Gatifloxacin 5 mg/mL Solution/ Drops, 1 bottle
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Quinolone Antimicrobial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Gatifloxacin ophthalmic solution is used to treat bacterial conjunctivitis (pinkeye; infection of the membrane that covers the outside of the eyeballs and the inside of the eyelids) in adults and children 1 year of age and older. Gatifloxacin is in a class of antibiotics called fluoroquinolones. It works by killing the bacteria that cause infection.
Read the full MedlinePlus article ↗- Zymaxid is an antibiotic eye drop used to treat bacterial pink eye (bacterial conjunctivitis). It targets specific bacteria that commonly cause eye infections, like Staphylococcus...
- Yes, the schedule is a bit different on the first day. On Day 1, you put one drop in the affected eye every two hours while you're awake, up to 8 times. Starting on Day 2 and throu...
- How do I use the drops, and does the schedule change over time?
- The most common things people notice are mild eye irritation, eye pain, and sometimes a strange taste in the mouth — that last one sounds odd, but it happens with eye drops because...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Gatifloxacin — tap one for details:
Gatifloxacin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
0.5 mg / 1 mL
UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $8.183 | $20.46 / 2.5 ml |
| Medicaid paysCMS SDUD · 12 mo | $15.37 | $38.42 / 2.5 ml |
| Medicare drug plans payPart D · Q2 2026 | $16.96 | $42.40 / 2.5 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Gatifloxacin 5 mg/mLthis 61314-0672-25 | Sandoz | 1 bottle | $8.183 | AT | Availability likely | — |
| Gatifloxacin 5 mg/mL 69315-0331-02 | Leading | 2.5 ml | $8.183 | AT | Availability likely | — |
| Zymaxid 5 mg/mL 00023-3615-01 | Allergan, | 1 bottle | — | AT | FDA listed | — |
| Gatifloxacin Ophthalmic Solution 0.5% 5 mg/mL 65145-0207-01 | Caplin | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 61314-0672-25 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (61314-672-25) / 2.5 mL in 1 BOTTLE, DROPPER | 2016-10-03 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Gatifloxacin ophthalmic solution 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: • Aerobic gram-positive bacteria Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis group * Streptococcus oralis * Streptococcus pneumoniae • Aerobic gram-negative bacteria Haemophilus influenzae * Efficacy for these organisms were studied in fewer than 10 infections. Gatifloxacin ophthalmic solution is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group , Streptococcus oralis, Streptococcus pneumoniae ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Day 1: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times. • Day 2 through Day 7: Instill one drop two to four times daily in the affected eye(s) while awake. Day 1: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1. Days 2 through 7: Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Four (4) mL bottle containing 2.5 mL of a 0.5% sterile topical ophthalmic solution. 4 mL size bottle filled with 2.5 mL of gatifloxacin ophthalmic solution, 0.5%. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Gatifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see Warnings and Precautions (5.1) ]. Gatifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Hypersensitivity ( 5.1 ) • Growth of Resistant Organisms with Prolonged Use ( 5.2 ) • Corneal Endothelial Cell Injury ( 5.3 )
5.1Hypersensitivity Some patients receiving topical ophthalmic gatifloxacin experienced hypersensitivity reactions including anaphylactic reactions, angioedema (including pharyngeal, laryngeal, or facial edema), dyspnea, urticaria, and itching, even following a single dose. Rare cases of Stevens-Johnson Syndrome were reported in association with topical ophthalmic gatifloxacin use. If an allergic reaction to gatifloxacin occurs, discontinue the drug [see Patient Counseling Information (17) ].
5.2Growth of Resistant Organisms with Prolonged Use Prolonged use of gatifloxacin ophthalmic solution 0.5% may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, examine the patient with the aid of magnification, such as slit lamp biomicroscopy and where appropriate, fluorescein staining.
