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Ciprofloxacin and Fluocinolone Acetonide .75; .0625 mg/.25mL; mg/.25mL Solution

by Xspire Pharma, LLC · 1 POUCH in 1 CARTON (42195-128-14) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE
NDC 42195-0128-14
🏷️ FDA NDC (as labeled) 42195-128-14 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 17, 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 2025. 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) 42195-128-14
Product NDC 42195-128
11-digit billing NDC 42195012814
NCPDP billing unit EA — each (per item)
Application # NDA208251
SPL Set ID f7664db7-c1aa-4b40-8df8-9cc0b57825f6
Chemical class Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Quinolone Antimicrobial [EPC], Quinolones
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2025)
Route AURICULAR (OTIC)
Dosage form SOLUTION
Substance CIPROFLOXACIN; FLUOCINOLONE ACETONIDE
GPI-14 87991002382025
GCN Seq No 076088
GCN 41358
HICL code 040806
Ingredient (HICL) Ciprofloxacin Hcl/Fluocinolone
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 Q8F
Therapeutic class — specific (HIC3) Otic Preparations,Anti-Inflammatory-Antibiotics
AHFS code 08:12.18.00
AHFS class Quinolone Antibiotics
FDB label name CIPROFLOX-FLUOCINLN 0.3-0.025%
FDB brand name Ciprofloxacin Hcl-Fluocinolone
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 42195-128-14 — 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 → 42195-0128-14. 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

LabelerXspire Pharma, LLC
Application holderLABORATORIOS SALVAT SA
FDA applicationNDA208251 (NDA AUTHORIZED GENERIC)
Labeler code42195
Product typeHuman Prescription Drug
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 CIPROFLOX-FLUOCINLN 0.3-0.025% Ingredient Ciprofloxacin Hcl/Fluocinolone

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII RDH86HJV5Z
    Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
  • 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.

4 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
Ciprofloxacin and Fluocinolone Acetonide .75; .0625 mg/.25mL; mg/.25mLthis 42195-0128-14 Xspire 1 pouch — — Discontinued —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2016
First FDA approval
Apr 2016
📍
2026
Currently FDA-listed
10 years listed
🛡️
2030
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2030. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 29, 2016 RLD RS ⏳ ~3.5 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8932610 — method of use (U-1578)
2016 2018 2020 2022 2024 2026 2028 2030
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 8932610 ↗ Method of use U-1578 Mar 24, 2030
Common questions
Is there a generic version of CIPROFLOX-FLUOCINLN 0.3-0.025%?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for CIPROFLOX-FLUOCINLN 0.3-0.025%. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Mar 2030 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
42195-0128-14 You're viewing this 1 POUCH in 1 CARTON (42195-128-14) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE 2021-10-04 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 — 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.
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 42195-128-14, 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: 42195-0128-14, written without dashes as 42195012814. 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 42195-0128-14, the first segment (42195) is the labeler code FDA assigned to Xspire Pharma, LLC; the middle segment (0128) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (14) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Xspire Pharma, LLC 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 108 words ▾

1 INDICATIONS AND USAGE Ciprofloxacin and Fluocinolone Acetonide Otic Solution is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Staphylococcus aureus , Streptococcus pneumoniae , Haemophilus influenzae , Moraxella catarrhalis , and Pseudomonas aeruginosa . Ciprofloxacin and Fluocinolone Acetonide Otic Solution is a combination of ciprofloxacin, a fluoroquinolone antibacterial, and fluocinolone acetonide, a corticosteroid, indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Staphylococcus aureus , Streptococcus pneumoniae , Haemophilus influenzae , Moraxella catarrhalis , and Pseudomonas aeruginosa ( 1 )

⏱️ Dosage and Administration 210 words ▾

2 DOSAGE AND ADMINISTRATION Ciprofloxacin and Fluocinolone Acetonide Otic Solution is for otic use only. It is not for ophthalmic use, or for injection. The recommended dosage regimen is as follows: Instill the contents of one single-dose vial 0.25 mL into the affected ear canal twice daily (approximately every 12 hours) for 7 days.

