg/mL)
Dosage form	Ophthalmic solution
Route	Topical ophthalmic
Size	10 mL
Manufacturer	Sola Pharmaceuticals
NDC	70512-793-10

Indications and Usage

A fluoroquinolone antibacterial indicated for the treatment of bacterial conjunctivitis and corneal ulcers caused by susceptible strains of organisms such as Staphylococcus aureus, Pseudomonas aeruginosa, and Haemophilus influenzae.

Dosage and Administration

For conjunctivitis, instill one to two drops in the affected eye(s) every 2 to 4 hours on days 1 and 2, then four times daily on days 3 through 7. For corneal ulcer, instill one to two drops every 30 minutes while awake on days 1 and 2, then hourly while awake on days 3 through 7 to 9, tapering thereafter.

Warnings and Precautions

• Not for injection; do not inject subconjunctivally or into the anterior chamber
• Serious and occasionally fatal hypersensitivity reactions have been reported with systemic quinolones; discontinue at the first sign of rash or allergic reaction
• Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi
• Discontinue contact lens wear during treatment of an eye infection

Contraindications

Contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any component of the product.

Adverse Reactions

The most frequently reported adverse reaction is transient ocular burning or discomfort. Other reactions include stinging, redness, itching, and blurred vision.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F), and protect from light.

How Supplied

Supplied as a sterile ophthalmic solution, 10 mL in a bottle.

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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