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ciprofloxacin hydrochloride and hydrocortisone 2 mg/mL; 10 mg/mL Suspension/ Drops — NDC 00781-6218-70 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ciprofloxacin hydrochloride and hydrocortisone 2 mg/mL; 10 mg/mL Suspension/ Drops — NDC 0781-6218-70 (Billing 00781-6218-70)

by Sandoz Inc · 1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE

This is a package of ciprofloxacin hydrochloride and hydrocortisone 2 mg/mL; 10 mg/mL Suspension/ Drops from Sandoz Inc, marketed since Mar 1999 and currently FDA-listed; retail pharmacies pay about $26.91 per mL (NADAC). It is this product's only package size.

NDC 00781-6218-70
🏷️ FDA NDC (as labeled) 0781-6218-70 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 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

NDC database record

One package, one record: these facts belong to NDC 0781-6218-70 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0781 labeler · 6218 product · 70 package
Package marketed since
Aug 21, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0781621870 5
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0781-6218-70
Product NDC 0781-6218
11-digit billing NDC 00781621870
NCPDP billing unit ML — per mL (volume)
RxCUI 309305
UNII 4BA73M5E37, WI4X0X7BPJ
Application # NDA020805
SPL Set ID c0881bbe-cc95-45d4-9878-3bc8946eff26
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1999-03-15
Route AURICULAR (OTIC)
Dosage form SUSPENSION/ DROPS
Substance CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 309305
Why two NDCs? The FDA registers this code as 0781-6218-70 — a 4-4-2 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 labeler segment → 00781-6218-70. 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 Fluoroquinolone Antibacterial class.

Pharmacologic class Fluoroquinolone Antibacterial
Drug family (ATC) Fluoroquinolones, Fluoroquinolones, Antiinfectives
How it works Cytochrome P450 1A2 Inhibitors
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.

Clinical

📖 What it is MedlinePlus · NLM

Ciprofloxacin and hydrocortisone otic is used to treat outer ear infections in adults and children. Ciprofloxacin is in a class of medications called quinolone antibiotics. Hydrocortisone is in a class of medications called corticosteroids. The combination of ciprofloxacin and hydrocortisone works by killing the bacteria that cause infection and reducing swelling in the ear.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's treating swimmer's ear — the medical name is acute otitis externa. That's an infection of the outer ear canal, not the middle ear. The ciprofloxacin in the drops kills the spe...
  • Cold liquid going into your ear canal can stimulate nerves there and cause sudden dizziness. Holding the bottle in your hand for one to two minutes before using it brings it closer...
  • Why do I need to warm the bottle before using it?
  • Yes — and it makes a real difference. Lying with the affected ear facing up after instilling the drops lets gravity help the medication flow down into the ear canal and stay in con...
📖 Read our full Ciprofloxacin and Hydrocortisone Otic guide →

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.

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 $26.909 $269.09 / 10 ml
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Sep 2026 $26.909 $26.909
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00781-6218-70 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE 2026-08-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ciprofloxacin hydrochloride and hydrocortisone 2 mg/mL; 10 mg/mL 00713-0851-09 Cosette 1 bottle $26.909 AB Availability likely —
ciprofloxacin hydrochloride and hydrocortisone 2 mg/mL; 10 mg/mLthis 00781-6218-70 Sandoz 1 bottle $26.909 AB Availability likely —
Cipro Hc 2 mg/mL; 10 mg/mL 66758-0087-70 Sandoz 1 bottle $34.932 AB Availability likely +30%
Cipro Hc 2 mg/mL; 10 mg/mL 76420-0273-10 Asclemed 10 ml — AB FDA listed —
Cipro Hc 2 mg/mL; 10 mg/mL 50090-6043-00 A-S 10 ml — AB FDA listed —
Cipro Hc 2 mg/mL; 10 mg/mL 50090-7631-00 A-S 1 bottle — AB FDA listed —
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

🏛️
1999
On the market since
Mar 1999
📍
2026
Currently FDA-listed
27 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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.

🧪 Avoiding an ingredient? See Ciprofloxacin and Hydrocortisone Otic inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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 QHQ97HF0PY
    A plant-derived fatty substance from soybeans that helps stabilize and mix oil and water components in medicines. It acts as an emulsifier and helps the drug dissolve or disperse properly.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • 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.

10 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.

Manufacturer & labeler

LabelerSandoz Inc
Application holderSANDOZ INC
FDA applicationNDA020805 (NDA AUTHORIZED GENERIC)
Labeler code00781
First marketedMar 1999
Product typeHuman Prescription Drug
Portfolio395 products on file

More NDCs from Sandoz Inc labeler code 00781

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.

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 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 42 words ▾

INDICATIONS AND USAGE Ciprofloxacin hydrochloride and hydrocortisone otic suspension is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa , Staphylococcus aureus , and Proteus mirabilis .

⏱️ Dosage and Administration 114 words ▾

DOSAGE AND ADMINISTRATION SHAKE WELL IMMEDIATELY BEFORE USING. For children (age 1 year and older) and adults, 3 drops of the suspension should be instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for 1-2 minutes to avoid the 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 the drops should be instilled. This position should be maintained for 30-60 seconds to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear.

