ciprofloxacin 3 mg/mL Solution — NDC 69315-308-05 (Billing 69315-0308-05)
This is a package of ciprofloxacin 3 mg/mL Solution from Leading Pharma, LLC, marketed since Nov 2018 and currently FDA-listed; retail pharmacies pay about $1.50 per mL (NADAC). It is the main listing for this product, which comes in 3 package sizes.
NDC database record
One package, one record: these facts belong to NDC 69315-308-05 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 69315 labeler · 308 product · 05 package
- Package marketed since
- Nov 1, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0369315308028, 0369315308059
- Medicaid fills, this package
- 67,557 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 015861
- GCN: 33580
- GPI-14 (Medi-Span): 86101023102010
- HICL (First Databank): 004124
- AHFS class code: 08:12.18.00
- RxCUI (RxNorm): 309307
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Fluoroquinolone Antibacterial class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 8, 2026
Clinical
- It treats bacterial infections such as urinary tract, respiratory, skin, bone and abdominal infections, depending on the form. Eye and ear versions treat eye and ear infections. It...
- Swallow them as prescribed, usually every 12 hours, and finish the full course unless your doctor says otherwise. Keep them 2 hours before or 6 hours after antacids, multivitamins,...
- How should I take my ciprofloxacin tablets?
- The most common ones are nausea, diarrhea, vomiting, rash and abnormal liver tests. Most are mild, but tell your doctor if they bother you.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ciprofloxacin — tap one for details:
Ciprofloxacin may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.504 | $7.52 / 5 ml |
| Medicaid paysCMS SDUD · 12 mo | $2.47 | $12.34 / 5 ml |
| Medicare drug plans payPart D · Q2 2026 | $2.57 | $12.86 / 5 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 69315-0308-02 69315-308-02 | 1 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC | $3.08 / mL | $7.70 | 2018-11-01 | — | Active |
| 69315-0308-05 You're viewing this Main listing | 1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC | $1.50 / mL | $7.52 | 2018-11-01 | — | Active |
| 69315-0308-10 69315-308-10 | 1 BOTTLE, PLASTIC in 1 CARTON / 10 mL in 1 BOTTLE, PLASTIC | $0.7964 / mL | $7.96 | 2018-11-01 | — | Active |
Per mL, this pack runs about 89% above the cheapest pack (NDC 69315-0308-10, $0.7964 vs $1.50 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 80% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of ciprofloxacin 3 mg/mL Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ciprofloxacin Hydrochloride 3 mg/mL 61314-0656-05 | Sandoz | 1 bottle | $1.504 | AT | Availability likely | — |
| ciprofloxacin 3 mg/mLthis 69315-0308-05 | Leading | 1 bottle | $1.504 | AT | Availability likely | — |
| Ciprofloxacin Hydrochloride 3 mg/mL 72888-0102-21 | Advagen | 2.5 ml | $3.078 | AT | Availability likely | +105% |
| Ciprofloxacin Hydrochloride 3 mg/mL 50090-0882-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Ciprofloxacin Hydrochloride 3 mg/mL 50090-1754-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| ciprofloxacin 3 mg/mL 50090-4217-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Ciprofloxacin HCl Ophthalmic 3 mg/mL 59390-0217-02 | Altaire | 2.5 ml | — | AT | FDA listed | — |
| Ciprofloxacin Hydrochloride 3 mg/mL 63187-0985-05 | Proficient | 1 bottle | — | AT | FDA listed | — |
| Ciprofloxacin Hydrochloride 3 mg/mL 67296-0142-01 | Redpharm | 1 bottle | — | AT | FDA listed | — |
| ciprofloxacin 3 mg/mL 67296-1703-09 | Redpharm | 2 bottles | — | AT | FDA listed | — |
| Ciprofloxacin Hydrochloride 3 mg/mL 68071-3351-03 | NuCare | 10 ml | — | AT | FDA listed | — |
| Ciprofloxacin Hydrochloride 3 mg/mL 68071-4139-05 | NuCare | 5 ml | — | AT | FDA listed | — |
| Ciprofloxacin Hydrochloride 3 mg/mL 68071-4235-03 | NuCare | 2.5 ml | — | AT | FDA listed | — |
| ciprofloxacin 3 mg/mL 68071-4672-03 | NuCare | 2.5 ml | — | AT | FDA listed | — |
| ciprofloxacin 3 mg/mL 68071-4679-05 | NuCare | 5 ml | — | AT | FDA listed | — |
| ciprofloxacin 3 mg/mL 68788-7500-05 | Preferred | 1 bottle | — | AT | FDA listed | — |
| Ciprofloxacin Hydrochloride 3 mg/mL 68788-8198-05 | Preferred | 1 bottle | — | AT | FDA listed | — |
| Ciprofloxacin Hydrochloride 3 mg/mL 70518-1170-00 | REMEDYREPACK | 1 bottle | — | AT | FDA listed | — |
| ciprofloxacin 3 mg/mL 71205-0300-05 | Proficient | 1 bottle | — | AT | FDA listed | — |
| ciprofloxacin 3 mg/mL 76420-0588-02 | Asclemed | 1 bottle | — | AT | FDA listed | — |
| Ciprofloxacin Hydrochloride 3 mg/mL 76420-0942-03 | Asclemed | 1 bottle | — | AT | FDA listed | — |
| ciprofloxacin 3 mg/mL 80425-0499-01 | Advanced | 1 bottle | — | AT | FDA listed | — |
| ciprofloxacin 3 mg/mL 85766-0023-05 | Sportpharm | 1 bottle | — | AT | FDA listed | — |
| ciprofloxacin 3 mg/mL 85534-0075-00 | HAWAII | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 9, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 9, 2026
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 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.
