Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied: As a sterile ophthalmic solution: 2.5 mL, 5 mL and 10 mL in translucent LDPE bottle, translucent LDPE nozzle and tan coloured polypropylene closure. 2.5 mL - NDC 72888-102-21 5 mL - NDC 72888-102-22 10 mL - NDC 72888-102-23 STORAGE: Store at 2°C to 25°C (36°F to 77°F). 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. Distributed by: Advagen Pharma Ltd., East Windsor, NJ 08520, USA. Rev. 01, 09/2024; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-21 - 2.5 mL Carton Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-21 - 2.5 mL Container Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-22 - 5 mL Carton Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-22 - 5 mL Container Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-23 - 10 mL Carton Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-23 - 10 mL Container Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-21 - 2.5 mL Carton Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-21 - 2.5 mL Container Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-22 - 5 mL Carton Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-22 - 5 mL Container Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-23 - 10 mL Carton Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-23 - 10 mL Container
- How Supplied: As a sterile ophthalmic solution: 2.5 mL, 5 mL and 10 mL in translucent LDPE bottle, translucent LDPE nozzle and tan coloured polypropylene closure. 2.5 mL - NDC 72888-102-21 5 mL - NDC 72888-102-22 10 mL - NDC 72888-102-23 STORAGE: Store at 2°C to 25°C (36°F to 77°F). 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. Distributed by: Advagen Pharma Ltd., East Windsor, NJ 08520, USA. Rev. 01, 09/2024
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-21 - 2.5 mL Carton Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-21 - 2.5 mL Container Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-22 - 5 mL Carton Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-22 - 5 mL Container Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-23 - 10 mL Carton Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-23 - 10 mL Container Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-21 - 2.5 mL Carton Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-21 - 2.5 mL Container Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-22 - 5 mL Carton Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-22 - 5 mL Container Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-23 - 10 mL Carton Ciprofloxacin Ophthalmic Solution, 0.3% - NDC 72888-102-23 - 10 mL Container
Overview
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 contains: Active: Ciprofloxacin hydrochloride 3.5 mg equivalent to 3mg base. Preservative: Benzalkonium chloride 0.006%. Inactives: Acetic acid, edetate disodium 0.05%, mannitol 4.6%, Sodium acetate, hydrochloric acid and/or sodium hydroxide (to adjust pH) and water for injection. The pH is between 3.5 to 5.5 and the osmolality is between 290 to 300 mOsms/kg. Ciprofloxacin Structure
Indications & 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 & 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-epithelialization 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.
Warnings & Precautions
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.
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.
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 Advagen Pharma Ltd, at 866-488-0312 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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