Gatifloxacin Ophthalmic
Gatifloxacin ophthalmic is an antibiotic eye drop used to treat bacterial conjunctivitis (pink eye).
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 5 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Gatifloxacin Ophthalmic: Patient Information Guide
A plain-language walkthrough of Gatifloxacin Ophthalmic — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Gatifloxacin ophthalmic solution 0.5% is an antibiotic eye drop approved to treat bacterial conjunctivitis (pink eye) caused by specific susceptible bacteria.
- Zymaxid (gatifloxacin ophthalmic solution 0.5%) treats bacterial conjunctivitis caused by Staphylococcus aureus
- Zymaxid treats bacterial conjunctivitis caused by Staphylococcus epidermidis
- Zymaxid treats bacterial conjunctivitis caused by Streptococcus mitis group and Streptococcus oralis (studied in fewer than 10 infections each)
- Zymaxid treats bacterial conjunctivitis caused by Streptococcus pneumoniae
- Zymaxid treats bacterial conjunctivitis caused by Haemophilus influenzae
- Zymaxid is approved for use in patients one year of age and older
⚙️How it works▾
Gatifloxacin is a quinolone antibiotic that works by blocking two enzymes bacteria need to survive: DNA gyrase and topoisomerase IV. These enzymes help bacteria copy, repair, and divide their DNA. When gatifloxacin blocks them, the bacteria can no longer replicate and they die. Because it works differently from antibiotic classes like aminoglycosides, macrolides, and tetracyclines, it can sometimes be effective against bacteria resistant to those drugs.
When used as eye drops, blood levels of gatifloxacin remain extremely low — in clinical studies, levels were undetectable in the bloodstream — so the antibiotic effect is largely local, right where it's applied in the eye.
💊How it's taken▾
Zymaxid eye drops follow a two-phase schedule over 7 days. The dosing is more frequent on the first day, then tapers off:
- Day 1: One drop in the affected eye(s) every two hours while awake, up to 8 times
- Days 2–7: One drop in the affected eye(s) two to four times daily while awake
Follow your prescriber's exact instructions. Complete the full course of treatment even if your eye starts to feel better early — stopping too soon can allow the infection to return.
🤒Side effects — in detail▾
Most side effects with gatifloxacin eye drops are mild and affect the eyes or mouth. Common ones (reported in 1% or more of patients in clinical studies) include:
- Worsening of conjunctivitis symptoms
- Eye irritation
- Eye pain
- Dysgeusia — an unusual or bad taste in the mouth
- Eye discharge, dry eye, or increased tearing
- Eyelid swelling
- Headache
- Reduced visual acuity (blurred or reduced sharpness of vision)
Serious reactions such as severe allergic reactions (including anaphylaxis and throat swelling), difficulty breathing, or signs of Stevens-Johnson Syndrome (severe blistering rash) require immediate medical attention — stop the drops and call for help right away.
⚠️Warnings & precautions▾
- Serious allergic reactions: Even a single dose can trigger anaphylaxis, severe swelling of the throat or face, difficulty breathing, hives, or — rarely — Stevens-Johnson Syndrome. Stop the medication immediately and seek emergency care if these occur.
- Superinfection with prolonged use: Using these drops longer than prescribed can allow resistant organisms, including fungi, to grow in the eye. If symptoms worsen or change, contact your doctor.
- Eye use only: Gatifloxacin ophthalmic solution is strictly for the eye. If it were to enter the front chamber of the eye directly, it could damage the inner lining of the cornea (corneal endothelial cells). Do not attempt to inject or otherwise misuse these drops.
🔀What it interacts with▾
The FDA label for gatifloxacin ophthalmic solution 0.5% does not identify specific drug, food, or substance interactions for this topical eye drop formulation.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy to quinolones: Do not use if you have ever had an allergic reaction to gatifloxacin or any other quinolone antibiotic — this is a contraindication
- Allergy to ingredients: Tell your doctor if you are allergic to any component of this product
- Pregnancy: There is no human data on gatifloxacin eye drops in pregnancy; discuss the risks and benefits with your doctor
- Breastfeeding: It is not known whether this medication reaches breast milk at measurable levels when used as eye drops; discuss with your doctor
- Infants under 1 year: Safety and effectiveness have not been established in children younger than one year of age
- Children 1 year and older: Shown to be safe and effective in clinical trials for this age group
- Older adults: No differences in safety or effectiveness compared to younger adults; no special precautions noted
🔬Pharmacokinetics — how your body processes it▾
When gatifloxacin ophthalmic solution 0.5% is applied to the eye, very little of the drug is absorbed into the bloodstream. In a clinical study, blood levels were undetectable (below 5 ng/mL) at all time points — even with intensive dosing of two drops up to 8 times a day. This means the medication works locally in the eye with minimal systemic (whole-body) exposure.