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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.
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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.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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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.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII NVG71ZZ7P0
A salt derived from acetic acid, sodium acetate anhydrous is used in medicines as a buffer to help maintain stable pH levels and sometimes as a preservative or bulking agent in solid formulations.
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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.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Leading Pharma, LLC labeler code 69315
- Allopurinol 300 mg Tablet NDC 69315-292-01
- RectaSmoothe Lidocaine 5% 5 g/100g Cream NDC 69315-301-30
- Dorzolamide hydrochloride 20 mg/mL Solution NDC 69315-304-05
- Dorzolamide and Timolol 20 mg/mL; 5 mg/mL Solution NDC 69315-305-05
- NYSTATIN 100000 [USP'U]/g Powder NDC 69315-306-15
- NYSTATIN 100000 [USP'U]/g Ointment NDC 69315-307-15
- Procto-Med HC HYDROCORTISONE 25 mg/g Cream NDC 69315-312-28
- Lacosamide 10 mg/mL Solution NDC 69315-318-20
- OFLOXACIN 3 mg/mL Solution NDC 69315-320-05
- Ketorolac Tromethamine 5 mg/mL Solution/ Drops NDC 69315-322-03
- PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL Solution NDC 69315-323-08
- PHENYLEPHRINE HYDROCHLORIDE 100 mg/mL Solution NDC 69315-324-05
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ciprofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers: Pseudomonas aeruginosa Serratia marcescens * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Viridans Group) * Conjunctivitis: Haemophilus influenzae Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae *Efficacy for this organism was studied in fewer than 10 infections.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours.
Treatment may be continued after 14 days if corneal re-epithelialisation has not occurred. Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
⛔ Contraindications ▾
CONTRAINDICATIONS A history of hypersensitivity to ciprofloxacin or any other component of the medication is a contraindication to its use. A history of hypersensitivity to other quinolones may also contraindicate the use of ciprofloxacin.
⚠️ Warnings and Cautions ▾
WARNINGS NOT FOR INJECTION INTO THE EYE. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching.
Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated. Remove contact lenses before using.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The most frequently reported drug related adverse reaction was local burning or discomfort. In corneal ulcer studies with frequent administration of the drug, white crystalline precipitates were seen in approximately 17% of patients (see PRECAUTIONS ). Other reactions occurring in less than 10% of patients included lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia and a bad taste following instillation.
Additional events occurring in less than 1% of patients included corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision. To report SUSPECTED ADVERSE REACTIONS, contact LEADING PHARMA AT 1-844-740-7500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
🔄 Drug Interactions ▾
Drug Interactions: Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant, warfarin, and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.
🧒 Pediatric Use ▾
Pediatric Use: The safety and effectiveness of Ciprofloxacin ophthalmic solution 0.3% have been established in all ages. Use of Ciprofloxacin ophthalmic solution is supported by evidence from adequate and well controlled studies of Ciprofloxacin ophthalmic solution in adults, children and neonates [ see Clinical Studies ]. Although ciprofloxacin and other quinolones cause arthropathy in immature animals after oral administration, topical ocular administration of ciprofloxacin to immature animals did not cause any arthropathy and there is no evidence that the ophthalmic dosage form has any effect on the weight bearing joints.
🧓 Geriatric Use ▾
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🆘 Overdosage ▾
OVERDOSAGE A topical overdose of Ciprofloxacin ophthalmic solution 0.3% may be flushed from the eye(s) with warm tap water.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Systemic Absorption: A systemic absorption study was performed in which Ciprofloxacin ophthalmic solution 0.3% was administered in each eye every two hours while awake for two days followed by every four hours while awake for an additional 5 days. The maximum reported plasma concentration of ciprofloxacin was less than 5 ng/mL. The mean concentration was usually less than 2.5 ng/mL.
