Home › NDC Lookup › Ingredients › Ofloxacin › 72189-0108-05
👂image loading
(from DailyMed)

OFLOXACIN OTIC 3 mg/mL Solution, 5 mL

by DIRECT RX · 5 mL in 1 BOTTLE, DROPPER (72189-108-05)
NDC 72189-0108-05
🏷️ FDA NDC (as labeled) 72189-108-05 billing pads the product segment with a zero
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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 72189-108-05
Product NDC 72189-108
11-digit billing NDC 72189010805
NCPDP billing unit ML — per mL (volume)
RxCUI 242446
UNII A4P49JAZ9H
Application # ANDA076527
SPL Set ID a7952956-b64a-0f99-e053-2995a90a0f91
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 2020-06-08
Route AURICULAR (OTIC)
Dosage form SOLUTION
Substance OFLOXACIN
GPI-14 87100060002010
GPI class Ofloxacin
GCN Seq No 048292
GCN 13880
HICL code 006035
Ingredient (HICL) Ofloxacin
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q8
Therapeutic class — intermediate (HIC2) Otic Preparations
HIC3 code Q8W
Therapeutic class — specific (HIC3) Ear Preparations,Antibiotics
AHFS code 08:12.18.00
AHFS class Quinolone Antibiotics
FDB label name OFLOXACIN 0.3% EAR 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 72189-108-05 — 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 → 72189-0108-05. 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

LabelerDIRECT RX
Application holderAPOTEX INC
FDA applicationANDA076527 (ANDA)
Labeler code72189
First marketedJun 2020
Product typeHuman Prescription Drug
Portfolio204 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% EAR 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.

🧪 Full Ofloxacin 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 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 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 64980-0432-01 Rising 1 bottle $0.976 AT Availability likely —
Ofloxacin 3 mg/mL 65145-0144-01 Caplin 1 bottle $0.976 AT Availability likely —
Ofloxacin 3 mg/mL 69238-1616-06 Amneal 1 bottle $0.976 AT Availability likely —
Ofloxacin 3 mg/mL 70069-0687-01 Somerset 1 bottle $0.976 AT Availability likely —
ofloxacin 3 mg/mL 70756-0610-30 Lifestar 10 ml $0.976 AT Availability likely —
Ofloxacin 3 mg/mL 24208-0410-05 Bausch 1 bottle $1.114 AT Availability likely —
Ofloxacin Otic 3 mg/mL 60505-0363-01 Apotex 5 ml $1.114 AT Availability likely —
Ofloxacin 3 mg/mL 65145-0143-01 Caplin 1 bottle $1.114 AT Availability likely —
Ofloxacin 3 mg/mL 69238-1615-03 Amneal 1 bottle $1.114 AT Availability likely —
Ofloxacin 3 mg/mL 69315-0320-05 Leading 5 ml $1.114 AT Availability likely —
Ofloxacin 3 mg/mL 70069-0686-01 Somerset 1 bottle $1.114 AT Availability likely —
ofloxacin 3 mg/mL 70756-0609-15 Lifestar 5 ml $1.114 AT Availability likely —
ofloxacin 3 mg/mL 72603-0186-01 NorthStar 5 ml $1.114 AT Availability likely —
Ofloxacin Otic 3 mg/mL 50090-1090-00 A-S 5 ml — AT FDA listed —
Ofloxacin 3 mg/mL 50090-5670-00 A-S 1 bottle — AT FDA listed —
ofloxacin 3 mg/mL 50090-7207-00 A-S 5 ml — AT FDA listed —
Ofloxacin Otic 3 mg/mL 63187-0184-05 Proficient 5 ml — AT FDA listed —
Ofloxacin 3 mg/mL 63187-0472-05 Proficient 1 bottle — AT FDA listed —
Ofloxacin Otic 3 mg/mL 63629-8716-01 Bryant 5 ml — AT FDA listed —
Ofloxacin 3 mg/mL 67296-1925-01 Redpharm 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 67296-2159-05 Redpharm 5 ml — AT FDA listed —
Ofloxacin 3 mg/mL 67296-2179-05 Redpharm 1 bottle — AT FDA listed —
Ofloxacin Otic 3 mg/mL 68071-1588-05 NuCare 5 ml — AT FDA listed —
Ofloxacin Otic 3 mg/mL 68071-1630-03 NuCare 10 ml — AT FDA listed —
ofloxacin 3 mg/mL 68071-3604-03 NuCare 10 ml — AT FDA listed —
Ofloxacin 3 mg/mL 68788-4086-01 Preferred 1 bottle — AT FDA listed —
ofloxacin 3 mg/mL 68788-8551-01 Preferred 10 ml — AT Discontinued —
ofloxacin 3 mg/mL 70518-3984-00 REMEDYREPACK 5 ml — AT FDA listed —
Ofloxacin Otic 3 mg/mL 70518-4226-00 REMEDYREPACK 5 ml — AT FDA listed —
Ofloxacin Otic 3 mg/mL 71335-2822-01 Bryant 5 ml — AT FDA listed —
Ofloxacin Otic 3 mg/mL 72162-1709-02 Bryant 5 ml — AT FDA listed —
Ofloxacin Otic 3 mg/mLthis 72189-0108-05 DIRECT 5 ml — AT FDA listed —
Olfoxacin Otic Soln 3 mg/mL 72189-0490-05 Direct_Rx 5 ml — AT FDA listed —
ofloxacin 3 mg/mL 76420-0748-05 Asclemed 5 ml — AT FDA listed —
ofloxacin 3 mg/mL 76420-0749-10 Asclemed 10 ml — AT FDA listed —
ofloxacin 3 mg/mL 82804-0061-05 Proficient 5 ml — 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

🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 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.

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

Medicare Part D (outpatient prescription) spending for Ofloxacin (matched by generic name) — 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. CMS lists 2 products for this generic; we show the highest-spend one. 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72189-0108-05 You're viewing this 5 mL in 1 BOTTLE, DROPPER (72189-108-05) 2020-06-08 Active

🧭 About this NDC listing & data coverage

Finished prescription product
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 72189-108-05, 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: 72189-0108-05, written without dashes as 72189010805. 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 72189-0108-05, the first segment (72189) is the labeler code FDA assigned to DIRECT RX; the middle segment (0108) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by DIRECT RX. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DIRECT RX 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Patient Medication Information
🎯 Indications and Usage 78 words ▾

of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa, and Staphylococcus aureus. Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus,and Streptococcus pneumoniae.

⏱️ Dosage and Administration ~2 min read ▾

Otitis Externa The recommended dosage regimen for the treatment of otitis externa is: For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days. For patients 13 years and older: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution.

The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.

Acute Otitis Media in Pediatric Patients with Tympanostomy Tubes The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (from one to 12 years old) with tympanostomy tubes is: Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear twice daily for ten days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness that may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled.

The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.

Chronic Suppurative Otitis Media with Perforated Tympanic Membranes The recommended dosage regimen for the treatment of chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older is: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for fourteen days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness that may result from the instillation of a cold solution. The patient should lie with the affected ear upward, before instilling the drops.

The tragus should then be pumped 4 times by pushing inward to facilitate penetration into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.

⛔ Contraindications 27 words ▾

Ofloxacin otic solution 0.3% is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.

⚠️ Warnings 84 words ▾

NOT FOR OPHTHALMIC USE. NOT FOR INJECTION. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, 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. If an allergic reaction to ofloxacin is suspected, stop 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 ~2 min read ▾

Subjects with Otitis Externa In the phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with ofloxacin otic solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). The following treatment-related adverse events occurred in two or more of the subjects.

Incidence Rate Adverse Event Studies 002/003* BID (N=229) Studies 016/017 QD (N=310) Study 020 QD (N=489) * Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative. Study 020 (QD) was open and non-comparative. Application Site Reaction 3% 16.8% 0.6% Pruritus 4% 1.2% 1.0% Earache 1% 0.6% 0.8% Dizziness 1% 0.0% 0.6% Headache 0% 0.3% 0.2% Vertigo 1% 0.0% 0.0% An unexpected increased incidence of application site reaction was seen in studies 016/017 and was similar for both ofloxacin and the active control drug (neomycin-polymyxin B sulfate-hydrocortisone).