Discard unused portion after therapy is completed.

⛔ Contraindications 66 words ▾

CONTRAINDICATIONS Ciprofloxacin hydrochloride and hydrocortisone otic suspension is contraindicated in persons with a history of hypersensitivity to hydrocortisone, ciprofloxacin, or any member of the quinolone class of antimicrobial agents. This nonsterile product should not be used if the tympanic membrane is known or suspected to be perforated. Use of this product is contraindicated in viral infections of the external canal, including varicella and herpes simplex infections.

⚠️ Warnings 73 words ▾

WARNINGS NOT FOR OPHTHALMIC USE. NOT FOR INJECTION. Ciprofloxacin hydrochloride and hydrocortisone otic suspension 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. Serious acute hypersensitivity reactions may require immediate emergency treatment. The dropper cap contains natural rubber (latex) which may cause severe allergic reactions.

🤒 Adverse Reactions 153 words ▾

ADVERSE REACTIONS In Phase 3 clinical trials, a total of 564 patients were treated with ciprofloxacin hydrochloride and hydrocortisone otic suspension. Adverse events with at least remote relationship to treatment included headache (1.2%) and pruritus (0.4%). The following treatment-related adverse events were each reported in a single patient: migraine, hypesthesia, paresthesia, fungal dermatitis, cough, rash, urticaria, and alopecia.

The following reactions have been identified during post-approval use of ciprofloxacin hydrochloride and hydrocortisone otic suspension in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to ciprofloxacin hydrochloride and hydrocortisone otic suspension, or a combination of these factors, include: dizziness, ear canal erythema, ear congestion, hypoacusis, and medication residue.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 169 words ▾

Pregnancy: Teratogenic Effects: Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and IV doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed.

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Animal reproduction studies have not been conducted with ciprofloxacin hydrochloride and hydrocortisone otic suspension.

No adequate and well-controlled studies have been performed in pregnant women. Caution should be exercised when ciprofloxacin hydrochloride and hydrocortisone otic suspension is used by a pregnant woman.

🧒 Pediatric Use 51 words ▾

Pediatric Use: The safety and efficacy of ciprofloxacin hydrochloride and hydrocortisone otic suspension have been established in pediatric patients 2 years and older (131 patients) in adequate and well-controlled clinical trials. Efficacy has been extrapolated for patients, age 1 year and above based on studies in adults and older pediatric patients.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY The plasma concentrations of ciprofloxacin were not measured following three drops of otic suspension administration because the systemic exposure to ciprofloxacin is expected to be below the limit of quantitation of the assay (0.05 μg/mL). Similarly, the predicted C max of hydrocortisone is within the range of endogenous hydrocortisone concentration (0-150 ng/mL), and therefore cannot be differentiated from the endogenous cortisol. Preclinical studies have shown that ciprofloxacin hydrochloride and hydrocortisone otic suspension was not toxic to the guinea pig cochlea when administered intratympanically twice daily for 30 days and was only weakly irritating to rabbit skin upon repeated exposure.

Hydrocortisone has been added to aid in the resolution of the inflammatory response accompanying bacterial infection. Microbiology Ciprofloxacin has in vitro activity against a wide range of gram-positive and gram-negative microorganisms. The bactericidal action of ciprofloxacin results from interference with the enzyme, DNA gyrase, which is needed for the synthesis of bacterial DNA.

Cross-resistance has been observed between ciprofloxacin and other fluoroquinolones. There is generally no cross-resistance between ciprofloxacin and other classes of antibacterial agents, such as beta-lactams or aminoglycosides. Ciprofloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections of acute otitis externa as described in the INDICATIONS AND USAGE section: Aerobic Gram-positive Microorganism Staphylococcus aureus Aerobic Gram-negative Microorganisms Proteus mirabilis Pseudomonas aeruginosa

📦 How Supplied / Storage and Handling 76 words ▾

HOW SUPPLIED Ciprofloxacin hydrochloride and hydrocortisone otic suspension is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser: NDC 0781-6218-70. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Avoid freezing.

Protect from light. Manufactured by Siegfried El Masnou, S.A. El Masnou Barcelona, Spain for Sandoz Inc., Princeton, NJ 08540 Revised: 05/2026 3602921 01 US

📋 Description 151 words ▾

DESCRIPTION Ciprofloxacin hydrochloride and hydrocortisone otic suspension contains the synthetic broad spectrum antibacterial agent, ciprofloxacin hydrochloride, combined with the anti-inflammatory corticosteroid, hydrocortisone, in a preserved, nonsterile suspension for otic use. Each mL contains ciprofloxacin hydrochloride (equivalent to 2 mg ciprofloxacin), 10 mg hydrocortisone, and 9 mg benzyl alcohol as a preservative. The inactive ingredients are glacial acetic acid, phospholipon 90H (modified lecithin), polysorbate 20, polyvinyl alcohol, purified water, sodium acetate, and sodium chloride.

