HomeNDC LookupIngredientsOfloxacin › 24208-0434-05
Ofloxacin 3 mg/mL Solution/ Drops — NDC 24208-0434-05 package photo

Ofloxacin 3 mg/mL Solution/ Drops

by Bausch & Lomb Incorporated · 1 BOTTLE, DROPPER in 1 CARTON (24208-434-05) / 5 mL in 1 BOTTLE, DROPPER
NDC 24208-0434-05
🏷️ FDA NDC (as labeled) 24208-434-05 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle, dropper Cost per mL$1.27 NADAC Per package$6.34 / 5 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $3.72/unit · Part D plans $1.98/unit — full pricing hub ↓
Also comes in: 10 mL 24208-0434-10
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 24208-434-05
Product NDC 24208-434
11-digit billing NDC 24208043405
NCPDP billing unit ML — per mL (volume)
RxCUI 312075
UNII A4P49JAZ9H
Application # ANDA076622
SPL Set ID ad40954d-0b1d-47c5-8bd5-8a1efd9a7153
Established class (EPC) Quinolone Antimicrobial
Chemical class Quinolones
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2004-05-14
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance OFLOXACIN
GPI-14 86101047002020
GPI class Ofloxacin
GCN Seq No 019734
GCN 36600
HICL code 006035
Ingredient (HICL) Ofloxacin
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 08:12.18.00
AHFS class Quinolone Antibiotics
FDB label name OFLOXACIN 0.3% EYE DROPS
FDB brand name Ofloxacin
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 24208-434-05 — 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 → 24208-0434-05. 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.

🏷️ RxNorm drug class

This medicine belongs to the Quinolone Antimicrobial class.

Pharmacologic class Quinolone Antimicrobial
Drug family (ATC) Fluoroquinolones, Fluoroquinolones, Antiinfectives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerBausch & Lomb Incorporated
Application holderBAUSCH AND LOMB INC
FDA applicationANDA076622 (ANDA)
Labeler code24208
First marketedMay 2004
Product typeHuman Prescription Drug
Portfolio92 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 OFLOXACIN 0.3% EYE DROPS Ingredient Ofloxacin
📗 Our plain-language guide HelloPharmacist
  • No — please don't do that. The ear drops and eye drops are different formulations made for very different tissues. Using ear drops in your eye could cause irritation or harm. If yo...
  • I was given ofloxacin ear drops. Can I use them in my eye instead if I don't have the eye drops right now?
  • The biggest ones to act on right away are tendon pain or a popping sensation (especially around the heel or shoulder), numbness or tingling in your hands or feet, and severe mental...
  • What are the most serious side effects I should actually watch out for?
📖 Read our full Ofloxacin guide →
11
Nutrient depletion considerations

Ofloxacin may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.

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 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.

5 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 DailyMedingredient 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 $1.268 $6.34 / 5 ml
Medicaid paysCMS SDUD · 12 mo $3.72 $18.59 / 5 ml
Medicare drug plans payPart D · Q2 2026 $1.98 $9.88 / 5 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $2.380 $1.268
▼ Down 28% over the last 24 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
Ofloxacin 3 mg/mL 64980-0515-01 Rising 1 bottle $1.183 AT Availability likely save 7%
Ofloxacin 3 mg/mL 65145-0142-01 Caplin 10 ml $1.183 AT Availability likely save 7%
ofloxacin 3 mg/mL 70756-0650-30 Lifestar 1 bottle $1.183 AT Availability likely save 7%
ofloxacin 3 mg/mL 00904-7434-05 Major 1 bottle $1.268 AT Availability likely
Ofloxacin 3 mg/mLthis 24208-0434-05 Bausch 1 bottle $1.268 AT Availability likely
Ofloxacin 3 mg/mL 60505-0560-00 Apotex 1 bottle $1.268 AT Availability likely
Ofloxacin 3 mg/mL 65145-0141-01 Caplin 5 ml $1.268 AT Availability likely
Ofloxacin 3 mg/mL 69315-0327-05 Leading 5 ml $1.268 AT Availability likely
Ofloxacin 3 mg/mL 70069-0411-01 Somerset 1 bottle $1.268 AT Availability likely
Ofloxacin 3 mg/mL 70512-0793-05 SOLA 1 bottle $1.268 AT Availability likely
ofloxacin 3 mg/mL 70756-0607-30 Lifestar 1 bottle $1.268 AT Availability likely
Ofloxacin 3 mg/mL 72485-0613-10 ARMAS 1 bottle $1.268 AT Availability likely
ofloxacin 3 mg/mL 72603-0192-01 NorthStar 5 ml $1.268 AT Availability likely
Ocuflox 3 mg/mL 11980-0779-05 Allergan, 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 50090-1744-00 A-S 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 50090-5186-00 A-S 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 50090-5209-00 A-S 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 50090-5425-00 A-S 1 bottle AT FDA listed
ofloxacin 3 mg/mL 50090-6794-00 A-S 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 50090-7264-00 A-S 1 bottle AT FDA listed
ofloxacin 3 mg/mL 50090-7761-00 A-S 5 ml AT FDA listed
Ofloxacin ophthalmic 3 mg/mL 59390-0140-05 Altaire 5 ml AT FDA listed
Ofloxacin 3 mg/mL 60760-0917-05 St. 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 60760-0970-05 ST. 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 63187-0268-05 Proficient 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 63187-0662-05 Proficient 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 63187-0734-05 Proficient 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 68071-1607-05 NuCare 5 ml AT FDA listed
Ofloxacin 3 mg/mL 68071-2254-05 NuCare 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 68071-2265-01 NuCare 1 bottle AT FDA listed
ofloxacin 3 mg/mL 68071-3448-05 NuCare 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 68071-3566-01 NuCare 1 bottle AT FDA listed
ofloxacin 3 mg/mL 68071-3919-05 NuCare 5 ml AT FDA listed
Ofloxacin 3 mg/mL 68788-7693-05 Preferred 1 bottle AT FDA listed
ofloxacin 3 mg/mL 68788-8449-05 Preferred 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 68788-8761-05 Preferred 1 bottle AT FDA listed
ofloxacin 3 mg/mL 70518-3710-00 REMEDYREPACK 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 71205-0420-05 Proficient 1 bottle AT FDA listed
Ofloxacin Ophth Soln 3 mg/mL 72189-0472-05 Direct_Rx 5 ml AT FDA listed
ofloxacin 3 mg/mL 82804-0101-05 Proficient 1 bottle AT FDA listed
Ofloxacin 3 mg/mL 70518-3573-00 REMEDYREPACK 1 bottle AT Discontinued
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

