Gatifloxacin 0.5% 2.5mL

NDC: 69315-331-02

Gatifloxacin 0.5% Ophthalmic Solution, 2.5 mL — Leading Pharma, LLC

Active ingredients	Gatifloxacin anhydrous 0.5% (5 mg/mL)
Dosage form	Sterile ophthalmic solution
Route	Topical ophthalmic
Size	2.5 mL
Manufacturer	Leading Pharma, LLC
NDC	69315-331-02

Indications and Usage

Treatment of bacterial conjunctivitis caused by susceptible strains of organisms including Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, and Haemophilus influenzae.

Dosage and Administration

On Day 1, instill one drop into the affected eye(s) every two hours while awake, up to eight times daily. On Days 2 through 7, instill one drop two to four times daily while awake.

Warnings and Precautions

• For topical ophthalmic use only; not for injection into the eye
• Hypersensitivity and serious anaphylactic reactions may occur
• Prolonged use may result in overgrowth of non-susceptible organisms, including fungi
• Avoid contact lens wear during active bacterial conjunctivitis

Contraindications

Contraindicated in patients with hypersensitivity to gatifloxacin, to other quinolones, or to any component of the formulation.

Adverse Reactions

The most common adverse reactions include worsening of conjunctivitis, eye irritation, dysgeusia, and eye pain.

Storage and Handling

Store at 15°C to 25°C (59°F to 77°F); protect from freezing.

How Supplied

Sterile ophthalmic solution supplied in a 2.5 mL fill (5 mL 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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