This finding is believed to be the result of specific questioning of the subjects regarding the incidence of application site reactions. In once daily dosing studies, there were also single reports of nausea, seborrhea, transient loss of hearing, tinnitus, otitis externa, otitis media, tremor, hypertension and fungal infection. In twice daily dosing studies, the following treatment-related adverse events were each reported in a single subject: dermatitis, eczema, erythematous rash, follicular rash, hypoaesthesia, tinnitus, dyspepsia, hot flushes, flushing and otorrhagia.

Subjects with Acute Otitis Media with Tympanostomy Tubes (AOM TT) and Subjects with Chronic Suppurative Otitis Media (CSOM) with Perforated Tympanic Membranes In phase III clinical trials which formed the basis for approval, the following treatment-related adverse events occurred in 1% or more of the 656 subjects with non-intact tympanic membranes in AOM TT or CSOM treated twice-daily with ofloxacin otic solution: Adverse Event Incidence (N=656) Taste Perversion 7% Earache 1% Pruritus 1% Paraesthesia 1% Rash 1% Dizziness 1% Other treatment-related adverse reactions reported in subjects with non-intact tympanic membranes included: diarrhea (0.6%), nausea (0.3%), vomiting (0.3%), dry mouth (0.5%), headache (0.3%), vertigo (0.5%), otorrhagia (0.6%), tinnitus (0.3%), fever (0.3%).

The following treatment-related adverse events were each reported in a single subject: application site reaction, otitis externa, urticaria, abdominal pain, dysaesthesia, hyperkinesia, halitosis, inflammation, pain, insomnia, coughing, pharyngitis, rhinitis, sinusitis, and tachycardia. Post-marketing Adverse Events Cases of uncommon transient neurospsychiatric disturbances have been included in spontaneous post-marketing reports. A causal relationship with ofloxacin otic solution 0.3% is unknown.

🧬 Clinical Pharmacology ~1 min read ▾

Pharmacokinetics Drug concentrations in serum (in subjects with tympanostomy tubes and perforated tympanic membranes), in otorrhea, and in mucosa of the middle ear (in subjects with perforated tympanic membranes) were determined following otic administration of ofloxacin solution. In two single-dose studies, mean ofloxacin serum concentrations were low in adult patients with tympanostomy tubes, with and without otorrhea, after otic administration of a 0.3% solution (4.1 ng/mL (n=3) and 5.4 ng/mL (n=5), respectively).

In adults with perforated tympanic membranes, the maximum serum drug level of ofloxacin detected was 10 ng/mL after administration of a 0.3% solution. Ofloxacin was detectable in the middle ear mucosa of some adult subjects with perforated tympanic membranes (11 of 16 subjects). The variability of ofloxacin concentration in middle ear mucosa was high.

The concentrations ranged from 1.2 to 602 μg/g after otic administration of a 0.3% solution. Ofloxacin was present in high concentrations in otorrhea (389 - 2850 μg/g, n=13) 30 minutes after otic administration of a 0.3% solution in subjects with chronic suppurative otitis media and perforated tympanic membranes. However, the measurement of ofloxacin in the otorrhea does not necessarily reflect the exposure of the middle ear to ofloxacin.

Microbiology Ofloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. Ofloxacin exerts its antibacterial activity by inhibiting DNA gyrase, a bacterial topoisomerase. DNA gyrase is an essential enzyme which controls DNA topology and assists in DNA replication, repair, deactivation, and transcription.

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 isolates of the following microorganisms, both in vitro and clinically in otic infections as described in the INDICATIONS AND USAGE section.

Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus Streptococcus pneumoniae Aerobic and facultative gram-negative microorganisms: Escherichia coli Haemophilus influenzae Moraxella catarrhalis Proteus mirabilis Pseudomonas aeruginosa

📦 How Supplied / Storage and Handling 14 words ▾

Ofloxacin Otic Solution 0.3% is supplied in bottles containing 5 mL and 10 mL.

📋 Description 93 words ▾

Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxy-quinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid.

