Ciprofloxacin and Dexamethasone Otic
Ciprofloxacin and dexamethasone otic is a prescription antibiotic-plus-steroid ear drop combination used to treat bacterial ear infections, including acute otitis media and acute otitis externa.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 13 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Ciprofloxacin and Dexamethasone Otic: Patient Information Guide
A plain-language walkthrough of Ciprofloxacin and Dexamethasone Otic — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Ciprofloxacin and dexamethasone otic is used to treat bacterial ear infections caused by specific susceptible bacteria. It is available as brands Ciprodex and Ciprofloxacin and Dexamethasone ear drops.
- Acute otitis media (middle ear infection) with tympanostomy tubes: For children 6 months and older who have ear tubes, caused by Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, or Pseudomonas aeruginosa
- Acute otitis externa (swimmer's ear): For children 6 months and older, adults, and elderly patients, caused by Staphylococcus aureus or Pseudomonas aeruginosa
⚙️How it works▾
Ciprofloxacin kills bacteria by blocking DNA gyrase, an enzyme bacteria need to replicate their DNA. Without it, bacteria cannot reproduce and die off. Dexamethasone, a corticosteroid, works alongside the antibiotic by blocking multiple inflammatory signals in the body — reducing swelling, fluid buildup, and the rush of immune cells that cause pain and redness in the infected ear.
There is generally no cross-resistance between ciprofloxacin and other classes of antibiotics like beta-lactams or aminoglycosides. However, resistance can occur between ciprofloxacin and other fluoroquinolone antibiotics.
💊How it's taken▾
These drops are given twice daily for seven days, instilled directly into the affected ear. Always shake the bottle well and warm it in your hand for a minute or two before use. After instilling the drops, pump the tragus gently and hold the ear-up position for 60 seconds to help the medication penetrate properly. Follow your prescriber's exact instructions — do not use for longer than directed.
🤒Side effects — in detail▾
Most side effects with these ear drops are mild and local. Common ones reported in clinical trials include:
- Ear discomfort
- Ear pain
- Ear itching (pruritus)
- Ear debris or residue in the canal
- Ear congestion
- Taste changes (taste perversion)
- Irritability (mainly in young children)
- Redness (erythema)
More serious reactions reported after market release include swelling of the ear, headache, rash, skin peeling, and vomiting. Stop use immediately and seek medical attention if you develop any signs of a severe allergic reaction such as rash, swelling, or difficulty breathing.
⚠️Warnings & precautions▾
- Severe allergic reactions: Serious and occasionally fatal allergic (anaphylactic) reactions have been reported with quinolone antibiotics. Signs include rash, throat or face swelling, difficulty breathing, and loss of consciousness. Stop using the drops and get emergency help immediately if these occur.
- Microbial overgrowth: Using these drops longer than prescribed can allow non-susceptible bacteria or fungi to take over the ear, making infection harder to treat. If things aren't improving after one week, contact your doctor for further testing.
- Persistent or recurring ear discharge: If discharge continues after finishing the full course, or if you have two or more episodes within six months, a deeper evaluation is needed to rule out an underlying condition like a cholesteatoma (a skin growth in the ear), a foreign body, or a tumor.
🔀What it interacts with▾
The FDA label for these ear drops does not identify specific drug, food, or supplement interactions. However, always tell your doctor or pharmacist about all medications and supplements you are taking.
- No specific drug-drug interactions are listed in the product labeling for this otic (ear) formulation
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy to quinolones: Do not use if you are allergic to ciprofloxacin, any other quinolone antibiotic, or any component of the drops
- Viral or fungal ear infections: Do not use for ear infections caused by viruses (like herpes simplex) or fungi — this antibiotic will not work against them and is contraindicated
- Pregnancy: There are no well-controlled studies in pregnant women. Because very little of the medication is absorbed into the bloodstream from the ear, the risk is expected to be minimal — but discuss with your provider
- Breastfeeding: Very little drug is expected to reach breast milk through otic use, but the benefits and risks should be weighed with your provider
- Children: Safety and effectiveness have been established in children 6 months and older; no clinically meaningful hearing changes were found in pediatric patients tested during trials
🚑If you take too much▾
Because these drops are applied directly to the ear and very little is absorbed into the bloodstream, an accidental overdose in the ear is not expected to cause toxic effects. If you or a child accidentally swallows the ear drops or you have concerns, contact Poison Control or your doctor right away.
📡Pharmacodynamics — effects in the body▾
Ciprofloxacin kills bacteria by interfering with DNA gyrase, blocking bacterial DNA synthesis and reproduction. Dexamethasone reduces the body's inflammatory response in the infected ear by suppressing multiple inflammatory signals, which decreases swelling, fluid leakage, and the accumulation of inflammatory cells — helping relieve pain and congestion alongside the antibiotic's antibacterial action.
🔬Pharmacokinetics — how your body processes it▾
When applied to the ear, very little ciprofloxacin or dexamethasone is absorbed into the bloodstream. In studies with pediatric patients after tympanostomy tube insertion, blood levels of ciprofloxacin reached only about 0.1% of what you'd see with an oral dose, and dexamethasone levels were about 14% of an oral dose. Peak blood levels appeared within 15 minutes to 2 hours after applying the drops. The minimal systemic absorption means the drops work locally in the ear with very limited whole-body exposure.
