Home › NDC Lookup › Ingredients › Gatifloxacin › 50383-0189-02
Gatifloxacin 5 mg/mL Solution/ Drops, 1 bottle — NDC 50383-0189-02 package photo

Gatifloxacin 5 mg/mL Solution/ Drops, 1 bottle

by Akorn · 1 BOTTLE, DROPPER in 1 CARTON (50383-189-02) / 2.5 mL in 1 BOTTLE, DROPPER
NDC 50383-0189-02
🏷️ FDA NDC (as labeled) 50383-189-02 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 50383-189-02
Product NDC 50383-189
11-digit billing NDC 50383018902
NCPDP billing unit ML — per mL (volume)
Application # ANDA203189
SPL Set ID 14312de6-67d4-4de2-854c-ef764090dd83
Chemical class Quinolone Antimicrobial [EPC], Quinolones
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2023)
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance GATIFLOXACIN ANHYDROUS
GCN Seq No 066373
GCN 28627
HICL code 020788
Ingredient (HICL) Gatifloxacin
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6W
Therapeutic class — specific (HIC3) Ophthalmic Antibiotics
AHFS code 52:04.04.00
AHFS class Antibacterials (52:04)
FDB label name GATIFLOXACIN 0.5% EYE DROPS
FDB brand name Gatifloxacin
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 50383-189-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 50383-0189-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerAkorn
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA203189 (ANDA)
Labeler code50383
Product typeHuman Prescription Drug
Portfolio3 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name GATIFLOXACIN 0.5% EYE DROPS Ingredient Gatifloxacin
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Gatifloxacin Ophthalmic guide →
7
Nutrient depletion considerations

Gatifloxacin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Gatifloxacin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

  • 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?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $10.769 $26.92 / 2.5 ml
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Mar 2022 Jul 2022 Nov 2022 $12.971 $8.055
▲ Up 2% over the last 12 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gatifloxacin 5 mg/mL 61314-0672-25 Sandoz 1 bottle $8.855 AT Availability likely save 18%
Gatifloxacin 5 mg/mL 69315-0331-02 Leading 2.5 ml $8.855 AT Availability likely save 18%
Gatifloxacin 5 mg/mLthis 50383-0189-02 Akorn 1 bottle $10.769 — Discontinued —
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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Gatifloxacin — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Gatifloxacin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$266.5K
Claims incl. refills
6.3K
Beneficiaries
4.9K
Spend / beneficiary
$54.64
Spend / claim
$42.11
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50383-0189-02 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (50383-189-02) / 2.5 mL in 1 BOTTLE, DROPPER 2014-10-06 Inactivated by FDA

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 50383-189-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50383-0189-02, written without dashes as 50383018902. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 50383-0189-02, the first segment (50383) is the labeler code FDA assigned to Akorn; the middle segment (0189) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Akorn is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 91 words ▾

1 INDICATIONS AND USAGE Gatifloxacin ophthalmic solution 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 88 words ▾

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 17 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution: 0.5% gatifloxacin (5 mg/mL) Ophthalmic solution: 0.5% gatifloxacin (5mg/mL) (3)

⛔ Contraindications 60 words ▾

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 167 words ▾

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 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 ~1 min read ▾

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 Hi-Tech Pharmacal Co., Inc. at 1- 800- 262-9010 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 ophthalmic solution (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 ~2 min read ▾

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 200 words ▾

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 53 words ▾

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 18 words ▾

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

🧬 Clinical Pharmacology ~1 min read ▾

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 words ▾

12.1Mechanism of Action Gatifloxacin is a quinolone antimicrobial [see Microbiology (12.4)].

📦 How Supplied / Storage and Handling 52 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Gatifloxacin Ophthalmic Solution, 0.5% is supplied sterile in a white, low density polyethylene (LDPE) bottle with a controlled dropper tip, and a tan cap in the following sizes: 2.5 mL in 6 mL bottle Storage: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing.

📋 Description 110 words ▾

11 DESCRIPTION Gatifloxacin sterile ophthalmic solution is an 8-methoxyfluoroquinolone anti-infective 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, anhydrous. Its molecular formula is C 19 H 22 FN 3 O 4 and its molecular weight is 375.4.

Its chemical structure is: Gatifloxacin ophthalmic solution, 0.5% is a clear, pale yellow, sterile, preserved aqueous solution with an osmolality of 260- 330 mOsm/kg and a pH of 5.1-5.7. Gatifloxacin ophthalmic solution, 0.5% contains Active: gatifloxacin 0.5% (5 mg/mL); Inactives: benzalkonium chloride 0.005%; edetate disodium; hydrochloric acid; purified water; and sodium chloride. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH to approximately 6.

Chemical Structure

💬 Information for Patients 58 words ▾

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)].

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50379-0031-01 · MSN 50383-0261-61 · Akorn →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.