📦How to store it▾
Store at 20° to 25°C (68° to 77°F) . Protect from freezing.
📄 Written from Gatifloxacin Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Gatifloxacin Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Zymaxid used for? ▾
How do I use the drops, and does the schedule change over time? ▾
What side effects should I expect, and which ones should make me call the doctor? ▾
Can I use these drops if I'm pregnant or breastfeeding? ▾
My eye is feeling a lot better after 2 days — can I stop the drops early? ▾
Is it safe to give these drops to my child? ▾
Is Gatifloxacin Ophthalmic available over the counter? ▾
When was Gatifloxacin Ophthalmic first available? ▾
Who makes Gatifloxacin Ophthalmic? ▾
💬 Answers drafted from Gatifloxacin Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Gatifloxacin Ophthalmic comes
Gatifloxacin Ophthalmic is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Eye drops
How this form is used
- Zymaxid is used to treat bacterial conjunctivitis (pink eye) caused by susceptible bacteria including Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, and Haemophilus influenzae
- Zymaxid has been shown to be safe and effective for bacterial conjunctivitis in patients one year of age and older
- Zymaxid: On Day 1, instill one drop into the affected eye(s) every two hours while awake, up to 8 times
- Zymaxid: On Days 2 through 7, instill one drop two to four times daily in the affected eye(s) while awake
- Zymaxid is for eye use only — do not swallow or inject
- Zymaxid: Follow your prescriber's instructions and complete the full 7-day course
📊 Gatifloxacin Ophthalmic across the U.S. market
How Gatifloxacin Ophthalmic appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Gatifloxacin Ophthalmic is used
A general measure of how commonly Gatifloxacin Ophthalmic is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Gatifloxacin Ophthalmic is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Gatifloxacin Ophthalmic prescribed? Of the 1,597 medications we measure, Gatifloxacin Ophthalmic ranks #1,385 by Medicaid prescriptions — more than 13% of them.
Utilization by Gatifloxacin Ophthalmic product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
gatifloxacin 5 MG/ML Ophthalmic Solution
Summed across the 1 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 992395
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Gatifloxacin Ophthalmic, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 10 listed Gatifloxacin Ophthalmic NDCs with Medicaid activity.
🔍 Compare Gatifloxacin Ophthalmic products
A representative set of FDA-listed product records for Gatifloxacin Ophthalmic — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Eye drops | ||||
| 5 mg/mL | Ophthalmic | Akorn | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Allergan, Inc. × 3 listings | NDA | View NDC → |
| 5 mg/mL | Ophthalmic | Caplin Steriles Limited | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Leading Pharma, LLC | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Pacific Pharma, Inc. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 5 mg/mL | Ophthalmic | Sandoz Inc × 2 listings | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Torrent Pharmaceuticals Limited | ANDA | View NDC → |
Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Gatifloxacin Ophthalmic NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Gatifloxacin Ophthalmic — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Gatifloxacin Ophthalmic in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Gatifloxacin Ophthalmic went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 228476 3 dose forms · 5 strengths
-
Dose form (SCDF) Ophthalmic Solution RxCUI 402433In current FDA listings -
Dose form (SCDF) Oral Suspension RxCUI 644540No current FDA listingClinical drug / strength (SCD) 40 MG/MLRxCUI 644541 -
Dose form (SCDF) Oral Tablet RxCUI 374621No current FDA listingClinical drug / strength (SCD) 200 MGRxCUI 310445400 MGRxCUI 314009
Look up RxCUI 228476 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Gatifloxacin Ophthalmic is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Gatifloxacin Ophthalmic belongs to the Quinolone Antimicrobial class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 5 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Allergan, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.