Use this dosing for patients aged 6 months of age and older. Warm the solution by holding the vial in the hand for 1 to 2 minutes. This is to avoid dizziness, which may result from the instillation of a cold solution into the ear canal.

The patient should lie with the affected ear upward, and then instill the medication. Pump the tragus 4 times by pushing inward to facilitate penetration of the medication into the middle ear. Maintain this position for 1 minute.

Repeat, if necessary, for the opposite ear [see Instructions for Use ] . Ciprofloxacin and Fluocinolone Acetonide Otic Solution is for otic administration only. It is not for ophthalmic use, or for injection.

( 2 ) Instill the contents of one single-dose vial (0.25 mL) into the affected ear canal twice daily for 7 days. ( 2 ) Use this dosing regimen for patients aged 6 months and older. ( 2 )

💊 Dosage Forms and Strengths 75 words ▾

3 DOSAGE FORMS AND STRENGTHS Otic Solution: Each single-dose vial of Ciprofloxacin and Fluocinolone Acetonide Otic Solution (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) delivers 0.25 mL of solution equivalent to ciprofloxacin 0.75 mg and fluocinolone acetonide 0.0625 mg. Otic Solution: Each single-dose vial of Ciprofloxacin and Fluocinolone Acetonide Otic Solution (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) delivers 0.25 mL of solution equivalent to ciprofloxacin 0.75 mg and fluocinolone acetonide 0.0625 mg.

⛔ Contraindications 111 words ▾

4 CONTRAINDICATIONS Ciprofloxacin and Fluocinolone Acetonide Otic Solution is contraindicated in: Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other components of Ciprofloxacin and Fluocinolone Acetonide Otic Solution. Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections. Ciprofloxacin and Fluocinolone Acetonide Otic Solution is contraindicated in: Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any component of Ciprofloxacin and Fluocinolone Acetonide Otic Solution.

( 4 ) Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity : Discontinue use at the first appearance of a skin rash or any other sign of hypersensitivity. ( 5.1 ) Potential for Microbial Overgrowth: Prolonged use may result in the overgrowth of non-susceptible bacteria and fungi. If such infections occur, discontinue use and institute alternative therapy. ( 5.2 )

5.1Hypersensitivity Reactions Ciprofloxacin and Fluocinolone Acetonide Otic Solution should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching.

Serious acute hypersensitivity reactions may require immediate emergency treatment.

5.2Potential for Microbial Overgrowth with Prolonged Use Prolonged use of Ciprofloxacin and Fluocinolone Acetonide Otic Solution may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.

5.3Continued or Recurrent Otorrhea If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within 6 months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [ see Warnings and Precautions (5.1) ] The most common adverse reactions that occurred in ≥1 patient were otorrhea, excessive granulation tissue, ear infection, ear pruritus, tympanic membrane disorder, auricular swelling and balance disorder ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xspire Pharma at 1-888-252-3901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, 224 patients with AOMT were treated with Ciprofloxacin and Fluocinolone Acetonide Otic Solution for a median duration of 7 days. All the patients received at least one dose of Ciprofloxacin and Fluocinolone Acetonide Otic Solution.

There were 220 patients who received at least one dose of ciprofloxacin (CIPRO) and 213 patients received at least one dose of fluocinolone acetonide (FLUO). The most common adverse reactions that occurred in 1 or more patients are as follows: Table 1: Selected Adverse Reactions that Occurred in 1 or more Patients in the Ciprofloxacin and Fluocinolone Acetonide Otic Solution Group Adverse Reactions Selected adverse reactions that occurred in ≥ 1 patient in the Ciprofloxacin and Fluocinolone Acetonide Otic Solution group derived from all reported adverse events that could be related to the study drug or the drug class.