🏛️
2004
On the market since
May 2004
📍
2026
Currently FDA-listed
22 years listed
🔓
·
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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 24208-0434-05, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
8.8K
Units reimbursed last 4 qtrs
48.8K
Gross reimbursed last 4 qtrs
$181.5K
Avg / prescription
$20.55
Avg / unit
$3.7171
Latest quarter Q4 2025
2.7KRx
Medicaid pays / mL
$3.7171
gross reimbursed
vs
NADAC / mL
$1.2678
acquisition cost
=
Spread
+$2.4493
+193% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
49% FFS 51% MCO
Fee-for-service · 4,361 Rx Managed care · 4,472 Rx
State Medicaid map
Alaska: no data reported AK Maine: 423 units · 30.3 per 100k residents ME Washington: 760 units · 9.7 per 100k residents WA Idaho: no data reported ID Montana: 125 units · 11.0 per 100k residents MT North Dakota: no data reported ND Minnesota: 251 units · 4.4 per 100k residents MN Wisconsin: 155 units · 2.6 per 100k residents WI Michigan: 1,160 units · 11.6 per 100k residents MI New York: 14,940 units · 76.3 per 100k residents NY Vermont: no data reported VT New Hampshire: 105 units · 7.5 per 100k residents NH Oregon: 60 units · 1.4 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 250 units · 2.0 per 100k residents IL Indiana: 100 units · 1.5 per 100k residents IN Ohio: 4,050 units · 34.4 per 100k residents OH Pennsylvania: 8,016 units · 61.8 per 100k residents PA New Jersey: 1,255 units · 13.5 per 100k residents NJ Massachusetts: 325 units · 4.6 per 100k residents MA California: 5,853 units · 15.0 per 100k residents CA Utah: 130 units · 3.8 per 100k residents UT Colorado: 165 units · 2.8 per 100k residents CO Nebraska: 80 units · 4.0 per 100k residents NE Missouri: 735 units · 11.9 per 100k residents MO Kentucky: 629 units · 13.9 per 100k residents KY West Virginia: no data reported WV Virginia: 770 units · 8.8 per 100k residents VA Maryland: 1,673 units · 27.1 per 100k residents MD Connecticut: 275 units · 7.6 per 100k residents CT Rhode Island: no data reported RI Arizona: 220 units · 3.0 per 100k residents AZ New Mexico: 136 units · 6.4 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 365 units · 5.1 per 100k residents TN North Carolina: 475 units · 4.4 per 100k residents NC South Carolina: 170 units · 3.2 per 100k residents SC Delaware: no data reported DE Oklahoma: 285 units · 7.0 per 100k residents OK Louisiana: 535 units · 11.7 per 100k residents LA Mississippi: 185 units · 6.3 per 100k residents MS Alabama: 630 units · 12.3 per 100k residents AL Georgia: 410 units · 3.7 per 100k residents GA D.C.: 105 units · 15.5 per 100k residents DC Hawaii: no data reported HI Texas: 900 units · 3.0 per 100k residents TX Florida: 1,245 units · 5.5 per 100k residents FL
Units reimbursed · per 100k residents
1.476.3
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 76.3 /100k
2 Pennsylvania 61.8 /100k
3 Ohio 34.4 /100k
4 Maine 30.3 /100k
5 Maryland 27.1 /100k
6 D.C. 15.5 /100k
7 California 15.0 /100k
8 Kentucky 13.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle this page24208-0434-05 8,833 Rx · $181,513
1 bottle24208-0434-10 1,277 Rx · $26,910
Drug total (last 4 qtrs): 10,110 Rx · 61,131 units · $208,423 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Ofloxacin — the program that covers self-administered drugs. 15 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 Ofloxacin. 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
$5.52M
Claims incl. refills
354K
Beneficiaries
303.5K
Spend / beneficiary
$18.18
Spend / claim
$15.58
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ofloxacin — the ingredient across all brands.