5.3Corneal Endothelial Cell Injury Gatifloxacin ophthalmic solution is for topical ophthalmic use. Gatifloxacin ophthalmic solution may cause corneal endothelial cell injury if introduced directly into the anterior chamber of the eye.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity [see Contraindications (4) and Warnings and Precautions (5.1) ] • Growth of Resistant Organisms With Prolonged Use [see Warnings and Precautions (5.2) ] • Corneal Endothelial Cell Injury [see Warnings and Precautions (5.3) ] Most common adverse reactions occurring in ≥ 1 % of patients included worsening of conjunctivitis, eye irritation, dysgeusia, and eye pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In clinical studies of patients with bacterial conjunctivitis treated with gatifloxacin (N=717), the most frequently reported adverse reactions occurring in ≥1% of patients were: worsening of the conjunctivitis, eye irritation, dysgeusia, and eye pain.
Additional adverse reactions reported with other formulations of gatifloxacin ophthalmic solution in other clinical studies included chemosis, conjunctival hemorrhage, dry eye, eye discharge, eyelid edema, headache, increased lacrimation, keratitis, red eye, papillary conjunctivitis, and reduced visual acuity.
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of gatifloxacin ophthalmic solution or with other formulations of gatifloxacin ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions included anaphylactic reactions and angioedema (including pharyngeal, oral or facial edema), blepharitis, dyspnea, eye pruritus, eye swelling (including corneal and conjunctival edema), hypersensitivity, including signs and symptoms of eye allergy and allergic dermatitis, nausea, pruritus (including pruritus generalized, rash, urticaria), and vision blurred.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on the use of gatifloxacin ophthalmic solution in pregnant women to inform a drug-associated risk. Administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. Administration of gatifloxacin to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses.
Data Animal Data Oral administration of gatifloxacin to pregnant rats throughout organogenesis produced teratogenic effects in rat fetuses, including skeletal/craniofacial malformations, delayed ossification, atrial enlargement, and reduced fetal weight, at doses greater than or equal to 150 mg/kg/day (approximately 600-fold higher than the maximum recommended human ophthalmic dose [MRHOD] for gatifloxacin ophthalmic solution of 0.04 mg/kg/day, on a mg/m 2 basis). No teratogenic effects were observed in rat or rabbit fetuses at doses of gatifloxacin up to 50 mg/kg/day (approximately 200- and 400-fold higher than the MRHOD, respectively, on a mg/m 2 basis).
In a perinatal/postnatal study in rats, oral administration of gatifloxacin during late gestation through lactation produced an increase in late gestation fetal loss and neonatal/perinatal mortality at 200 mg/kg/day (approximately 800-fold higher than the MRHOD on a mg/m 2 basis).
8.2Lactation Risk Summary There is no information regarding the presence of gatifloxacin ophthalmic solution in human milk, the effect of gatifloxacin on breastfed infants, or the effect of gatifloxacin on milk production. Gatifloxacin was found in the breast milk of rats following oral administration of gatifloxacin during lactation. However, systemic levels of gatifloxacin following topical ocular administration are low [see Clinical Pharmacology (12.3) ] , and it is not known whether gatifloxacin would be present in maternal milk at measurable levels following topical ocular administration.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for gatifloxacin ophthalmic solution and any potential adverse effects on the breastfed child from gatifloxacin ophthalmic solution.
8.4Pediatric Use The safety and effectiveness of gatifloxacin ophthalmic solution in infants below one year of age have not been established. Gatifloxacin ophthalmic solution has been demonstrated in clinical trials to be safe and effective for the treatment of bacterial conjunctivitis in pediatric patients one year or older [see Clinical Studies (14) ].
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on the use of gatifloxacin ophthalmic solution in pregnant women to inform a drug-associated risk. Administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. Administration of gatifloxacin to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses.