Number (%) of Patients Ciprofloxacin and Fluocinolone Acetonide Otic Solution N=224 CIPRO N=220 FLUO N=213 Otorrhea 12 (5.4%) 9 (4.1%) 12 (5.6%) Excessive granulation tissue 3 (1.3%) 0 (0.0%) 2 (0.9%) Ear infection 2 (0.9%) 3 (1.4%) 1 (0.5%) Ear pruritus 2 (0.9%) 1 (0.5%) 1 (0.5%) Tympanic membrane disorder 2 (0.9%) 0 (0.0%) 0 (0.0%) Auricular swelling 1 (0.4%) 1 (0.5%) 0 (0.0%) Balance disorder 1 (0.4%) 0 (0.0%) 0 (0.0%)

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of ciprofloxacin and fluocinolone acetonide otic solution, 0.3% / 0.025% outside the US. 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. Immune system disorders: allergic reaction.

Infections and infestations: candidiasis. Nervous system disorders: dysgeusia, paresthesia (tingling in ears), dizziness, headache. Ear and labyrinth disorders: ear discomfort, hypoacusis, tinnitus, ear congestion.

Vascular disorders: flushing. Skin and subcutaneous tissue disorders: skin exfoliation. Injury, poisoning and procedural complications: device occlusion (tympanostomy tube obstruction).

👥 Use in Specific Populations 185 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Ciprofloxacin and Fluocinolone Acetonide Otic Solution is negligibly absorbed following otic administration and maternal use is not expected to result in fetal exposure to ciprofloxacin and fluocinolone acetonide [see Clinical Pharmacology (12.3) ].

8.2Lactation Risk Summary Ciprofloxacin and Fluocinolone Acetonide Otic Solution is negligibly absorbed by the mother following otic administration and breastfeeding is not expected to result in exposure of the infant to ciprofloxacin and fluocinolone acetonide [ see Clinical Pharmacology (12.3) ].

8.4Pediatric Use Ciprofloxacin and Fluocinolone Acetonide Otic Solution has been studied in patients as young as 6 months in adequate and well-controlled clinical trials. No major differences in safety and effectiveness have been observed between adult and pediatric patients [ see Indications and Usage (1) and Dosage and Administration (2) ].

8.5Geriatric Use Clinical studies of Ciprofloxacin and Fluocinolone Acetonide Otic Solution did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🤰 Pregnancy 37 words ▾

8.1Pregnancy Risk Summary Ciprofloxacin and Fluocinolone Acetonide Otic Solution is negligibly absorbed following otic administration and maternal use is not expected to result in fetal exposure to ciprofloxacin and fluocinolone acetonide [see Clinical Pharmacology (12.3) ].

🧒 Pediatric Use 52 words ▾

8.4Pediatric Use Ciprofloxacin and Fluocinolone Acetonide Otic Solution has been studied in patients as young as 6 months in adequate and well-controlled clinical trials. No major differences in safety and effectiveness have been observed between adult and pediatric patients [ see Indications and Usage (1) and Dosage and Administration (2) ].

🧓 Geriatric Use 49 words ▾

8.5Geriatric Use Clinical studies of Ciprofloxacin and Fluocinolone Acetonide Otic Solution did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 27 words ▾

10 OVERDOSAGE Due to the characteristics of this preparation, no toxic effects are to be expected with an otic overdose of Ciprofloxacin and Fluocinolone Acetonide Otic Solution.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ciprofloxacin is a fluoroquinolone antibacterial [ see Microbiology (12.4) ]. Fluocinolone acetonide, a corticosteroid, inhibits the local biosynthesis of prostaglandins, which explains part of its anti-inflammatory efficacy. At the cellular level, corticosteroids induce peptides called lipocortins.

Lipocortins antagonize phospholipase A2, an enzyme which causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal enzymes and the complement system.