Top reported reactions

Eye Pain348
Headache289
Pain280
Fatigue272
Nausea260
Arthralgia256
Diarrhoea250

Age at onset

Neonate5
Infant10
Child45
Adolescent29
Adult666
Elderly802

Reporter sex

7,263 reports
Male · 46%
Female · 54%
Unknown · 0%

Serious outcomes

Hospitalization2,671
Disabling375
Life-threatening356
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 680 180
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
24208-0434-05 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (24208-434-05) / 5 mL in 1 BOTTLE, DROPPER $1.27 / mL $6.34 2004-05-14 Active
24208-0434-10 1 BOTTLE, DROPPER in 1 CARTON (24208-434-10) / 10 mL in 1 BOTTLE, DROPPER $1.18 / mL $11.83 2004-05-14 Active

Per mL, this pack runs about 7% above the cheapest pack (NDC 24208-0434-10, $1.18 vs $1.27 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 87% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 24208-0434-05?
NDC 24208-0434-05 is listed by the FDA — 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Ofloxacin 3 mg/mL Solution/ Drops?
Bill NDC 24208-0434-05 — the 11-digit billing format is 24208043405. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 76 words

INDICATIONS AND USAGE Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: CONJUNCTIVITIS: Gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Gram-negative bacteria: Enterobacter cloacae Haemophilus influenzae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Gram-negative bacteria: Pseudomonas aeruginosa Serratia marcescens* Anaerobic species: Propionibacterium acnes *Efficacy for this organism was studied in fewer than 10 infections.

⏱️ Dosage and Administration 120 words

DOSAGE AND ADMINISTRATION The recommended dosage regimen for the treatment of bacterial conjunctivitis is: Days 1 and 2 Instill one to two drops every two to four hours in the affected eye(s). Days 3 through 7 Instill one to two drops four times daily. The recommended dosage regimen for the treatment of bacterial corneal ulcer is: Days 1 and 2 Instill one to two drops into the affected eye every 30 minutes, while awake.

Awaken at approximately four and six hours after retiring and instill one to two drops. Days 3 through 7 to 9 Instill one to two drops hourly, while awake. Days 7 to 9 through Instill one to two drops, four times daily. treatment completion DO NOT

Contraindications 31 words

CONTRAINDICATIONS Ofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication ( see WARNINGS ).

⚠️ Warnings 126 words

WARNINGS NOT FOR INJECTION. Ofloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. There are rare reports of anaphylactic reaction/shock and fatal hypersensitivity reactions in patients receiving systemic quinolones, some following the first dose, including ofloxacin.

Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue the drug.

Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation should be administered as clinically indicated.

🤒 Adverse Reactions 73 words

ADVERSE REACTIONS Ophthalmic Use The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness and nausea have been received.

Refer to Warnings for additional adverse reactions. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 63 words

Drug Interactions Specific drug interaction studies have not been conducted with ofloxacin ophthalmic solution. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

🧒 Pediatric Use 64 words

Pediatric Use Safety and effectiveness in infants below the age of one year have not been established. Quinolones, including ofloxacin, have been shown to cause arthropathy in immature animals after oral administration; however, topical ocular administration of ofloxacin to immature animals has not shown any arthropathy. There is no evidence that the ophthalmic dosage form of ofloxacin has any effect on weight bearing joints.

🧓 Geriatric Use 17 words

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

🧬 Clinical Pharmacology ~2 min read

CLINICAL PHARMACOLOGY Pharmacokinetics Serum, urine and tear concentrations of ofloxacin were measured in 30 healthy women at various time points during a ten-day course of treatment with ofloxacin ophthalmic solution. The mean serum ofloxacin concentration ranged from 0.4 ng/mL to 1.9 ng/mL. Maximum ofloxacin concentration increased from 1.1 ng/mL on day one to 1.9 ng/mL on day 11 after QID dosing for 10 1/2 days.