Microbiology : Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms. The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA. Ciprofloxacin has been shown to be active against most strains of the following organisms both in vitro and in clinical infections ( see INDICATIONS AND USAGE ).
Aerobic gram-Positive microorganisms: Staphylococcus aureus (methicillin-susceptible strains) Staphylococcus epidermidis (methicillin-susceptible strains) Streptococcus pneumoniae Streptococcus (Viridans Group) Aerobic gram-negative microorganisms: Haemophilus influenzae Pseudomonas aeruginosa Serratia marcescens Ciprofloxacin has been shown to be active in vitro against most strains of the following organisms, however, the clinical significance of these data is unknown: Gram-Positive: Enterococcus faecalis (Many strains are only moderately susceptible) Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus saprophyticus Streptococcus pyogenes Gram-Negative Acinetobacter calcoaceticus subsp. anitratus Aeromonas caviae Aeromonas hydrophila Brucella melitensis Campylobacter coli Campylobacter jejuni Citrobacter diversus Citrobacter freundii Edwardsiella tarda Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus ducreyi Haemophilus parainfluenzae Kiebsiella pneumoniae Klebsiella oxytoca Legionella pneumophila Moraxella (Branhamella) catarrhalis Morganella morganii Neisseria gonorrhoeae Neisseria meningitides Pasteurella multocida Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Salmonella enteritidis Salmonella typhi Shigella sonneii Shigella flexneri Vibrio cholera Vibrio parahaemolyticus Vibrio vulnificus Yersinia enterocolitica Other Organisms: Chlamydia trachomatis (only moderately susceptible) and Mycobacterium tuberculosis (only moderately susceptible).
Most strains of Pseudomonas cepacia and some strains of Pseudomonas maltophilia are resistant to ciprofloxacin as are most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile. The minimal bactericidal concentration (MBC) generally does not exceed the minimal inhibitory concentration (MIC) by more than a factor of 2. Resistance to ciprofloxacin in vitro usually develops slowly (multiple-step mutation).
Ciprofloxacin does not cross-react with other antimicrobial agents such as beta-lactams or aminoglycosides; therefore, organisms resistant to these drugs may be susceptible to ciprofloxacin.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED As a sterile ophthalmic solution: 2.5 mL, 5 mL and 10 mL in translucent LDPE bottle with insert cap assembly comprising of a tan colored HDPE screw cap over a LDPE nozzle with tamper evident LDPE dust cover sealing the bottle cap. 2.5 mL - NDC 69315-308-02 5 mL – NDC 69315-308-05 10 mL – NDC 69315-308-10 STORAGE: Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature]. Retain in carton until contents are used and protect from light.
ANIMAL PHARMACOLOGY: Ciprofloxacin and related drugs have been shown to cause arthropathy in immature animals of most species tested following oral administration. However, a one month topical ocular study using immature Beagle dogs did not demonstrate any articular lesions. CLINICAL STUDIES: Following therapy with Ciprofloxacin ophthalmic solution 0.3%, 76% of the patients with corneal ulcers and positive bacterial cultures were clinically cured and complete re-epithelialisation occurred in about 92% of the ulcers.
In 3 and 7 day multicenter clinical trials, 52% of the patients with conjunctivitis and positive conjunctival cultures were clinically cured and 70-80% had all causative pathogens eradicated by the end of treatment. In a randomized, double-masked, multicenter, parallel-group clinical trial of pediatric patients with bacterial conjunctivitis, between birth and 31 days of age, patients were dosed with Ciprofloxacin ophthalmic solution or another anti-infective agent. Clinical outcomes for the trial demonstrated a clinical cure rate of 80% at Day 9 and a microbiological eradication success rate of 85% at Day 9.
Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials. Rx Only Distributed by: Leading Pharma, LLC. Fairfield, NJ07004 Manufactured By: FDC Limited, B-8, MIDC Industrial Area, Waluj, Aurangabad - 431 136, Maharashtra, India Revision: 10/2019 STERILE OPHTHALMIC SOLUTION CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0.3% INSTRUCTIONS FOR USE Read this Instruction for Use before you start using Ciprofloxacin ophthalmic solution and each time you get a refill.
There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. Use Ciprofloxacin ophthalmic solution as prescribed by your doctor.
Ask your doctor if you have questions about how to use Ciprofloxacin ophthalmic solution. Important information: Ciprofloxacin ophthalmic solution is for use in the eye only. Ciprofloxacin ophthalmic solution should not be injected into the eye.