12.3Pharmacokinetics In two studies in children with AOMT aged ≥ 6 months to 12 years, blood samples were taken in subgroups of 16 and 14 patients, at Visit 1 (prior to the first dose) and Visit 3 (within 1 and 2 hours after the last dose) respectively, to determine the plasma concentrations of ciprofloxacin and/or fluocinolone acetonide following administration of Ciprofloxacin and Fluocinolone Acetonide Otic Solution at the recommended dosage regimen of 0.25 mL twice daily. Pharmacokinetic (PK) analysis resulted in only 1 sample showing a detectable concentration of ciprofloxacin in plasma of 3.0 mcg/L after 7 days of treatment, and no detectable concentrations in plasma of fluocinolone acetonide were observed.

However, the sample with detectable ciprofloxacin concentrations was from a patient who had bilateral AOMT (protocol deviation because all patients participating in the PK study were to have unilateral otorrhea) and who received treatment in both ears with ciprofloxacin 0.3% otic solution, the active comparator.

12.4Microbiology Mechanism of Action The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase, which is needed for the synthesis of bacterial DNA. Resistance Bacterial resistance to quinolones can develop through chromosomal or plasmid-mediated mechanisms. In vitro studies demonstrated cross-resistance between ciprofloxacin and some fluoroquinolones.

There is generally no cross-resistance between ciprofloxacin and other classes of antibacterial agents such as beta-lactams or aminoglycosides. Antimicrobial Activity Ciprofloxacin has been shown to be active against most isolates of the following bacteria, both in vitro and clinically in otic infections [ see Indications and Usage (1) ]: Aerobic Bacteria: Gram-positive Bacteria: Staphylococcus aureus Streptococcus pneumoniae Gram-negative Bacteria: Pseudomonas aeruginosa Haemophilus influenzae Moraxella catarrhalis

🧬 Mechanism of Action 80 words ▾

12.1Mechanism of Action Ciprofloxacin is a fluoroquinolone antibacterial [ see Microbiology (12.4) ]. Fluocinolone acetonide, a corticosteroid, inhibits the local biosynthesis of prostaglandins, which explains part of its anti-inflammatory efficacy. At the cellular level, corticosteroids induce peptides called lipocortins.

Lipocortins antagonize phospholipase A2, an enzyme which causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal enzymes and the complement system.

📦 How Supplied / Storage and Handling 89 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How supplied Ciprofloxacin and Fluocinolone Acetonide Otic Solution, 0.3 %/0.025 %, is a sterile, preservative-free, clear otic solution supplied in blue translucent single-dose 0.25 mL vials. Fourteen single-dose vials are packaged in a protective foil pouch contained in a carton (NDC 42195-128-14). Storage Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Protect from light; store unused vials in pouch and discard 7 days after opening the pouch. Do not open until ready to use. Discard vial after use.

📦 Storage and Handling 42 words ▾

Storage Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light; store unused vials in pouch and discard 7 days after opening the pouch. Do not open until ready to use. Discard vial after use.

📋 Description 149 words ▾

11 DESCRIPTION Ciprofloxacin and Fluocinolone Acetonide Otic Solution, 0.3% / 0.025% is a sterile, preservative-free, clear otic solution containing the fluoroquinolone antibacterial, ciprofloxacin hydrochloride, combined with the corticosteroid, fluocinolone acetonide. Each single-dose vial contains a deliverable volume of 0.25 mL solution of ciprofloxacin hydrochloride equivalent to 0.75 mg ciprofloxacin and 0.0625 mg fluocinolone acetonide. The pH of the solution ranges from 3.5 to 5.0.

The inactive ingredients are polysorbate 80, glycerin, povidone K90F and water for injection. Ciprofloxacin is available as the monohydrochloride, monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C 17 H 18 FN 3 O 3 ∙HCl∙H 2 O.

