Gatifloxacin is an ophthalmic fluoroquinolone antibiotic. It belongs to a group of quinolones known as 8-methoxy fluoroquinolones. Gatifloxacin is effective against both gram-positive and gram-negative bacteria. Compared to other fluoroquinolones, gatifloxacin and other 8-methoxyfluoroquinolones have markedly improved activity against penicillin-susceptible and -resistant pneumococci. Gatifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis in adults and pediatric patients 1 year and older.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Ophthalmic Administration
-Apply topically to the eye. For topical ophthalmic use only.
-Instruct patient on proper instillation of eye solution.
-Avoid contamination of the eye solution; do not to touch the tip of the eye dropper to the eye, fingertips, or other surface.
Serious hypersensitivity reactions, including anaphylactoid reactions, angioedema (including pharyngeal edema, laryngeal edema, or facial edema), dyspnea, urticaria, and pruritus, have been reported with ophthalmic gatifloxacin, even following a single dose. Rare cases of Stevens-Johnson syndrome have also been reported with topical gatifloxacin use. Rash (unspecified) has been noted in postmarketing reports. Gatifloxacin should be discontinued if an allergic reaction or any other sign of hypersensitivity appears.
The most frequent adverse reactions (1% or more) reported in patients receiving gatifloxacin ophthalmic solution include worsening of conjunctivitis, ocular irritation, and ocular pain. Additional adverse reactions reported in clinical studies include chemosis, conjunctival hemorrhage (ocular hemorrhage), xerophthalmia, ocular discharge, eyelid edema, increased lacrimation, keratitis, red eye, papillary conjunctivitis, and visual impairment (reduced visual acuity). Blepharitis, ocular pruritus, eye swelling (corneal edema and conjunctival edema), and blurred vision have been reported in postmarketing surveillance.
Prolonged use of gatifloxacin ophthalmic preparations may result in overgrowth of nonsusceptible organisms. If superinfection, including fungal infection, occurs with gatifloxacin use, discontinue therapy and institute an alternative.
Taste disturbance (dysgeusia) (1% or more) and nausea (postmarketing) have been reported during clinical trials with gatifloxacin ophthalmic solution.
Headache has been reported during clinical trials with gatifloxacin ophthalmic solution.
Gatifloxacin is for topical ophthalmic use only. Corneal endothelial cell injury may occur if gatifloxacin ophthalmic solution is introduced directly into the chamber of the eye.
Gatifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to gatifloxacin, a history of quinolone hypersensitivity, or hypersensitivity to any components of the medication.
There are no available data on the use of gatifloxacin ophthalmic preparations during pregnancy to inform a drug-associated risk. Because of the minimal systemic absorption of gatifloxacin after topical ophthalmic administration, there is expected to be minimal risk of maternal and fetal toxicity when administered during pregnancy.
There is no information regarding the presence of gatifloxacin administered ophthalmically in human milk, the effect of gatifloxacin on breastfed infants, or the effect of gatifloxacin on milk production. Ophthalmic use of gatifloxacin would result in minimal absorption during breast-feeding. To minimize the amount of drug that reaches the systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after ophthalmic administration.
Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Haemophilus influenzae (beta-lactamase negative), Haemophilus influenzae (beta-lactamase positive), Staphylococcus aureus (MSSA), Staphylococcus epidermidis, Streptococcus mitis, Streptococcus oralis, Streptococcus pneumoniae
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.
For the treatment of bacterial conjunctivitis:
Ophthalmic dosage (0.5% solution):
Adults: 1 drop in the affected eye(s) every 2 hours while awake, up to 8 times daily, for 1 day, then 1 drop in the affected eye(s) 2 to 4 times daily while awake for 6 days.
Children and Adolescents: 1 drop in the affected eye(s) every 2 hours while awake, up to 8 times daily, for 1 day, then 1 drop in the affected eye(s) 2 to 4 times daily while awake for 6 days.
For ophthalmic surgical infection prophylaxis*:
Ophthalmic dosage:
Adults: 1 drop to the affected eye(s) every 5 to 15 minutes for 5 doses within 1 hour before the start of the procedure. Perioperative antisepsis with povidone-iodine is recommended. Subconjunctival or intracameral antibiotics at the end of the procedure is optional. The necessity of continuing topical antimicrobials postoperatively has not been established.
Maximum Dosage Limits:
-Adults
8 drops/day in affected eye(s).
-Geriatric
8 drops/day in affected eye(s).
-Adolescents
8 drops/day in affected eye(s).
-Children
8 drops/day in affected eye(s).
Patients with Hepatic Impairment Dosing
No dosage adjustments are needed.
Patients with Renal Impairment Dosing
No dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Gatifloxacin products.
Gatifloxacin is bactericidal via inhibition of DNA gyrase (topoisomerase II), an enzyme that is involved in the replication, transcription, and repair of bacterial DNA, as well as topoisomerase IV, an enzyme that helps separate the daughter DNA molecules. In gram-negative bacteria, the primary target is the DNA gyrase A subunit, while the primary target in gram-positive bacteria is generally topoisomerase IV.
Gatifloxacin is administered topically to the eye. Systemic absorption is minimal.
-Route-Specific Pharmacokinetics
Other Route(s)
Ophthalmic Route
Gatifloxacin ophthalmic solution 0.5% was administered to one eye of 6 healthy subjects each in an escalated dosing regimen starting with a single 2 drop dose, then 2 drops 4 times daily for 7 days, and finally 2 drops 8 times daily for 3 days. At all time points, serum concentrations of gatifloxacin are below detectable limits (5 ng/mL).