If you use other medicines in your eye, wait at least 10 minutes between using Ciprofloxacin ophthalmic solution and your other eye medicines. If you wear contact lenses, remove them before using Ciprofloxacin ophthalmic solution. Wait at least 15 minutes after using Ciprofloxacin ophthalmic solution before placing your contact lenses back in your eyes.
Do not touch your eye, fingers, or other surfaces with the tip of the Ciprofloxacin ophthalmic solution bottle. You may get bacteria on the tip of the bottle that can cause you to get an eye infection. This eye infection can lead to serious eye damage or vision loss.
If you think you have gotten bacteria on the tip of the bottle or you have an eye infection, call your doctor right away. Wash your hands before each use. Before you use a bottle of Ciprofloxacin ophthalmic solution for the first time: Check the expiration date on the bottle before use.
Do not use Ciprofloxacin ophthalmic solution if the expiration date has passed. Check that the seal on the dust cover is not broken or missing. Do not use the medicine if the seal is broken or missing.
Call your doctor or pharmacist. Each time you use Ciprofloxacin ophthalmic solution: Step 1: Turn the dust cover clockwise to break the seal. Step 2: Remove the dust cover and throw it away.
Step 3: Turn the tan coloured cap anti-clockwise and remove. Place the cap on a… [Excerpted — this section continues on DailyMed.]
📋 Description ▾
DESCRIPTION Ciprofloxacin ophthalmic solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid.
It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C 17 H 18 FN 3 O 3 •HCl•H 2 O and its chemical structure is as follows: Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of Ciprofloxacin ophthalmic solution 0.3% contains : Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base.
Preservative: benzalkonium chloride 0.006%. Inactives: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and water for injection. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm.
Ciprofloxacin hydrochloride
💬 Information for Patients ▾
Information for patients: Do not touch dropper tip to any surface, as this may contaminate the solution.
⚠️ Precautions ▾
PRECAUTIONS General: As with other antibacterial preparations, prolonged use of ciprofloxacin may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction. In clinical studies of patients with bacterial corneal ulcer, a white crystalline precipitate located in the superficial portion of the corneal defect was observed in 35 (16.6%) of 210 patients. The onset of the precipitate was within 24 hours to 7 days after starting therapy.
In one patient, the precipitate was immediately irrigated out upon its appearance. In 17 patients, resolution of the precipitate was seen in 1 to 8 days (seven within the first 24 to 72 hours), in five patients, resolution was noted in 10 to 13 days. In nine patients, exact resolution days were unavailable; however, at follow-up examinations, 18 to 44 days after onset of the event, complete resolution of the precipitate was noted.
In three patients, outcome information was unavailable. The precipitate did not preclude continued use of ciprofloxacin, nor did it adversely affect the clinical course of the ulcer or visual outcome. (see ADVERSE REACTIONS).
Information for patients: Do not touch dropper tip to any surface, as this may contaminate the solution. Drug Interactions: Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant, warfarin, and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.
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, two of the eight tests were positive, but the results of the following three 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.
After daily oral dosing for up to two years, there is no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species. Pregnancy Reproduction studies have been performed in rats and mice at doses up to six times the usual daily human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to ciprofloxacin. In rabbits, as with most antimicrobial agents, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion.
No teratogenicity was observed at either dose.After intravenous administration, at doses up to 20 mg/kg, no maternal toxicity was produced and no mbryotoxicity or teratogenicity was observed. There are no adequate and well controlled studies in pregnant women. Ciprofloxacin ophthalmic solution 0.3% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether topically applied ciprofloxacin is excreted in human milk. However, it is k… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers: It is not known whether topically applied ciprofloxacin is excreted in human milk. However, it is known that orally administered ciprofloxacin is excreted in the milk of lactating rats and oral ciprofloxacin has been reported in human breast milk after a single 500 mg dose. Caution should be exercised when Ciprofloxacin ophthalmic solution 0.3% is administered to a nursing mother.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 2.5 ml Container and Carton Label NDC 69315-308-02 Ciprofloxacin Ophthalmic Solution USP 0.3% as base Sterile Rx Only 5 ml Container and Carton Label NDC 69315-308-05 Ciprofloxacin Ophthalmic Solution USP 0.3% as base Sterile Rx Only 10 ml Container and Carton Label NDC 69315-308-10 Ciprofloxacin Ophthalmic Solution USP 0.3% as base Sterile Rx Only containerlabel2point5ml containerlabel5ml containerlabel10ml cartonlabel2point5ml cartonlabel5ml cartonlabel10ml