📦How to store it▾
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Avoid freezing. Protect from light.
📄 Written from Ciprofloxacin and Dexamethasone Otic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Ciprofloxacin and Dexamethasone Otic — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this ear drop treating — is it just for swimmer's ear? ▾
How do I actually put these drops in correctly? ▾
What side effects should I expect, and which ones mean I need to call someone? ▾
My child has ear tubes. Is it safe to use these drops? ▾
What if my ear isn't getting better after a week? ▾
Can I use these drops if I'm pregnant or breastfeeding? ▾
Is Ciprofloxacin and Dexamethasone Otic available over the counter? ▾
When was Ciprofloxacin and Dexamethasone Otic first available? ▾
Who makes Ciprofloxacin and Dexamethasone Otic? ▾
💬 Answers drafted from Ciprofloxacin and Dexamethasone Otic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Ciprofloxacin and Dexamethasone Otic comes
Ciprofloxacin and Dexamethasone Otic is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Ear drops
How this form is used
- Treats acute otitis media (middle ear infection) in children 6 months and older who have tympanostomy tubes
- Treats acute otitis externa (swimmer's ear) in children 6 months and older, adults, and elderly patients
- For ear use only — not for eyes or injection; shake well before each use
- Warm the bottle in your hand for 1–2 minutes before use to avoid dizziness from cold drops
- Lie with the affected ear upward, instill the drops, then pump the tragus (the small flap in front of the ear canal) inward 5 times; hold position for 60 seconds
- Discard any unused portion after completing the 7-day course
📊 Ciprofloxacin and Dexamethasone Otic across the U.S. market
How Ciprofloxacin and Dexamethasone Otic appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Ciprofloxacin and Dexamethasone Otic is used
A general measure of how commonly Ciprofloxacin and Dexamethasone Otic is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Ciprofloxacin and Dexamethasone Otic is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Ciprofloxacin and Dexamethasone Otic prescribed? Of the 1,594 medications we measure, Ciprofloxacin and Dexamethasone Otic ranks #241 by Medicaid prescriptions — more than 85% of them.
Utilization by Ciprofloxacin and Dexamethasone Otic product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
Other Ciprofloxacin and Dexamethasone Otic products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 6 of 16 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ciprofloxacin and Dexamethasone Otic, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 16 listed Ciprofloxacin and Dexamethasone Otic NDCs with Medicaid activity.
🔍 Compare Ciprofloxacin and Dexamethasone Otic products
A representative set of FDA-listed product records for Ciprofloxacin and Dexamethasone Otic — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Ear drops | ||||
| CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL; DEXAMETHASONE 1 mg/mL | Auricular (otic) | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL; DEXAMETHASONE 1 mg/mL | Auricular (otic) | Armas Pharmaceuticals Inc. | ANDA | View NDC → |
| 3; 1 mg/mL; mg/mL | Auricular (otic) | Bryant Ranch Prepack × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL; DEXAMETHASONE 1 mg/mL | Auricular (otic) | Dr. Reddy's Laboratories, Inc. | ANDA | View NDC → |
| 3; 1 mg/mL; mg/mL | Auricular (otic) | Dr. Reddy's Laboratories, Inc. | ANDA | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL; DEXAMETHASONE 1 mg/mL | Auricular (otic) | NorthStar RxLLC | ANDA | View NDC → |
| 3; 1 mg/mL; mg/mL | Auricular (otic) | NorthStar RxLLC | ANDA | View NDC → |
| 3; 1 mg/mL; mg/mL | Auricular (otic) | Novartis Pharmaceuticals Corporation × 2 listings | NDA | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL; DEXAMETHASONE 1 mg/mL | Auricular (otic) | NuCare Pharmaceutical, Inc. | ANDA | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL; DEXAMETHASONE 1 mg/mL | Auricular (otic) | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 3; 1 mg/mL; mg/mL | Auricular (otic) | Proficient Rx LP | NDA | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL; DEXAMETHASONE 1 mg/mL | Auricular (otic) | Redpharm Drug × 2 listings | ANDA | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL; DEXAMETHASONE 1 mg/mL | Auricular (otic) | Sandoz Inc | NDA AUTHORIZED GENERIC | View NDC → |
| 3; 1 mg/mL; mg/mL | Auricular (otic) | Sandoz Inc | NDA AUTHORIZED GENERIC | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL; DEXAMETHASONE 1 mg/mL | Auricular (otic) | Sentiss Pharmaceuticals LLC | ANDA | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL; DEXAMETHASONE 1 mg/mL | Auricular (otic) | Sportpharm LLC | ANDA | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL; DEXAMETHASONE 1 mg/mL | Auricular (otic) | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 3; 1 mg/mL; mg/mL | Auricular (otic) | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL; DEXAMETHASONE 1 mg/mL | Auricular (otic) | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
Showing 22 of 22 products — FDA National Drug Code Directory. See every product, package size and price: browse all 22 Ciprofloxacin and Dexamethasone Otic NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ciprofloxacin and Dexamethasone Otic — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ciprofloxacin and Dexamethasone Otic in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Ciprofloxacin and Dexamethasone Otic went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Ciprofloxacin and Dexamethasone Otic is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Ciprofloxacin and Dexamethasone Otic belongs to the Fluoroquinolone Antibacterial class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 13 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Sandoz Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.