Hydrochloric acid or sodium hydroxide may be added for adjustment of pH. Ciprofloxacin, a fluoroquinolone, is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17 H 18 FN 3 O 3 •HCI•H 2 O and its chemical structure is as follows: Hydrocortisone, pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-(11(β)-, is an anti-inflammatory corticosteroid.

Its empirical formula is C 21 H 30 O 5 and its chemical structure is: Ciprofloxacin chemical structure Hydrocortisone chemical structure

💬 Information for Patients 50 words ▾

Information for Patients: If rash or allergic reaction occurs, discontinue use immediately and contact your physician. Do not use in the eyes. Avoid contaminating the dropper with material from the ear, fingers, or other sources. Protect from light. Shake well immediately before using. Discard unused portion after therapy is completed.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: As with other antibiotic preparations, use of this product may result in overgrowth of nonsusceptible organisms, including fungi. If the infection is not improved after one week of therapy, cultures should be obtained to guide further treatment. Information for Patients: If rash or allergic reaction occurs, discontinue use immediately and contact your physician.

Do not use in the eyes. Avoid contaminating the dropper with material from the ear, fingers, or other sources. Protect from light.

Shake well immediately before using. Discard unused portion after therapy is completed. Carcinogenesis, Mutagenesis, Impairment of Fertility: Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below: Salmonella/Microsome Test (Negative) E. coli DNA Repair Assay (Negative) Mouse Lymphoma Cell Forward Mutation Assay (Positive) Chinese Hamster V 79 Cell HGPRT Test (Negative) Syrian Hamster Embryo Cell Transformation Assay (Negative) Saccharomyces cerevisiae Point Mutation Assay (Negative) Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative) Rat Hepatocyte DNA Repair Assay (Positive) Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results: Rat Hepatocyte DNA Repair Assay Micronucleus Test (Mice) Dominant Lethal Test (Mice) Long-term carcinogenicity studies in mice and rats have been completed for ciprofloxacin.

After daily oral doses of 750 mg/kg (mice) and 250 mg/kg (rats) were administered for up to 2 years, there was no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species. No long-term studies of ciprofloxacin hydrochloride and hydrocortisone otic suspension have been performed to evaluate carcinogenic potential. Fertility studies performed in rats at oral doses of ciprofloxacin up to 100 mg/kg/day revealed no evidence of impairment.

This would be over 1000 times the maximum recommended clinical dose of ototopical ciprofloxacin based upon body surface area, assuming total absorption of ciprofloxacin from the ear of a patient treated with ciprofloxacin hydrochloride and hydrocortisone otic suspension twice per day. Long-term studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical hydrocortisone. Mutagenicity studies with hydrocortisone were negative.

Pregnancy: Teratogenic Effects: Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and IV doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed.

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Animal reproduction studies have not been conducted with ciprofloxacin hydrochloride and hydrocortisone otic suspension.

No adequate and well-controlled studies have been performed in pregnant women. Caution should be exercised when ciprofloxacin hydrochloride and hydrocortisone otic suspension is used by a pregnant woman. Nursing Mothers: Ciprofloxacin is excreted in human milk with systemic use.

It is not known whether ciprofloxacin is excreted in human milk following topical otic administration. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🍼 Nursing Mothers 62 words ▾

Nursing Mothers: Ciprofloxacin is excreted in human milk with systemic use. It is not known whether ciprofloxacin is excreted in human milk following topical otic administration. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility: Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below: Salmonella/Microsome Test (Negative) E. coli DNA Repair Assay (Negative) Mouse Lymphoma Cell Forward Mutation Assay (Positive) Chinese Hamster V 79 Cell HGPRT Test (Negative) Syrian Hamster Embryo Cell Transformation Assay (Negative) Saccharomyces cerevisiae Point Mutation Assay (Negative) Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative) Rat Hepatocyte DNA Repair Assay (Positive) Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results: Rat Hepatocyte DNA Repair Assay Micronucleus Test (Mice) Dominant Lethal Test (Mice) Long-term carcinogenicity studies in mice and rats have been completed for ciprofloxacin.

After daily oral doses of 750 mg/kg (mice) and 250 mg/kg (rats) were administered for up to 2 years, there was no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species. No long-term studies of ciprofloxacin hydrochloride and hydrocortisone otic suspension have been performed to evaluate carcinogenic potential. Fertility studies performed in rats at oral doses of ciprofloxacin up to 100 mg/kg/day revealed no evidence of impairment.

This would be over 1000 times the maximum recommended clinical dose of ototopical ciprofloxacin based upon body surface area, assuming total absorption of ciprofloxacin from the ear of a patient treated with ciprofloxacin hydrochloride and hydrocortisone otic suspension twice per day. Long-term studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical hydrocortisone. Mutagenicity studies with hydrocortisone were negative.

📄 Package Label / Principal Display Panel 25 words ▾

PRINCIPAL DISPLAY PANEL NDC 0781-6218-70 Rx Only Ciprofloxacin 0.2% HCl and Hydrocortisone 1% Otic Suspension NOT FOR OPHTHALMIC OR ORAL USE 10 mL SANDOZ 10mlcarton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00781-6206-75 · Sandoz 00781-7104-54 · Sandoz →
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.