Maximum serum ofloxacin concentrations after ten days of topical ophthalmic dosing were more than 1000 times lower than those reported after standard oral doses of ofloxacin. Tear ofloxacin concentrations ranged from 5.7 to 31 mcg/g during the 40 minute period following the last dose on day 11. Mean tear concentration measured four hours after topical ophthalmic dosing was 9.2 mcg/g.

Corneal tissue concentrations of 4.4 mcg/mL were observed four hours after beginning topical ocular application of two drops of ofloxacin ophthalmic solution every 30 minutes. Ofloxacin was excreted in the urine primarily unmodified. Microbiology Ofloxacin has in vitro activity against a broad range of gram-positive and gram-negative aerobic and anaerobic bacteria.

Ofloxacin is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Ofloxacin is thought to exert a bactericidal effect on susceptible bacterial cells by inhibiting DNA gyrase, an essential bacterial enzyme which is a critical catalyst in the duplication, transcription, and repair of bacterial DNA. Cross-resistance has been observed between ofloxacin and other fluoroquinolones.

There is generally no cross-resistance between ofloxacin and other classes of antibacterial agents such as beta-lactams or aminoglycosides. Ofloxacin has been shown to be active against most strains of the following organisms both in vitro and clinically, in conjunctival and/or corneal ulcer infections ( see INDICATIONS AND USAGE ). AEROBES, GRAM-POSITIVE: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae AEROBES, GRAM-NEGATIVE: Enterobacter cloacae Haemophilus influenzae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens* ANAEROBIC SPECIES: Propionibacterium acnes *Efficacy for this organism was studied in fewer than 10 infections.

The safety and effectiveness of ofloxacin ophthalmic solution in treating ophthalmologic infections due to the following organisms have not been established in adequate and well-controlled clinical trials. Ofloxacin ophthalmic solution has been shown to be active in vitro against most strains of these organisms but the clinical significance in ophthalmologic infections is unknown. AEROBES, GRAM-POSITIVE: Enterococcus faecalis Listeria monocytogenes Staphylococcus capitis Staphylococcus hominus Staphylococcus simulans Streptococcus pyogenes AEROBES, GRAM-NEGATIVE: Acinetobacter calcoaceticus var. anitratus Acinetobacter calcoaceticus var. lwoffi Citrobacter diversus Citrobacter freundii Enterobacter aerogenes Enterobacter agglomerans Escherichia coli Haemophilus parainfluenzae Klebsiella oxytoca Klebsiella pneumoniae Moraxella (Branhamella) catarrhalis Moraxella lacunata Morganella morganii Neisseria gonorrhoeae Pseudomonas acidovorans Pseudomonas fluorescens Shigella sonnei OTHER: Chlamydia trachomatis Clinical Studies Conjunctivitis In a randomized, double-masked, multicenter clinical trial, ofloxacin ophthalmic solution was superior to its vehicle after 2 days of treatment in patients with conjunctivitis and positive conjunctival cultures.

Clinical outcomes for the trial demonstrated a clinical improvement rate of 86% (54/63) for the ofloxacin treated group versus 72% (48/67) for the placebo treated group after 2 days of therapy. Microbiological outcomes for the same clinical trial demonstrated an eradication rate for causative pathogens of 65% (41/63) for the ofloxacin treated group versus 25% (17/67) for the vehicle treated group after 2 days of therapy. Please note that microbiologic eradication doe…

📦 How Supplied / Storage and Handling 28 words

HOW SUPPLIED Ofloxacin ophthalmic solution, 0.3% is supplied sterile in plastic dropper bottles with tan caps in the following sizes: 5 mL NDC 24208-434-05 10 mL NDC 24208-434-10

📦 Storage and Handling 55 words

NOTE: Store at 15°C to 25°C (59°F to 77°F). KEEP OUT OF REACH OF CHILDREN. FOR OPHTHALMIC USE ONLY. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates 9118306 (FOLDED) 9118206 (FLAT) Rev. 04/2023

📋 Description 111 words

DESCRIPTION Ofloxacin ophthalmic solution, 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Chemical Name: (±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H -pyrido[1,2,3- de ]-1,4- benzoxazine-6-carboxylic acid.

Contains: Active: ofloxacin 0.3% (3 mg/mL) Preservative: benzalkonium chloride (0.005%) Inactives: sodium chloride and purified water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin ophthalmic solution is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8).

It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure. chem

💬 Information for Patients 49 words

Information for Patients Avoid contaminating the applicator tip with material from the eye, fingers or other source. Systemic quinolones, including ofloxacin, have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.