Data Animal Data Oral administration of gatifloxacin to pregnant rats throughout organogenesis produced teratogenic effects in rat fetuses, including skeletal/craniofacial malformations, delayed ossification, atrial enlargement, and reduced fetal weight, at doses greater than or equal to 150 mg/kg/day (approximately 600-fold higher than the maximum recommended human ophthalmic dose [MRHOD] for gatifloxacin ophthalmic solution of 0.04 mg/kg/day, on a mg/m 2 basis). No teratogenic effects were observed in rat or rabbit fetuses at doses of gatifloxacin up to 50 mg/kg/day (approximately 200- and 400-fold higher than the MRHOD, respectively, on a mg/m 2 basis).
In a perinatal/postnatal study in rats, oral administration of gatifloxacin during late gestation through lactation produced an increase in late gestation fetal loss and neonatal/perinatal mortality at 200 mg/kg/day (approximately 800-fold higher than the MRHOD on a mg/m 2 basis).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of gatifloxacin ophthalmic solution in infants below one year of age have not been established. Gatifloxacin ophthalmic solution has been demonstrated in clinical trials to be safe and effective for the treatment of bacterial conjunctivitis in pediatric patients one year or older [see Clinical Studies (14) ].
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Gatifloxacin is a quinolone antimicrobial [see Microbiology (12.4) ].
12.3Pharmacokinetics Gatifloxacin ophthalmic solution 0.5% was administered to one eye of 6 healthy male 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 gatifloxacin levels were below the lower limit of quantification (5 ng/mL) in all subjects.
12.4Microbiology Gatifloxacin is an 8-methoxyfluoroquinolone with a 3-methylpiperazinyl substituent at C7. The antibacterial action of gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription, and repair of bacterial DNA.
Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division. The mechanism of action of fluoroquinolones including gatifloxacin is different from that of aminoglycoside, macrolide, and tetracycline antibiotics. Therefore, gatifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to gatifloxacin.
There is no cross-resistance between gatifloxacin and the aforementioned classes of antibiotics. Cross-resistance has been observed between systemic gatifloxacin and some other fluoroquinolones. Resistance to gatifloxacin in vitro develops via multiple-step mutations.
Resistance to gatifloxacin in vitro occurs at a general frequency of 1 x 10 -7 to 10 -10 . Gatifloxacin has been shown to be active against most isolates of the following organisms both microbiologically and clinically, in conjunctival infections: • Aerobic gram-positive bacteria Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis group * Streptococcus oralis * Streptococcus pneumoniae • Aerobic gram-negative bacteria Haemophilus influenzae * Efficacy for these organisms were studied in fewer than 10 infections.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Gatifloxacin is a quinolone antimicrobial [see Microbiology (12.4) ].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Gatifloxacin ophthalmic solution 0.5% is supplied sterile in white bottles with natural LDPE dispensing plugs and tan polypropylene (PP) closure in the following size: 2.5 mL in 4 mL bottle: NDC 61314-672-25 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.
📦 Storage and Handling ▾
Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.
📋 Description ▾
11 DESCRIPTION Gatifloxacin ophthalmic solution is a quinolone antimicrobial topical ophthalmic solution for the treatment of bacterial conjunctivitis. Its chemical name is (±)-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid, sesquihydrate. Its molecular formula is C 19 H 22 FN 3 O 4 · 1½H 2 O and its molecular weight is 402.42.
Its chemical structure is: Gatifloxacin ophthalmic solution is a clear, pale yellow to greenish yellow, sterile, preserved aqueous solution with an osmolality of 260 to 330 mOsm/kg and a pH of 5.1 to 5.7. Gatifloxacin ophthalmic solution contains Active: gatifloxacin, anhydrous 0.5% (5 mg/mL); Preservatives: benzalkonium chloride 0.005%; Inactives: edetate disodium dihydrate; purified water; and sodium chloride. Gatifloxacin ophthalmic solution may contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Structure formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Avoiding Contamination of the Product Instruct patients to avoid contaminating the applicator tip with material from the eye, fingers, or other source. Potential for Hypersensitivity Reactions Advise patients to discontinue use immediately and contact the physician at the first sign of a rash or hypersensitivity reaction [see Warnings and Precautions (5.1) and Contraindication (4) ]. Manufactured by Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540 300069996-0225