The chemical structure of ciprofloxacin hydrochloride is: The chemical name of fluocinolone acetonide is (6α,11β,16α)-6,9-difluoro-11,21-dihydroxy- 16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone[67-73-2]. Its molecular formula is C 24 H 30 F 2 O 6 . The chemical structure of fluocinolone acetonide is: Chemical Structure-Ciprofloxin Chemical Structure-Fluocinolone Acetonide

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Administration Instructions Advise patients that Ciprofloxacin and Fluocinolone Acetonide Otic Solution is for otic use only. It is not to be used in the eyes.

Advise patients to warm the otic solution by holding the vial in the hand for 1 to 2 minutes before instilling it in the ear, to avoid dizziness. Hypersensitivity Reactions Advise patients to immediately discontinue Ciprofloxacin and Fluocinolone Acetonide Otic Solution at the first appearance of a skin rash or any other sign of hypersensitivity [see Warnings and Precautions (5.1) ]

PATIENT INFORMATION Ciprofloxacin and Fluocinolone Acetonide (sip-roh-flok-suh-sin and floo-oh-SIN-oh-lone uh-SEET-oh-nide) Otic Solution What is Ciprofloxacin and Fluocinolone Acetonide Otic Solution? Ciprofloxacin and Fluocinolone Acetonide Otic Solution is a prescription medicine used in the ear only (otic use) that contains 2 medicines, a quinolone antibiotic medicine called ciprofloxacin and a corticosteroid medicine called fluocinolone acetonide. Ciprofloxacin and Fluocinolone Acetonide Otic Solution is used in children 6 months of age and older to treat a type of middle ear infection called acute otitis media with tympanostomy tubes (AOMT) in children who have a tube in their eardrum known as a tympanostomy tube, to prevent having too much fluid in the middle ear.

It is not known if Ciprofloxacin and Fluocinolone Acetonide Otic Solution is safe and effective in children under 6 months of age. Who should not use Ciprofloxacin and Fluocinolone Acetonide Otic Solution? Do not use Ciprofloxacin and Fluocinolone Acetonide Otic Solution if you: Are allergic to ciprofloxacin, quinolones, fluocinolone acetonide, corticosteroids or any of the ingredients in Ciprofloxacin and Fluocinolone Acetonide Otic Solution.

See the end of this Patient Information leaflet for a complete list of ingredients in Ciprofloxacin and Fluocinolone Acetonide Otic Solution. Have an outer ear canal infection caused by certain viruses including chicken pox (varicella) and the herpes simplex virus. Have an ear infection caused by a fungus.

What should I tell my healthcare provider before using Ciprofloxacin and Fluocinolone Acetonide Otic Solution? Before using Ciprofloxacin and Fluocinolone Acetonide Otic Solution, tell your healthcare provider about all of your medical conditions, including if you: Are pregnant or plan to become pregnant, although Ciprofloxacin and Fluocinolone Acetonide Otic Solution is not expected to harm your baby. Are breastfeeding or plan to breastfeed, although Ciprofloxacin and Fluocinolone Acetonide Otic Solution is not expected to pass into your breast milk and to harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Ciprofloxacin and Fluocinolone Acetonide Otic Solution? Read the detailed Instructions for Use that come with Ciprofloxacin and Fluocinolone Acetonide Otic Solution. Use Ciprofloxacin and Fluocinolone Acetonide Otic Solution exactly as your healthcare provider tells you to use it.

Ciprofloxacin and Fluocinolone Acetonide Otic Solution is for use in the ear only (otic use). Do not inject Ciprofloxacin and Fluocinolone Acetonide Otic Solution or use Ciprofloxacin and Fluocinolone Acetonide Otic Solution in the eye. Ciprofloxacin and Fluocinolone Acetonide Otic Solution comes as a liquid in single-dose vials.

Apply the entire dose of Ciprofloxacin and Fluocinolone Acetonide Otic Solution from 1 of the single-dose vials, into the affected ear 2 times a day (for a total of 2 single-dose vials a day) for 7 days. Each dose should be about 12 hours apart. If your symptoms do n…

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