ciprofloxacin 0.3 % Ophthalmic Solution
Generic Name: CIPROFLOXACIN HYDROCHLORIDE SOLUTION
Brand Name: CIPROFLOXACIN
- Substance Name(s):
- CIPROFLOXACIN HYDROCHLORIDE
WARNINGS
SECTION 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.
OVERDOSAGE
SECTION A topical overdose of Ciprofloxacin Ophthalmic Solution may be flushed from the eye(s) with warm tap water.
DESCRIPTION
SECTION Ciprofloxacin Ophthalmic Solution is a synthetic, sterile, multiple dose, antimicrobial for topical 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 C17H18FN3O3•HCl•H2O 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 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.
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INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION 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 & ADMINISTRATION SECTION 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.
How Supplied: As a sterile ophthalmic solution, in a plastic dispenser: 2.5 mL NDC16571-120-25 5 mL NDC16571-120-50 STORAGE: Store at 25°C (77°F); excursions permitted to15 – 30°C (59 – 86°F) [See USP controlled room temperature].
Protect from light.
Retain in carton until contents are used.