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Medicine guide

Ciprofloxacin

3 mg/mL · Solution

  • Prescription only
  • Fluoroquinolone Antibacterial
Active substance
Ciprofloxacin
Made by
A-S Medication Solutions

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-10-01

What it is

Fluoroquinolone Antibacterial

Used for
  • Haemophilus influenzae Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae *Efficacy for this organism was studied in fewer than 10 infections.
Do not take it if

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.

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
73other products contain Ciprofloxacin — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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.

From the official label · 2024-10-01 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-10-01

Do not take it if

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.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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.

Quoted from the official label, section “Dosage & Administration”.

Other 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.
  • 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:
  • Drug Interactions:
  • 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:
  • Pediatric Use:
  • Geriatric Use:

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • 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.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • 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.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

A topical overdose of Ciprofloxacin ophthalmic solution 0.3% may be flushed from the eye(s) with warm tap water.

Quoted from the official label, section “Overdosage”.

Use in children

  • 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.

Quoted from the official label, section “Pediatric Use”.

Use in older people

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • 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

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Do not touch dropper tip to any surface, as this may contaminate the solution.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

Product: 50090-4217 NDC: 50090-4217-0 5 mL in a BOTTLE, PLASTIC / 1 in a CARTON

Quoted from the official label, section “How Supplied”.

How to store it

  • 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.
  • Manufactured By:
  • FDC Limited, B-8, MIDC Industrial Area, Waluj, Aurangabad - 431 136, Maharashtra, India

Quoted from the official label, section “Storage and Handling”.

What is in it

  • 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

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (20)

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Same active substance, strength and form in other countries

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Every strength and form (4)

Details

Made byA-S Medication Solutions
Active substanceCiprofloxacin
Used inAntibiotics, antivirals and antifungals taken into the body
Strength3 mg/mL
FormSolution
RouteOphthalmic
Packs1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC
NDC50090-4217

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

122 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Show all forms · 6 forms
  • Injection, Solution1 products
  • Kit1 products

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

CiproPrescription onlyKit Bayer HealthCare Pharmaceuticals Inc. · CiprofloxacinCiprofloxacin250 mgPrescription onlyTablet, Film Coated Hikma Pharmaceuticals USA Inc. · CiprofloxacinCiprofloxacin500 mgPrescription onlyTablet, Film Coated Hikma Pharmaceuticals USA Inc. · CiprofloxacinCiprofloxacin750 mgPrescription onlyTablet, Film Coated Hikma Pharmaceuticals USA Inc. · CiprofloxacinCiprofloxacin500 mgPrescription onlyTablet, Film Coated Major Pharmaceuticals · CiprofloxacinCiprofloxacin500 mgPrescription onlyTablet, Film Coated Teva Pharmaceuticals USA, Inc. · Ciprofloxacin

See every product with Ciprofloxacin