The empirical formula of ofloxacin is C18H20FN3O4 and its molecular weight is 361.38. The structural formula is: [structure] Ofloxacin Otic Solution contains 0.3% (3 mg/mL) ofloxacin with benzalkonium chloride (0.0025%), hydrochloric acid, sodium chloride, and water for injection. Additional hydrochloric acid and/or sodium hydroxide may be added to adjust the pH (6.5 ± 0.5).

💬 Patient Medication Information ~3 min read ▾

Rx Only Ofloxacin Otic Solution, 0.3% IMPORTANT PATIENT INFORMATION AND INSTRUCTIONS. READ BEFORE USE. What is Ofloxacin Otic Solution?

Ofloxacin Otic Solution is an antibiotic in a sterile solution used to treat ear infections caused by certain bacteria found in: patients (12 years and older) who have a middle ear infection and have a hole in the eardrum pediatric patients (between 1 and 12 years of age) who have a middle ear infection and have a tube in the eardrum patients (6 months and older) who have an infection in the ear canal Middle Ear Infection A middle ear infection is a bacterial infection behind the eardrum. People with a hole or a tube in the eardrum may notice a discharge (fluid draining) in the ear canal.

Ear canal infection An ear canal infection (also known as "Swimmer's Ear") is a bacterial infection of the ear canal. The ear canal and the outer part of the ear may swell, turn red, and be painful. Also, a fluid discharge may appear in the ear canal.

Who should NOT use Ofloxacin Otic Solution? Do not use this product if you are allergic to ofloxacin or to other quinolone antibiotics. Do not give this product to pediatric patients who: have an ear canal infection and are less than 6 months of age because no data were collected from this population have a middle ear infection and have a tube in the eardrum and are less than one year of age because no data were collected from this population have a middle ear infection and have a hole in the eardrum and are less than 12 years of age because no data were collected from this population How should Ofloxacin Otic Solution be given?

1. Wash hands The person giving Ofloxacin Otic Solution should wash his/her hands with soap and water. [ofloxacin03] 2. Clean ear & warm bottle Gently clean any discharge that can be removed easily from the outer ear.

DO NOT INSERT ANY OBJECT OR SWAB INTO THE EAR CANAL. [ofloxacin04] Hold the bottle of Ofloxacin Otic Solution in the hand for one or two minutes to warm the solution. Before using the medication for the first time, be sure the white plastic sealing tape between the bottle and the cap is unbroken. [ofloxacin05] [ofloxacin06] To break the seal and open the bottle, unscrew the cap by turning as indicated by the arrow. 3.

Add drops For a Middle Ear Infection: The person receiving Ofloxacin Otic Solution should lie on his/her side with the infected ear up. Patients (12 and older) should have 10 drops of Ofloxacin Otic Solution put into the infected ear. Pediatric patients under 12 should have 5 drops put into the infected ear.

The tip of the bottle should not touch the fingers or the ear or any other surfaces. For an Ear Canal Infection ("Swimmer's Ear"): The person receiving Ofloxacin Otic Solution should lie on his/her side with the infected ear up. Patients (13 and older) should have 10 drops of Ofloxacin Otic Solution put into the infected ear.

Pediatric patients under 13 should have 5 drops put into the infected ear. The tip of the bottle should not touch the fingers or the ear or any other surfaces. [ofloxacin07] BE SURE TO FOLLOW THE INSTRUCTIONS BELOW FOR THE PATIENT’S SPECIFIC EAR INFECTION. 4.

Press ear or pull ear For a Middle Ear Infection: While the person receiving Ofloxacin Otic Solution lies on his/her side, the person giving the drops should gently press the TRAGUS (see diagram) 4 times in a pumping motion. This will allow the drops to pass through the hole or tube in the eardrum and into the middle ear. [ofloxacin08] [ofloxacin09] For an Ear Canal Infection ("Swimmer's Ear"): While the person receiving the drops lies on his/her side, the person giving the drops should gently pull the outer ear upward and backward.

This will allow the ear drops to flow down into the ear canal. [ofloxacin10] 5. Stay on side The person who received the ear drops should remain on his/her side for at least 5 minutes. [ofloxacin11] Repeat Steps 2-5 for the other ear if both ears are infected. How often should Ofloxacin Otic Solution…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72189-0107-30 · DIRECT 72189-0109-30 · DIRECT →
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.