Gatifloxacin

Gatifloxacin is a quinolone antimicrobial [ see Microbiology ( 12.4 ) ] .

• ZYMAXID ® 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 .ICD-10: H10.9

• ZYMAXID ® 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 )] . ZYMAXID ® is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication.contraindicated

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 )

Hypersensitivity ( 5.1 ) Growth of Resistant Organisms with Prolonged Use ( 5.2 ) Corneal Endothelial Cell Injury ( 5.3 ) 5.1 Hypersensitivity 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 )] . 5.2 Growth of Resistant Organisms with Prolonged Use Prolonged use of ZYMAXID ® 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. 3 Corneal Endothelial Cell Injury ZYMAXID ® is for topical ophthalmic use. ZYMAXID ® may cause corneal endothelial cell injury if introduced directly into the anterior chamber of the eye.

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 Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6. 1 Clinical 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 ZYMAXID ® (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.

8.1 Pregnancy Risk Summary There are no available data on the use of ZYMAXID ® 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 ZYMAXID ® 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).

Metabolism

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.

• May 18, 2010NDANDA022548Abbvie
• Jul 11, 2016ANDAANDA204227Sandoz
• Nov 3, 2021ANDAANDA213542Caplin

1. 1Hypoglycaemia1518.6%
2. 2Hyperglycaemia965.5%
3. 3Diarrhoea714.1%
4. 4Anaphylactic Reaction704.0%
5. 5Drug Intolerance683.9%
6. 6Eye Pain673.8%
7. 7Drug Ineffective643.7%
8. 8Dizziness593.4%
9. 9Dyspnoea553.1%
10. 10Off Label Use553.1%
11. 11Rash553.1%
12. 12Nausea492.8%
13. 13Chronic Kidney Disease472.7%
14. 14Renal Failure472.7%
15. 15Blood Glucose Increased462.6%

Recent PubMed references pinned to Gatifloxacin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Dual drug loaded dissolvable annular microneedle patch to treat bacterial conjunctivitis.
  International journal of pharmaceutics · 2026 · Naik S, Arawindh R, Bharatam ST, et al.
  PMID 41996999DOI 10.1016/j.ijpharm.2026.126869
• Development, in silico, in vitro, and in vivo evaluation of gatiserts: HME-based ophthalmic inserts for prolonged ocular delivery of gatifloxacin.
  Drug delivery and translational research · 2026 · Sharma A, Behera SK, Singh J, et al.
  PMID 41225245DOI 10.1007/s13346-025-02011-7
• Concentration-dependent photoluminescence biomass-derived carbon dots as fluorescent sensors for economical, green, rapid and sensitive detection of gatifloxacin in foods.
  Food chemistry · 2025 · Zhang H, Wang X, Li H, et al.
  PMID 40712417DOI 10.1016/j.foodchem.2025.145588
• Rapid oxidation of gatifloxacin by ozone/sulfite process: Generation of reactive species and radical-mediated mechanisms.
  Water research · 2025 · Yin J, Lin T, Chen H, et al.
  PMID 40527105DOI 10.1016/j.watres.2025.124016
• Defect-rich Co,N-doped Ti(3)C(2)Tx/C/poly (3,4-ethylenedioxy thiophene) molecularly imprinted sensor for ultrasensitive electrochemical detection of gatifloxacin.
  Talanta · 2025 · Zhang G, Wang Z, Jamal R, et al.
  PMID 40403571DOI 10.1016/j.talanta.2025.128364
• Preparation of Hybrid Molecularly Imprinted Polymers Based on 3-Triethoxysilylpropyl Methacrylic Amide for Solid-Phase Extraction of Gatifloxacin From Lake Water.
  Journal of separation science · 2025 · Chai M, Liu C, Zhang L, et al.
  PMID 40089922DOI 10.1002/jssc.70122
• A Viscoelastic Supramolecular Hydrogel Co-Assembled from Gatifloxacin and Deoxyguanosine for the Treatment of Bacterial Keratitis.
  Chembiochem : a European journal of chemical biology · 2025 · Hu J, Shen F, Luo J, et al.
  PMID 39908061DOI 10.1002/cbic.202400971
• Ultrasensitive Lateral Flow Immunoassay of Fluoroquinolone Antibiotic Gatifloxacin Using Au@Ag Nanoparticles as a Signal-Enhancing Label.
  Biosensors · 2024 · Hendrickson OD, Byzova NA, Panferov VG, et al.
  PMID 39727863DOI 10.3390/bios14120598

The 10 most recently updated of 39 ClinicalTrials.gov registrations naming Gatifloxacin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events
  Completed · Observational · 117,911 enrolled · Janssen Research & Development, LLC
  NCT03479736updated 2025-06-25
• The Individualized M(X) Drug-resistant TB Treatment Strategy Study
  Terminated · Phase 4 · Interventional · 205 enrolled · Centre for the AIDS Programme of Research in South Africa
  NCT03237182updated 2023-09-01
• Analysis of Postoperative Ocular Surface Changes and Intervention Effect After PPV in MGD Dry Eye Patients
  Completed · Phase 4 · Interventional · 40 enrolled · Tianjin Medical University Eye Hospital
  NCT05771194updated 2023-03-16
• Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen
  Completed · Phase 4 · Interventional · 35 enrolled · Carolina Eyecare Physicians, LLC
  NCT03578276updated 2022-06-10
• Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.
  Terminated · Phase 3 · Interventional · 46 enrolled · Laboratorios Sophia S.A de C.V.
  NCT03696342updated 2021-08-24
• Patients Response to Early Switch To Oral:Osteomyelitis Study
  Terminated · Early phase 1 · Interventional · 11 enrolled · Julio Ramirez
  NCT02099240updated 2021-04-06
• Swiss PACK-CXL Multicenter Trial for the Treatment of Infectious Keratitis
  Completed · Phase 3 · Interventional · 35 enrolled · University Hospital, Geneva
  NCT02717871updated 2020-10-20
• Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin)
  Completed · Phase 2 · Interventional · 150 enrolled · Laboratorios Sophia S.A de C.V.
  NCT02980523updated 2019-05-22
• A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
  Completed · Phase 3 · Interventional · 859 enrolled · Allergan
  NCT00518089updated 2019-04-23
• Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis
  Completed · Phase 1 · Phase 2 · Interventional · 70 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT00396084updated 2018-11-08

Frequently asked questions

How does Gatifloxacin work?

Gatifloxacin is a quinolone antimicrobial [ see Microbiology ( 12.4 ) ] .

What is Gatifloxacin used for?

According to FDA labeling, Gatifloxacin carries indications including: ZYMAXID ® 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 .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Gatifloxacin?

Gatifloxacin is classified as Fluoroquinolones, DNA Gyrase Inhibitors, Topoisomerase 4 Inhibitors, Decreased DNA Integrity, Decreased DNA Replication, Decreased Protein Synthesis, Decreased Transcription to RNA.

What are the brand names for Gatifloxacin?

Gatifloxacin is marketed under brand names including Zymaxid.

What are the contraindications for Gatifloxacin?

Gatifloxacin labeling lists contraindications including: ZYMAXID ® 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 )] . ZYMAXID ® is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication.. Always consult the full prescribing information and a clinician.