Description
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.
